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:

Carilion Materials Management

INN (International Name):

MOEXIPRIL HYDROCHLORIDE

Composition:

MOEXIPRIL HYDROCHLORIDE 7.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Moexipril hydrochloride tablets USP are indicated for treatment of patients with hypertension. It may be used alone or in combination with thiazide diuretics. In using moexipril hydrochloride tablets USP, 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 tablets USP do not have a similar risk (see WARNINGS ). In considering use of moexipril hydrochloride tablets USP, 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 ). Moexipril hydrochloride tablets are contraindicated in patients who are hypersensitive to this product and in patients with a history of a

Product summary:

Product: 68151-1472 NDC: 68151-1472-0 1 TABLET, FILM COATED in a PACKAGE Product: 68151-1473 NDC: 68151-1473-1 1 TABLET, FILM COATED in a BLISTER PACK

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MOEXIPRIL HYDROCHLORIDE- MOEXIPRIL HYDROCHLORIDE TABLET, FILM COATED
CARILION MATERIALS MANAGEMENT
----------
MOEXIPRIL HYDROCHLORIDE TABLETS USP, 7.5 MG AND 15 MG
0017
5150
RX ONLY
WARNING: FETAL TOXICITY
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
•
•
DESCRIPTION
Moexipril hydrochloride, USP, the hydrochloride salt of moexipril, 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:
C
H N O •HCl M.W. 535.04
Moexipril hydrochloride, USP 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 USP are supplied as bisected, coated
tablets containing 7.5 mg and 15
mg of moexipril hydrochloride, USP for oral administration. In
addition to the active ingredient,
moexipril hydrochloride, USP, the tablet core contains the following
inactive ingredients:
crospovidone, lactose monohydrate, magnesium stearate, pregelatinized
starch and sodium bicarbonate.
The film coating of the 7.5 mg tablet contains: hypromellose, iron
oxide red, lactose monohydrate,
titanium dioxide and triacetin. The film coating of the 15 mg tablet
contains: hypromellose, iron oxide
red, lactose monohydrate, titanium dioxide and triacetin.
Moexipril hydrochloride tablets USP meet USP _Dissolution Test 2_.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
WHEN PREGNANCY IS DETECTED, DISCONTINUE MOEXIPRIL HYDROCHLORIDE
TABLETS AS SOON AS
POS S IBLE.
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH TO
THE DEVELOPING FETUS. SEE WARNINGS: FETAL TOXICITY
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34
2
7
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