البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
LISINOPRIL (UNII: E7199S1YWR) (LISINOPRIL ANHYDROUS - UNII:7Q3P4BS2FD), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
REMEDYREPACK INC.
LISINOPRIL
LISINOPRIL 20 mg
ORAL
PRESCRIPTION DRUG
Lisinopril and hydrochlorothiazide t ablets 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 var
Lisinopril and Hydrochlorothiazide Tablets, for oral administration, are available as: 10 mg/12.5 mg Light pink, round, biconvex tablets, debossed " E " over "71" on one side and plain on the other and supplied as: NDC 0185-7100-01 bottles of 100 NDC 0185-7100-10 bottles of 1000 20 mg/12.5 mg White, round, biconvex tablets, debossed " E " over "152" on one side and plain on the other and supplied as: NDC 0185-0152-01 bottles of 100 NDC 0185-0152-10 bottles of 1000 20 mg/25 mg Light pink, round, biconvex tablets, debossed " E " over "173" on one side and plain on the other and supplied as: NDC 0185-0173-01 bottles of 100 NDC 0185-0173-10 bottles of 1000 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from excessive light and humidity. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. KEEP TIGHTLY CLOSED. *AN69 is a registered trademark of Hospal Ltd. Manufactured by Sandoz Inc. Princeton, NJ 08540 46192944 Rev. September 2018 MF7100REV09/18 7459
Abbreviated New Drug Application
LISINOPRIL AND HYDROCHLOROTHIAZIDE- LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET REMEDYREPACK INC. ---------- LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS RX ONLY WARNING: FETAL TOXICITY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ WHEN PREGNANCY IS DETECTED, DISCONTINUE LISINOPRIL AND HYDROCHLOROTHIAZIDE AS SOON AS POS S IBLE. 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 combines an angiotensin converting enzyme inhibitor, lisinopril, and a diuretic, hydrochlorothiazide. Lisinopril, USP, 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 441.52. It is soluble in water, sparingly soluble in methanol, and practically insoluble in ethanol. Hydrochlorothiazide, USP 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 297.73, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Lisinopril and hydrochlorothiazide Tablets are available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: lisinopril and hydrochlorothiazide Tablets, 10 mg/12.5 mg, 20 mg/12.5 mg, and 20 mg/25 mg. Inactive ingredients are: calcium phosphate, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, and pregelatinized starch (corn). Lisinopril and hydrochlorothiazide Tablets, 10 mg/12.5 mg, and 20 mg/25 mg also contain iron oxides. CLINICAL PHARMACOLOGY LISINOPRIL AND HYDROCHLOROTHIAZIDE As a result of i اقرأ الوثيقة كاملة