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

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Glenmark Pharmaceuticals Inc., USA

INN (International Name):

MOEXIPRIL HYDROCHLORIDE

Sammensetning:

MOEXIPRIL HYDROCHLORIDE 7.5 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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

Produkt oppsummering:

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.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE- MOEXIPRIL
HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED
GLENMARK PHARMACEUTICALS INC., USA
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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.