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Irbesartan (Irbesartan)

Trade Name : Irbesartan

West-Ward Pharmaceuticals Corp.

TABLET

Strength 75 mg/1

IRBESARTAN Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]

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Product information is meant for

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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 Irbesartan (Irbesartan) which is also known as Irbesartan and Manufactured by West-Ward Pharmaceuticals Corp.. It is available in strength of 75 mg/1 per ml. Read more

Irbesartan (Irbesartan) 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

Validated Cold Chain Shipment

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.

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  • No data
  • WARNING: FETAL TOXICITY
  • See full prescribing information for complete boxed warning.
  • When pregnancy is detected, discontinue irbesartan as soon as possible. ()
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ()
  • Irbesartan is an angiotensin II receptor blocker (ARB) indicated for:
  • No data
  • Irbesartan Tablets USP are supplied for oral administration as 75 mg, 150 mg and 300 mg.
  • Tablets: 75 mg, 150 mg, 300 mg ()
  • Irbesartan is contraindicated in patients who are hypersensitive to any component of this product.
  • Do not co-administrate aliskiren with irbesartan in patients with diabetes.
  • No data
  • The following important adverse reactions are described elsewhere in the labeling:
  • To report SUSPECTED ADVERSE REACTIONS, contact
  • West-Ward Pharmaceuticals Corp. at 1-800-962-8364
  • or FDA at 1-800-FDA-1088 or n
  • u2022
  • 6.1
  • No data
  • No data
  • u2022
  • 8.3
  • No data are available in regard to overdosage in humans. However, daily doses of 900 mg for 8 weeks were well-tolerated. The most likely manifestations of overdosage are expected to be hypotension and tachycardia; bradycardia might also occur from overdose. Irbesartan is not removed by hemodialysis.
  • Acute oral toxicity studies with irbesartan in mice and rats indicated acute lethal doses were in excess of 2000 mg/kg, about 25-fold and 50-fold the MRHD (300 mg) on a mg/m basis, respectively.
  • Irbesartan is an angiotensin II receptor (AT subtype) antagonist.
  • Irbesartan is a non-peptide compound, chemically described as a 2-butyl-3-[-(-1-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one.
  • Its molecular formula is CHNO, and the structural formula:
  • Irbesartan USP is a white to off-white crystalline powder with a molecular weight of 428.5. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan is slightly soluble in alcohol and methylene chloride and practically insoluble in water.
  • Irbesartan Tablets USP are available for oral administration in unscored tablets containing 75 mg, 150 mg, or 300 mg of irbesartan USP. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose, magnesium stearate and microcrystalline cellulose.
  • No data
  • No data
  • No data
  • Irbesartan Tablets USP
  • 75 mg tablets are supplied as white to off-white speckled, round biconvex tablets, plain on one side with u201c54u201d over u201c085u201d debossed on the other side.
  • NDC 0054-0250-13: Bottle of 30 TabletsNDC 0054-0250-22: Bottle of 90 Tablets
  • 150 mg tablets are supplied as white to off-white speckled, round biconvex tablets, plain on one side with u201c54u201d over u201c194u201d debossed on the other side.
  • NDC 0054-0251-13: Bottle of 30 TabletsNDC 0054-0251-22: Bottle of 90 Tablets
  • 300 mg tablets are supplied as white to off-white speckled, modified oval biconvex tablets, plain on one side with u201c54 661u201d debossed on the other side.
  • NDC 0054-0252-13: Bottle of 30 TabletsNDC 0054-0252-22: Bottle of 90 Tablets
  • Storage
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]
  • Pregnancy
  • Advise female patients of childbearing age about the consequences of exposure to irbesartan during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible.
  • Potassium Supplementsn- [see ]
  • Distr. by: Eatontown, NJ 07724
  • 10005204/06
  • Revised January 2019
  • No data
  • No data
  • No data

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