SPL Set ID: 17561aae-f0bc-4ffc-a007-985b17e9baf0
1 drug(s) with this SPL Set ID
Irbesartan and Hydrochlorothiazide Tablets, USP are a combination of an angiotensin II receptor antagonist (AT 1 subtype), irbesartan, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Irbesartan is a non-peptide compound, chemically described as 2-Butyl-3-[p-(O-1H-tetrazol-5-yl-phenyl)benzyl]-1,3-diazaspiro-[4.4]non-1-en-4-one. Its empirical formula is C 25 H 28 N 6 O, and its structural formula is: 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. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7 H 8 ClN 3 O 4 S 2 and its structural formula is: Hydrochlorothiazide, USP is a white or almost white, crystalline powder with a molecular weight of 297.74. Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution. Irbesartan and Hydrochlorothiazide Tablets, USP are available for oral administration containing either 150 mg or 300 mg of irbesartan, USP combined with 12.5 mg or 25 mg of hydrochlorothiazide, USP. Inactive ingredients include: colloidal silicon dioxide, croscarmellose sodium, ferric oxide red (150 mg/12.5 mg and 300 mg/25 mg), ferric oxide yellow (300 mg/12.5 mg), lactose, magnesium stearate, microcrystalline cellulose and povidone. irbesartan-chem-structure hydrochlorothiazide.jpg