Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Rising Pharmaceuticals, Inc.
BENAZEPRIL HYDROCHLORIDE
BENAZEPRIL HYDROCHLORIDE 10 mg
ORAL
PRESCRIPTION DRUG
Benazepril HCl and Hydrochlorothiazide is indicated for the treatment of hypertension. This fixed combination drug is not indicated for the initial therapy of hypertension (see DOSAGE AND ADMINISTRATION). Benazepril HCl and Hydrochlorothiazide is contraindicated in patients who are anuric. Benazepril HCl and Hydrochlorothiazide is also contraindicated in patients who are hypersensitive to benazepril, to any other ACE inhibitor, to hydrochlorothiazide, or to other sulfonamide-derived drugs. Hypersensitivity reactions are more likely to occur in patients with a history of allergy or bronchial asthma. Benazepril HCl and Hydrochlorothiazide is also contraindicated in patients with a history of angioedema with or without previous ACE inhibitor treatment. Benazepril HCl and Hydrochlorothiazide is contraindicated in combination with a neprilysin (e.g., sacubitril). Do not administer Benazepril HCl and Hydrochlorothiazide within 36 hours of switching to or from sacubitril/valsartan a neprilysin inhibitor (see WARNING
Benazepril HCl USP and Hydrochlorothiazide USP is available in tablets of three different strengths: Tablets of each strength are supplied in bottles that contain a desiccant and 100 tablets. The National Drug Codes for the various packages are: Tablets are oblong and scored, with "LOTENSIN HCT" on one side and appropriate number imprinted on the other side. Storage: Do not store above 86ºF (30ºC). Protect from moisture and light. Dispense in tight, light -resistant container (USP). Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07663 Manufactured for: Validus Pharmaceuticals LLC Parsippany, NJ 07054 © 2018 Validus Pharmaceuticals LLC 60064-02 August 2018
New Drug Application Authorized Generic
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE - BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET RISING PHARMACEUTICALS, INC. ---------- BENAZEPRIL HCL USP AND HYDROCHLOROTHIAZIDE USP TABLETS COMBINATION TABLETS 10 MG/12.5 MG 20 MG/12.5 MG 20 MG/25 MG RX ONLY PRESCRIBING INFORMATION WARNING: FETAL TOXICITY WHEN PREGNANCY IS DETECTED, DISCONTINUE BENAZEPRIL HCL AND HYDROCHLOROTHIAZIDE 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 Benazepril hydrochloride USP is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride’s chemical name is 3-[[1-(ethoxycarbonyl)- 3-phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1_H_-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is _Its empirical formula is C_ _H N O ·HCl, and its molecular weight is 460.96._ Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Hydrochlorothiazide USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in _n_-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide’s chemical name is 6-chloro-3,4-dihydro-2_H_-1,2,4- benzothiadiazine-7-sulfonamide 1,1-dioxide; its structural formula is _Its empirical formula is C H ClN O S , and its molecular weight is 297.73. Hydrochlorothiazide is a_ _thiazide diuretic._ Benazepril HCl and Hydrochlorothiazide is a combination of benazepril and hydrochlorothiazide USP. The tablets are formulated for oral administration with a combination of 10 or 20 mg of benazepril and 12.5 or 25 mg of hydrochlorothiazide USP. The inactive ingredients of the tablet Preberite celoten dokument