BENAZEPRIL HYDROCHLORIDE tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703)

Disponibil de la:

Blenheim Pharmacal, 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 tablets, USP are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. Benazepril HCl, USP is contraindicated in patients who are hypersensitive to benazepril or to any other ACE inhibitor. Benazepril HCl, USP is also contraindicated in patients with a history of angioedema with or without previous ACE inhibitor treatment. Do not co-administer aliskiren with angiotensin receptor blockers, ACE inhibitors, including benazepril HCl, USP in patients with diabetes.

Rezumat produs:

Benazepril HCl tablets, USP, 5 mg , are supplied as white, biconvex, round, uncoated tablets, debossed with “51” on one side and “A” on the other side. They are available as follows: Bottles of 30: NDC 65162-751-03 Bottles of 100: NDC 65162-751-10 Bottles of 500: NDC 65162-751-50 Benazepril HCl tablets, USP, 10 mg , are supplied as white, biconvex, round, uncoated tablets, debossed with “52” on one side and “A” on the other side. They are available as follows: Bottles of 30: NDC 65162-752-03 Bottles of 100: NDC 65162-752-10 Bottles of 500: NDC 65162-752-50 Benazepril HCl tablets, USP, 20 mg , are supplied as white, biconvex, round, uncoated tablets, debossed with “53” on one side and “A” on the other side. They are available as follows: Bottles of 30: NDC 65162-753-03 Bottles of 100: NDC 65162-753-10 Bottles of 500: NDC 65162-753-50 Benazepril HCl tablets, USP, 40 mg , are supplied as white, biconvex, round, uncoated tablets, debossed with “54” on one side and “A” on the other side. They are available as follows: Bottles of 30: NDC 65162-754-03 Bottles of 100: NDC 65162-754-10 Bottles of 500: NDC 65162-754-50 Storage: Store at 20º to 25°C (68° to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container as defined in the USP.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

BENAZEPRIL HYDROCHLORIDE- BENAZEPRIL HYDROCHLORIDE TABLET
BLENHEIM PHARMACAL, INC.
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BENAZEPRIL HYDROCHLORIDE TABLETS, USP
WARNING: FETAL TOXICITY
WHEN PREGNANCY IS DETECTED, DISCONTINUE BENAZEPRIL HYDROCHLORIDE 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
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Benazepril and benazeprilat inhibit angiotensin-converting enzyme
(ACE) in human subjects and animals.
ACE is a peptidyl dipeptidase that catalyzes the conversion of
angiotensin I to the vasoconstrictor
substance, angiotensin II. Angiotensin II also stimulates aldosterone
secretion by the adrenal cortex.
Inhibition of ACE results in decreased plasma angiotensin II, which
leads to decreased vasopressor
activity and to decreased aldosterone secretion. The latter decrease
may result in a small increase of
serum potassium. Hypertensive patients treated with benazepril HCl
alone for up to 52 weeks had
elevations of serum potassium of up to 0.2 mEq/L. Similar patients
treated with benazepril HCl and
hydrochlorothiazide for up to 24 weeks had no consistent changes in
their serum potassium (see
PRECAUTIONS).
Removal of angiotensin II negative feedback on renin secretion leads
to increased plasma renin activity.
In animal studies, benazepril had no inhibitory effect on the
vasopressor response to angiotensin II and
did not interfere with the hemodynamic effects of the autonomic
neurotransmitters acetylcholine,
epinephrine, and norepinephrine.
ACE is identical to kininase, an enzyme that degrades bradykinin.
Whether increased levels of
bradykinin, a potent vasodepressor peptide, play a role in the
therapeutic effects of benazepril HCl
remains to be elucidated.
While the mechanism through which benazepril lowers blood pressure is
believed to be primarily
suppression of the renin-angiotensin-aldosterone system, benazepril
has an antihypertensive effect even
in patients with low-renin hypertension (see INDICATION