Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703)
STAT RX USA LLC
BENAZEPRIL HYDROCHLORIDE
BENAZEPRIL HYDROCHLORIDE 20 mg
ORAL
PRESCRIPTION DRUG
Benazepril hydrochloride is indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. In using Benazepril hydrochloride, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that Benazepril hydrochloride does not have a similar risk (see WARNINGS). Black patients receiving ACE-inhibitors have been reported to have a higher incidence of angioedema compared to nonblacks. It should also be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in nonblacks Benazepril hydrochloride is contraindicated in patients who are hypersensitive to this product or to any other ACE inhibitor. Benazepril hydrochloride is also contraindicated in patients with a history of angioedema with or without pre
Benazepril Hydrochloride Tablets, USP are supplied as follows: 5 mg (white biconvex, round, uncoated tablets, debossed with “51” on one side and “A” on the other side) Bottles of 30: NDC 65162-751-03 Bottles of 100: NDC 65162-751-10 Bottles of 500: NDC 65162-751-50 10 mg (white biconvex, round, uncoated tablets, debossed with “52” on one side and “A” on the other side) Bottles of 30: NDC 65162-752-03 Bottles of 100: NDC 65162-752-10 Bottles of 500: NDC 65162-752-50 20 mg (white biconvex, round, uncoated tablets, debossed with “53” on one side and “A” on the other side) Bottles of 30: NDC 65162-753-03 Bottles of 100: NDC 65162-753-10 Bottles of 500: NDC 65162-753-50 40 mg (white biconvex, round, uncoated tablets, debossed with “54” on one side and “A” on the other side) Bottles of 30: NDC 65162-754-03 Bottles of 100: NDC 65162-754-10 Bottles of 500: NDC 65162-754-50 Store at 20º to 25°C (68° to 77ºF) (see USP Controlled Room Temperature) Dispense in tight container (USP). Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by Amneal Pharmaceuticals Glasgow, KY 42141 Rev. 12-2009
Abbreviated New Drug Application
BENAZEPRIL - BENAZEPRIL HYDROCHLORIDE TABLET STAT RX USA LLC ---------- RX ONLY PRESCRIBING INFORMATION USE IN PREGNANCY WHEN USED IN PREGNANCY, ACE INHIBITORS CAN CAUSE INJURY AND EVEN DEATH TO THE DEVELOPING FETUS. When pregnancy is detected, benazepril hydrochloride should be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal Morbidity and Mortality. DESCRIPTION Benazepril hydrochloride is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Its chemical name is 3-[[1-(ethoxy-carbonyl)-3-phenyl-(1S)-propyl]amino]- 2,3,4,5-tetrahydro-2-oxo-1H-1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is BENAZEPRIL 20MG STRUCTURE Its empirical formula is C H N O •HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Benazepril Hydrochloride Tablets, USP are supplied as white and round biconvex tablets containing 5 mg, 10 mg, 20 mg, and 40 mg of benazepril hydrochloride for oral administration. The inactive ingredients are crospovidone, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized corn starch, and talc. 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 hydrochloride alone for up to 52 weeks had elevations of serum potassium of up to 0.2 mEq/L. Similar patients treated with Διαβάστε το πλήρες έγγραφο