BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE tablet, film coated

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Upsher-Smith Laboratories, LLC

INN (Rahvusvaheline Nimetus):

BENAZEPRIL HYDROCHLORIDE

Koostis:

BENAZEPRIL HYDROCHLORIDE 10 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Benazepril hydrochloride and hydrochlorothiazide tablets are indicated for the treatment of hypertension. This fixed combination drug is not indicated for the initial therapy of hypertension (see DOSAGE AND ADMINISTRATION). Benazepril hydrochloride and hydrochlorothiazide is contraindicated in patients who are anuric. Benazepril hydrochloride 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 hydrochloride and hydrochlorothiazide is also contraindicated in patients with a history of angioedema with or without previous ACE inhibitor treatment. Benazepril hydrochloride and hydrochlorothiazide is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer benazepril hydrochloride and hydrochlorothiazide within 36 hours o

Toote kokkuvõte:

Benazepril Hydrochloride and Hydrochlorothiazide Tablets, for oral administration, are available as 10 mg/12.5 mg Pink, oblong, film-coated tablets, debossed "E 204" on one side and scored on the other side and supplied as: NDC 0832-0483-11 bottles of 100 20 mg/12.5 mg Lavender, oblong, film-coated tablets, debossed "E 211" on one side and scored on the other side and supplied as: NDC 0832-0484-11 bottles of 100 20 mg/25 mg Maroon, oblong, film-coated tablets, debossed "E 277" on one side and scored on the other side and supplied as: NDC 0832-0485-11 bottles of 100 Each strength is supplied in bottles that contain a desiccant. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Keep tightly closed. KEEP OUT OF THE REACH OF CHILDREN. Manufactured for UPSHER-SMITH LABORATORIES, LLC. Maple Grove, MN 55369 © 2017 Upsher-Smith Laboratories, LLC. Rev. September 2018 MF0483REV09/18

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE- BENAZEPRIL
HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED
UPSHER-SMITH LABORATORIES, LLC
----------
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 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 HYDROCHLORIDE 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 molecular 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:
24
28
2
5
Its molecular formula is C H ClN O S , and its molecular weight is
297.73. Hydrochlorothiazide is a
thiazide diuretic.
The tablets are a combination of benazepril hydrochloride and
hydrochlorothiazide USP. They are
formulated for oral administration with a combination of 10 mg, or 20
mg of benazepril hydrochloride
and 12.5 mg, or 25 mg of hydrochlorothiazide USP. The inactive
ingredient