Moexipril Hydrochloride and Hydrochlorothiazide Tablets USP Rx only

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:

AvKARE, 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 USP 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 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 and Hydrochlorothiazide Tablets USP 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 hypersensitiv

Product summary:

Moexipril Hydrochloride and Hydrochlorothiazide Tablets USP are available as follows: 7.5 mg/12.5 mg: Yellow, film-coated, capsule shaped tablet scored on side 1 with “9” on one side of the score and “3” on the other side of the score; on side 2, debossed with “5213”. They are available in bottles of 100 tablets. (NDC 42291-576-01) 15 mg/12.5 mg: White, film-coated, capsule shaped tablet scored on side 1 with “9” on one side of the score and “3” on the other side of the score; on side 2, debossed with “5214”. They are available in bottles of 100 tablets. (NDC 42291-577-01) 15 mg/25 mg: Yellow, film-coated, capsule shaped tablet scored on side 1 with “9” on one side of the score and “3” on the other side of the score; on side 2, debossed with “5215”. They are available in bottles of 100 tablets. (NDC 42291-578-01) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from excessive moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured for: AvKARE, Inc.                   Pulaski, TN 38478 Mfg. Rev. 08/15 AV 03/17 (P)

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE- MOEXIPRIL
HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED
AVKARE, INC.
----------
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS USP
RX ONLY
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
1. WHEN PREGNANCY IS DETECTED, DISCONTINUE MOEXIPRIL HYDROCHLORIDE AND
HYDROCHLOROTHIAZIDE TABLETS AS SOON AS POSSIBLE.
2. 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 tablets USP are a
combination of an angiotensin-
converting enzyme (ACE) inhibitor, moexipril hydrochloride, USP, and a
diuretic, hydrochlorothiazide,
USP. 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. It is
chemically described as [3 _S_-[2[ _R_*(
_R_*)],3
_R_*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-6,7-
dimethoxy-3-isoquinolinecarboxylic acid, monohydrochloride. Moexipril
hydrochloride, USP is a non-
sulfhydryl containing precursor of the active ACE inhibitor
moexiprilat and its structural formula is:
C
H
N
O
•HCl M.W. 535.04
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. It is
chemically described as 2
_H_-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:
27
34
2
7
C
H
ClN
O
S
M.W. 297.75
Moexipril hydrochloride and hydrochlorothiazide tablets USP are
available for oral administration in
three strengths. The inactive ingredients in all strengths are lactose
monohydrate, magnesium stearate,
povidone, and sodium bicarbonate. The film coating in all strengths
contains polyethylene glycol,
polyvinyl alcohol, talc, a