MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE- moexipril hydrochloride and hydrochlorothiazide tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MOEXIPRIL HYDROCHLORIDE (UNII: Q1UMG3UH45) (MOEXIPRILAT - UNII:H3753190JS), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Available from:

Heritage Pharmaceuticals Inc.

INN (International Name):

MOEXIPRIL HYDROCHLORIDE

Composition:

MOEXIPRIL HYDROCHLORIDE 7.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 does 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

Product summary:

Moexipril hydrochloride and hydrochlorothiazide tablets 7.5 mg / 12.5 mg are Orange colored, oval shaped, biconvex, film coated tablets scored on one side and debossed with ‘H 35’ on other side. They are supplied as follows: Bottles of 100                      NDC 23155-035-01 Bottles of 500                      NDC 23155-035-05 Moexipril hydrochloride/hydrochlorothiazide tablets 15 mg / 12.5 mg are white to off-white colored, oval shaped, biconvex, film coated tablets scored on one side and debossed with ‘H 36’ on other side. They are supplied as follows: Bottles of 100                      NDC 23155-036-01 Bottles of 500                      NDC 23155-036-05 Moexipril hydrochloride/hydrochlorothiazide tablets 15 mg / 25 mg are Orange colored, oval shaped, biconvex, film coated tablets scored on one side and debossed with ‘H 37’ on other side. They are supplied as follows: Bottles of 100                      NDC 23155-037-01 Bottles of 500                      NDC 23155-037-05 Store, tightly closed, at controlled room temperature 20° -25°C (68° -77°F). Protect from excessive moisture. If product package is subdivided, dispense in tight containers as described in USP-NF. Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901. DRUG (3784) Rev. 10/17

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE- MOEXIPRIL
HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED
HERITAGE PHARMACEUTICALS INC.
----------
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET,7.5 MG/12.5 MG,
15 MG/12.5 MG, 15
MG/25 MGRX ONLY THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION
NEEDED TO USE MOEXIPRIL
HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE MOEXIPRIL
HYDROCHLORIDE AND
HYDROCHLOROTHIAZIDE (MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE)
TABLET, FILM
COATED FOR ORAL USE. INITIAL U.S. APPROVAL:
WARNING:FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WHEN PREGNANCY IS DETECTED, DISCONTINUE MOEXIPRIL HYDROCHLORIDE AND
HYDROCHLOROTHIAZIDE TABLETS 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
DESCRIPTION
Moexipril hydrochloride and hydrochlorothiazide tablet is a
combination of an angiotensin-converting
enzyme (ACE) inhibitor, moexipril hydrochloride, and a diuretic,
hydrochlorothiazide.
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
nonsulfhydryl containing
precursor of the active ACE inhibitor moexiprilat and its structural
formula is:
Hydrochlorothiazide 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 has the empirical formula C H ClN O S and a
molecular weight of 297.75. It is
chemically describ