The U. S. Food and Drug Administration has approved a marketing authorization for Nexium, the purple pill that treats heartburn, stomach problems and indigestion, in adults aged 18 and over.
This means that the drug could have a major impact on patients suffering from heartburn, stomach problems and indigestion. The drug will also help lower the price of Nexium, and it will likely be available at the pharmacy without a prescription.
The agency will have to approve Nexium before it becomes available to the general public.
The FDA is currently requiring a letter of authorization (NAVA) from the manufacturer, AstraZeneca, requesting that the drug be sold in the U. without the need for a prescription.
As part of the approval process, the drug will be available through a network of pharmacies nationwide, but the agency will be able to request a pharmacy license for the drug in the states where it is being approved. The NAAA allows patients to obtain a prescription from an authorized pharmacy when they have a valid prescription from their doctor.
The FDA has also been looking at whether patients could be eligible for the drug. In particular, the agency is looking for drugs with a high enough drug weight to be sold by pharmacies without requiring a prescription.
The FDA is also looking at ways to prevent patients from buying prescription drugs over the Internet.
The drug will be available without a prescription to doctors and patients in the U. at a cost of $12 for a 30-day supply. The price may be reduced, though, by a percentage of the value of the prescription.
The agency is also considering whether to add a warning to the drug that warns patients of the serious side effects that may be associated with certain drugs.
The warning that may be included in the drug’s label has been issued by the agency’s Drug Safety Advisory Committee. The agency is asking that the drug be approved at a lower cost, and the committee will decide whether to recommend that the drug be sold.
The drug is available as a generic version of Nexium. The FDA has already said it believes the drug is safe and effective in treating heartburn and stomach problems.
The drug is being studied in other countries and the FDA is evaluating its safety and effectiveness.
The drug may be sold to patients who need to be monitored for heartburn and stomach problems.
The company has been looking at the safety and effectiveness of the drug for many years. It has a new drug application for the drug, called “The Nexium Heartburn Action Plan,” which is expected to be submitted to the FDA later this year.
It also has a new, more widely-used drug called Prevacid.
The FDA said it would wait for the drug’s approval to be granted in its New Drug Application in two years.
The FDA is also considering whether to add a warning that the drug is associated with a high risk of heart attacks and strokes. The FDA has not yet received a written warning about the risk.
The FDA has also been looking at whether the drug could be used for heartburn.
The drug has been studied in other countries and the FDA is reviewing its use in developing countries.
The FDA is also evaluating whether patients who have heartburn, indigestion, or other symptoms of GERD can get relief from the drug.
The drug will be available in the U. through a network of pharmacies nationwide, but the agency will be able to request a pharmacy license for the drug in the states where it is being approved.
The FDA has not yet approved the drug for the treatment of heartburn or stomach problems.
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The Nexium-Rx is an anti-ulcer drug. It is used to treat conditions such as acid reflux and GERD, such as stomach ulcers and heartburn.
Nexium-Rx is a prescription medication containing the active ingredient esomeprazole. It is a proton pump inhibitor (PPI) that blocks the acid production in the stomach. It is used to treat the symptoms of GERD and other acid reflux conditions.
One Nexium-RX tablet should be swallowed with water. Do not chew or crush the tablet. Swallow the tablet whole with water. Do not crush or break the tablet, or open the tablet and use it only as needed. Do not take the tablet more often than directed. Do not give the tablet to a child younger than 10 years of age. Do not use this medication for longer than 14 days.
Headache, flushing (warmth, redness, or redness in the face, neck, or chest), or stomach upset may occur. These effects may be temporary or may resolve on their own. If they are not treated, they may be serious. Call your doctor or seek medical attention immediately if any of the following side effects occur: chest pain, trouble breathing, or swelling of the face, lips, tongue, or throat.
Contact your doctor immediately if these side effects occur. These are common side effects of Nexium-Rx and should be reported to your nearest primary care physician.
The recommended dose of Nexium-Rx is 10 mg to 20 mg once daily. Do not increase the dose more than recommended. Take the medicine at the same time every day.
Some side effects of Nexium-Rx may occur. These side effects may be temporary or may resolve on their own. Call your doctor if any of the following side effects occur: headache, nausea, vomiting, diarrhea, constipation, dizziness, drowsiness, ringing in the ears, dizziness, or weakness in one or both arms or legs.
If any of these side effects become serious, contact your doctor immediately. You may require hospitalization if you experience serious side effects.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
The information provided on this page is for guidance only. It contains information that may help you make informed decisions about your health. It does not replace medical advice. If you have any questions or concerns about your health, please consult your doctor.
The information provided at this time does not take the place of consulting with your health care professional. Before taking Nexium-Rx, you should ask your doctor or pharmacist for a list of the medicines you are taking. You should also ask if the symptoms of the disease or conditions you are taking medication for (such as stomach upset, constipation) are a result of your treatment.
Tell your doctor if you do not feel well while taking Nexium-Rx. Your doctor will try to adjust the dosage of this medicine to find a better result. Your doctor may stop the use of Nexium-Rx once you are feeling better.
Nexium® 24HR 20mg Mini Capsules provide lasting relief from frequent heartburn and acid reflux in a 53% smaller capsule (based on volume of the capsule vs Nexium® 24HR Once Daily Dosing Tablet)
Nexium 24 Hour Once Daily Dosing provides lasting relief for frequent heartburn & acid reflux.
Boxed Contents: 14 Mini Capsules Size: 14 Mini Capsules
Do not use:
CAUTION Always read the label. Follow the directions for use.
Each capsule contains Esomeprazole magnesium trihydrate 22.3mg (equivalent to esomeprazole 20mg)
Active Ingredients: Each capsule contains Esomeprazole magnesium trihydrate 22.3mg (equivalent to esomeprazole 20mg)
Adults 18 years, of age and over: Take 1 capsule daily for at least 7 days and up to 14 days.
Swallow the capsule whole with water, with or without food. Do not crush, chew or open the capsule. Not intended for immediate relief. It may take a few days to achieve maximum results.
Do not take for more than 14 days unless directed by a doctor.
USAGE ADVICE The bottle contains a sealed container with silica gel desiccant. Keep the bottle tightly closed to protect from moisture.
SAFETY DIRECTIONS
Carefully read the enclosed leaflet before use.
Ask your doctor or pharmacist before use if you:
STORAGE INSTRUCTIONS Store below 25°C in a cool, dry place. Storage Temperature: Below 25°C.
ReferencesAlternate Name:Pharmapure RX Esomep-EZS
Description:Nexium treats gastroesophageal reflux disease (GERD), esophagitis, and stomach ulcers. The generic version of Nexium is esomeprazole magnesium. For a supply of 30 oral tablets of Nexium Delayed-Release Capsules 40 mg is approximately $287. Take advantage of our LowerMyRx discount to receive a typical Nexium discount of up to 80% off of the retail price at participating pharmacies near you.
Dosage Form:Capsule Delayed Release
Administration Route:By mouth
Drug Class:Gastric Acid Secretion Inhibitor, Gastrointestinal Agent
Generic Available:Yes
Strength:20 MG
Warnings:Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, lupus, vitamin B12 deficiency, or osteoporosis. This medicine may cause the following problems: Kidney problems, including acute tubulointerstitial nephritisIncreased risk of broken bones in the hip, wrist, or spine (more likely if used several times per day or longer than 1 year)Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, and drug reaction with eosinophilia and systemic symptoms (DRESS)LupusFundic gland polyps (abnormal growth in the upper part of your stomach) This medicine can cause diarrhea. Call your doctor if the diarrhea becomes severe, does not stop, or is bloody. Do not take any medicine to stop diarrhea until you have talked to your doctor. Diarrhea can occur 2 months or more after you stop taking this medicine. Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results. Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments. Keep all medicine out of the reach of children. Never share your medicine with anyone. Stomach pain, nausea, vomiting, weight loss, bloody or black stools
Food Warnings:Do not use esomeprazole if you are also using medicines that contain rilpivirine., Some medicines can affect how esomeprazole works. Tell your doctor if you are using any of the following: Atazanavir, cilostazol, diazepam, digoxin, erlotinib, ketoconazole, methotrexate, mycophenolate mofetil, nelfinavir, rifampin, saquinavir, St John's wort, tacrolimus, voriconazoleBlood thinner (including clopidogrel or warfarin)Diuretic (water pill)Iron supplements, This medicine can cause diarrhea. Diarrhea can occur 2 months or more after you stop taking this medicine., Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results., Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments., Keep all medicine out of the reach of children.
InboxWhat is Inbox Do not take If you think you are having trouble swallowing. This medicine may cause the following problems: Gastroesophageal reflux disease (GERD), esophageal reflux, heartburn, stomach pain, nausea, vomiting, decreased appetite, smelly or painful sex, pain, or keep getting these ingredients from your body. If you think you are having trouble swallowing this medicine, let your doctor know.
Product NAMENexium Delayed-Release Capsules 40 mg; generic esomeprazole magnesium
Pack SizeWhat is the generic name?Nexium
This is a brand name, not a generic. The brand name is Prilosec, also known as Nexium 40 mg. The brand name Prilosec is sometimes referred to by its generic name, esomeprazole magnesium.
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