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:

Bryant Ranch Prepack

INN (International Name):

FOSINOPRIL SODIUM

Composition:

FOSINOPRIL SODIUM 40 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:

Product: 63629-7293 NDC: 63629-7293-1 30 TABLET in a BOTTLE NDC: 63629-7293-2 90 TABLET in a BOTTLE NDC: 63629-7293-3 28 TABLET in a BOTTLE Product: 63629-7663 NDC: 63629-7663-1 30 TABLET in a BOTTLE NDC: 63629-7663-2 45 TABLET in a BOTTLE NDC: 63629-7663-3 60 TABLET in a BOTTLE NDC: 63629-7663-4 90 TABLET in a BOTTLE NDC: 63629-7663-5 300 TABLET in a BOTTLE NDC: 63629-7663-6 800 TABLET in a BOTTLE NDC: 63629-7663-7 1000 TABLET in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FOSINOPRIL SODIUM- FOSINOPRIL TABLET
BRYANT RANCH PREPACK
----------
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
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
30
45
7
serum potassium.
In 647 hypertensive patients treated with fosinopril alone for an
average of 29 weeks, mean