Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703)
Blenheim Pharmacal, Inc.
BENAZEPRIL HYDROCHLORIDE
BENAZEPRIL HYDROCHLORIDE 10 mg
ORAL
PRESCRIPTION DRUG
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.
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.
Abbreviated New Drug Application
BENAZEPRIL HYDROCHLORIDE- BENAZEPRIL HYDROCHLORIDE TABLET BLENHEIM PHARMACAL, INC. ---------- 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 Διαβάστε το πλήρες έγγραφο