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Esomeprazole Magnesium (Esomeprazole Magnesium)

Trade Name : Esomeprazole magnesium

AstraZeneca Pharmaceuticals LP

CAPSULE, DELAYED RELEASE

Strength 20 mg/1

ESOMEPRAZOLE MAGNESIUM 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 AstraZeneca Pharmaceuticals LP. It is available in strength of 20 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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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.

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  • No data
  • Warnings and Precautions, Fundic Gland Polyps u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a006/2018
  • Esomeprazole magnesium is a proton pump inhibitor indicated for the following:
  • H. pylori
  • Esomeprazole magnesium delayed-release capsules are supplied as delayed-release capsules for oral administration. The recommended dosages are outlined in Table 1. 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.
  • 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 n
  • Directions for use specific to the route and available methods of administration for each of these dosage forms are presented in Table 2.
  • Esomeprazole magnesium delayed-release capsules
  • 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 capsules 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. n
  • Patients with severe liver impairment-do not exceed dose of 20 mg. n
  • Esomeprazole magnesium delayed-release capsules, 20 mg - opaque, hard gelatin, powder blue colored capsules with u201c0382u201d and u201c20 mgu201d in black on the body.
  • Esomeprazole magnesium delayed-release capsules, 40 mg - opaque, hard gelatin, powder blue colored capsules with u201c0384u201d and u201c40 mgu201d in black on the body.
  • u2022
  • (3)
  • Esomeprazole magnesium delayed-release capsules are 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
  • For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with esomeprazole magnesium delayed-release capsules, 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
  • Fundic Gland Polyps
  • The following serious adverse reactions are described below and elsewhere in labeling:
  • Most common adverse reactions :
  • 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 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 for oral administration 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:
  • Figure 1
  • 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.
  • Esomeprazole magnesium is supplied in delayed-release capsules. 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 TekPrint SW-9008 black ink.
  • No data
  • No data
  • No data
  • Esomeprazole magnesium delayed-release capsules, 20 mg, are opaque, hard gelatin, powder blue colored capsules with u201c0382u201d and u201c20 mgu201d in black on the body. They are supplied as follows:
  • NDC 0186-0382-30 unit of use bottles of 30
  • NDC 0186-0382-90 bottles of 90
  • Esomeprazole magnesium delayed-release capsules, 40 mg, are opaque, hard gelatin, powder blue colored capsules with u201c0384u201d and u201c40 mgu201d in black on the body. They are supplied as follows:
  • NDC 0186-0384-30 unit of use bottles of 30
  • NDC 0186-0384-90 bottles of 90
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15 to 30u00b0C (59 to 86u00b0F). [See USP Controlled Room Temperature]. Keep esomeprazole magnesium delayed-release capsules container tightly closed. Dispense in a tight container if the product package of esomeprazole magnesium delayed-release capsules 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
  • No data
  • NDC 0186-0382-30
  • ESOMEPRAZOLE
  • MAGNESIUM
  • DEALYED-RELEASE
  • CAPSULES
  • 20 mg*
  • Rx onlyu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a030 Capsules
  • Dispense the accompanying
  • Medication Guide to each
  • patient.
  • NDC 0186-0384-30
  • ESOMEPRAZOLE
  • MAGNESIUM
  • DELAYED-RELEASE
  • CAPSULES
  • 40 mg*
  • Rx onlyu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a030 Capsules
  • Dispense the accompanying
  • Medication Guide to each
  • patient.

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