FOSINOPRIL SODIUM tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Lake Erie Medical DBA Quality Care Products LLC

INN (International ime):

FOSINOPRIL SODIUM

Sastav:

FOSINOPRIL SODIUM 20 mg

Tip recepta:

PRESCRIPTION DRUG

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

FOSINOPRIL SODIUM- FOSINOPRIL SODIUM TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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FOSINOPRIL SODIUM TABLETS
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
should be discontinued as soon as possible. See WARNINGS,
FETAL/NEONATAL MORBIDITY AND
MORTALITY .
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:
Empirical 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.
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