UNIVASC- moexipril hydrochloride tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MOEXIPRIL HYDROCHLORIDE (UNII: Q1UMG3UH45) (MOEXIPRILAT - UNII:H3753190JS)

Available from:

UCB, Inc.

INN (International Name):

MOEXIPRIL HYDROCHLORIDE

Composition:

MOEXIPRIL HYDROCHLORIDE 7.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

univasc ® is indicated for treatment of patients with hypertension. It may be used alone or in combination with thiazide diuretics. In using univasc ® , 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 univasc ® does not have a similar risk (see WARNINGS). In considering use of univasc ® , 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). univasc ® is contraindicated in patients who are hypersensitive to this product and in patients with a history of angioedema related to previous treatme

Product summary:

univasc ® (moexipril hydrochloride) 7.5 mg tablets are pink colored, biconvex, film-coated and scored with engraved code 707 on the unscored side and SP above and 7.5 below the score. They are supplied as follows: univasc ® (moexipril hydrochloride) 15 mg tablets are salmon colored, biconvex, film-coated, and scored with engraved code 715 on the unscored side and SP above and 15 below the score. They are supplied as follows: Store, tightly closed, at controlled room temperature 20° to 25°C (68° to 77°F). Protect from excessive moisture. If product package is subdivided, dispense in tight containers as described in USP-NF.

Authorization status:

New Drug Application

Summary of Product characteristics

UNIVASC- MOEXIPRIL HYDROCHLORIDE TABLET, FILM COATED
UCB, INC.
----------
UNIVASC
TABLETS
(MOEXIPRIL HYDROCHLORIDE)
RX ONLY
WARNING
FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WHEN PREGNANCY IS DETECTED, DISCONTINUE UNIVASC 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
univasc
(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.
univasc
is supplied as scored, coated tablets containing 7.5 mg and 15 mg of
moexipril hydrochloride
for oral administration. In addition to the active ingredient,
moexipril hydrochloride, the tablet core
contains the following inactive ingredients: lactose, magnesium oxide,
crospovidone, magnesium
stearate and gelatin. The film coating contains hydroxypropyl
cellulose, hypromellose, polyethylene
glycol 6000, magnesium stearate, titanium dioxide, and ferric oxide.
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
adre