FOSINOPRIL SODIUM- fosinopril sodium 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

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fosinopril sodium tablets are indicated for the treatment of hypertension. They 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 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 sodium tablets do not have a similar risk (see WARNINGS ). In considering use of fosinopril sodium tablets, 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

Product summary:

Fosinopril Sodium Tablets, for oral administration, are available as 10 mg White to off-white, biconvex oval tablets, debossed “E 41” on one side and bisected on the other side, packaged with a desiccant and supplied as: NDC 0185-0041-09 bottles of 90 NDC 0185-0041-10 bottles of 1000 20 mg White to off-white, capsule-shaped tablets, debossed “E 42” on one side and plain on the other side, packaged with a desiccant and supplied as: NDC 0185-0042-09 bottles of 90 NDC 0185-0042-10 bottles of 1000 40 mg White to off-white, biconvex round tablets, debossed “E ” over “47” on one side and plain on the other side, packaged with a desiccant and supplied as: NDC 0185-0047-09 bottles of 90 NDC 0185-0047-10 bottles of 1000 STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense contents in a tight container as defined in the USP with a child-resistant closure, as required. Protect from moisture. KEEP TIGHTLY CLOSED. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Distributed by Sandoz Inc. Princeton, NJ 08540 OS7960 Rev. February 2016 MF0041REV02/16

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FOSINOPRIL SODIUM- FOSINOPRIL SODIUM TABLET
EON LABS, INC.
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FOSINOPRIL SODIUM TABLETS
WARNING: FETAL TOXICITY
•
•
DESCRIPTION
Fosinopril sodium tablets are the sodium salt of fosinopril, 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 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:
Molecular formula: C
H NNaO P Molecular weight: 585.65
Fosinopril Sodium is available for oral administration as 10 mg, 20
mg, and 40 mg tablets. Inactive
ingredients include: lactose, microcrystalline cellulose, carnauba
wax, crospovidone, and zinc stearate.
CLINICAL PHARMACOLOGY
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.
WHEN PREGNANCY IS DETECTED, DISCONTINUE FOSINOPRIL SODIUM TABLETS 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.
30
45
7
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 increases in
serum potassium of 0.1 mEq/L were obser