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Esomeprazole Magnesium (Esomeprazole Magnesium)

Trade Name : Esomeprazole Magnesium

Teva Pharmaceuticals USA, Inc.

CAPSULE, DELAYED RELEASE

Strength 40 mg/1

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

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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 (Esomeprazole Magnesium) which is also known as Esomeprazole Magnesium and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 40 mg/1 per ml. Read more

Esomeprazole Magnesium (Esomeprazole Magnesium) 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

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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.

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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  • No data
  • Warnings and Precautions, Fundic Gland Polyps ()u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0 06/2018
  • Esomeprazole Magnesium Delayed-Release Capsules are a proton pump inhibitor indicated for the following:
  • Treatment of gastroesophageal reflux disease (GERD). ()
  • Risk reduction of NSAID-associated gastric ulcer. ()
  • H. pylori
  • Pathological hypersecretory conditions, including Zollinger-Ellison syndrome. ()
  • Esomeprazole Magnesium Delayed-Release Capsules are supplied as delayed-release capsules for oral administration. The recommended dosages are outlined in . Esomeprazole Magnesium Delayed-Release Capsules 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.
  • Table 1: Recommended Dosage Schedule for Esomeprazole Magnesium Delayed-Release Capsules
  • 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 (Child-Pugh Classes A and B), no dosage adjustment is necessary. For patients with severe liver impairment (Child-Pugh Class C), a dose of 20 mg of esomeprazole magnesium delayed-release capsules 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: Administration Options
  • Esomeprazole magnesium 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 esomeprazole magnesium 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, esomeprazole magnesium 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 esomeprazole magnesium 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.
  • See full prescribing information for administration options. ()
  • Patients with severe liver impairment-do not exceed dose of 20 mg. ()
  • Esomeprazole magnesium delayed-release capsules, 20 mg, are available as off-white to pale yellow granule-filled, light turquoise blue, opaque, hard-gelatin capsules, spin-printed u201cu201d and u201c6450u201d on the cap and u201c20 mgu201d on the body in gold ink containing 20 mg esomeprazole packaged in bottles of 30, 90, and 1000 capsules.
  • Esomeprazole magnesium delayed-release capsules, 40 mg, are available as off-white to pale yellow granule-filled, light turquoise blue, opaque, hard-gelatin capsules, spin-printed u201cu201d and u201c6451u201d on the cap and u201c40 mgu201d on the body in gold ink containing 40 mg esomeprazole packaged in bottles of 30, 90, and 1000 capsules.
  • Esomeprazole Magnesium Delayed-Release Capsules: 20 mg and 40 mg. ()
  • Esomeprazole magnesium 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 [n ].n For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with esomeprazole magnesium, refer to the CONTRAINDICATIONS section of their package inserts.
  • Patients with known hypersensitivity to proton pump inhibitors (PPIs) (angioedema and anaphylaxis have occurred). ()
  • No data
  • Gastric Malignancy
  • Acute Interstitial Nephritis
  • Arrayn- Clostridium difficile
  • Bone Fracture
  • Cutaneous and Systemic Lupus Erythematosusn- 5.5
  • 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
  • Fundic Gland Polyps
  • The following serious adverse reactions are described below and elsewhere in labeling:
  • Most common adverse reactions ():
  • Adults (u2265 18 years) (incidence u2265 1%) are headache, diarrhea, nausea, flatulence, abdominal pain, constipation, and dry mouth.
  • Pediatric (1 to 17 years) (incidence u2265 2%) are headache, diarrhea, abdominal pain, nausea, and somnolence.
  • No data
  • May affect plasma levels of antiretroviral drugs u2013 use with atazanavir and nelfinavir is not recommended; if saquinavir is used with esomeprazole magnesium, monitor for toxicity and consider saquinavir dose reduction. ()
  • May interfere with drugs for which gastric pH affects bioavailability (e.g., ketoconazole, iron salts, erlotinib, digoxin and mycophenolate mofetil). Patients treated with esomeprazole magnesium and digoxin may need to be monitored for digoxin toxicity. ()
  • Combined inhibitor of CYP2C19 and 3A4 may raise esomeprazole levels. ()
  • Clopidogrel: esomeprazole magnesium decreases exposure to the active metabolite of clopidogrel. ()
  • May increase systemic exposure of cilostazol and an active metabolite. Consider dose reduction. ()
  • Tacrolimus: esomeprazole magnesium may increase serum levels of tacrolimus. ()
  • Methotrexate: esomeprazole magnesium may increase serum levels of methotrexate. ()
  • 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 esomeprazole magnesium 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 Esomeprazole Magnesium Delayed-Release Capsules USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1-benzimidazole-1-yl) magnesium dihydrate. 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.) It has a molecular weight of 749.2 as a dihydrate and 713.1 on an anhydrous basis. The structural formula is:
  • (CHNOS)Mg u2022 2 HO M.W. 749.2
  • The magnesium salt is an off-white to pale yellow colored crystalline powder. It contains 2 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.
  • Each Esomeprazole Magnesium Delayed-Release Capsule USP contains either 20 mg or 40 mg of esomeprazole (present as 21.69 mg or 43.38 mg esomeprazole magnesium dihydrate) in the form of enteric-coated granules. In addition, each delayed-release capsule contains the following inactive ingredients: FD&C blue #1, gelatin, hypromellose, methacrylic acid copolymer dispersion, polysorbate 80, propylene glycol, shellac, sugar spheres, talc, titanium dioxide, triethyl citrate, and yellow iron oxide.
  • No data
  • No data
  • No data
  • Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg, are available as off-white to pale yellow granule-filled, light turquoise blue, opaque, hard-gelatin capsules, spin-printed u201cu201d and u201c6450u201d on the cap and u201c20 mgu201d on the body in gold ink containing 20 mg esomeprazole packaged in bottles of 30 andu00a090 capsules.
  • NDC 0093--56tbottle of 30NDC 0093--98tbottle of 90
  • NDC 0093--56tbottle of 30NDC 0093--98tbottle of 90
  • Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).
  • KEEP CONTAINER TIGHTLY CLOSED.
  • KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
  • 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
  • All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.
  • Manufactured In India By: n n
  • Manufactured For:n n
  • Rev. Eu00a06/2018
  • Esomeprazole (ES-oh-MEP-ra-zole) Magnesium (mag-NEE-zee-um) Delayed-Release Capsules
  • Read the Medication Guide that comes with esomeprazole magnesium delayed-release capsules before you start taking esomeprazole magnesium delayed-release capsules 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 esomeprazole magnesium delayed-release capsules?
  • Esomeprazole magnesium delayed-release capsules may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.
  • Esomeprazole magnesium delayed-release capsules can cause serious side effects, including:
  • Esomeprazole magnesium delayed-release capsules can have other serious side effects. See n
  • What are esomeprazole magnesium delayed-release capsules?
  • Esomeprazole magnesium delayed-release capsules are a prescription medicine called a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules reduce the amount of acid in your stomach.
  • Esomeprazole magnesium delayed-release capsules are used in adults:
  • For children and adolescents 1 year to 17 years of age, esomeprazole magnesium delayed-release capsules may be prescribed for up to 8 weeks for short-term treatment of GERD.
  • Who should not take esomeprazole magnesium delayed-release capsules?
  • Do not take esomeprazole magnesium delayed-release capsules if you:
  • What should I tell my doctor before taking esomeprazole magnesium delayed-release capsules?
  • Before you take esomeprazole magnesium delayed-release capsules, 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 esomeprazole magnesium delayed-release capsules?
  • What are the possible side effects of esomeprazole magnesium delayed-release capsules?
  • Esomeprazole magnesium delayed-release capsules can cause serious side effects, including:
  • The most common side effects with esomeprazole magnesium delayed-release capsules may include:
  • Other side effects:
  • Serious allergic reactions.
  • Your doctor may stop esomeprazole magnesium delayed-release capsules 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 esomeprazole magnesium delayed-release capsules.
  • 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 esomeprazole magnesium delayed-release capsules?
  • Keep esomeprazole magnesium delayed-release capsules and all medicines out of the reach of children.
  • General information about esomeprazole magnesium delayed-release capsules
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use esomeprazole magnesium delayed-release capsules for a condition for which they were not prescribed. Do not give esomeprazole magnesium delayed-release capsules to other people, even if they have the same symptoms you have. They may harm them.
  • This Medication Guide summarizes the most important information about esomeprazole magnesium delayed-release capsules. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about esomeprazole magnesium delayed-release capsules that is written for health professionals.
  • For more information about esomeprazole magnesium delayed-release capsules, call 1-888-838-2872.
  • What are the ingredients in esomeprazole magnesium delayed-release capsules?
  • Active Ingredient
  • Inactive ingredients in esomeprazole magnesium delayed-release capsules (including the capsule shells):
  • Instructions for Use
  • For instructions on taking esomeprazole magnesium delayed-release capsules, see the section of this leaflet called u201cu201d
  • Esomeprazole magnesium delayed-release capsules may be given through a nasogastric tube (NG tube) or gastric tube, as prescribed by your doctor. Follow the instructions below:
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.
  • Manufactured In India By:n n
  • Manufactured For: n n
  • Rev.u00a0Du00a06/2018
  • No data
  • No data

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