FOSINOPRIL SODIUM tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

FOSINOPRIL SODIUM (UNII: NW2RTH6T2N) (FOSINOPRIL - UNII:R43D2573WO)

Dostopno od:

Camber Pharmceuticals Inc.

INN (mednarodno ime):

FOSINOPRIL SODIUM

Sestava:

FOSINOPRIL SODIUM 10 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Fosinopril sodium tablets are indicated for the treatment of hypertension. It 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

Povzetek izdelek:

Fosinopril Sodium Tablets, USP 10 mg tablets: White, round, biconvex partially scored tablets debossed with “IG”on one side and “200” on other side. They are supplied in bottles of 90 (NDC 31722-200-90) and 1000 (NDC 31722- 200-10). Bottles contain a desiccant canister. 20 mg tablets: White, round, biconvex tablets debossed with “IG” on one side and “201” on other side. They are supplied in bottles of 90 (NDC 31722-201-90) and 1000 (NDC 31722-201-10). Bottles contain a desiccant canister. 40 mg tablets: White, round, biconvex tablets debossed with “IG” on one side and “202” on other side. They are supplied in bottles of 90 (NDC 31722-202-90) and 1000 (NDC 31722-202-10). Bottles contain a desiccant canister. STORAGE Store at 20° C to 25° C (68° to 77°F) [see USP Controlled Room Temperature] Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Manufactured by: InvaGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 Rev. 02/10 Barcode: 202-02-2010

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

FOSINOPRIL SODIUM - FOSINOPRIL SODIUM TABLET
CAMBER PHARMCEUTICALS INC.
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FOSINOPRIL SODIUM TABLETS
10 MG, 20 MG AND 40 MG
RX ONLY
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 Tablet
should be discontinued as soon as possible. SEE WARNINGS:
FETAL/NEONATAL MORBIDITY AND
MORTALITY.
DESCRIPTION
Fosinopril sodium tablet is the sodium salt of fosinopril, the ester
prodrug of an angiotensin coverting
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-oxopro-
poxy)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 C30H45NNaO7P, and its molecular weight is
585.65.
Fosinopril Sodium is available for oral administrations as 10 mg, 20
mg, and 40 mg tablets. Inactive
ingredients include: crospovidone, lactose, microcrystalline
cellulose, magnesium stearate, and
povidone.
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 l 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