MOEXIPRIL HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

moexipril hydrochloride (UNII: Q1UMG3UH45) (Moexiprilat - UNII:H3753190JS)

Available from:

Apotex Corp.

INN (International Name):

moexipril hydrochloride

Composition:

moexipril hydrochloride 7.5 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MOEXIPRIL HYDROCHLORIDE- MOEXIPRIL HYDROCHLORIDE TABLET
APOTEX CORP.
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MOEXIPRIL HYDROCHLORIDE TABLETS 7.5 MG AND 15 MG WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WHEN PREGNANCY IS DETECTED, DISCONTINUE MOEXIPRIL HYDROCHLORIDE 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, the hydrochloride salt of moexipril, 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-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:
Moexipril hydrochloride 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 are supplied as scored tablets
containing 7.5 mg and 15 mg of
moexipril hydrochloride for oral administration. In addition to the
active ingredient, moexipril
hydrochloride, the tablet contains the following inactive ingredients:
magnesium carbonate,
crospovidone, copovidone and zinc stearate.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Moexipril hydrochloride is a prodrug for moexiprilat, which inhibits
ACE in humans and animals. The
mechanism through which moexiprilat lowers blood pressure is believed
to be primarily inhibition of
ACE activity. ACE is a peptidyl dipeptidase that catalyzes the
conversion of the inactive decapeptide
angiotensin I to the vasoconstrictor substance angiotensin II.
Angiotensin II is a potent peripheral
vasoconstrictor that also stimulates aldosterone secretion by the
adrenal cortex and provides negative
feedback on renin secretion. ACE is identical to kininase II, an
enzyme that degrades bradykinin,