Drug Catalog - Product Detail
IRBESARTAN TB 75MG 90
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 43547-0277-09 | SOLCO HEALTHCARE | 90 | 75MG | TABLET |
Generic Name
Substance Name
Product Type
Route
Application Number
Description
DESCRIPTION Irbesartan is an angiotensin II receptor (AT 1 subtype) antagonist. Irbesartan is a non-peptide compound, chemically described as a 2-butyl-3-[ p -( o -1 H -tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro [4.4]non-1-en-4-one. Its empirical formula is C 25 H 28 N 6 O, and the structural formula: 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 is available for oral administration in unscored tablets containing 75 mg, 150 mg, or 300 mg of irbesartan. Inactive ingredients include: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, and magnesium stearate. Irbesartan Chemical Structure
How Supplied
HOW SUPPLIED Irbesartan Tablets USP, 75 mg are white or off-white, capsule-shaped, biconvex, debossed ‘HH’ on one side and ‘329’ on the other side. NDC numbers are supplied as follows: NDC 43547-277-03: bottles of 30 NDC 43547-277-09: bottles of 90 NDC 43547-277-50: bottles of 500 Irbesartan Tablets USP, 150 mg are white or off-white, capsule-shaped, biconvex , debossed ‘HH’ on one side and ‘330’ on the other side. NDC numbers are supplied as follows: NDC 43547-278-03: bottles of 30 NDC 43547-278-09: bottles of 90 NDC 43547-278-50: bottles of 500 Irbesartan Tablets USP, 300 mg, are white or off-white, capsule-shaped, biconvex tablet debossed ‘HH’ on one side and ‘331’ on the other side. NDC numbers are supplied as follows: NDC 43547-279-03: bottles of 30 NDC 43547-279-09: bottles of 90 NDC 43547-279-50: bottles of 500 Storage Store at 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. You may report side effects to Solco Healthecare US LLC. at 1-866-257-2597 or FDA at 1-800-FDA-1088.
Indications & Usage
INDICATIONS AND USAGE Hypertension Irbesartan is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. Nephropathy in Type 2 Diabetic Patients Irbesartan is indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (>300 mg/day) in patients with type 2 diabetes and hypertension. In this population, Irbesartan reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end-stage renal disease (need for dialysis or renal transplantation) (see CLINICAL PHARMACOLOGY: Clinical Studies ).
Dosage and Administration
DOSAGE AND ADMINISTRATION Irbesartan may be administered with other antihypertensive agents and with or without food. Hypertension The recommended initial dose of Irbesartan is 150 mg once daily. Patients requiring further reduction in blood pressure should be titrated to 300 mg once daily. A low dose of a diuretic may be added, if blood pressure is not controlled by Irbesartan alone. Hydrochlorothiazide has been shown to have an additive effect (see CLINICAL PHARMACOLOGY: Clinical Studies ). Patients not adequately treated by the maximum dose of 300 mg once daily are unlikely to derive additional benefit from a higher dose or twice-daily dosing. No dosage adjustment is necessary in elderly patients, or in patients with hepatic impairment or mild to severe renal impairment. Nephropathy in Type 2 Diabetic Patients The recommended target maintenance dose is 300 mg once daily. There are no data on the clinical effects of lower doses of Irbesartan on diabetic nephropathy (see CLINICAL PHARMACOLOGY: Clinical Studies ). Volume- and Salt-Depleted Patients A lower initial dose of Irbesartan (75 mg) is recommended in patients with depletion of intravascular volume or salt (eg, patients treated vigorously with diuretics or on hemodialysis) (see WARNINGS: Hypotension in Volume- or Salt-Depleted Patients ).