FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FOSINOPRIL SODIUM (UNII: NW2RTH6T2N) (FOSINOPRILAT - UNII:S312EY6ZT8), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Available from:

Physicians Total Care, Inc.

INN (International Name):

FOSINOPRIL SODIUM

Composition:

FOSINOPRIL SODIUM 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 and 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 Angioedema: ). Fosinopril sodium and hydrochlorothiazide tablets are contraindicated in patients who are anuric. Fosinopril sodium and hydrochlorothiazide tablets are also contraindicated in patients who are hypersensitive to fosinopril, to

Product summary:

Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg are white, round biconvex tablets debossed with "I" on one side and "3" on the other and are available in: Fosinopril Sodium and Hydrochlorothiazide Tablets, 20 mg/12.5 mg are white, round biconvex tablets debossed with "15" on one side and bisect on the other and are available in:

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE - FOSINOPRIL SODIUM AND
HYDROCHLOROTHIAZIDE TABLET
PHYSICIANS TOTAL CARE, INC.
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FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLETS, USP
RX ONLY
USE IN PREGNANCY
WHEN USED IN PREGNANCY DURING THE SECOND AND THIRD TRIMESTERS, ACE
INHIBITORS CAN CAUSE
INJURY AND EVEN DEATH TO THEDEVELOPING FETUS. When pregnancy is
detected, fosinopril sodium
and hydrochlorothiazide tablets, USP should be discontinued as soon as
possible. See
WARNINGS: FETAL/NEONATAL MORBIDITY AND MORTALITY.
DESCRIPTION
Fosinopril sodium, USP 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, USP's chemical name is L-
proline, 4-cyclohexyl-1-[[[2- methyl1-( 1-oxopropoxy)-propoxy]-(4
phenylbutyl)-phosphinyl] acetyl]-,
sodium salt, _trans-; _its structural formula is:
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-2H-1 ,2,4-
benzothiadiazine-7-sulfonamide 1,1-dioxide; its structural formula is:
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 mg/12.5 mg, containing 10 mg of
fosinopril sodium and 12.5 mg of
hydrochlorothiazide, USP; and fosinopril sodium and
hydrochlorothiazide tablets, 20 mg/12.5 mg,
containing 20 mg of fosinopril sodium and 12.5 mg of
hydrochloroth