Irbesartan (Irbesartan)

Trade Name : Irbesartan

Bryant Ranch Prepack

TABLET

Strength 150 mg/1

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

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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 Irbesartan (Irbesartan) which is also known as Irbesartan and Manufactured by Bryant Ranch Prepack. It is available in strength of 150 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

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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.

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  • WARNING: FETAL TOXICITYn
  • See full prescribing information for complete boxed warning.n
  • u2022u00a0When pregnancy is detected, discontinue irbesartan tablets as soon as possible. () u2022u00a0Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ()n
  • Irbesartan is an angiotensin II receptor blocker (ARB) indicated for: u2022u00a0Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. () u2022u00a0Treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. ()
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  • Irbesartan tablets 75 mg are a white to off-white film coated, oval, debossed on one side with u201cML 94u201d and plain on the other side. Irbesartan tablets 150 mg are a white to off-white film coated, oval, debossed on one side with u201cML 95u201d and plain on the other side. Irbesartan tablets 300 mg are a white to off-white film coated, oval, debossed on one side with u201cML 96u201d and plain on the other side.
  • u2022u00a0Tablets: 75 mg, 150 mg, 300 mg ()
  • Irbesartan tablets are contraindicated in patients who are hypersensitive to any component of this product. Do not coadminister aliskiren with irbesartan tablets in patients with diabetes.
  • u2022u00a0Hypersensitivity to any component of this product. () u2022u00a0Coadministration with aliskiren in patients with diabetes. ()
  • u2022u00a0Hypotension: Correct volume or salt depletion prior to administration. () u2022u00a0Monitor renal function and serum potassium. ()
  • The following important adverse reactions are described elsewhere in the labeling: u2022u00a0Hypotension in Volume or Salt-Depleted Patients u2022u00a0Impaired Renal Function n
  • u2022u00a0Nephropathy in type 2 diabetic patients: The most common adverse reactions which were more frequent than placebo were hyperkalemia dizziness, orthostatic dizziness, and orthostatic hypotension. ()
  • u2022u00a0Lithium: Risk of lithium toxicity () u2022u00a0Non-Steroidal Anti-inflammatory Drugs (NSAIDs) and COX-2 inhibitors: Increased risk of renal impairment. Reduced antihypertensive effects. () u2022u00a0Dual blockade of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia. ()
  • u2022u00a0Nursing Mothers: Potential for adverse effects in infant. ()
  • 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 USP is an angiotensin II receptor (AT subtype) antagonist. Irbesartan USP 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 USP is slightly soluble in alcohol and methylene chloride and practically insoluble in water.
  • Irbesartan is available for oral administration in unscored tablets containing 75 mg, 150 mg, or 300 mg of irbesartan USP. Inactive ingredients include: carboxymethylcellulose calcium, povidone, colloidal silicon dioxide, sodium starch glycolate, talc and magnesium stearate. The film coating comprises of hypromellose, lactose monohydrate, titanium dioxide and polyethylene glycol.
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  • Product: 71335-1263
  • NDC: 71335-1263-1 30 TABLET in a BOTTLE
  • NDC: 71335-1263-2 60 TABLET in a BOTTLE
  • NDC: 71335-1263-3 90 TABLET in a BOTTLE
  • Arrayn- Pregnancy
  • Advise female patients of childbearing age about the consequences of exposure to irbesartan tablets 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 Supplements
  • Advise patients receiving irbesartan tablets not to use potassium supplements or salt substitutes containing potassium without consulting their healthcare provider n
  • Manufactured for : Macleods Pharma USA, Inc. Plainsboro, NJ 08536
  • Manufactured by : Macleods Pharmaceuticals Ltd. Daman (U.T.), INDIA
  • Packaged by:n- ORn
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