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)

Available from:

Eon Labs, Inc.

INN (International Name):

FOSINOPRIL SODIUM

Composition:

FOSINOPRIL SODIUM 10 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE- FOSINOPRIL SODIUM AND
HYDROCHLOROTHIAZIDE TABLET
EON LABS, INC.
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FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLETS
RX ONLY
WARNING: FETAL TOXICITY
•
•
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 is
designated chemically as 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 is designated chemically as
6-chloro-3,4-dihydro-2_H_-1,2,4-
benzothiadiazine-7-sulfonamide 1,1-dioxide; its structural formula is:
WHEN PREGNANCY IS DETECTED, DISCONTINUE FOSINOPRIL AND
HYDROCHLOROTHIAZIDE 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.
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 fosinopril sodium-hydrochlorothiazide
tablets 20/12.5, containing