SPL Set ID: e6c35575-9c3f-42f8-b8b8-577a29f9d381
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 a 2-butyl-3-[ p -( o -1 H- tetrazol-5-yl-phenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one. Its molecular 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 molecular formula is C 7 H 8 ClN 3 O 4 S 2 and its structural formula is: Hydrochlorothiazide USP is a white, or practically white, crystalline powder with a molecular weight of 297.7. 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 irbesartan USP combined with 12.5 mg hydrochlorothiazide USP. Inactive ingredients include: colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, ferric oxide yellow, lactose, magnesium stearate, microcrystalline cellulose and povidone.