FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Fosinopril Sodium (UNII: NW2RTH6T2N) (Fosinopril - UNII:R43D2573WO), Hydrochlorothiazide (UNII: 0J48LPH2TH) (Hydrochlorothiazide - UNII:0J48LPH2TH)

Available from:

Andrx Pharmaceuticals, Inc.

INN (International Name):

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE

Pharmaceutical form:

TABLET

Composition:

10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fosinopril sodium and hydrochlorothiazide tablets are indicated for the treatment of hypertension. These fixed dose combinations are not indicated for initial therapy. (See DOSAGE AND ADMINISTRATION .) In using fosinopril sodium-hydrochlorothiazide tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril does not have a similar risk (see WARNINGS: Neutropenia/Agranulocytosis ). ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS: Head and Neck Angioedema and Intestinal Angiodema .) Fosinopril sodium and hydrochlorothiazide tablets are contraindicated in patients who are anuric. Fosinopril sodium and hydrochlorothiazide tablets is also contraindicated in patients who are hypersensitive to fosinopril, to any

Product summary:

Fosinopril sodium and hydrochlorothiazide tablets is available in two different strengths. Dosage strengths of both components, tablet characteristics, and available quantities/packaging are identified below. Store at 25° C (77° F); excursions permitted to 15°–30° C (59°–86° F) [see USP Controlled Room temperature]. Protect from moisture by keeping bottle tightly closed. Manufactured by: Andrx Pharmaceuticals, Inc. Ft. Lauderdale, FL 33314 Rev date: 01/04 7439

Summary of Product characteristics

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE- FOSINOPRIL SODIUM AND
HYDROCHLOROTHIAZIDE TABLET
ANDRX PHARMACEUTICALS, INC.
----------
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLETS
RX ONLY
USE IN PREGNANCY
WHEN USED IN PREGNANCY DURING THE SECOND AND THIRD TRIMESTERS, ACE
INHIBITORS CAN CAUSE
INJURY AND EVEN DEATH TO THE DEVELOPING FETUS. When pregnancy is
detected, fosinopril sodium
and hydrochlorothiazide tablets should be discontinued as soon as
possible. SEE WARNINGS:
FETAL/NEONATAL MORBIDITY AND MORTALITY.
DESCRIPTION
Fosinopril sodium is a white to off-white crystalline powder, soluble
(>100 mg/mL) in water, in
ethanol, and in methanol, and slightly soluble in hexane. Fosinopril
sodium's chemical name is L-proline,
4-cyclohexyl-1-[[[2-methyl-1-(1-oxopropoxy)- propoxy]-(4 phenylbutyl)-
phosphinyl]acetyl]-, sodium
salt, _trans_-; its structural formula is:
Its empirical formula is C
H NNaO P, and its molecular weight is 585.65.
Fosinoprilat, the active metabolite of fosinopril, is a non-sulfhydryl
angiotensin-converting enzyme
inhibitor. Fosinopril is converted to fosinoprilat by hepatic cleavage
of the ester group.
Hydrochlorothiazide, USP is a white, or practically white, practically
odorless, crystalline powder. It
is slightly soluble in water; freely soluble in sodium hydroxide
solution, in n-butylamine, and in
dimethylformamide; sparingly soluble in methanol; and insoluble in
ether, in chloroform, and in dilute
mineral acids. Hydrochlorothiazide's chemical name is
6-chloro-3,4-dihydro-2_H_-1,2,4-
benzothiadiazine-7-sulfonamide 1,1-dioxide; its structural formula is:
30
45
7
Its empirical formula is C H ClN O S and its molecular weight is
297.73.
Hydrochlorothiazide is a thiazide diuretic.
Fosinopril sodium and hydrochlorothiazide tablets are a combination of
fosinopril sodium and
hydrochlorothiazide, USP. It is available for oral use in two tablet
strengths: Fosinopril sodium and
hydrochlorothiazide tablets 10/12.5, containing 10 mg of fosinopril
sodium and 12.5 mg of
hydrochlorothiazide, USP; and fosino