FOSINOPRIL SODIUM tablet

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Golden State Medical Supply

INN (Међународно име):

FOSINOPRIL SODIUM

Састав:

FOSINOPRIL SODIUM 10 mg

Тип рецептора:

PRESCRIPTION DRUG

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

FOSINOPRIL SODIUM- FOSINOPRIL SODIUM TABLET
GOLDEN STATE MEDICAL SUPPLY
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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 Na
tablets should be discontinued as soon as possible. See WARNINGS,
FETAL/NEONATAL MORBIDITY
AND MORTALITY.
DESCRIPTION
Fosinopril Na tablets, USP contain the sodium salt of fosinopril, the
ester pro-drug 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-cyclo-hexyl-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:
Its empirical formula is C
H NNaO P, and its molecular weight is 585.65.
Fosinopril Na tablets, USP are available for oral administration as 10
mg, 20 mg, and 40 mg
tablets.Inactive ingredients are: crospovidone, lactose and zinc
stearate.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
In animals and humans, fosinopril 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.
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 p