FOSINOPRIL SODIUM- fosinopirl sodium tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

A-S Medication Solutions

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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

Product samenvatting:

Product: 50090-3780 NDC: 50090-3780-0 30 TABLET in a BOTTLE

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

FOSINOPRIL SODIUM- FOSINOPIRL SODIUM TABLET
A-S MEDICATION SOLUTIONS
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FOSINOPRIL SODIUM TABLETS, USP, FOR ORAL USE
RX ONLY
WARNING: FETAL TOXICITY
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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
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 mEq/L were observed. Similar increases were
observed among all patients
treated with fosinopril, including those receiving concomitant
diuretic therapy. Removal of angiotensin
II negative feedback on renin secretion leads to increase