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:

Ranbaxy Pharmaceuticals 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, USP is 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, USP, 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 is contraindicated in patients who are anuric. Fosinopril sodium and hydrochlorothiazide is also contraindicated in patients who are hypersensitive to fosinopril, to any othe

Product summary:

Fosinopril sodium and hydrochlorothiazide tablets, USP is available in two different strengths. Dosage strengths of both components, tablet characteristics, and available quantities/packaging are identified below. Storage Store at 20 - 25° C (68 - 77° F) [See USP Controlled Room Temperature]. Protect from moisture by keeping bottle tightly closed. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . You may report side effects to FDA at 1-800-FDA-1088 . Manufactured for: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA by: Ranbaxy Laboratories Ltd. New Delhi – 110 019, India November 2013

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE - FOSINOPRIL SODIUM AND
HYDROCHLOROTHIAZIDE TABLET
RANBAXY PHARMACEUTICALS INC.
----------
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE TABLETS, USP
RX ONLY
WARNING: FETAL TOXICITY
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
DESCRIPTION
Fosinopril sodium, USP is a white to off-white powder, freely soluble
in methanol; soluble in
chloroform and water. Fosinopril sodium, USP 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 molecular 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, USP is designated chemically as
6-chloro-3,4-dihydro-2_H_-1,2,4-
benzothiadiazine-7-sulfonamide 1,1-dioxide; its structural formula is:
30
45
7
Its molecular formula is C H ClN O S , and its molecular weight is
297.73. Hydrochlorothiazide,
USP is a thiazide diuretic.
Fosinopril sodium and hydrochlorothiazide tablets, USP is a
combination of fosinopril sodium, USP and
hydrochlorothiazide, USP. It is available for oral use in two tablet
strengths: Fosinopril sodium
hydrochlorothiazide tablets, USP 10/12.5, containing 10 mg of
fosinopril sodium, USP and 12.5 mg of
hydrochlorothiazide, USP; and fosinopril sodium and
hydrochlorothiazide tablets, USP 2