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:

Heritage Pharmaceuticals Inc. d/b/a Avet 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 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, 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 is also contraindicated in patients who are hypersensitive to fosinopril, to any other ACE inhibi

Product summary:

Fosinopril sodium and hydrochlorothiazide tablets, USP are available as follows: 10 mg / 12.5 mg – Each orange and white colored, speckled, round, biconvex uncoated tablet debossed with "HP60" on one side and plain on the other side contains 10 mg fosinopril sodium, USP and 12.5 mg hydrochlorothiazide, USP. Tablets are supplied in bottles of 30, 100 and 500. 20 mg / 12.5 mg – Each orange and white colored, speckled, round, biconvex uncoated tablet debossed with "HP61" separated by a score line on one side and plain on the other side contains 20 mg fosinopril sodium, USP and 12.5 mg hydrochlorothiazide, USP. Tablets are supplied in bottles of 30, 100 and 500. Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture by keeping bottle tightly closed. Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India. Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ07724 1.866.901.DRUG (3784)

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE- FOSINOPRIL SODIUM AND
HYDROCHLOROTHIAZIDE TABLET
HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.
----------
RX ONLY
BOXED WARNING
WARNING: FETAL TOXICITY
WHEN PREGNANCY IS DETECTED, DISCONTINUE FOSINOPRIL AND
HYDROCHLOROTHIAZIDE AS SOON AS
POS S IBLE.
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 crystalline powder,
soluble (>100 mg/mL) in water, in
ethanol, and in methanol, and slightly soluble in hexane. 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 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-2H-1,2,4-
benzothiadi-azine-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, USP is a
combination of fosinopril sodium and
hydrochlorothiazide, USP. It is available for oral use in two tablet
strengths: fosinopril sodium and
hydrochlorothiazide 10 mg/12.5 mg, containing 10 mg of fosinopril
sodium, USP and 12.5 mg of
hydrochlorothiazide, USP; and fosinopril sodium and
hydrochlorothiazide