FOSINOPRIL SODIUM- fosinopril tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FOSINOPRIL SODIUM (UNII: NW2RTH6T2N) (FOSINOPRILAT - UNII:S312EY6ZT8)

Available from:

Cipla USA Inc.

INN (International Name):

FOSINOPRIL SODIUM

Composition:

FOSINOPRIL SODIUM 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fosinopril sodium tablets are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. Fosinopril sodium tablets are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see DOSAGE AND ADMINISTRATION ). In using fosinopril sodium, 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 sodium does not have a similar risk (see WARNINGS ). In considering use of fosinopril sodium, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (

Product summary:

Fosinopril Sodium Tablets, USP 10 mg tablets: White, round, biconvex partially scored tablets debossed with "IG" on one side and "200" on other side. They are supplied in bottles of 90 (NDC 69097-856-05) and 1000 (NDC 69097-856-15). Bottles contain a desiccant canister. 20 mg tablets: White, round, biconvex tablets debossed with "IG" on one side and "201" on other side. They are supplied in bottles of 90 (NDC 69097-857-05) and 1000 (NDC 69097-857-15). Bottles contain a desiccant canister. 40 mg tablets: White, round, biconvex tablets debossed with "IG" on one side and "202" on other side. They are supplied in bottles of 90 (NDC 69097-858-05) and 1000 (NDC 69097-858-15). Bottles contain a desiccant canister. STORAGE Store at 20° C to 25° C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture by keeping bottle tightly closed. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059 Revised: 05/2020

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FOSINOPRIL SODIUM- FOSINOPRIL TABLET
CIPLA USA INC.
----------
FOSINOPRILSODIUM TABLETS, USP
10MG, 20MG AND 40MG
RX ONLY
WARNING: FETAL TOXICITY
WHEN PREGNANCY IS DETECTED, DISCONTINUE FOSINOPRIL SODIUM TABLETS 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 tablet, USP is the sodium salt of fosinopril USP,
the ester prodrug of
an angiotensin converting enzyme (ACE) inhibitor, fosinoprilat. It
contains a phosphinate
group capable of specific binding to the active site of angiotensin
converting enzyme.
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-.
Fosinopril sodium, USP is a white to off-white crystalline powder. It
is soluble in water
(100 mg/mL), methanol, and ethanol and slightly soluble in hexane. Its
structural formula
is:
Its empirical formula is C
H
NNaO P, and its molecular weight is 585.65.
Fosinopril Sodium, USP is available for oral administrations as 10 mg,
20 mg, and 40 mg
tablets. Inactive ingredients include: crospovidone, lactose,
microcrystalline cellulose,
magnesium stearate, and povidone.
CLINICAL PHARMACOLOGY
30
45
7
MECHANISM OF ACTION
In animals and humans, fosinopril sodium is hydrolyzed by esterases to
the
pharmacologically active form, fosinoprilat, a specific competitive
inhibitor of angiotensin-
converting enzyme (ACE).
ACE is a peptidyl dipeptidase that catalyzes the conversion of
angiotensin I to the
vasoconstrictor substance, angiotensin II. Angiotensin II also
stimulates aldosterone
secretion by the adrenal cortex. Inhibition of ACE results in
decreased plasma
angiotensin II, which leads to decreased vasopressor activity and to
decreased
aldosterone secretion. The latter decrease may result in a small
increase of serum
potassium.
In 647 hypertensive patients treated with fosinopril alone for an
average of 29 weeks,
mean in