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:

Teva Pharmaceuticals 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. 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, 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: White to off-white, scored, rectangular-shaped tablet debossed “9” on one side of the score and “3” on the other side of the score. On the opposite side of the tablet debossed “72” on one side of the score and “22” on the other side of the score. They are supplied in bottles of 90 (NDC 0093-7222-98) and 1000 (NDC 0093-7222-10). Fosinopril sodium tablets USP, 20 mg: White to off-white, capsule-shaped tablet debossed “93” on one side and “7223” on the other side. They are supplied in bottles of 90 (NDC 0093-7223-98) and 1000 (NDC 0093-7223-10). Fosinopril sodium tablets USP, 40 mg: White to off-white, round tablet, debossed “93” on one side and “7224” on the other side. They are supplied in bottles of 90 (NDC 0093-7224-98) and 1000 (NDC 0093-7224-10). Store at 20° 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 In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. I 11/2015

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FOSINOPRIL SODIUM- FOSINOPRIL SODIUM TABLET
TEVA PHARMACEUTICALS USA, INC.
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FOSINOPRIL SODIUM TABLETS USP
7222
7223
7224
RX ONLY
USE IN PREGNANCY
WHEN USED IN PREGNANCY DURING THE SECOND AND THIRD TRIMESTERS, ACE
INHIBITORS CAN CAUSE
INJURY AND EVEN DEATH TO THE DEVELOPING FETUS. When pregnancy is
detected, fosinopril sodium
tablets should be discontinued as soon as possible. See WARNINGS,
FETAL/NEONATAL MORBIDITY
AND MORTALITY.
DESCRIPTION
Fosinopril sodium is 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 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:
C
H NNaO P M.W. 585.65
Fosinopril sodium is available for oral administration as 10 mg, 20
mg, and 40 mg tablets. Inactive
ingredients include: crospovidone, glyceryl behenate, isopropyl
alcohol, lactose anhydrous, NF,
microcrystalline cellulose, povidone, and sodium lauryl sulfate.
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).
30
45
7
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 f