Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
IRBESARTAN (UNII: J0E2756Z7N) (IRBESARTAN - UNII:J0E2756Z7N)
AvPAK
IRBESARTAN
IRBESARTAN 75 mg
ORAL
PRESCRIPTION DRUG
1.1 Hypertension Irbesartan tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic cl
Irbesartan Tablets USP, 75 mg are white, capsule shaped, biconvex tablets debossed with ‘158’ on one side and ‘H’ on the other side. They are supplied as follows: NDC 50268-440-15 (10 tablets per card, 5 cards per carton). Irbesartan Tablets USP, 150 mg are white, capsule shaped, biconvex tablets debossed with‘159’ on one side and ‘H’ on the other side. They are supplied as follows: NDC 50268-441-15 (10 tablets per card, 5 cards per carton). Irbesartan Tablets USP, 300 mg are white, capsule shaped, biconvex tablets debossed with ‘160’ on one side and ‘H’ on the other side. They are supplied as follows: NDC 50268-442-15 (10 tablets per card, 5 cards per carton). Dispensed in Blister Punch Material. For Institutional Use Only. Storage Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature] Manufactured for: AvKARE Pulaski, TN 38478 Mfg. Rev. 09/19 AV Rev. 07/23 (P)
Abbreviated New Drug Application
IRBESARTAN- IRBESARTAN TABLET AVPAK ---------- IRBESARTAN TABLETS USP RX ONLY WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning . • 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) 5.3 IMPAIRED RENAL FUNCTION Changes in renal function including acute renal failure can be caused by drugs that inhibit the reninangiotensin system. Patients whose renal function may depend in part on the activity of the reninangiotensin system (e.g., patients with renal artery stenosis, chronic kidney disease, severe heart failure, or volume depletion) may be at particular risk of developing acute renal failure or death on irbesartan. Monitor renal function periodically in these patients. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on irbesartan [see Drug Interactions (7.3)]. DESCRIPTION Irbesartan USP is an angiotensin II receptor (AT1 subtype) antagonist. Irbesartan USP is a non-peptide compound, chemically described as a 2-butyl-3-[p-(o- 1H-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one. Its empirical formula is C H N O, 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 25 28 6 pH of 7.4. Irbesartan 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: calcium stearate, carboxy methyl cellulose calcium, colloidal silicon dioxide, microcrystalline cellulose and povidone. CLINICAL PHARMACOLOGY MECHANISM OF ACTION Angiotensin II is a potent vasoconstrictor formed from angiotensin I in a reaction catalyzed by angiotensin-c Прочетете целия документ