BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE tablet, film coated

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Bryant Ranch Prepack

INN (Διεθνής Όνομα):

BENAZEPRIL HYDROCHLORIDE

Σύνθεση:

BENAZEPRIL HYDROCHLORIDE 20 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

NDC: 63629-2680-1: 30 Tablets in a BOTTLE NDC: 63629-2680-2: 90 Tablets in a BOTTLE NDC: 63629-2680-3: 100 Tablets in a BOTTLE NDC: 63629-2680-4: 60 Tablets in a BOTTLE

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE- BENAZEPRIL
HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED
BRYANT RANCH PREPACK
----------
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS
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
24
28
2
5
6-chloro-3,4-dihydro-2_H_-1,2,4-benzothiadiazine-7-sulfonamide
1,1-dioxide; its structural
formula is:
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 5
mg, 10 mg, or 20
mg of benazepril hydrochloride and 6.25 mg, 12.5 mg, or 25 mg of
hydrochlorothiazide,
USP. The inactive ingredients of the tablets are colloidal sil