FOSINOPRIL SODIUM tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

A-S Medication Solutions

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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

Ürün özeti:

Product: 50090-4743 NDC: 50090-4743-0 30 TABLET in a BOTTLE NDC: 50090-4743-1 90 TABLET in a BOTTLE

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

FOSINOPRIL SODIUM- FOSINOPRIL SODIUM TABLET
A-S MEDICATION SOLUTIONS
----------
FOSINOPRIL SODIUM TABLETS, USP, FOR ORAL USE
RX ONLY
WARNING: FETAL TOXICITY
•
•
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, USP, is available for oral administration as 10 mg,
20 mg, and 40 mg
tablets. Inactive ingredients include: crospovidone, lactose
monohydrate,
microcrystalline cellulose, povidone, and sodium stearyl fumarate.
CLINICAL PHARMACOLOGY
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
30
45
7
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 serum
potassium.
In 647 hypertensive patients treated with fosinopril alone for an
average of 29 weeks,
mean increases in serum potassium of 0.1