Country: United States
Language: English
Source: NLM (National Library of Medicine)
LISINOPRIL (UNII: E7199S1YWR) (LISINOPRIL ANHYDROUS - UNII:7Q3P4BS2FD), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Quality Care Products, LLC
ORAL
PRESCRIPTION DRUG
Lisinopril and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including lisinopril and hydrochlorothiazide. 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
Lisinopril and hydrochlorothiazide tablets, USP are available in three combinations of lisinopril with hydrochlorothiazide; 10 mg/12.5 mg, 20 mg/12.5 mg, and 20 mg/25 mg. The 10 mg/12.5 mg tablets are peach, round, biconvex tablets debossed IG on one side and 446 on the other side. They are available as follows: The 20 mg/12.5 mg tablets are white to off-white, round, biconvex tablets debossed IG on one side and 447 on the other side. They are available as follows: The 20 mg/25 mg tablets are peach, round, biconvex tablets debossed IG on one side and 448 on the other side. They are available as follows: 55700-900-30 55700-900-90 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from excessive light and humidity. *AN69 is a registered trademark of Hospal Ltd. Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059 Iss. 11/2019
Abbreviated New Drug Application
LISINOPRIL AND HYDROCHLOROTHIAZIDE- LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS TABLET QUALITY CARE PRODUCTS, LLC ---------- LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS, USP RX ONLY WARNING: FETAL TOXICITY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ 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. DESCRIPTION Lisinopril and hydrochlorothiazide tablets, USP combines 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 C H N O . 2H O and its structural formula is: Lisinopril, USP is a white to off-white, crystalline powder, with a molecular weight of 441.53. 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 C H ClN O S and its structural formula is: 21 31 3 5 2 7 8 3 4 2 Hydrochlorothiazide, USP is a white, or practically white, crystalline powder with a molecular weight of 297.72, 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 mg/12.5 mg, containing 10 mg lisinopril and 12.5 mg hydrochlorothiazide, lisinopril and hydrochlorothiazide tablets 20 mg/12.5 mg, containing 20 mg lisinopril and 12.5 mg hydrochlorothiazide and lisinopril and hydrochlorothiazide tablets 20 mg/25 mg, containing 20 mg lisinopril and 25 mg hydrochlorothiazide. Inactive ingredients are d Read the complete document