BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Disponibil de la:

Rising Pharmaceuticals, Inc.

INN (nume internaţional):

BENAZEPRIL HYDROCHLORIDE

Compoziție:

BENAZEPRIL HYDROCHLORIDE 10 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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

Rezumat produs:

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

Statutul autorizaţiei:

New Drug Application Authorized Generic

Caracteristicilor produsului

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