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Esomeprazole Magnesium (Nexium)

Trade Name : NEXIUM

AstraZeneca Pharmaceuticals LP

GRANULE, DELAYED RELEASE

Strength 10 mg/1

ESOMEPRAZOLE MAGNESIUM Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]

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You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

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Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Esomeprazole Magnesium (Nexium) which is also known as NEXIUM and Manufactured by AstraZeneca Pharmaceuticals LP. It is available in strength of 10 mg/1 per ml. Read more

Esomeprazole Magnesium (Nexium) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Read more
  • No data
  • No data
  • u00a0
  • (5.12)
  • NEXIUM is a proton pump inhibitor indicated for the following:
  • H. pylori
  • NEXIUM is supplied as delayed-release capsules for oral administration or in packets for preparation of delayed-release oral suspensions. The recommended dosages are outlined in Table 1. NEXIUM should be taken at least one hour before meals.
  • The duration of proton pump inhibitor administration should be based on available safety and efficacy data specific to the defined indication and dosing frequency, as described in the prescribing information, and individual patient medical needs. Proton pump inhibitor treatment should only be initiated and continued if the benefits outweigh the risks of treatment.
  • Please refer to amoxicillin and clarithromycin prescribing information for Contraindications, Warnings, and dosing in elderly and renally-impaired patients.
  • Specific Populations
  • Hepatic Insufficiency
  • In patients with mild to moderate liver impairment (Childu2011Pugh Classes A and B), no dosage adjustment is necessary. For patients with severe liver impairment (Childu2011Pugh Class C), a dose of 20 mg of NEXIUM should not be exceeded .
  • Directions for use specific to the route and available methods of administration for each of these dosage forms are presented in Table 2.
  • NEXIUM Delayed-Release Capsules
  • NEXIUM Delayed-Release Capsules should be swallowed whole.
  • Alternatively, for patients who have difficulty swallowing capsules, one tablespoon of applesauce can be added to an empty bowl and the NEXIUM Delayed-Release Capsule can be opened, and the granules inside the capsule carefully emptied onto the applesauce. The granules should be mixed with the applesauce and then swallowed immediately: do not store for future use. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The granules should not be chewed or crushed. If the granules/applesauce mixture is not used in its entirety, the remaining mixture should be discarded immediately.
  • For patients who have a nasogastric tube in place, NEXIUM Delayed-Release Capsules can be opened and the intact granules emptied into a 60 mL catheter tipped syringe and mixed with 50 mL of water. It is important to only use a catheter tipped syringe when administering NEXIUM through a nasogastric tube. Replace the plunger and shake the syringe vigorously for 15 seconds. Hold the syringe with the tip up and check for granules remaining in the tip. Attach the syringe to a nasogastric tube and deliver the contents of the syringe through the nasogastric tube into the stomach. After administering the granules, the nasogastric tube should be flushed with additional water. Do not administer the granules if they have dissolved or disintegrated.
  • The mixture must be used immediately after preparation.
  • NEXIUM For Delayed-Release Oral Suspension
  • NEXIUM For Delayed-Release Oral Suspension should be administered as follows:
  • For patients who have a nasogastric or gastric tube in place, NEXIUM For Delayed-Release Oral Suspension can be administered as follows:
  • See full prescribing information for administration options. n
  • Patients with severe liver impairment-do not exceed dose of 20 mg. n
  • NEXIUM Delayed-Release Capsules, 20 mg - opaque, hard gelatin, amethyst colored capsules with two radial bars in yellow on the cap and NEXIUM 20 mg in yellow on the body.
  • NEXIUM Delayed-Release Capsules, 40 mg - opaque, hard gelatin, amethyst colored capsules with three radial bars in yellow on the cap and NEXIUM 40 mg in yellow on the body.
  • NEXIUM For Delayed-Release Oral Suspension, 2.5 mg, 5 mg, 10 mg, 20 mg or 40 mg - unit dose packet containing a fine yellow powder, consisting of white to pale brownish esomeprazole granules and pale yellow inactive granules.
  • NEXIUM is contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria .
  • For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with NEXIUM, refer to the CONTRAINDICATIONS section of their package inserts.
  • Patients with known hypersensitivity to proton pump inhibitors (PPIs) (angioedema and anaphylaxis have occurred). n
  • No data
  • Gastric Malignancy:
  • Acute Interstitial Nephritis
  • Arrayn- Clostridium difficile-
  • Bone Fracture:
  • Cutaneous and Systemic Lupus Erythematosus:
  • Interaction with Clopidogrel:
  • Cyanocobalamin (Vitamin B-12) Deficiency:
  • Hypomagnesemia:
  • Interaction with St. Johnu2019s Wort or Rifampin:
  • Interactions with Diagnostic Investigations for Neuroendocrine Tumors:
  • Interaction with Methotrexate
  • The following serious adverse reactions are described below and elsewhere in labeling:
  • Most common adverse reactions :
  • To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or n
  • >
  • >
  • No data
  • No data
  • A single oral dose of esomeprazole at 510 mg/kg (about 124 times the human dose on a body surface area basis), was lethal to rats. The major signs of acute toxicity were reduced motor activity, changes in respiratory frequency, tremor, ataxia, and intermittent clonic convulsions.
  • The symptoms described in connection with deliberate NEXIUM overdose (limited experience of doses in excess of 240 mg/day) are transient. Single doses of 80 mg of esomeprazole were uneventful. Reports of overdosage with omeprazole in humans may also be relevant. Doses ranged up to 2,400 mg (120 times the usual recommended clinical dose). Manifestations were variable, but included confusion, drowsiness, blurred vision, tachycardia, nausea, diaphoresis, flushing, headache, dry mouth, and other adverse reactions similar to those seen in normal clinical experience (see omeprazole package insert - ). No specific antidote for esomeprazole is known. Since esomeprazole is extensively protein bound, it is not expected to be removed by dialysis. In the event of overdosage, treatment should be symptomatic and supportive.
  • As with the management of any overdose, the possibility of multiple drug ingestion should be considered. For current information on treatment of any drug overdose contact a Poison Control Center at 1u2013800u2013222u20131222.
  • The active ingredient in the proton pump inhibitor NEXIUM (esomeprazole magnesium) Delayed-Release Capsules for oral administration and NEXIUM (esomeprazole magnesium) For Delayed-Release Oral Suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1-benzimidazole-1-yl) magnesium trihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (CHNOS)Mg x 3 HO with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is:
  • The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25u00b0C and about 8 hours at 37u00b0C.
  • NEXIUM is supplied in delayed-release capsules and in packets for a delayed-release oral suspension. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 22.3 mg, or 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate 40-55, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer type C, polysorbate 80, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, FD&C Blue #1, FD&C Red #40, D&C Red #28, titanium dioxide, shellac, ethyl alcohol, isopropyl alcohol, n-butyl alcohol, propylene glycol, sodium hydroxide, polyvinyl pyrrolidone, and D&C Yellow #10.
  • Each packet of NEXIUM For Delayed-Release Oral Suspension contains 2.5 mg, 5 mg, 10 mg, 20 mg, or 40 mg of esomeprazole, in the form of the same enteric-coated granules used in NEXIUM Delayed-Release Capsules, and also inactive granules. The inactive granules are composed of the following ingredients: dextrose, xanthan gum, crospovidone, citric acid, iron oxide, and hydroxypropyl cellulose. The esomeprazole granules and inactive granules are constituted with water to form a suspension and are given by oral, nasogastric, or gastric administration.
  • No data
  • No data
  • No data
  • NEXIUM Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules with two radial bars in yellow on the cap and NEXIUM 20 mg in yellow on the body. They are supplied as follows:
  • NDC 0186-5020-31 unit of use bottles of 30
  • NDC 0186-5020-54 bottles of 90
  • NDC 0186-5020-82 bottles of 1000
  • NEXIUM Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, amethyst colored capsules with three radial bars in yellow on the cap and NEXIUM 40 mg in yellow on the body. They are supplied as follows:
  • NDC 0186-5040-31 unit of use bottles of 30
  • NDC 0186-5040-54 bottles of 90
  • NDC 0186-5040-82 bottles of 1000
  • NEXIUM For Delayed-Release Oral Suspension is supplied as a unit dose packet containing a fine yellow powder, consisting of white to pale brownish esomeprazole granules and pale yellow inactive granules. NEXIUM unit dose packets are supplied as follows:
  • NDC 0186-4025-01 unit dose packages of 30: 2.5 mg packets
  • NDC 0186-4050-01 unit dose packages of 30: 5 mg packets
  • NDC 0186-4010u201301 unit dose packages of 30: 10 mg packets
  • NDC 0186-4020u201301 unit dose packages of 30: 20 mg packets
  • NDC 0186-4040u201301 unit dose packages of 30: 40 mg packets
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15 to 30u00b0C (59 to 86u00b0F). [See USP Controlled Room Temperature]. Keep NEXIUM Delayed-Release Capsules container tightly closed. Dispense in a tight container if the NEXIUM Delayed-Release Capsules product package is subdivided.
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Adverse Reactions
  • Advise patients to report to their healthcare provider if they experience any signs or symptoms consistent with:
  • Drug Interactions
  • Administration
  • Distributed by:
  • AstraZeneca Pharmaceuticals LP
  • Wilmington, DE 19850
  • NEXIUM and the color purple as applied to the capsule are registered trademarks of the AstraZeneca group of companies.
  • u00a9AstraZeneca 2018
  • NEXIUM (nex-e-um)
  • (esomeprazole magnesium)
  • Delayed-Release Capsules
  • NEXIUM (nex-e-um)
  • (esomeprazole magnesium)
  • For Delayed-Release n- Oral Suspension
  • Read the Medication Guide that comes with NEXIUM before you start taking NEXIUM and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.
  • What is the most important information I should know about NEXIUM?
  • NEXIUM may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.
  • NEXIUM can cause serious side effects, including:
  • NEXIUM can have other serious side effects. See u201c?u201d
  • What is NEXIUM?
  • NEXIUM is a prescription medicine called a proton pump inhibitor (PPI). NEXIUM reduces the amount of acid in your stomach.
  • NEXIUM is used in adults:
  • For children and adolescents 1 year to 17 years of age, NEXIUM may be prescribed for up to 8 weeks for short-term treatment of GERD.
  • In children ages 1 month to less than 1 year of age, NEXIUM is only used to treat GERD with acid-related damage to the esophagus (erosive esophagitis) for up to 6 weeks.
  • It is not known if NEXIUM is effective in children under 1 month of age.
  • Who should not take NEXIUM?
  • Do not take NEXIUM if you:
  • What should I tell my doctor before taking NEXIUM?
  • Before you take NEXIUM, tell your doctor if you:
  • Tell your doctor about all of the medicines you take
  • Especially tell your doctor if you take:
  • How should I take NEXIUM?
  • What are the possible side effects of NEXIUM?
  • NEXIUM can cause serious side effects, including:
  • Your doctor may check the level of magnesium in your body before you start taking NEXIUM or during treatment if you will be taking NEXIUM for a long period of time.
  • The most common side effects with NEXIUM may include:
  • Other side effects:
  • Serious allergic reactions
  • Your doctor may stop NEXIUM if these symptoms happen.
  • Tell your doctor if you have any side effects that bother you or that do not go away. These are not all the possible side effects with NEXIUM.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store NEXIUM?
  • Keep NEXIUM and all medicines out of the reach of children.
  • General information about NEXIUM
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use NEXIUM for a condition for which it was not prescribed. Do not give NEXIUM to other people, even if they have the same symptoms you have. It may harm them.
  • This Medication Guide summarizes the most important information about NEXIUM. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about NEXIUM that is written for health professionals.
  • For more information, go to www.purplepill.com or call 1-800-463-9486.
  • What are the ingredients in NEXIUM?
  • Active ingredient: esomeprazole magnesium trihydrate
  • Inactive ingredients in NEXIUM Delayed-Release Capsules (including the capsule shells):
  • Inactive granules in NEXIUM For Delayed-Release Oral Suspension:
  • Instructions for Use
  • For instructions on taking Delayed-Release Capsules, see the section of this leaflet called u201cu201d
  • Take NEXIUM For Delayed-Release Oral Suspension as follows:
  • NEXIUM Delayed-Release Capsules and NEXIUM For Delayed-Release Oral Suspension may be given through a nasogastric tube (NG tube) or gastric tube, as prescribed by your doctor. Follow the instructions below:
  • NEXIUM Delayed-Release Capsules:
  • NEXIUM For Delayed-Release Oral Suspension:
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • AstraZeneca Pharmaceuticals LP
  • Wilmington, DE 19850
  • Revised 06/2018
  • NEXIUM is a registered trademark of the AstraZeneca group of companies.
  • u00a92018 AstraZeneca Pharmaceuticals LP. All rights reserved
  • NDC 0186-5020-31
  • NEXIUMn
  • (esomeprazole magnesium)
  • 30 Delayed-Release
  • Capsules
  • Rx onlyu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a020 mg*
  • Dispense the accompanying
  • Medication Guide to each patient.
  • AstraZeneca
  • NDC 0186-5040-31
  • NEXIUMn
  • (esomeprazole magnesium)
  • 30 Delayed-Release
  • Capsules
  • Rx onlyu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a040 mg*
  • Dispense the accompanying
  • Medication Guide to each patient.
  • AstraZeneca
  • NDC 0186-4025-01
  • NEXIUMn
  • (esomeprazole magnesium*)
  • 2.5 mg
  • For Delayed-Release Oral Suspension
  • Each carton contains 30 Child-resistant packets.
  • *Each packet contains 2.8 mg of esomeprazole magnesium trihydrate
  • which is equivalent to 2.5 mg of esomeprazole as enteric-coated granules.
  • Dispense the enclosed Medication Guide to each patient.
  • 30 Single Dose Packets
  • Rx only
  • AstraZeneca
  • NDC 0186-4050-01
  • NEXIUMn
  • (esomeprazole magnesium*)
  • 5 mg
  • For Delayed-Release
  • Oral Suspension
  • Each carton contains 30 Child-resistant packets.
  • *Each packet contains 5.6 mg of esomeprazole magnesium trihydrate
  • which is equivalent to 5 mg of esomeprazole as enteric-coated granules.
  • Dispense the enclosed Medication Guide to each patient.
  • Rx only
  • 30 Single Dose Packets
  • AstraZeneca
  • NDC 0186-4010-01
  • NEXIUMn
  • (esomeprazole magnesium*)
  • 10 mg
  • For Delayed-Release
  • Oral Suspension
  • Each carton contains 30 Child-resistant packets.
  • *Each packet contains 11.1 mg of esomeprazole magnesium trihydrate
  • which is equivalent to 10 mg of esomeprazole as enteric-coated granules.
  • Dispense the enclosed Medication Guide to each patient.
  • Rx only
  • 30 Single Dose Packets
  • AstraZeneca
  • NDC 0186-4020-01
  • NEXIUMn
  • (esomeprazole magnesium*)
  • 20 mg
  • For Delayed-Release
  • Oral Suspension
  • Each carton contains 30 Child-resistant packets.
  • *Each packet contains 22.3 mg of esomeprazole magnesium trihydrate
  • which is equivalent to 20 mg of esomeprazole as enteric-coated granules.
  • Dispense the enclosed Medication Guide to each patient.
  • Rx only
  • 30 Single Dose Packets
  • AstraZeneca
  • NDC 0186-4040-01
  • NEXIUMn
  • (esomeprazole magnesium*)
  • 40 mg
  • For Delayed-Release Oral Suspension
  • Each carton contains 30 Child-resistant packets.
  • *Each packet contains 44.5 mg of esomeprazole magnesium trihydrate
  • which is equivalent to 40 mg of esomeprazole as enteric-coated granules.
  • Dispense the enclosed Medication Guide to each patient.
  • Rx only
  • 30 Single Dose Packets
  • AstraZeneca

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