Country: United States
Language: English
Source: NLM (National Library of Medicine)
MOEXIPRIL HYDROCHLORIDE (UNII: Q1UMG3UH45) (MOEXIPRILAT - UNII:H3753190JS), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Glenmark Pharmaceuticals Inc., USA
MOEXIPRIL HYDROCHLORIDE
MOEXIPRIL HYDROCHLORIDE 7.5 mg
ORAL
PRESCRIPTION DRUG
Moexipril hydrochloride and hydrochlorothiazide tablets are indicated for treatment of patients with hypertension. This fixed combination is not indicated for the initial therapy of hypertension (see DOSAGE AND ADMINISTRATION). In using moexipril hydrochloride and hydrochlorothiazide tablets, 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 and hydrochlorothiazide tablets do not have a similar risk (see WARNINGS, Neutropenia/Agranulocytosis ). In addition, ACE inhibitors, for which adequate data are available, cause a higher rate of angioedema in black than in nonblack patients (see WARNINGS, Angioedema ). Moexipril hydrochloride and hydrochlorothiazide tablets are contraindicated in patients who are hypersensitive to any component of this product and in patients with a history of angioedema related to prev
Moexipril hydrochloride and hydrochlorothiazide tablets 7.5 mg/12.5 mg are yellow colored, oval shaped, biconvex, film-coated tablets with 'G' and breakline engraved on one side and ‘207’ engraved on the other side. They are supplied as follows: Bottles of 30 NDC 68462-207-30 Bottles of 100 NDC 68462-207-01 Bottles of 1000 NDC 68462-207-10 Moexipril hydrochloride and hydrochlorothiazide tablets 15 mg/12.5 mg are white colored, oval shaped, biconvex, film-coated tablets with ‘G' and breakline engraved on one side and ‘206’ engraved on the other side. They are supplied as follows: Bottles of 30 NDC 68462-206-30 Bottles of 100 NDC 68462-206-01 Bottles of 1000 NDC 68462-206-10 Moexipril hydrochloride and hydrochlorothiazide tablets 15 mg/25 mg are yellow colored, oval shaped, biconvex, film-coated tablets with ‘G' and breakline engraved on one side and ‘205’ engraved on the other side. They are supplied as follows: Bottles of 30 NDC 68462-205-30 Bottles of 100 NDC 68462-205-01 Bottles of 1000 NDC 68462-205-10 Store, tightly closed, at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature]. Protect from excessive moisture. If product package is subdivided, dispense in tight containers as described in USP-NF.
Abbreviated New Drug Application
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE- MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED GLENMARK PHARMACEUTICALS INC., USA ---------- MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS 7.5 MG/12.5 MG, 15 MG/12.5 MG AND 15 MG/25 MG RX ONLY WARNING: FETAL TOXICITY • • DESCRIPTION Moexipril hydrochloride and hydrochlorothiazide tablets are a combination of an angiotensin- converting enzyme (ACE) inhibitor, moexipril hydrochloride, and a diuretic, hydrochlorothiazide USP. Moexipril hydrochloride is a fine white to off-white powder. It is soluble (about 10% weight-to- volume) in distilled water at room temperature. It has the empirical formula C H N O •HCl and a molecular weight of 535.04. It is chemically described as [3S-[2[R*(R*)],3R*]]-2-[2-[[1- (Ethoxycarbonyl)-3-phenyl-propyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-3-isoquino- linecarboxylic acid, monohydrochloride. Moexipril hydrochloride is a non-sulfhydryl containing precursor of the active ACE inhibitor moexiprilat and its structural formula is: Hydrochlorothiazide USP is a white, or practically white, crystalline powder. It is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine and in dimethylformamide. Hydrochlorothiazide USP has the empirical formula C H ClN O S and a molecular weight of 297.75. It is chemically described as 2H-1,2,4-Benzothiadiazine-7-sulfonamide, 6-chloro-3,4-dihydro-,1,1- dioxide. Hydrochlorothiazide USP is a thiazide diuretic and its structural formula is: Moexipril hydrochloride and hydrochlorothiazide tablets are available for oral administration in three tablet strengths. The inactive ingredients in all strengths are crospovidone, lactose monohydrate, magnesium oxide, magnesium stearate and povidone. The film-coating in all strengths contains hydroxypropyl cellulose, hypromellose, polyethylene glycol 6000, magnesium stearate and titanium WHEN PREGNANCY IS DETECTED, DISCONTINUE MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEAS SOON AS POSSIBLE. Read the complete document