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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

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
  • u2022u00a0u00a0 When pregnancy is detected, discontinue Irbesartan Tablets as soon as possible. u2022u00a0u00a0 Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus n
  • WARNING: FETAL TOXICITYn n
  • When pregnancy is detected, discontinue Irbesartan Tablets as soon as possible. (5.1)
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1)n
  • Irbesartan Tablets USP is an angiotensin II receptor blocker (ARB) indicated for: u2022u00a0u00a0 Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) u2022u00a0u00a0 Treatment of diabetic nephropathy in hypertensive patients with type 2u00a0diabetes, an elevated serum creatinine, and proteinuria. (1.2)
  • No data
  • Irbesartan Tabletsu00a0 75 mg are available as white to off white, oval shaped, biconvex, uncoated tablet, debossed with u201cL131u201d on one side and u201c75u201d on other side.
  • Irbesartan Tabletsu00a0 150 mg are available as white to off white, oval shaped, biconvex, uncoated tablet, debossed with u201cL132u201d on one side and u201c150u201d on other side.
  • Irbesartan Tabletsu00a0 300 mg are available as white to off white, oval shaped, biconvex, uncoated tablet, debossed with u201cL133u201d on one side and u201c300u201d on other side.
  • u2022u00a0u00a0 Tablets: 75 mg, 150 mg, 300 mg (3)
  • 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 u00a0diabetes.
  • u2022u00a0u00a0 Hypersensitivity to any component of this product. (4) u2022u00a0u00a0 Coadministration with aliskiren in patients with diabetes. (4)
  • u2022u00a0u00a0 Hypotension: Correct volume or salt depletion prior to u00a0administration. (5.2) u2022u00a0u00a0 Monitor renal function and serum potassium. (5.3)
  • The following important adverse reactions are described elsewhere in the labeling: u2022u00a0u00a0 Hypotension in Volume or Salt-Depleted Patients u2022u00a0u00a0 Impaired Renal Functionn
  • u2022u00a0u00a0 Nephropathy in type 2 diabetic patients: The most common adverseu00a0reactions which were more frequent than placebo were hyperkalemia dizziness, orthostatic dizziness, and orthostatic hypotension. (6.1)n n n
  • u2022u00a0u00a0 Lithium: Risk of lithium toxicity. (7) u2022u00a0u00a0 Non-Steroidal Anti-inflammatory Drugs (NSAIDs) and COX-2 u00a0inhibitors: Increased risk of renal impairment. Reduced u00a0antihypertensive effects. (7) u2022u00a0u00a0 Dual blockade of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia. (7)
  • u2022u00a0u00a0 Nursing Mothers: Potential for adverse effects in infants. (8.3)
  • No u00a0data u00a0are u00a0available u00a0in u00a0regard u00a0to u00a0overdosage u00a0in u00a0humans. u00a0However, u00a0daily u00a0doses u00a0of u00a0900 u00a0mg u00a0for 8 u00a0weeks u00a0were u00a0well-tolerated. u00a0The u00a0most u00a0likely u00a0manifestations u00a0of u00a0overdosage u00a0are u00a0expected u00a0to u00a0be hypotension u00a0and u00a0tachycardia; u00a0bradycardia u00a0might u00a0also u00a0occur u00a0from u00a0overdose. u00a0Irbesartan u00a0is u00a0not removed by u00a0hemodialysis.
  • Acute u00a0oral u00a0toxicity u00a0studies u00a0with u00a0irbesartan u00a0in u00a0mice u00a0and u00a0rats u00a0indicated u00a0acute u00a0lethal u00a0doses u00a0were u00a0in excess of 2000 mg/kg, about 25-fold and 50-fold the MRHD (300 mg) on a mg/m u00a0basis, respectively.
  • Irbesartan Tablet is an angiotensin II receptor (AT 1u00a0 subtype)u00a0antagonist.
  • Irbesartan is a non-peptide compound, chemically described as au00a0 2-butyl-3-[-(-1-tetrazol-5u00ad ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one.
  • Its empirical formula is CHNO, and the structural u00a0formula:n n n
  • Irbesartan 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 is available for oral administration in unscored tablets containing 75 mg, 150 mg and 300 mg of Irbesartan. Inactive ingredients include: lactose, povidone k-30, croscarmellose sodium and magnesium stearate.
  • No data
  • No data
  • No data
  • Product: 71335-0423
  • NDC: 71335-0423-1 30 TABLET in a BOTTLE
  • NDC: 71335-0423-2 60 TABLET in a BOTTLE
  • NDC: 71335-0423-3 90 TABLET in a BOTTLE
  • Pregnancy
  • Advise u00a0female u00a0patients u00a0of u00a0childbearing u00a0age u00a0about u00a0the u00a0consequences u00a0of u00a0exposure u00a0to u00a0Irbesartan Tablets during pregnancy. Discuss treatment options with women planning to become pregnant. u00a0Patients should be asked to report pregnancies to their physicians as soon as u00a0possible.
  • Arrayn- Potassium u00a0Supplements
  • Advise patients receiving Irbesartan Tablets not to use potassium supplements or salt substitutes containing potassium without consulting their healthcare provider n
  • u00a0
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • For more information, you can also call Alembic Pharmaceuticals Limited at 1-866-210-9797.
  • Manufactured by:
  • Alembic Pharmaceuticals Limited
  • (Formulation Division),
  • Panelav 389350, Gujarat, India
  • Manufactured for:
  • Alembic Pharmaceuticals, Inc.
  • 750 Route 202, Bridgewater, NJ 08807
  • USA
  • Revised: 08/2018
  • No data

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