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While these reviews might be helpful, they are not a substitute for the expertise, skill, knowledge and judgement of healthcare practitioners in patient care. 38 Ratings with 33 User Reviews What next.Compare all 212 medications used in the treatment of Pneumonia. Reviews for Levaquin to treat Pneumonia Just finished a 7 day course of Levaquin 500 mg oral tabs for pneumonia. My infection was not severe, but I noticed effects practically immediately. Within 24 hours I felt so much better. It did make me slightly nauseous at first, until I began taking it only on a full stomach. Did not notice any other side effects. I drank a LOT of water while I was sick, which may have helped. FeelingMuchBetter taken for less than 1 month April 6, 2016 4 users found this comment helpful. I was given this Horrific medication as my provider thought I had pneumonia and after taking it for 8 days, I could hardly walk and my knees were stiff and I could not get up or put any weight on my legs. My hands were swollen and I could not make a fist or open my water bottle. This Drug should be taken off the market immediately. How can a physician in good conscience prescribe this medication to anyone. I just hope that I am not a permanently crippled by this medication. My chest X-ray came back negative to I did not even need an antibiotic and just needed a cough medicine and Mucinex to clear up my cough. The one time I did not have time to read the drug information because I was moving and my doctor decides to prescribe me this Rita Ma taken for less than 1 month March 9, 2016 5 users found this comment helpful. Sure it got rid of the pneumonia. But at what cost Bad anxiety terrible pain in knees and ankles. I was given xanax to deal with the side effects of the levaquin. Never taking this agin. Nrem24 taken for less than 1 month February 25, 2016 8 users found this comment helpful. I have pneumonia in both lungs for the second time in 35 days. I was hospitalized this time though, so it s definitely worse the the first illness. The only side effect I ve noticed is nausea. If I drink water quickly, I immediately feel the need to throw up. Problem is that I m always thirsty. I am home now thank goodness, still sick but I have what I need. I left AMA because I ve got four kids with Christmas on their brains. Hopefully my pills will do the trick. 9 users found this comment helpful. Levaquin seems to be the only antibiotic that actually helped clear up my lungsit is just very unfortunate that it has such awful side effects. I contracted a yeast infection after 2 days. The medication made me an absolute insomniac. There was no way to sleep, which made things worse. I am willing to deal with these side effects to get better, but it s certainly not for those who don t want to deal with possibly getting worse before they get better. I am 23. 10 users found this comment helpful. 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It absolutely was the levaquin making me so sick to my stomach because when I don t take it, I don t have those symptoms ksbarent taken for less than 1 month May 6, 2015 17 users found this comment helpful. Was sick for a week with pneumonia and went to urgent care. 102F fever, cough, no appetite, severe fatigue. Prescribed Levaquin and started feeling better in 2-3 days. Fatigue and cough continued for several weeks. Lost 7 pounds. I did not experience any side effects at all. Would highly recommend this medication. Ewock taken for less than 1 month October 23, 2014 61 users found this comment helpful. I had a high fever and was treated with Augmentin for a sinus infection but it turned into pneumonia. I was given Levaquin for 14 days 500 mg. It helped the pneumonia but it is hard on your stomach and I have now developed plantar fascitis. Debbie doodles February 11, 2014 27 users found this comment helpful. Took it for 3 days. Numb skin, lips, hands and feet. I can t sense temperature. Heart rate irregular. Seeing cardiologist tomorrow. Severe pain in lower extremities, only when trying to sleep though. Oh and my legs feel like they weigh 200lbs each. Today is 11 days off of medicine and still no relief. WARNING BEWARE.. February 11, 2014 34 users found this comment helpful. Took Cipro for a pseudomonas infection and then five months later took Levaquin. Joint and tendon pain just kept getting worse and I m still suffering from these side effects two months after discontinuing. The Owl. PhD Physics taken for less than 1 month December 23, 2013 This medicine made me feel absolutely horrible. Funny chest feeling, foggy head, dizzy, and an overall bad feeling. Never want to take again. Last three days took 1/2 in a.m. and other 1/2 in p.m. That was a lot better. Have been off for about two weeks, and still a foggy and light headed. Do not want to take again ever. I am 71 years old and it is not recommended for older people. 43 users found this comment helpful. I was hospitalized with pneumonia receiving Levaquin and fluids via IV. By the fifth day, the fever was gone and the cough was almost gone. I felt overwhelmingly tired for several weeks but my doctor said that is to be expected with pneumonia. 59 users found this comment helpful. Went to the ER with severe coughing, chest pains and fever. After Xrays, CT scan and blood tests, I was diagnosed with pneumonia. The doc started me on Levaquin via IV and gave me a 5 day dose of 750mg. I am on day 4 and feel SO much better. Still coughing a little, but nothing compared to before. K.Charlene.T taken for less than 1 month July 24, 2013 66 users found this comment helpful. Adverse reaction to Levaquin. Extreme numbness and tingling in my fingers and toes, ongoing dry mouth. First prescribed a few years ago for an infection. After complaining about the numbness I was told to discard them and given another antibiotic. Went in this time for pneumonia and was given a tablet before I realized this was the same medication I had an adverse reaction to before. Experiencing the same reaction after only one tablet, it s now 3 days later. Bridalmack taken for less than 1 month June 22, 2013 28 users found this comment helpful. It worked great for my pneumonia but it caused my heart rate to go up, chest pain and anxiety. I would ask for a different one if you have heart issues or tachycardia. After six hours I began to feel relief. After day four, I m close to 100 curedbut I have six more days to take Levaquin 750mg. I m also eating a cup of yogurt per day. Make sure you drink lots of water with this medicine or you will feel horrible. Otherwise, I love it. 71 users found this comment helpful. This antibiotic is really helping. I had horrible chest pain, mucus, hard time breathing, fever, etc. I was diagnosed with pneumonia and sinusitis. I was given a 10 day course of 500mg of Levaquin. I am on day 7 and only a few side effects. Minor dizziness, headaches, MAJOR fatigue and feeling of being in a fog. Overall tolerable but I cannot wait to be done. I feel pretty much back to normal with only a tickling cough left. Also I should note that I sleep VERY well and my appetite has not been affected. I am pleased considering how sick I was and the fact that other antibiotics made me feel horrible in the past. CareBearMoore taken for less than 1 month October 15, 2012 65 users found this comment helpful. I am a serious marathon runner. Started suffering from strange respiratory problems 3 weeks before Chicago marathon. Flew into town to run with a 102f fever. Doctor prescribed this. Within 48 hours things started improving. Now 6 days in on 10 day treatment and most symptoms gone. No side effects. Didn t run marathon, but this medicine seemed to break a nasty infection. 60 users found this comment helpful. I got a severe allergic reaction after taking this medicine for 2 days: my lips were really swollen, fingers got swollen, I got skin rash. It seemed to be helping with the pneumonia though. 20 users found this comment helpful. I went from bedridden to feeling good again in two days. I am on a 5 day plan and on day 3 some ankle aches and pressure in my head. Overall feeling a lot better. I am in the medical field and this is by far the best antibiotic you can get outside of the hospital. If you have a bacterial infection in your lungs and you want it to clear up right away then this is the medicine for you. On the downside it is a very expensive but at some point you get tired of being sick and realize it is worth every single penny. You will be well in no time. 121 users found this comment helpful. Seems to be the only antibiotic that will work for me. 33 users found this comment helpful. 7-day regime prescribed: now in day 3 and feeling great. Day 0 I was flat in bed with 105 fever. I am 60 and no side effects at all. 56 users found this comment helpful. This medicine is amazing and I would like to thank all the inventors and people involved in developing and commercializing this medication. I was afflicted with a pneumonia and after I started taking, I started seeing a benefit within 24-48 hours. 7 days of treatment did the job and I have myself back. 53 users found this comment helpful. Micromedex Care Notes:Pneumonia Symptoms and treatment for:Pneumonia Drugs.com Health Center:Acute Bronchitis in Adults Mayo Clinic Reference:PneumoniaMore about Levaquin levofloxacin Side EffectsDuring Pregnancy or BreastfeedingDosage InformationDrug ImagesDrug InteractionsSupport GroupPricing CouponsEn Espanol247 Reviews - Add your own review/ratingGeneric Availability Consumer resourcesLevaquinLevaquin solutionLevaquin tabletsLevaquin Advanced Reading Levaquin Intravenous Advanced Reading Professional resourcesLevaquin AHFS Monograph Levaquin FDA Other formulationsLevaquin Leva-Pak Related treatment guidesEpididymitis, Sexually TransmittedPneumoniaBacterial InfectionBladder InfectionBronchitisMore 18 Availability Rx Prescription only Pregnancy Category C Risk cannot be ruled out CSA Schedule N Not a controlled drug Approval History Calendar Drug history at FDA Fighting Allergy Season with Medications Medications for High Blood Pressure Irritable Bowel Syndrome Treatments Aren t One-Size-Fits-All Fighting Diabetes Deadly Impact on Minorities Ortho-McNeil-Janssen Pharmaceuticals, Inc. Climate Change May Mean More Smoggy Days to Come: Study Doctors Issue Call to Combat Climate Change Health Care Workers Skipped Hand Washing One-Third of the Time: Study How long does tendonitis last from taking Levaquin. Can you drink alcohol while taking Levaquin. If allergic to penicillin can I take Levaquin. Does tioconazole have any reactions to levaquin. Can I stop taking levaquin and start taking amoxicillin. 39 Ratings with 33 User Reviews I have been using this drug for 5 days. I have pneumonia and bronchitis. My cough is better and I am beginning to cough up mucus. My only problem is that I am very tired and want to sleep a lot. I have 5 more days and we will see. 37 users found this comment helpful. I was given Levaquin for pneumonia. I now in a lot of pain in the arch of both my feet and lower back. I am being treated by my Doctor for the side effects. Caused severe tendinitis in my knee, and a minor attack of tendinitis in my thumb. 23 users found this comment helpful. I had mild to severe coughing for several months, tried several other antibiotics and nothing worked until Lavaquin. I almost gave up. Two weeks ago went into the emergency room on Las Vegas with increased breathing and coughing problems. Blood tests, lung xrays, cat scan, oxygen, etc. etc. Two to three days after taking some prednisone, and a 10 day prescription for Levaquin all seems to have completely cleared up 44 users found this comment helpful. This medicine is very good. It really is effective. The side effects are tolerable. I would strongly recommend that the directions are followed by the patient. 31 users found this comment helpful. I ve been given this medicine twice - once for serious bronchitis/pneumonia that nearly required hospitialization. Since I am a well trained athlete, hospitalization for a lung infection was serious. Doctors tried several other drugs before the Levaquin, but Levaquin was best. Now dealing with a relatively minor bronchitis and have it again. I ve never had any of the side effects others listed - bear in mind that weakness and headaches and many other symptoms might just be the progression of the disease and not due to the drug. It s hard to tell since each bout is different but compared to many other drugs, this is statistically a very good bet. If you have bronchitis or a respiratory infection, take your medicines with lots of fluids. 73 users found this comment helpful. Worked well. Very few side effects. 25 users found this comment helpful. Was on this medication for 10 days. At 9 days I woke up very dizzy. The condition was better on the 10th day, however it became worse on day 11. 15 users found this comment helpful. Popular antibiotics known as fluoroquinolones, which include Cipro and Levaquin, have been associated with a potential increased risk of ruptured tendons. Although this risk has been known for some time, manufacturers of these antibiotics provide inadequate warnings to doctors and consumers. As a result, users continue to experience Cipro and Levaquin tendon ruptures because they are not aware that they should be concerned about development of tendon pain or inflammation. PRIOR POST 1/7/08 : Cipro and Levaquin lawsuit filed by consumer group regarding risk of tendon ruptures Fluoroquinolones are a class of antibiotics which are used to prevent bacteria from reproducing in the body, which could cause infection. Levaquin levofloxacin and Cipro ciprofloxacin are two of the more popular drugs in this class of antibiotics, but others which could also be associated with the risk of tendon damage include Tequin gatifloxacin, Penetrex enoxacin, Factive gemifloxacin, Maxaquin lomefloxacin, Avelox moxifloxacin, Noroxin norfloxacin, Floxin Ofloxacin and Trovan trovafloxacin. For over a decade, manufacturers of these antibiotics have received reports of people suffering inflamed or ruptured tendons, particularly in the shoulder, hand and Achilles tendon. The tendon problems have occured within a few days of taking the antibiotic or months after the course of therapy is finished. Tendon ruptures are a serious and debilitating injury which can require extensive therapy, weeks of casting and possible surgery. An achilles tendon rupture is a complete tear of the tendon which connects the calf muscle and the heel of the foot. A tear of this tendon could cause the heel to lose stability, impairing a person s ability to walk, run, jump or perform any activities which involve use of the foot. Last month the consumer advocacy group, Public Citizen, filed a Cipro and Levaquin lawsuit against the FDA asking the court to require the drug regulators to act on a petition they filed over a year ago. Although the current warning label does mention the risk of tendon damage, Public Citizen believes that stronger warnings should be added to the label and that a seperate information guide should be provided to those taking the drug so that they will know that the first signs of tendon problems should be reported to their doctors. Education about the possible risks of Cipro and Levaquin tendon ruptures could help prevent inflamed tendons from actually rupturing. The adverse effects of the antibiotics could be compounded with prolonged exposure to the drugs, and if early symptoms of tendon problems are reported, a doctor may switch their patient to a different type of antibiotic. CIPRO AND LEVAQUIN TENDON RUPTURE LAWSUITS The lawyers at Saiontz Kirk, P.A. are reviewing the potential for Cipro and Levaquin lawsuits on behalf of users of fluoroquinolone antibiotics who have suffered a ruptured tendon or permanent tendon damage. If you, a friend or family member have experienced tendon problems after using an antibiotic, request a free consultation. LEVAQUIN TABS Levofloxacin drug information product resources from MPR including dosage information, educational materials, patient assistance.Levaquin is related to group of antibiotic medicine that is known as fluoroquinolones and used for the treatment of bacterial infection in a body. A happy yarn shop in Portland, OR and online. We love unique and natural fiber yarns and making pretty things with string. Swane s Nurseries have been operating since 1919. Extensive rose display gardens, cafe, giftshop and complete garden centre on a large site. Ample parking, undercover. Use that is common When I was nauseated early in pregnancy, I didn t know about zofran, I took OTC motion sickness tablets, and b-vitamin supplements and both methods helped. Whe. Doctors give trusted answers on uses, effects, side-effects, and cautions: Dr. Fowler on zofran over the counter: There is no such product over the counter. 1 Answer - Posted in: zofran, zofran odt, otc - Answer: In the USA no Zofran prep is available OTC. They are prescription meds. Find patient medical information for Zofran oral on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Generic Zofran ODT Availability Doctor insights on: Zofran Otc Equivalent Share Share Follow HealthTap / Embed Dr. James Henning Dr. Henning 1 1 Is it possible to get Zofran otc. Zofran ODT is a brand name of ondansetron, approved by the FDA in the following formulation s : ZOFRAN ODT ondansetron - tablet, orally disintegrating;oral Manufacturer: NOVARTIS PHARMS CORP Approval date: January 27, 1999 Strength s : 4MG AB, 8MG RLD AB Has a generic version of Zofran ODT been approved. A generic version of Zofran ODT has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Zofran ODT and have been approved by the FDA: ondansetron tablet, orally disintegrating;oral Manufacturer: AUROBINDO PHARMA Manufacturer: GLENMARK GENERICS Approval date: August 13, 2007 Manufacturer: SUN PHARM INDS LTD Approval date: February 24, 2011 Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Zofran ODT. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication. See also: About generic drugs. Patents are granted by the U.S. Patent and Trademark Office at any time during a drug s development and may include a wide range of claims. Inventor s : Winterborn; Ian Keith Assignee s : Glaxo Wellcome Inc. The invention relates to a freeze-dried dosage form for oral administration capable of being rapidly disintegrated in the mouth comprising ondansetron in the form of its free base or a pharmaceutically acceptable solvate thereof and one or more pharmaceutically acceptable excipients. Methods for the manufacture of such compositions and for their use in the treatment of conditions mediated through the action of 5-hydroxytryptamine 5HT at 5HT.sub.3 receptors are also described. Ondansetron freeze-dried dosage form compositions for oral administration Assignee s : Glaxco Wellcome Inc. Drug PatentA drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. Drug ExclusivityExclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. RLDA Reference Listed Drug RLD is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application ANDA. By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. ABProducts meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading i.e., identical active ingredients s, dosage form, and route s of administration and having the same strength see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code i.e., AB1, AB2, AB3, etc.. Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against. Was given Ondansetron 4mg tablet at ER for ulcer what over counter medication replaces this. There is no such product over the counter. Ondansetron is a very powerful anti-emetic. Ondansetron is a nausea and vomiting agent which is a kind of gastroenterology drug. Is it possible to get Zofran otc. And, although advertisements for the purchase of this drug without a prescription are plentiful on the internet, caution is strongly advised. It s best to obtain a proper prescription. Since one can t access saline,zofran and tormadol whenever they like what are some OTC for zofran and tormadol. OTC meds to try to lessen nausea in place of zofran can include things like Dramamine meclizine, dimenhydrinate, like Benadryl or Zyrtec dyphenhydramine, loratadine, cetirizine, or like Zantac famotidine, ranitidine. Toradol is an NSAID like OTC ibuprofen or naproxen. Not sure what you meant about saline. Salt water saline so you can make that easily enough. What can I give my two year old that is close to zofran OTC for nausea and vomiting. 5 ml 1/2 hour before eating or drinking. I prefer the lemon flavor but also available in cherry flavor. avoid dairy products give small sips of fluids frequently to prevent dehydration ANY nausea med rec to take to my GI. Zofran, phernegan, reglan their relations anaphylaxis. OTC not strong enough. SEVERE nausea w/some vomiting. Ginger can reduce nausea upset stomach. You can drink slightly flattened ginger ale or nibble on crystallized ginger. Or pour boiling water over freshly sliced organic ginger steep x 5 min in a covered pot. Sip. Is it ok to continue taking metformin even if i don t have polycystic ovaries anymore. Is it true it counters the effect of OTC pills weight gain If you have Insulin resistance or even diabetes metformin is fine to take. Some people have lost weight on metformin, perhaps due to GI side effects. I haven t heard that it can interfere with diet pills but those can be dangerous on their own. Norovirus is going around my house and I have some Zofran left over. If I feel symptoms coming on can I take the Zofran as a preventative measure. Norovirus is a nasty virus that causes stomach flu. It is highly infectious, that s why you ll see it on the news when everyone on the cruise ship gets sick. If the illness is going around your household, you may get it too unless you re extremely careful with hygiene hand washing. Alcohol based hand rubs aren t 100 for norovirus. Zofran will help with nausea/vomiting if really needed. Just started bentyl 20mg 3x daily for ibs- should it be making me nauseous/seasick. Will that fade over time. Is it safe to take Zofran as well. Usually you should not feel seasick. Discuss with your doctor since i don t know details of your history.He may adjust dosage or change medication. You can take zofran now till seen your doctor. How long can I take Zofran w/o harm. Have persistent nausea/vomiting for 1.5 years, been on 24mg/day for over 6 mos w/ no diagnosis or treatment plan. You are treating symptoms rather than the cause. I eeccpmend a virtual consult 5 yr old daughter vomiting diarrhea is it ok to give zofran pepto. If so, how much how often. Started over an hr ago. Liquid diet until better. Never give a prescription med not prescribed to a person without permission of that person s doctor. Also, adult Pepto-bismol should not be given to children 16 years and younger. Read labels Try sips 1-2 tsps of flat 7-up/sprite every 10 minutes for a couple of hours, then gradually increase amount slowly as long as its not being vomited. See MD if no better in 12-24 hours on clear liquids Zofran is a nausea and vomiting agent which is a kind of gastroenterology drug. Talk to a doctor live online for free What is the best over-the-counter drug to prevent premature ejaculation. Best over-the-counter medication for ear ache Best over-the-counter expectorant Ask a doctor a question free online Silvadene cream over-the-counter Over the counter treatment for oral thrush What over-the-counter drugs can cause you to miscarry. Over the counter eye drops for scratched cornea What is the best over-the-counter medications for bronchitis. Learn about the prescription medication Zofran Ondansetron Hydrochloride, drug uses, dosage, side effects, drug interactions, warnings, reviews and patient labeling. Zofran ondansetron is used to prevent nausea and vomiting caused by surgery or cancer medicines. Includes Zofran side effects, interactions and indications. Zofran is a brand name for the drug ondansetron, prescribed to treat or prevent nausea and vomiting. Doctors sometimes prescribe Zofran to treat nausea and vomiting. Use that is common The Easy Paychecks Affiliate System Gets People Working To Generate Continuous 100 and 40 Commissions Paid Directly To You. Working To Generate Continuous 100 and 40 Commissions Paid Directly To You. Your Information is 100 Secure And Will Never Be Shared With Subscribers will receive Doyle s Success Newsletter by email. THE EASY PAYCHECKS AFFILIATE SYSTEM genius with 35 years experience. have to explain anything to anyone. streams of 100 and 40 payments flowing to you indefinitely. MARKETERS make money 5 ways without mailing Internet Marketing System is setup for everyone - no money by mailing one powerful sales letter. 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Common use Buy Generic Nexium Online with 40 mg dosage without Prescription required. Get Free coupons and Discounts for all Anti-Acidity group tablets. Etodolac lodine.Nexium I.V. 40mg Powder for solution for injection/infusion - Summary of Product Characteristics SPC by AstraZeneca UK Limited Nexium for injection and. Medscape - Peptic ulcer, GERD, esophagitis, heartburn dosing for Nexium, Nexium 24HR esomeprazole, frequency-based adverse effects, comprehensive interactions. Nexium 40 mg gastro-resistant tabletsEach gastro-resistant tablet contains 44.5 mg esomeprazole magnesium trihydrate equivalent to 40 mg esomeprazole. Excipient s with known effect Each gastro-resistant tablet contains 30 mg sucroseFor the full list of excipients, see section 6.1.Gastro-resistant tabletA pink, oblong, biconvex, film-coated tablet engraved 40 mg on one side and on the other side. Nexium tablets are indicated in adults for:Gastroesophageal Reflux Disease GERD treatment of erosive reflux esophagitis.Prolonged treatment after i.v. induced prevention of rebleeding of peptic ulcers.Treatment of Zollinger Ellison Syndrome Nexium tablets are indicated in adolescents from the age of 12 years for:Gastroesophageal Reflux Disease GERD - treatment of erosive reflux esophagitis Gastroesophageal Reflux Disease GERD - Treatment of erosive reflux esophagitis40 mg once daily for 4 weeks.An additional 4 weeks treatment is recommended for patients in whom esophagitis has not healed or who have persistent symptoms. Prolonged treatment after i.v. induced prevention of rebleeding of peptic ulcers.40 mg once daily for 4 weeks after i.v. induced prevention of rebleeding of peptic ulcers. Treatment of Zollinger Ellison SyndromeThe recommended initial dosage is Nexium 40 mg twice daily. The dosage should then be individually adjusted and treatment continued as long as clinically indicated. Based on the clinical data available, the majority of patients can be controlled on doses between 80 to 160 mg esomeprazole daily. With doses above 80 mg daily, the dose should be divided and given twice daily. Renal impairmentDose adjustment is not required in patients with impaired renal function. Due to limited experience in patients with severe renal insufficiency, such patients should be treated with caution see section 5.2. Hepatic impairmentDose adjustment is not required in patients with mild to moderate liver impairment. For patients with severe liver impairment, a maximum dose of 20 mg Nexium should not be exceeded see section 5.2. ElderlyDose adjustment is not required in the elderly.Paediatric populationAdolescents from the age of 12 years Gastroesophageal Reflux Disease GERD - treatment of erosive reflux esophagitis40 mg once daily for 4 weeks.An additional 4 weeks treatment is recommended for patients in whom esophagitis has not healed or who have persistent symptoms.Children below the age of 12 yearsFor posology in patients aged 1 to 11 reference is made to the Nexium sachet SmPC. Method of administrationThe tablets should be swallowed whole with liquid. The tablets should not be chewed or crushed. For patients who have difficulty in swallowing, the tablets can also be dispersed in half a glass of non-carbonated water. No other liquids should be used as the enteric coating may be dissolved. Stir until the tablets disintegrate and drink the liquid with the pellets immediately or within 30 minutes. Rinse the glass with half a glass of water and drink. The pellets must not be chewed or crushed.For patients who cannot swallow, the tablets can be dispersed in non-carbonated water and administered through a gastric tube. It is important that the appropriateness of the selected syringe and tube is carefully tested. For preparation and administration instructions see section 6.6.Hypersensitivity to the active substance, to substituted benzimidazoles or to any of the excipients listed in section 6.1. Esomeprazole should not be used concomitantly with nelfinavir see section 4.5. In the presence of any alarm symptom e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment with Nexium may alleviate symptoms and delay diagnosis. Long term usePatients on long-term treatment particularly those treated for more than a year should be kept under regular surveillance. On demand treatmentPatients on on-demand treatment should be instructed to contact their physician if their symptoms change in character.Helicobacter pylori eradicationWhen prescribing esomeprazole for eradication of Helicobacter pylori, possible drug interactions for all components in the triple therapy should be considered. Clarithromycin is a potent inhibitor of CYP3A4 and hence contraindications and interactions for clarithromycin should be considered when the triple therapy is used in patients concurrently taking other drugs metabolised via CYP3A4 such as cisapride. Gastrointestinal infectionsTreatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter see section 5.1. Absorption of vitamin B12Esomeprazole, as all acid-blocking medicines, may reduce the absorption of vitamin B12 cyanocobalamin due to hypo- or achlorhydria. This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy. HypomagnesaemiaSevere hypomagnesaemia has been reported in patients treated with proton pump inhibitors PPIs like esomeprazole for at least three months, and in most cases for a year. Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmia can occur but they may begin insidiously and be overlooked. In most affected patients, hypomagnesaemia improved after magnesium replacement and discontinuation of the PPI.For patients expected to be on prolonged treatment or who take PPIs with digoxin or drugs that may cause hypomagnesaemia e.g. diuretics, healthcare professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment. Risk of fractureProton pump inhibitors, especially if used in high doses and over long durations 1 year, may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in presence of other recognised risk factors. Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10-40. Some of this increase may be due to other risk factors. Patients at risk of osteoporosis should receive care according to current clinical guidelines and they should have an adequate intake of vitamin D and calcium. Subacute cutaneous lupus erythematosus SCLE Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping Nexium. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors. Combination with other medicinal productsCo-administration of esomeprazole with atazanavir is not recommended see section 4.5. If the combination of atazanavir with a proton pump inhibitor is judged unavoidable, close clinical monitoring is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir; esomeprazole 20 mg should not be exceeded.Esomeprazole is a CYP2C19 inhibitor. When starting or ending treatment with esomeprazole, the potential for interactions with drugs metabolised through CYP2C19 should be considered. An interaction is observed between clopidogrel and esomeprazole see section 4.5. The clinical relevance of this interaction is uncertain. As a precaution, concomitant use of esomeprazole and clopidogrel should be discouraged.When prescribing esomeprazole for on demand therapy, the implications for interactions with other pharmaceuticals, due to fluctuating plasma concentrations of esomeprazole should be considered. See section 4.5. SucroseThis medicinal product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Interference with laboratory testsIncreased Chromogranin A CgA level may interfere with investigations for neuroendocrine tumours. To avoid this interference, esomeprazole treatment should be stopped for at least 5 days before CgA measurements see section 5.1. Effects of esomeprazole on the pharmacokinetics of other drugs Protease inhibitorsOmeprazole has been reported to interact with some protease inhibitors. The clinical importance and the mechanisms behind these reported interactions are not always known. Increased gastric pH during omeprazole treatment may change the absorption of the protease inhibitors. Other possible interaction mechanisms are via inhibition of CYP2C19. For atazanavir and nelfinavir, decreased serum levels have been reported when given together with omeprazole and concomitant administration is not recommended. Co-administration of omeprazole 40 mg once daily with atazanavir 300 mg/ritonavir 100 mg to healthy volunteers resulted in a substantial reduction in atazanavir exposure approximately 75 decrease in AUC, Cmax and Cmin. Increasing the atazanavir dose to 400 mg did not compensate for the impact of omeprazole on atazanavir exposure. The co-administration of omeprazole 20 mg qd with atazanavir 400 mg/ritonavir 100 mg to healthy volunteers resulted in a decrease of approximately 30 in the atazanavir exposure as compared with the exposure observed with atazanavir 300 mg/ritonavir 100 mg qd without omeprazole 20 mg qd. Co-administration of omeprazole 40 mg qd reduced mean nelfinavir AUC, Cmax and Cmin by 36 39 and mean AUC, Cmax and Cmin for the pharmacologically active metabolite M8 was reduced by 75-92. Due to the similar pharmacodynamic effects and pharmacokinetic properties of omeprazole and esomeprazole, concomitant administration with esomeprazole and atazanavir is not recommended see section 4.4 and concomitant administration with esomeprazole and nelfinavir is contraindicated see section 4.3. For saquinavir with concomitant ritonavir, increased serum levels 80-100 have been reported during concomitant omeprazole treatment 40 mg qd. Treatment with omeprazole 20 mg qd had no effect on the exposure of darunavir with concomitant ritonavir and amprenavir with concomitant ritonavir. Treatment with esomeprazole 20 mg qd had no effect on the exposure of amprenavir with and without concomitant ritonavir. Treatment with omeprazole 40 mg qd had no effect on the exposure of lopinavir with concomitant ritonavir. MethotrexateWhen given together with PPIs, methotrexate levels have been reported to increase in some patients. In high-dose methotrexate administration a temporary withdrawal of esomeprazole may need to be considered. TacrolimusConcomitant administration of esomeprazole has been reported to increase the serum levels of tacrolimus. A reinforced monitoring of tacrolimus concentrations as well as renal function creatinine clearance should be performed, and dosage of tacrolimus adjusted if needed. Medicinal products with pH dependent absorptionGastric acid suppression during treatment with esomeprazole and other PPIs might decrease or increase the absorption of medicinal products with a gastric pH dependent absorption. As with other medicinal products that decrease intragastric acidity, the absorption of medicinal products such as ketoconazole, itraconazole and erlotinib can decrease and the absorption of digoxin can increase during treatment with esomeprazole. Concomitant treatment with omeprazole 20 mg daily and digoxin in healthy subjects increased the bioavailability of digoxin by 10 up to 30 in two out of ten subjects. Digoxin toxicity has been rarely reported. However, caution should be exercised when esomeprazole is given at high doses in elderly patients. Therapeutic drug monitoring of digoxin should then be reinforced. Medicinal products metabolised by CYP2C19 Esomeprazole inhibits CYP2C19, the major esomeprazole-metabolising enzyme. Thus, when esomeprazole is combined with drugs metabolised by CYP2C19, such as diazepam, citalopram, imipramine, clomipramine, phenytoin etc., the plasma concentrations of these drugs may be increased and a dose reduction could be needed. This should be considered especially when prescribing esomeprazole for on-demand therapy. DiazepamConcomitant administration of 30 mg esomeprazole resulted in a 45 decrease in clearance of the CYP2C19 substrate diazepam. PhenytoinConcomitant administration of 40 mg esomeprazole resulted in a 13 increase in trough plasma levels of phenytoin in epileptic patients. It is recommended to monitor the plasma concentrations of phenytoin when treatment with esomeprazole is introduced or withdrawn. VoriconazoleOmeprazole 40 mg once daily increased voriconazole a CYP2C19 substrate Cmax and AUC by 15 and 41, respectively. CilostazolOmeprazole as well as esomeprazole act as inhibitors of CYP2C19. Omeprazole, given in doses of 40 mg to healthy subjects in a cross-over study, increased Cmax and AUC for cilostazol by 18 and 26 respectively, and one of its active metabolites by 29 and 69 respectively. CisaprideIn healthy volunteers, concomitant administration of 40 mg esomeprazole resulted in a 32 increase in area under the plasma concentration-time curve AUC and a 31 prolongation of elimination half-life t1/2 but no significant increase in peak plasma levels of cisapride. The slightly prolonged QTc interval observed after administration of cisapride alone, was not further prolonged when cisapride was given in combination with esomeprazole see also section 4.4. WarfarinConcomitant administration of 40 mg esomeprazole to warfarin-treated patients in a clinical trial showed that coagulation times were within the accepted range. However, post-marketing, a few isolated cases of elevated INR of clinical significance have been reported during concomitant treatment. Monitoring is recommended when initiating and ending concomitant esomeprazole treatment during treatment with warfarin or other coumarine derivatives. ClopidogrelResults from studies in healthy subjects have shown a pharmacokinetic PK / pharmacodynamic PD interaction between clopidogrel 300 mg loading dose/75 mg daily maintenance dose and esomeprazole 40 mg p.o.daily resulting in decreased exposure to the active metabolite of clopidogrel by an average of 40 and resulting in decreased maximum inhibition of ADP induced platelet aggregation by an average of 14. When clopidogrel was given together with a fixed dose combination of esomeprazole 20 mg ASA 81 mg compared to clopidogrel alone in a study in healthy subjects there was a decreased exposure by almost 40 of the active metabolite of clopidogrel. However, the maximum levels of inhibition of ADP induced platelet aggregation in these subjects were the same in the clopidogrel and the clopidogrel the combined esomeprazole ASA product groups.Inconsistent data on the clinical implications of a PK/PD interaction of esomeprazole in terms of major cardiovascular events have been reported from both observational and clinical studies. As a precaution concomitant use of clopidogrel should be discouraged. Investigated medicinal products with no clinically relevant interaction Amoxicillin and quinidineEsomeprazole has been shown to have no clinically relevant effects on the pharmacokinetics of amoxicillin or quinidine. Naproxen or rofecoxibStudies evaluating concomitant administration of esomeprazole and either naproxen or rofecoxib did not identify any clinically relevant pharmacokinetic interactions during short-term studies. Effects of other medicinal products on the pharmacokinetics of esomeprazole Medicinal products which inhibit CYP2C19 and/or CYP3A4Esomeprazole is metabolised by CYP2C19 and CYP3A4. Concomitant administration of esomeprazole and a CYP3A4 inhibitor, clarithromycin 500 mg b.i.d., resulted in a doubling of the exposure AUC to esomeprazole. Concomitant administration of esomeprazole and a combined inhibitor of CYP2C19 and CYP3A4 may result in more than doubling of the esomeprazole exposure. The CYP2C19 and CYP3A4 inhibitor voriconazole increased omeprazole AUC by 280. A dose adjustment of esomeprazole is not regularly required in either of these situations. However, dose adjustment should be considered in patients with severe hepatic impairment and if long-term treatment is indicated. Medicinal products which induce CYP2C19 and/or CYP3A4Drugs known to induce CYP2C19 or CYP3A4 or both such as rifampicin and St. John s wort may lead to decreased esomeprazole serum levels by increasing the esomeprazole metabolism. Paediatric populationInteraction studies have only been performed in adults. PregnancyClinical data on exposed pregnancies with Nexium are insufficient. With the racemic mixture omeprazole data on a larger number of exposed pregnancies stemmed from epidemiological studies indicate no malformative nor foetotoxic effects. Animal studies with esomeprazole do not indicate direct or indirect harmful effects with respect to embryonal/foetal development. Animal studies with the racemic mixture do not indicate direct or indirect harmful effects with respect to pregnancy, parturition or postnatal development. Caution should be exercised when prescribing to pregnant women.A moderate amount of data on pregnant women between 300-1000 pregnancy outcomes indicates no malformative or foeto/neonatal toxicity of esomeprazole.Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity see section 5.3. Breast-feedingIt is not known whether esomeprazole is excreted in human breast milk. There is insufficient information on the effects of esomeprazole in newborns/infants. Esomeprazole should not be used during breast-feeding. FertilityAnimal studies with the racemic mixture omeprazole, given by oral administration do not indicate effects with respect to fertility.Esomeprazole has minor influence on the ability to drive or use machines. Adverse reactions such as dizziness uncommon and blurred vision rare has been reported see section 4.8. If affected patients should not drive or use machines. Summary of the safety profileHeadache, abdominal pain, diarrhoea and nausea are among those adverse reactions that have been most commonly reported in clinical trials and also from post-marketing use. In addition, the safety profile is similar for different formulations, treatment indications, age groups and patient populations. No dose-related adverse reactions have been identified. Tabulated list of adverse reactionsThe following adverse drug reactions have been identified or suspected in the clinical trials programme for esomeprazole and post-marketing. None was found to be dose-related. The reactions are classified according to frequency very common 1/10; common 1/100 to 1/10; uncommon 1/1,000 to 1/100; rare 1/10,000 to 1/1,000; very rare 1/10,000; not known cannot be estimated from the available data. System Organ ClassFrequencyUndesirable EffectBlood and lymphatic system disorders Hypersensitivity reactions e.g. fever, angioedema and anaphylactic reaction/shock Metabolism and nutrition disorders Hypomagnesaemia see section 4.4 ; severe hypomagnesaemia can correlate with hypocalcaemia. Hypomagnesaemia may also be associated with hypokalaemia. Agitation, confusion, depression Dizziness, paraesthesia, somnolence Respiratory, thoracic and mediastinal disorders Abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting Stomatitis, gastrointestinal candidiasis Hepatitis with or without jaundice Hepatic failure, encephalopathy in patients with pre-existing liver disease Skin and subcutaneous tissue disorders Dermatitis, pruritus, rash, urticaria Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis TEN Subacute cutaneous lupus erythematosus see section 4.4 Musculoskeletal and connective tissue disorders Fracture of the hip, wrist or spine see section 4.4 Interstitial nephritis; in some patients renal failure has been reported concomitantly. Reproductive system and breast disorders General disorders and administration site conditions Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard.There is very limited experience to date with deliberate overdose. The symptoms described in connection with 280 mg were gastrointestinal symptoms and weakness. Single doses of 80 mg esomeprazole were uneventful. No specific antidote is known. Esomeprazole is extensively plasma protein bound and is therefore not readily dialyzable. As in any case of overdose, treatment should be symptomatic and general supportive measures should be utilised.Pharmacotherapeutic group: Drugs for acid-related disorders proton pump inhibitorsATC Code: A02B C05Esomeprazole is the S-isomer of omeprazole and reduces gastric acid secretion through a specific targeted mechanism of action. It is a specific inhibitor of the acid pump in the parietal cell. Both the R- and S-isomer of omeprazole have similar pharmacodynamic activity. Mechanism of actionEsomeprazole is a weak base and is concentrated and converted to the active form in the highly acidic environment of the secretory canaliculi of the parietal cell, where it inhibits the enzyme H K -ATPase the acid pump and inhibits both basal and stimulated acid secretion. Pharmacodynamic effectsAfter oral dosing with esomeprazole 20 mg and 40 mg the onset of effect occurs within one hour. After repeated administration with 20 mg esomeprazole once daily for five days, mean peak acid output after pentagastrin stimulation is decreased 90 when measured 6 7 hours after dosing on day five.After five days of oral dosing with 20 mg and 40 mg of esomeprazole, intragastric pH above 4 was maintained for a mean time of 13 hours and 17 hours, respectively over 24 hours in symptomatic GERD patients. The proportion of patients maintaining an intragastric pH above 4 for at least 8, 12 and 16 hours respectively were for esomeprazole 20 mg 76, 54 and 24. Corresponding proportions for esomeprazole 40 mg were 97, 92 and 56. Using AUC as a surrogate parameter for plasma concentration, a relationship between inhibition of acid secretion and exposure has been shown. Healing of reflux esophagitis with esomeprazole 40 mg occurs in approximately 78 of patients after four weeks, and in 93 after eight weeks.One weeks treatment with esomeprazole 20 mg b.i.d. and appropriate antibiotics, results in successful eradication of H. pylori in approximately 90 of patients.After eradication treatment for one week, there is no need for subsequent monotherapy with antisecretory drugs for effective ulcer healing and symptom resolution in uncomplicated duodenal ulcers.In a randomised, double blind, placebo-controlled clinical study, patients with endoscopically confirmed peptic ulcer bleeding characterised as Forrest Ia, Ib, IIa or IIb 9, 43, 38 and 10 respectively were randomised to receive Nexium solution for infusion n 375 or placebo n 389. Following endoscopic haemostasis, patients received either 80 mg esomeprazole as an intravenous infusion over 30 minutes followed by a continuous infusion of 8 mg per hour or placebo for 72 hours. After the initial 72 hour period, all patients received open label 40 mg oral Nexium for 27 days for acid suppression. The occurrence of rebleeding within 3 days was 5.9 in the Nexium treated group compared to 10.3 for the placebo group. At 30 days post-treatment, the occurrence of rebleeding in the Nexium treated versus the placebo treated group was 7.7 vs 13.6. During treatment with antisecretory medicinal products, serum gastrin increases in response to the decreased acid secretion. Also CgA increases due to decreased gastric acidity. The increased CgA level may interfere with investigations for neuroendocrine tumours. Literature reports indicate that proton pump inhibitor treatment should be stopped at least 5 days before CgA measurement. If CgA and gastrin levels have not normalised after 5 days, measurements should be repeated 14 days after cessation of esomeprazole treatment.An increased number of ECL cells possibly related to the increased serum gastrin levels, have been observed in both children and adults during long-term treatment with esomeprazole. The findings are considered to be of no clinical significance.During long-term treatment with antisecretory drugs, gastric glandular cysts have been reported to occur at a somewhat increased frequency. These changes are a physiological consequence of pronounced inhibition of acid secretion, are benign and appear to be reversible.Decreased gastric acidity due to any means including proton pump inhibitors, increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and, in hospitalised patients, possibly also Clostridium difficile. Clinical efficacyIn two studies with ranitidine as an active comparator, Nexium showed better effect in healing of gastric ulcers in patients using NSAIDs, including COX-2 selective NSAIDs.In two studies with placebo as comparator, Nexium showed better effect in the prevention of gastric and duodenal ulcers in patients using NSAIDs aged 60 and/or with previous ulcer, including COX-2 selective NSAIDs. Paediatric populationIn a study in paediatric GERD patients AbsorptionEsomeprazole is acid labile and is administered orally as enteric-coated granules. In vivo conversion to the R-isomer is negligible. Absorption of esomeprazole is rapid, with peak plasma levels occurring approximately 1-2 hours after dose. The absolute bioavailability is 64 after a single dose of 40 mg and increases to 89 after repeated once daily administration. For 20 mg esomeprazole the corresponding values are 50 and 68, respectively.Food intake both delays and decreases the absorption of esomeprazole although this has no significant influence on the effect of esomeprazole on intragastric acidity. DistributionThe apparent volume of distribution at steady state in healthy subjects is approximately 0.22 l/kg body weight. Esomeprazole is 97 plasma protein bound. BiotransformationEsomeprazole is completely metabolised by the cytochrome P450 system CYP. The major part of the metabolism of esomeprazole is dependent on the polymorphic CYP2C19, responsible for the formation of the hydroxy- and desmethyl metabolites of esomeprazole. The remaining part is dependent on another specific isoform, CYP3A4, responsible for the formation of esomeprazole sulphone, the main metabolite in plasma. EliminationThe parameters below reflect mainly the pharmacokinetics in individuals with a functional CYP2C19 enzyme, extensive metabolisers. Total plasma clearance is about 17 l/h after a single dose and about 9 l/h after repeated administration. The plasma elimination half-life is about 1.3 hours after repeated once daily dosing. Esomeprazole is completely eliminated from plasma between doses with no tendency for accumulation during once-daily administration.The major metabolites of esomeprazole have no effect on gastric acid secretion. Almost 80 of an oral dose of esomeprazole is excreted as metabolites in the urine, the remainder in the faeces. Less than 1 of the parent drug is found in urine. Linearity/non-linearityThe pharmacokinetics of esomeprazole has been studied in doses up to 40 mg b.i.d. The area under the plasma concentration-time curve increases with repeated administration of esomeprazole. This increase is dose-dependent and results in a more than dose proportional increase in AUC after repeated administration. This time- and dose-dependency is due to a decrease of first pass metabolism and systemic clearance probably caused by an inhibition of the CYP2C19 enzyme by esomeprazole and/or its sulphone metabolite. Poor metabolisersApproximately 2.9 1.5 of the population lack a functional CYP2C19 enzyme and are called poor metabolisers. In these individuals the metabolism of esomeprazole is probably mainly catalysed by CYP3A4. After repeated once daily administration of 40 mg esomeprazole, the mean area under the plasma concentration-time curve was approximately 100 higher in poor metabolisers than in subjects having a functional CYP2C19 enzyme extensive metabolisers. Mean peak plasma concentrations were increased by about 60. These findings have no implications for the posology of esomeprazole. Gender Following a single dose of 40 mg esomeprazole the mean area under the plasma concentration-time curve is approximately 30 higher in females than in males. No gender difference is seen after repeated once daily administration. These findings have no implications for the posology of esomeprazole. The metabolism of esomeprazole in patients with mild to moderate liver dysfunction may be impaired. The metabolic rate is decreased in patients with severe liver dysfunction resulting in a doubling of the area under the plasma concentration-time curve of esomeprazole. Therefore, a maximum of 20 mg should not be exceeded in patients with severe dysfunction. Esomeprazole or its major metabolites do not show any tendency to accumulate with once daily dosing. Renal impairmentNo studies have been performed in patients with decreased renal function. Since the kidney is responsible for the excretion of the metabolites of esomeprazole but not for the elimination of the parent compound, the metabolism of esomeprazole is not expected to be changed in patients with impaired renal function. ElderlyThe metabolism of esomeprazole is not significantly changed in elderly subjects 71-80 years of age. Paediatric populationAdolescents 12-18 years: Following repeated dose administration of 20 mg and 40 mg esomeprazole, the total exposure AUC and the time to reach maximum plasma concentration tmax in 12 to 18 year-olds was similar to that in adults for both esomeprazole doses.Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development. Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows: Carcinogenicity studies in the rat with the racemic mixture have shown gastric ECL-cell hyperplasia and carcinoids. These gastric effects in the rat are the result of sustained, pronounced hypergastrinaemia secondary to reduced production of gastric acid and are observed after long-term treatment in the rat with inhibitors of gastric acid secretion.Glycerol monostearate 40-55hyprolosehypromelloseiron oxide reddish-brown E 172 magnesium stearatemethacrylic acid ethyl acrylate copolymer 1:1 dispersion 30 per centcellulose microcrystallinesynthetic paraffinmacrogol, polysorbate 80crospovidonesodium stearyl fumaratesugar spheres sucrose and maize starch talctitanium dioxide E 171 triethyl citrate3 years.2 years in climate zones III-IV.Do not store above 30 C.Keep the container tightly closed bottle in order to protect from moisture. Store in the original package blister in order to protect from moisture. Polyethylene bottle with a tamper proof, polypropylene screw cap equipped with a desiccant capsule. Aluminium blister package.Bottles of 2, 5, 7, 14, 15, 28, 30, 56, 60, 100, 140 5x28 tablets.Blister packs in wallet and/or carton of 3, 7, 7x1, 14, 15, 25x1, 28, 30, 50x1, 56, 60, 90, 98, 100x1, 140 tablets.Not all pack sizes may be marketedNo special requirements for disposal. Administration through gastric tube1. Put the tablet into an appropriate syringe and fill the syringe with approximately 25 ml water and approximately 5 ml air. For some tubes, dispersion in 50 ml water is needed to prevent the pellets from clogging the tube.2. Immediately shake the syringe for approximately 2 minutes to disperse the tablet.3. Hold the syringe with the tip up and check that the tip has not clogged.4. Attach the syringe to the tube whilst maintaining the above position.5. Shake the syringe and position it with the tip pointing down. Immediately inject 5 10 ml into the tube. Invert the syringe after injection and shake the syringe must be held with the tip pointing up to avoid clogging of the tip. 6. Turn the syringe with the tip down and immediately inject another 5 10 ml into the tube. Repeat this procedure until the syringe is empty.7. Fill the syringe with 25 ml of water and 5 ml of air and repeat step 5 if necessary to wash down any sediment left in the syringe. For some tubes, 50 ml water is needed. AstraZeneca UK Limited,600 Capability Green,Luton, LU1 3LU, UK.Date of first authorisation: 10 March 2005Date of latest renewal: 10 March 2010 Horizon Place, 600 Capability Green, Luton, Bedfordshire, LU1 3LU medical.informationuk astrazeneca.com Medical Information Direct Line This site uses cookies. By continuing to browse the site you are agreeing to our policy on the use of cookies. Nexium I.V. 40 mg Powder for solution for injection/infusionEach vial contains esomeprazole 40 mg as sodium salt. Excipient s with known effectThis medicinal product contains Powder for solution for injection/infusion.White to off-white porous cake or powder. Nexium for injection and infusion is indicated in adults for: Gastric antisecretory treatment when the oral route is not possible, such as: - gastroesophageal reflux disease GERD in patients with esophagitis and/or severe symptoms of reflux. - healing of gastric ulcers associated with NSAID therapy.- prevention of gastric and duodenal ulcers associated with NSAID therapy, in patients at risk. Prevention of rebleeding following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers. Nexium for injection and infusion is indicated in children and adolescents aged 1-18 years for: Gastric antisecretory treatment when the oral route is not possible, such as:- gastroesophageal reflux disease GERD in patients with erosive reflux esophagitis and/or severe symptoms of reflux. Gastric antisecretory treatment when the oral route is not possible Patients who cannot take oral medication may be treated parenterally with 20 40 mg once daily. Patients with reflux esophagitis should be treated with 40 mg once daily. Patients treated symptomatically for reflux disease should be treated with 20 mg once daily. For healing of gastric ulcers associated with NSAID therapy the usual dose is 20 mg once daily. For prevention of gastric and duodenal ulcers associated with NSAID therapy, patients at risk should be treated with 20 mg once daily. Usually the intravenous treatment duration is short and transfer to oral treatment should be made as soon as possible. Prevention of rebleeding of gastric and duodenal ulcers Following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers, 80 mg should be administered as a bolus infusion over 30 minutes, followed by a continuous intravenous infusion of 8 mg/h given over 3 days 72 hours. The parenteral treatment period should be followed by oral acid-suppression therapy. Method of administrationFor preparation of reconstituted solution, see section 6.6.Injection40 mg dose5 ml of the reconstituted solution 8 mg/ml should be given as an intravenous injection over a period of at least 3 minutes. 20 mg dose2.5 ml or half of the reconstituted solution 8 mg/ml should be given as an intravenous injection over a period of at least 3 minutes. Any unused solution should be discarded.Infusion40 mg doseThe reconstituted solution should be given as an intravenous infusion over a period of 10 to 30 minutes.20 mg doseHalf of the reconstituted solution should be given as an intravenous infusion over a period of 10 to 30 minutes. Any unused solution should be discarded. 80 mg bolus doseThe reconstituted solution should be given as a continuous intravenous infusion over 30 minutes.8 mg/h doseThe reconstituted solution should be given as a continuous intravenous infusion over a period of 71.5 hours calculated rate of infusion of 8 mg/h. See section 6.3 for shelf-life of the reconstituted solution. Renal impairment Dose adjustment is not required in patients with impaired renal function. Due to limited experience in patients with severe renal insufficiency, such patients should be treated with caution see section 5.2. Hepatic impairment GERD: Dose adjustment is not required in patients with mild to moderate liver impairment. For patients with severe liver impairment, a maximum daily dose of 20 mg Nexium I.V. should not be exceeded see section 5.2. Bleeding ulcers: Dose adjustment is not required in patients with mild to moderate liver impairment. For patients with severe liver impairment, following an initial bolus dose of 80 mg Nexium for infusion, a continuous intravenous infusion dose of 4 mg/h for 71.5 hours may be sufficient see section 5.2. ElderlyDose adjustment is not required in the elderly. PosologyChildren and adolescents aged 1-18 years Gastric antisecretory treatment when the oral route is not possible Patients who cannot take oral medication may be treated parenterally once daily, as a part of a full treatment period for GERD see doses in table below. Usually the intravenous treatment duration should be short and transfer to oral treatment should be made as soon as possible. Recommended intravenous doses of esomeprazoleAge group Treatment of erosive reflux esophagitisSymptomatic treatment of GERD1-11 Years Weight 20 kg: 10 mg once daily Weight 20 kg: 10 mg or 20 mg once daily Method of administrationFor preparation of reconstituted solution, see section 6.6. 40 mg dose5 ml of the reconstituted solution 8 mg/ml should be given as an intravenous injection over a period of at least 3 minutes. 20 mg dose2.5 ml or half of the reconstituted solution 8 mg/ml should be given as an intravenous injection over a period of at least 3 minutes. Any unused solution should be discarded. 10 mg dose 1.25 ml of the reconstituted solution 8 mg/ml should be given as an intravenous injection over a period of at least 3 minutes. Any unused solution should be discarded. 40 mg doseThe reconstituted solution should be given as an intravenous infusion over a period of 10 to 30 minutes. 20 mg doseHalf of the reconstituted solution should be given as an intravenous infusion over a period of 10 to 30 minutes. Any unused solution should be discarded. 10 mg doseA quarter of the reconstituted solution should be given as an intravenous infusion over a period of 10 to 30 minutes. Any unused solution should be discarded.Hypersensitivity to the active substance, to substituted benzimidazoles or to any of the excipients listed in section 6.1.Esomeprazole should not be used concomitantly with nelfinavir see section 4.5. In the presence of any alarm symptom e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment with Nexium may alleviate symptoms and delay diagnosis. Gastrointestinal infectionsTreatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter see section 5.1. Absorption of vitamin B12Esomeprazole, as all acid-blocking medicines, may reduce the absorption of vitamin B12 cyanocobalamin due to hypo- or achlorhydria. This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy. HypomagnesaemiaSevere hypomagnesaemia has been reported in patients treated with proton pump inhibitors PPIs like esomeprazole for at least three months, and in most cases for a year. Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmia can occur but they may begin insidiously and be overlooked. In most affected patients, hypomagnesaemia improved after magnesium replacement and discontinuation of the PPI. For patients expected to be on prolonged treatment or who take PPIs with digoxin or medicinal products that may cause hypomagnesaemia e.g. diuretics, healthcare professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment. Risk of fractureProton pump inhibitors, especially if used in high doses and over long durations 1 year, may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in presence of other recognised risk factors. Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10-40. Some of this increase may be due to other risk factors. Patients at risk of osteoporosis should receive care according to current clinical guidelines and they should have an adequate intake of vitamin D and calcium. Subacute cutaneous lupus erythematosus SCLE Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping Nexium. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors. Combination with other medicinesCo-administration of esomeprazole with atazanavir is not recommended see section 4.5. If the combination of atazanavir with a proton pump inhibitor is judged unavoidable, close clinical monitoring is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir; esomeprazole 20 mg should not be exceeded.Esomeprazole is a CYP2C19 inhibitor. When starting or ending treatment with esomeprazole, the potential for interactions with medicinal products metabolised through CYP2C19 should be considered. An interaction is observed between clopidogrel and esomeprazole see section 4.5. The clinical relevance of this interaction is uncertain. As a precaution, concomitant use of esomeprazole and clopidogrel should be discouraged. Interference with laboratory testsIncreased Chromogranin A CgA level may interfere with investigations for neuroendocrine tumours. To avoid this interference, esomeprazole treatment should be stopped for at least 5 days before CgA measurements see section 5.1. Effects of esomeprazole on the pharmacokinetics of other medicinal products Protease inhibitorsOmeprazole has been reported to interact with some protease inhibitors. The clinical importance and the mechanisms behind these reported interactions are not always known. Increased gastric pH during omeprazole treatment may change the absorption of the protease inhibitors. Other possible interaction mechanisms are via inhibition of CYP 2C19.For atazanavir and nelfinavir, decreased serum levels have been reported when given together with omeprazole and concomitant administration is not recommended. Co-administration of omeprazole 40 mg once daily with atazanavir 300 mg/ritonavir 100 mg to healthy volunteers resulted in a substantial reduction in atazanavir exposure approximately 75 decrease in AUC, Cmax and Cmin. Increasing the atazanavir dose to 400 mg did not compensate for the impact of omeprazole on atazanavir exposure. The co-administration of omeprazole 20 mg qd with atazanavir 400 mg/ritonavir 100 mg to healthy volunteers resulted in a decrease of approximately 30 in the atazanavir exposure as compared with the exposure observed with atazanavir 300mg/ritonavir 100 mg qd without omeprazole 20 mg qd. Co-administration of omeprazole 40 mg qd reduced mean nelfinavir AUC, Cmax and Cmin by 36 39 and mean AUC, Cmax and Cmin for the pharmacologically active metabolite M8 was reduced by 75-92. Due to the similar pharmacodynamic effects and pharmacokinetic properties of omeprazole and esomeprazole, concomitant administration with esomeprazole and atazanavir is not recommended see section 4.4 and concomitant administration with esomeprazole and nelfinavir is contraindicated see section 4.3. For saquinavir with concomitant ritonavir, increased serum levels 80-100 have been reported during concomitant omeprazole treatment 40 mg qd. Treatment with omeprazole 20 mg qd had no effect on the exposure of darunavir with concomitant ritonavir and amprenavir with concomitant ritonavir. Treatment with esomeprazole 20 mg qd had no effect on the exposure of amprenavir with and without concomitant ritonavir. Treatment with omeprazole 40 mg qd had no effect on the exposure of lopinavir with concomitant ritonavir. MethotrexateWhen given together with PPIs, methotrexate levels have been reported to increase in some patients. In high-dose methotrexate administration a temporary withdrawal of esomeprazole may need to be considered. TacrolimusConcomitant administration of esomeprazole has been reported to increase the serum levels of tacrolimus. A reinforced monitoring of tacrolimus concentrations as well as renal function creatinine clearance should be performed, and dosage of tacrolimus adjusted if needed. Medicinal products with pH dependent absorptionGastric acid suppression during treatment with esomeprazole and other PPIs might decrease or increase the absorption of medicinal products with a gastric pH dependent absorption. As with other medicinal products that decrease intragastric acidity, the absorption of medicinal products such as ketoconazole, itraconazole and erlotinib can decrease and the absorption of digoxin can increase during treatment with esomeprazole. Concomitant treatment with omeprazole 20 mg daily and digoxin in healthy subjects increased the bioavailability of digoxin by 10 up to 30 in two out of ten subjects. Digoxin toxicity has been rarely reported. However, caution should be exercised when esomeprazole is given at high doses in elderly patients. Therapeutic medicinal product monitoring of digoxin should then be reinforced. Medicinal products metabolised by CYP2C19 Esomeprazole inhibits CYP2C19, the major esomeprazole-metabolising enzyme. Thus, when esomeprazole is combined with medicinal products metabolised by CYP2C19, such as diazepam, citalopram, imipramine, clomipramine, phenytoin etc., the plasma concentrations of these medicinal products may be increased and a dose reduction could be needed. No in vivo interaction studies have been performed with the high dose intravenous regimen 80 mg 8 mg/h. The effect of esomeprazole on medicinal products metabolised by CYP2C19 may be more pronounced during this regimen, and patients should be monitored closely for adverse effects, during the 3 day intravenous treatment period. DiazepamConcomitant oral administration of 30 mg esomeprazole resulted in a 45 decrease in clearance of the CYP2C19 substrate diazepam. PhenytoinConcomitant oral administration of 40 mg esomeprazole and phenytoin resulted in a 13 increase in trough plasma levels of phenytoin in epileptic patients. It is recommended to monitor the plasma concentrations of phenytoin when treatment with esomeprazole is introduced or withdrawn. VoriconazoleOmeprazole 40 mg once daily increased voriconazole a CYP2C19 substrate Cmax and AUC by 15 and 41, respectively. CilostazolOmeprazole as well as esomeprazole act as inhibitors of CYP2C19. Omeprazole, given in doses of 40 mg to healthy subjects in a cross-over study, increased Cmax and AUC for cilostazol by 18 and 26 respectively, and one of its active metabolites by 29 and 69 respectively. CisaprideIn healthy volunteers, concomitant oral administration of 40 mg esomeprazole and cisapride resulted in a 32 increase in area under the plasma concentration-time curve AUC and a 31 prolongation of elimination half-life t1/2 but no significant increase in peak plasma levels of cisapride. The slightly prolonged QTc interval observed after administration of cisapride alone, was not further prolonged when cisapride was given in combination with esomeprazole. WarfarinConcomitant oral administration of 40 mg esomeprazole to warfarin-treated patients in a clinical trial showed that coagulation times were within the accepted range. However, post-marketing of oral esomeprazole, a few isolated cases of elevated INR of clinical significance have been reported during concomitant treatment. Monitoring is recommended when initiating and ending concomitant esomeprazole treatment during treatment with warfarin or other coumarine derivatives. ClopidogrelResults from studies in healthy subjects have shown a pharmacokinetic PK / pharmacodynamic PD interaction between clopidogrel 300 mg loading dose/75 mg daily maintenance dose and esomeprazole 40 mg p.o.daily resulting in decreased exposure to the active metabolite of clopidogrel by an average of 40 and resulting in decreased maximum inhibition of ADP induced platelet aggregation by an average of 14. When clopidogrel was given together with a fixed dose combination of esomeprazole 20 mg ASA 81 mg compared to clopidogrel alone in a study in healthy subjects there was a decreased exposure by almost 40 of the active metabolite of clopidogrel. However, the maximum levels of inhibition of ADP induced platelet aggregation in these subjects were the same in the clopidogrel and the clopidogrel the combined esomeprazole ASA product groups.Inconsistent data on the clinical implications of a PK/PD interaction of esomeprazole in terms of major cardiovascular events have been reported from both observational and clinical studies. As a precaution concomitant use of clopidogrel should be discouraged. Investigated medicinal products with no clinically relevant interaction Amoxicillin or quinidineEsomeprazole has been shown to have no clinically relevant effects on the pharmacokinetics of amoxicillin or quinidine. Naproxen or rofecoxibStudies evaluating concomitant administration of esomeprazole and either naproxen or rofecoxib did not identify any clinically relevant pharmacokinetic interactions during short-term studies. Effects of other medicinal products on the pharmacokinetics of esomeprazole Medicinal products which inhibit CYP2C19 and/or CYP3A4Esomeprazole is metabolised by CYP2C19 and CYP3A4. Concomitant oral administration of esomeprazole and a CYP3A4 inhibitor, clarithromycin 500 mg b.i.d., resulted in a doubling of the exposure AUC to esomeprazole. Concomitant administration of esomeprazole and a combined inhibitor of CYP2C19 and CYP 3A4 may result in more than doubling of the esomeprazole exposure. The CYP2C19 and CYP3A4 inhibitor voriconazole increased omeprazole AUC by 280. A dose adjustment of esomeprazole is not regularly required in either of these situations. However, dose adjustment should be considered in patients with severe hepatic impairment and if long-term treatment is indicated. Medicinal products which induce CYP2C19 and/or CYP3A4Medicinal products known to induce CYP2C19 or CYP3A4 or both such as rifampicin and St. John s wort may lead to decreased esomeprazole serum levels by increasing the esomeprazole metabolism. Paediatric populationInteraction studies have only been performed in adults. PregnancyClinical data on exposed pregnancies with Nexium are insufficient. With the racemic mixture, omeprazole data on a larger number of exposed pregnancies from epidemiological studies indicate no malformative nor foetotoxic effect. Animal studies with esomeprazole do not indicate direct or indirect harmful effects with respect to embryonal/foetal development. Animal studies with the racemic mixture do not indicate direct or indirect harmful effects with respect to pregnancy, parturition or postnatal development. Caution should be exercised when prescribing Nexium to pregnant women.A moderate amount of data on pregnant women between 300-1000 pregnancy outcomes indicates no malformative or foeto/neonatal toxicity of esomeprazole.Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity see section 5.3. Breast-feedingIt is not known whether esomeprazole is excreted in human breast milk, there is insufficient information on the effects of esomeprazole in newborns/infants. Esomeprazole should not be used during breast-feeding. FertilityAnimal studies with the racemic mixture omeprazole, given by oral administration, do not indicate effects with respect to fertility. Esomeprazole has minor influence on the ability to drive or use machines. Adverse reactions such as dizziness uncommon and blurred vision uncommon have been reported see section 4.8. If affected patients should not drive or use machines. Summary of the safety profileHeadache, abdominal pain, diarrhoea and nausea are among those adverse reactions that have been most commonly reported in clinical trials and also from post-marketing use. In addition, the safety profile is similar for different formulations, treatment indications, age groups and patient populations. No dose-related adverse reactions have been identified. Tabulated list of adverse reactionsThe following adverse medicinal product reactions have been identified or suspected in the clinical trials programme for esomeprazole administered orally or intravenously and post-marketing when administered orally. The reactions are classified according to frequency: very common 1/10; common 1/100 to 1/1,000 to 1/10,000 to System Organ ClassFrequencyUndesirable EffectBlood and lymphatic system disorders Hypersensitivity reactions e.g. fever, angioedema and anaphylactic reaction/shock Metabolism and nutrition disorders Hypomagnesaemia see section 4.4 ; severe hypomagnesaemia can correlate with hypocalcaemia. Hypomagnesaemia may also be associated with hypokalaemia.Psychiatric disorders Agitation, confusion, depression Dizziness, paraesthesia, somnolence Respiratory, thoracic and mediastinal disorders Abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting Stomatitis, gastrointestinal candidiasis Hepatitis with or without jaundice Hepatic failure, encephalopathy in patients with pre-existing liver disease Skin and subcutaneous tissue disorders Administration site reactions Uncommon Dermatitis, pruritus, rash, urticaria Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis TEN Subacute cutaneous lupus erythematosus see section 4.4 Musculoskeletal and connective tissue disorders Fracture of the hip, wrist or spine see section 4.4 Interstitial nephritis: in some patients, renal failure has been reported concomitantly Reproductive system and breast disorders General disorders and administration site conditions Administration site reactions have mainly been observed in a study with high-dose exposure over 3 days 72 hours see section 5.3. Irreversible visual impairment has been reported in isolated cases of critically ill patients who have received omeprazole the racemate intravenous injection, especially at high doses, but no causal relationship has been established. Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard. Paediatric populationA randomised, open-label, multi-national study was conducted to evaluate the pharmacokinetics of repeated intravenous doses for 4 days of once daily esomeprazole in paediatric patients 0 to 18 years old see section 5.2. A total of 57 patients 8 children in the age group 1 5 years were included for safety evaluation. The safety results are consistent with the known safety profile of esomeprazole, and no new safety signals were identified.There is very limited experience to date with deliberate overdose. The symptoms described in connection with an oral dose of 280 mg were gastrointestinal symptoms and weakness. Single oral doses of 80 mg esomeprazole and intravenous doses of 308 mg esomeprazole over 24 hours were uneventful. No specific antidote is known. Esomeprazole is extensively plasma protein bound and is therefore not readily dialyzable. As in any case of overdose, treatment should be symptomatic and general supportive measures should be utilised.Pharmacotherapeutic group: Drugs for acid-related disorders, proton pump inhibitorATC Code: A02B C05Esomeprazole is the S-isomer of omeprazole and reduces gastric acid secretion through a specific targeted mechanism of action. It is a specific inhibitor of the acid pump in the parietal cell. Both the R- and S-isomer of omeprazole have similar pharmacodynamic activity. Mechanism of actionEsomeprazole is a weak base and is concentrated and converted to the active form in the highly acidic environment of the secretory canaliculi of the parietal cell, where it inhibits the enzyme H K -ATPase the acid pump and inhibits both basal and stimulated acid secretion. Pharmacodynamic effectsAfter 5 days of oral dosing with 20 mg and 40 mg of esomeprazole, intragastric pH above 4 was maintained for a mean time of 13 hours and 17 hours respectively, over 24 hours in symptomatic GERD patients. The effect is similar irrespective of whether esomeprazole is administered orally or intravenously.Using AUC as a surrogate parameter for plasma concentration, a relationship between inhibition of acid secretion and exposure has been shown after oral administration of esomeprazole. During intravenous administration of 80 mg esomeprazole as a bolus infusion over 30 minutes followed by a continuous intravenous infusion of 8 mg/h for 23.5 hours, intragastric pH above 4, and pH above 6 was maintained for a mean time of 21 hours and 11-13 hours, respectively, over 24 hours in healthy subjects.Healing of reflux esophagitis with esomeprazole 40 mg occurs in approximately 78 of patients after 4 weeks, and in 93 after 8 weeks of oral treatment.In a randomised, double blind, placebo-controlled clinical study, patients with endoscopically confirmed peptic ulcer bleeding characterised as Forrest Ia, Ib, IIa or IIb 9, 43, 38 and 10 respectively were randomised to receive Nexium solution for infusion n 375 or placebo n 389. Following endoscopic haemostasis, patients received either 80 mg esomeprazole as an intravenous infusion over 30 minutes followed by a continuous infusion of 8 mg per hour or placebo for 72 hours. After the initial 72 hour period, all patients received open-label 40 mg oral Nexium for 27 days for acid suppression. The occurrence of rebleeding within 3 days was 5.9 in the Nexium treated group compared to 10.3 for the placebo group. At 30 days post-treatment, the occurrence of rebleeding in the Nexium treated versus the placebo treated group was 7.7 vs 13.6. During treatment with antisecretory medicinal products, serum gastrin increases in response to the decreased acid secretion. Also CgA increases due to decreased gastric acidity. The increased CgA level may interfere with investigations for neuroendocrine tumours. Literature reports indicate that proton pump inhibitor treatment should be stopped at least 5 days before CgA measurement. If CgA and gastrin levels have not normalised after 5 days, measurements should be repeated 14 days after cessation of esomeprazole treatment.An increased number of ECL cells possibly related to the increased serum gastrin levels, have been observed in both children and adults during long-term treatment with esomeprazole. The findings are considered to be of no clinical significance.During long-term oral treatment with antisecretory medicinal products, gastric glandular cysts have been reported to occur at a somewhat increased frequency. These changes are a physiological consequence of pronounced inhibition of acid secretion, are benign and appear to be reversible.Decreased gastric acidity due to any means including proton pump inhibitors, increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and, in hospitalised patients, possibly also Clostridium difficile. Paediatric populationIn a placebo-controlled study 98 patients aged 1-11 months efficacy and safety in patients with signs and symptoms of GERD were evaluated. Esomeprazole 1 mg/kg once daily was given orally for 2 weeks open-label phase and 80 patients were included for an additional 4 weeks doubleblind, treatment-withdrawal phase. There was no significant difference between esomeprazole and placebo for the primary endpoint time to discontinuation due to symptom worsening.In a placebo-controlled study 52 patients aged DistributionThe apparent volume of distribution at steady state in healthy subjects is approximately 0.22 l/kg body weight. Esomeprazole is 97 plasma protein bound. BiotransformationEsomeprazole is completely metabolised by the cytochrome P450 system CYP. The major part of the metabolism of esomeprazole is dependent on the polymorphic CYP2C19, responsible for the formation of the hydroxy- and desmethyl metabolites of esomeprazole. The remaining part is dependent on another specific isoform, CYP3A4, responsible for the formation of esomeprazole sulphone, the main metabolite in plasma. EliminationThe parameters below reflect mainly the pharmacokinetics in individuals with a functional CYP2C19 enzyme, extensive metabolisers. Total plasma clearance is about 17 l/h after a single dose and about 9 l/h after repeated administration. The plasma elimination half-life is about 1.3 hours after repeated once daily dosing. Esomeprazole is completely eliminated from plasma between doses with no tendency for accumulation during once daily administration. The major metabolites of esomeprazole have no effect on gastric acid secretion. Almost 80 of an oral dose of esomeprazole is excreted as metabolites in the urine, the remainder in the faeces. Less than 1 of the parent medicinal product is found in urine. Linearity/non-linearityTotal exposure AUC increases with repeated administration of esomeprazole. This increase is dose-dependent and results in a non-linear dose-AUC relationship after repeated administration. This time- and dose-dependency is due to a decrease of first pass metabolism and systemic clearance probably caused by inhibition of the CYP2C19 enzyme by esomeprazole and/or its sulphone metabolite.Following repeated doses of 40 mg administered as intravenous injections, the mean peak plasma concentration is approx. 13.6 micromol/l. The mean peak plasma concentration after corresponding oral doses is approx. 4.6 micromol/l. A smaller increase of approx 30 can be seen in total exposure after intravenous administration compared to oral administration. There is a dose-linear increase in total exposure following intravenous administration of esomeprazole as a 30-minute infusion 40 mg, 80 mg or 120 mg followed by a continuous infusion 4 mg/h or 8 mg/h over 23.5 hours. Poor metabolisersApproximately 2.9 1.5 of the population lacks a functional CYP2C19 enzyme and is called poor metabolisers. In these individuals, the metabolism of esomeprazole is probably mainly catalysed by CYP3A4. After repeated once daily administration of 40 mg oral esomeprazole, the mean total exposure was approximately 100 higher in poor metabolisers than in subjects with a functional CYP2C19 enzyme extensive metabolisers. Mean peak plasma concentrations were increased by about 60. Similar differences have been seen for intravenous administration of esomeprazole. These findings have no implications for the posology of esomeprazole. GenderFollowing a single oral dose of 40 mg esomeprazole the mean total exposure is approximately 30 higher in females than in males. No gender difference is seen after repeated once daily administration. Similar differences have been observed for intravenous administration of esomeprazole. These findings have no implications for the posology of esomeprazole. Hepatic impairmentThe metabolism of esomeprazole in patients with mild to moderate liver dysfunction may be impaired. The metabolic rate is decreased in patients with severe liver dysfunction resulting in a doubling of the total exposure of esomeprazole. Therefore, a maximum dose of 20 mg should not be exceeded in GERD patients with severe dysfunction. For patients with bleeding ulcers and severe liver impairment, following an initial bolus dose of 80 mg, a maximum continuous intravenous infusion dose of 4 mg/h for 71.5 hours may be sufficient. Esomeprazole or its major metabolites do not show any tendency to accumulate with once daily dosing. Renal impairmentNo studies have been performed in patients with decreased renal function. Since the kidney is responsible for the excretion of the metabolites of esomeprazole but not for the elimination of the parent compound, the metabolism of esomeprazole is not expected to be changed in patients with impaired renal function. ElderlyThe metabolism of esomeprazole is not significantly changed in elderly subjects 71-80 years of age. Paediatric populationIn a randomised, open-label, multi-national, repeated dose study, esomeprazole was given as a once-daily 3-minute injection over four days. The study included a total of 59 paediatric patients 0 to 18 years old of which 50 patients 7 children in the age group 1 to 5 years completed the study and were evaluated for the pharmacokinetics of esomeprazole.The table below describes the systemic exposure to esomeprazole following the intravenous administration as a 3-minute injection in paediatric patients and adult healthy subjects. The values in the table are geometric means range. The 20 mg dose for adults was given as a 30-minute infusion. The Css, max was measured 5 minutes post-dose in all paediatric groups and 7 minutes post-dose in adults on the 40 mg dose, and after stop of infusion in adults on the 20 mg dose.Age groupDose groupAUC µmol h/l Css,max A patient in the age group 0 up to 1 month was defined as a patient with a corrected age of 32 complete weeks and ss,max following intravenous administration of esomeprazole as a 10 minute, 20 minute and 30 minute infusions will be reduced by on average 37 to 49, 54 to 66 and 61 to 72, respectively, across all age and dose groups compared to when the dose is administered as a 3 minute injection.Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development. Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows:Oral carcinogenicity studies in the rat with the racemic mixture have shown gastric ECL-cell hyperplasia and carcinoids. These gastric effects are the result of sustained, pronounced hypergastrinaemia secondary to reduced production of gastric acid, and are observed after long-term treatment in the rat with inhibitors of gastric acid secretion. In the non-clinical program for esomeprazole intravenous formulation there was no evidence of vaso-irritation but a slight tissue inflammatory reaction at the injection site after subcutaneous paravenous injection was noted see section 4.8. Disodium edetate Sodium hydroxide for pH adjustment This medicinal product should not be used with other medicinal products except those mentioned in section 6.6. 2 years in all climate zones. Shelf-life after reconstitutionChemical and physical in-use stability has been demonstrated for 12 hours at 30 C. From a microbiological point of view, the product should be used immediately. Store in the original package, in order to protect from light. Vials can however, be stored exposed to normal indoor light outside the box for up to 24 hours. Do not store above 30 C.5ml vial made of colourless borosilicate glass, type I. Stopper made of bromobutyl latex-free rubber, cap made of aluminium and a plastic flip-off seal.Pack sizes: 1 vial, 10 vials.Not all pack sizes may be marketed.The reconstituted solution should be inspected visually for particulate matter and discoloration prior to administration. Only clear solution should be used. For single use only.If the entire reconstituted content of the vial is not required, any unused solution should be discarded in accordance with local requirements. Injection 40 mgA solution for injection 8 mg/ml is prepared by adding 5ml of 0.9 sodium chloride for intravenous use to the esomeprazole 40 mg vial.The reconstituted solution for injection is clear and colourless to very slightly yellow. Infusion 40 mgA solution for infusion is prepared by dissolving the content of one vial with esomeprazole 40 mg in up to 100 ml of 0.9 sodium chloride for intravenous use. Infusion 80 mgA solution for infusion is prepared by dissolving the contents of two vials of esomeprazole 40 mg in up to 100 ml of 0.9 sodium chloride for intravenous use.The reconstituted solution for infusion is clear and colourless to very slightly yellow.AstraZeneca UK Limited,600 Capability Green,Luton, LU1 3LU,United Kingdom.Date of first authorisation: 10 March 2005Date of latest renewal: 10 March 2010 Horizon Place, 600 Capability Green, Luton, Bedfordshire, LU1 3LU medical.informationuk astrazeneca.com Medical Information Direct Line This site uses cookies. By continuing to browse the site you are agreeing to our policy on the use of cookies. I have been taking Nexium 40mg once a day along with Carafate 4x s a day and Nitroglycern TR once a day for my reflux problems since 2002. My Vitamin D levels keep getting lower every year. Below are Nexium Esomeprazole reviews, ratings, comments submitted by patients and caregivers. Nexium review by 37 year old female patient : Rating: Overall. Buy Nexium Online : Fast Secured Order Processing. Free pills as a gift for every customer. Order Nexium at the Best Price. Buy Brand and Generic Nexium. V. Nexium is the brand name for esomeprazole, a drug used to treat certain stomach and esophagus problems. Nexium is approved for the treatment of gastroesophageal. Common use Order Flomax Prescription Medication Online for the treatment of Enlarged Prostate at the Lowest Price Guaranteed from CanadaDrugPharmacy.com. 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The recommended dose of cefixime is 400 mg daily. This may be given as a 400 mg tablet or capsule daily or the 400 mg tablet may be split and given as one half tablet every 12 hours. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of 400 mg is recommended. The capsule and tablet may be administered without In the treatment of infections due to Streptococcus pyogenes, a therapeutic dosage of cefixime should be administered for at least Pediatric Patients 6 months or older The recommended dose is 8 mg/kg/day of the suspension. This may be administered as a single daily dose or may be given in two divided doses, as 4 mg/kg every 12 hours. Note: A suggested dose has been determined for each pediatric weight range. Refer to Table 1. Ensure all orders that specify a dose in milliliters include a concentration, because Suprax for oral suspension is available in three different concentrations 100 mg/5 mL, 200 mg/5 mL, and 500 Table 1: Suggested doses for pediatric patients Doses are suggested for each weight range and rounded for ease of administration Suprax cefixime for Oral Suspension Suprax cefixime Chewable Tablet 1 tablet of 100 mg and 1 tablet of 150 mg 1 tablet of 150 mg and 1 tablet of 200 mg The preferred concentrations of oral suspension to use are 100 mg/5 mL or 200 mg/5 mL for pediatric patients in these weight ranges. Children weighing more than 45 kg or older than 12 years should be treated with the recommended adult dose. Suprax cefixime Chewable Tablets must be chewed or crushed before swallowing. Otitis media should be treated with the chewable tablets or suspension. Clinical trials of otitis media were conducted with the chewable tablets or suspension, and the chewable tablets or suspension results in higher peak blood levels than the tablet when administered at the same dose. Therefore, the tablet or capsule should not be substituted for the chewable tablets or suspension in the treatment of otitis media see CLINICAL PHARMACOLOGY. In the treatment of infections due to Streptococcus pyogenes, a therapeutic dosage of cefixime should be administered for at least 10 days. the presence of impaired renal function. Normal dose and schedule may be employed in patients with creatinine clearances of 60 mL/min or greater. Refer to Table 2 for dose adjustments for adults with renal impairment. Neither hemodialysis nor peritoneal dialysis removes significant amounts of drug from Table 2: Doses for Adults with Renal Impairment 21 to 59 OR renal hemodialysis 20 or less OR continuous peritoneal dialysis are 200 mg/5 mL or 500 mg/5 mL for patients with this renal dysfunction Reconstitution Directions For Oral To reconstitute, suspend with 68 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well. To reconstitute, suspend with 51 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well. To reconstitute, suspend with 34 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well. To reconstitute, suspend with 26 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well. To reconstitute, suspend with 17 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well. To reconstitute, suspend with 14 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well. To reconstitute, suspend with 8 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well. suspension may be kept for 14 days either at room temperature, or under refrigeration, without significant loss of potency. Keep tightly closed. Shake well before using. Discard unused portion after 14 days. Learn about the prescription medication Suprax Cefixime, drug uses, dosage, side effects, drug interactions, warnings, reviews and patient labeling. SUPRAX 400 MG 10 FILM TABLET hakkında fiyat, atc kodlaması, eşdeğerleri, endikasyon, kontrendikasyon, yan etkiler, etkileşim gibi bilgiler içerir. Prospektüs. Suprax (Cefixime) Drug Information: Indications, Dosage and How Supplied - Prescribing Information at RxList |