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Author: Admin | 2025-04-28
LISINOPRIL AND HYDROCHLOROTHIAZIDE- lisinopril and hydrochlorothiazide tabletSolco Healthcare LLC WARNING: FETAL TOXICITY • When pregnancy is detected, discontinue lisinopril and hydrochlorothiazide tablets as soon as possible. • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See Warnings, Fetal Toxicity. You may report side effects to Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088. DESCRIPTIONLisinopril and hydrochlorothiazide tablets combine an angiotensin converting enzyme inhibitor, lisinopril, and a diuretic, hydrochlorothiazide.Lisinopril, a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor. It is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21 H31 N3 O5 . 2H2 O and its structural formula is: Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.52. It is soluble in water, sparingly soluble in methanol, and practically insoluble in ethanol.Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7 H8 ClN3 O4 S2 and its structural formula is:Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.73, which is slightly soluble in water, but freely soluble in sodium hydroxide solution.Lisinopril and hydrochlorothiazide tablets, USP, are available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: lisinopril and hydrochlorothiazide tablets 10-12.5 containing 10 mg lisinopril and 12.5 mg hydrochlorothiazide; lisinopril and hydrochlorothiazide tablets 20-12.5 containing 20 mg lisinopril and 12.5 mg hydrochlorothiazide; and, lisinopril and hydrochlorothiazide tablets 20-25 containing 20 mg lisinopril and 25 mg hydrochlorothiazide.Inactive Ingredients: 10-12.5 Tablets – mannitol, dibasic calcium phosphate dihydrate, pregelatinized starch, magnesium stearate.20-12.5 Tablets — mannitol, dibasic calcium phosphate dihydrate, pregelatinized starch, magnesium stearate, yellow ferric oxide.20-25 Tablets — mannitol, dibasic calcium phosphate dihydrate, pregelatinized starch, magnesium stearate, red ferric oxide.CLINICAL PHARMACOLOGY Lisinopril-Hydrochlorothiazide As a result of its diuretic effects, hydrochlorothiazide increases plasma renin activity, increases aldosterone
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