FOSINOPRIL SODIUM- fosinopril sodium tablet

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

A-S Medication Solutions

INN (Nama Antarabangsa):

FOSINOPRIL SODIUM

Komposisi:

FOSINOPRIL SODIUM 10 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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

Ringkasan produk:

Product: 50090-0890 NDC: 50090-0890-0 30 TABLET in a BOTTLE

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

FOSINOPRIL SODIUM- FOSINOPRIL SODIUM TABLET
A-S MEDICATION SOLUTIONS
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FOSINOPRIL SODIUM TABLETS
WARNING: FETAL TOXICITY
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•
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