Country: United States
Language: English
Source: NLM (National Library of Medicine)
MOEXIPRIL HYDROCHLORIDE (UNII: Q1UMG3UH45) (MOEXIPRILAT - UNII:H3753190JS)
Teva Pharmaceuticals USA, Inc.
MOEXIPRIL HYDROCHLORIDE
MOEXIPRIL HYDROCHLORIDE 7.5 mg
ORAL
PRESCRIPTION DRUG
Moexipril hydrochloride tablets USP are indicated for treatment of patients with hypertension. It may be used alone or in combination with thiazide diuretics. In using moexipril hydrochloride tablets USP, consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that moexipril hydrochloride tablets USP do not have a similar risk (see WARNINGS ). In considering use of moexipril hydrochloride tablets USP, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS, Angioedema ). Moexipril hydrochloride tablets are contraindicated in patients who are hypersensitive to this product and in patients with a history of a
Moexipril hydrochloride tablets USP, 7.5 mg, are pink, film-coated, oval, convex tablets debossed “17” on one side and bisected on the other. They are available in bottles of 100. (NDC 0093-0017-01) Moexipril hydrochloride tablets USP, 15 mg, are pink, film-coated, oval, convex tablets debossed “5150” on one side and “93” to the left of a bisect on the other side. They are available in bottles of 100. (NDC 0093-5150-01) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Distributed By: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. G 8/2015
Abbreviated New Drug Application
MOEXIPRIL HYDROCHLORIDE- MOEXIPRIL HYDROCHLORIDE TABLET, FILM COATED TEVA PHARMACEUTICALS USA, INC. ---------- MOEXIPRIL HYDROCHLORIDE TABLETS USP, 7.5 MG AND 15 MG 0017 5150 RX ONLY WARNING: FETAL TOXICITY SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. WHEN PREGNANCY IS DETECTED, DISCONTINUE MOEXIPRIL HYDROCHLORIDE TABLETS AS SOON AS POS S IBLE. DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND DEATH TO THE DEVELOPING FETUS. SEE WARNINGS: FETAL TOXICITY DESCRIPTION Moexipril hydrochloride, USP, the hydrochloride salt of moexipril, is chemically described as [3S- [2[R*(R*)],3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro- 6,7-dimethoxy-3-isoquinolinecarboxylic acid, monohydrochloride. It is a non-sulfhydryl containing precursor of the active angiotensin-converting enzyme (ACE) inhibitor moexiprilat and its structural formula is: C H N O •HCl M.W. 535.04 Moexipril hydrochloride, USP is a fine white to off-white powder. It is soluble (about 10% weight-to- volume) in distilled water at room temperature. Moexipril hydrochloride tablets USP are supplied as bisected, coated tablets containing 7.5 mg and 15 mg of moexipril hydrochloride, USP for oral administration. In addition to the active ingredient, moexipril hydrochloride, USP, the tablet core contains the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, pregelatinized starch and sodium bicarbonate. The film coating of the 7.5 mg tablet contains: hypromellose, iron oxide red, lactose monohydrate, titanium dioxide and triacetin. The film coating of the 15 mg tablet contains: hypromellose, iron oxide red, lactose monohydrate, titanium dioxide and triacetin. Moexipril hydrochloride tablets USP meet USP _Dissolution Test 2_. CLINICAL PHARMACOLOGY MECHANISM OF ACTION Moexipril hydrochloride is a prodrug for moexiprilat, which inhibits ACE in humans and animals. The 27 34 2 7 mechanism through which moexiprilat lowers blood pressure is believed to be pri Read the complete document