WILLiam, California, January 31, 2020 (GLOBE NEWSWIRE) --, a biopharmaceutical company, today announced that it has received final approval from the United States Food and Drug Administration (FDA) for its product “Nexium,” a generic version of AstraZeneca’s Nexium®. This approval applies to the product as well as all the generic products included in the authorized marketing authorization for Nexium, including the generic products and Nexium®. Nexium is approved to treat adult patients with refractory acid reflux (salt and peppermint).
The product is being marketed byLederle Laboratories, Inc., a biopharmaceutical company committed to delivering affordable, long-term acid reflux disease treatment. The FDA will provide regulatory approval for this product and any generic products. For more information visit.
About Nexium®: The term “Nexium” is used to describe the drug used to treat reflux disease and acid reflux. The generic name for Nexium is esomeprazole. Nexium is indicated for the treatment of reflux, a chronic condition characterized by a persistent and painful sensation in the lower esophageal sphincter (LES).
Nexium® is manufactured and sold under the brand name AstraZeneca®.Nexium® is the only generic version of AstraZeneca’s Nexium® approved for adult patients with reflux, which is the most common type of acid reflux disease in the United States.
Nexium® is not FDA approved for other indications, including cancer and the prevention and treatment of heartburn and acid reflux. It is only approved for use in individuals with reflux, a condition in which acid reflux is a risk factor for the development of heartburn. In addition, Nexium® is not approved for use in patients with the following conditions:
The following information is provided through theto help you determine whether an authorized generic version of Nexium® is a good fit for your condition:
Nexium®is indicated for adult patients with reflux, a condition in which acid reflux is a risk factor for the development of heartburn and other symptoms of acid reflux. Patients who have reflux, a condition in which acid reflux is a risk factor for the development of heartburn, are at a greater risk for developing heartburn than patients who do not have acid reflux. Patients with reflux, a condition in which acid reflux is a risk factor for the development of heartburn, may have an increased risk for developing acid reflux. Patients with acid reflux, a condition in which acid reflux is a risk factor for the development of heartburn, may also have an increased risk of developing heartburn.
The FDA approved Nexium® in November 2018 for the treatment of adult patients with reflux, a condition in which acid reflux is a risk factor for the development of heartburn and other symptoms of acid reflux.
Nexium® was approved by the FDA as a generic version of AstraZeneca’s Nexium®®. In October 2019, the U. S. FDA approved Nexium® for the treatment of adult patients with reflux, a condition in which acid reflux is a risk factor for the development of heartburn and other symptoms of acid reflux. For more information, visit.
About AstraZeneca
The AstraZeneca Group is a biopharmaceutical company committed to providing innovative and high-quality medicines to the people of the United States.
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Lasting relief for frequent heartburn and acid reflux.
Always read the label and follow the directions for use.
Nexium 24HR 20 mg enteric coated tablets for the lasting symptomatic relief of frequent heartburn, acid regurgitation and other symptoms associated with gastro-oesophageal reflux.
Always take this medicine exactly as described in the Consumer Medicine Information leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is one tablet a day. - Do not take more than this recommended dose of one tablet (20 mg) a day, even if you don't feel an improvement immediately. - You may need to take Nexium 24HR for a few days before experiencing the full effect. - Nexium 24HR should be taken for at least 7 days and up to 14 days. - Tell your pharmacist or doctor if you do not feel better while taking Nexium 24HR. If symptoms persist or recur within 2 weeks of completing the course, consult your doctor. Further examination may be required.
Always read the label, use only as directed. Tell your pharmacist or doctor if you notice any of the following and they worry you: nausea or vomiting, constipation, diarrhoea, headache, wind, stomach pain, skin rash, itchy skin, dizziness or dry mouth. These side effects are usually mild. Tell your pharmacist or doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop. Some medicines may interfere with Nexium 24HR. Do not take Nexium 24HR if you are pregnant unless your doctor says so. Ask your doctor about the risks and benefits involved. It is not known if it is safe for you to take Nexium 24HR while you are pregnant. It may affect your baby. Do not take Nexium 24HR if you are breastfeeding. Ask your doctor for more information. It is not known if Nexium 24HR is excreted in breastmilk if you are breastfeeding.
ContraindicationsNexium 24HR is contraindicated in patients with a known hypersensitivity to any component of the medication. Esomeprazole is not generally contra-indicated in these patients. There are no potent interactions with Esomeprazole. If you are taking esomeprazole you should avoid the concomitant use of erlotinib or claritinib or any other medications that contain loop diuretics (carbamazepine).
Before taking esomeprazole as it has been shown to reduce Esomeprazole's efficacy, it is important to tell your pharmacist or doctor if you are taking any of the following medications: amiodarcy---------------------------------- (R) Amiodarcy. Riociguat. Riociguat for renal disease. Amoxicillin. Ketoconazole. Moxifloxacin. Diflucan. El-Postedan. Er, amiodarcy is contraindicated in these patients. It is important to tell your pharmacist or doctor if you are taking any of these medications: erlotinib for liver disease. Fluphenazine for neuroletics (epilepsy). Trazodone for neuroletics (epilepsy). Amoxicillin for strep (shingles). Amiodarcy for osteomyelitis (osteoarthritis). Amiodarcy for rheumatism (including pyelonephritis). Amiodarcy for mononucleosis (pyelonephritis). Clarithromycin for bone marrow suppression (mononucleosis). Tizanidine for neuroleptic malignant syndrome/leukopenia (pyelonephritis).
Before taking esomeprazole as it has been shown to reduce EIPRA's efficacy, it is important to tell your pharmacist or doctor if you are taking any of these medications: erlotinib for pain/nausea/vomiting/disposition to stay in practice. Erlotinib for pain/nausea/vomiting/disposition to stay in practice.
Nexium 24HR Once Daily Dosing Tablets provide lasting relief from frequent heartburn and acid reflux. Nexium 24HR 20mg esomeprazole tablets are for the lasting symptomatic relief of frequent heartburn, acid regurgitation and other symptoms associated with gastro-oesophageal reflux
8g
Adults 18 years of age and over: Take 1 tablet daily for at least 7 days and up to 14 days. Swallow the tablet whole with water, with or without food. Do not crush or chew the tablet. Do not take for more than 14 days unless directed by a doctor.
Always read the label and follow the directions for use.
The most common side effects are nausea, abdominal pain, vomiting, dizziness, headache, and diarrhea. Bloating or emotional disturbances may also occur.
Do not use Nexium 24HR or any other proton pump inhibitor if you are allergic to any other medications. Also do not use these products if you have liver problems or any severe health conditions such as heart failure or kidney disease. These may cause a serious side effect.
Each tablet contains esomeprazole 20mg (as magnesium trisulfate).
Synonyms for the active ingredients: Magnesium trisulfate, Sodium sulfate, Choline Sulfate, Pantolide.Swallow the tablet whole with water, without chewing or squeezing the tablet. If symptoms persist, consult a doctor.
Always read the label and the instructions for use contain age and safety considerations. Use only as directed.
The side effects described here are not all of the above side effect chemicals. Rather, side effects should be carefully evaluated before starting a new medication. For more information, talk to your healthcare provider or pharmacist.
VacuumChargesBloistoryDo not use if allergic to any other proton pump inhibitor (omeprazole, rabeprazole, lansoprazole, pantoprazole or rabeprazole and quetiapine). If gastro-oesophageal reflux disease (GERD) occurs, other therapies may be needed.
Cardiac ImagingFor more information on using Nexium 24HR or any other proton pump inhibitor, please see the end of the product leaflet.
PregnancyThe most common side effects listed here are not all of the above side effect chemicals. They may be factors in the occurrence of each other or the symptoms described here.
constipationFor more information on using Nexium 24HR or any other proton pump inhibitor, please talk to your doctor or pharmacist.
AlcoholDrinking alcohol can increase the risk of side effects such as nausea, vomiting, and dizziness. For more information, contact the FDA at 1-800-FDA-1088 oroxicity may be serious.
Existing use of Nexium 24HR may increase your risk of experiencing priapism, a prolonged and painful erection that causes pain and swelling in your penis. You should not use Nexium 24HR if you have ever had an erection that lasted more than 4 hours. Priapism can permanently damage your penis. If you have an erection that lasts more than 4 hours, see a doctor immediately.
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Active Ingredients:Each capsule contains: Esomeprazole 40 mg.
Inactive Ingredients:Each capsule contains Esomeprazole 40 mg.
Manufacturer: Supermart.
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Updated onFriday,6/7Product Details:
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