FOSINOPRIL SODIUM- fosinopril sodium tablet

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Aphena Pharma Solutions - Tennessee, Inc.

INN (इंटरनेशनल नाम):

FOSINOPRIL SODIUM

रचना:

FOSINOPRIL SODIUM 20 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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 tablets, 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 tablets, 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

उत्पाद समीक्षा:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Fosinopril Sodium Tablets, 10 mg are white to off-white, biconvex oval tablets, debossed "E 41" on one side and bisected on the other side. Fosinopril Sodium Tablets, 20 mg are white to off-white, capsule-shaped tablets, debossed "E 42" on one side and plain on the other side. Fosinopril Sodium Tablets, 40 mg are white to off-white, biconvex round tablets, debossed " E " over "47" on one side and plain on the other side. Fosinopril Sodium Tablets, 10 mg, 20 mg, and 40 mg, packaged with a desiccant, are available in bottles of 90 and 1,000 tablets. STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). Protect from moisture. Sandoz Inc. Princeton, NJ 08540 Rev. 07/06 MF0041REV07/06 OS7960 MG #18651

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

FOSINOPRIL SODIUM- FOSINOPRIL SODIUM TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, INC.
----------
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 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 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:
Molecular 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 of 29 weeks, mean