FOSINOPRIL SODIUM tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Aurobindo Pharma Limited

INN (International Name):

FOSINOPRIL SODIUM

Sammensetning:

FOSINOPRIL SODIUM 10 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 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 tablets do 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

Produkt oppsummering:

Fosinopril Sodium Tablets USP, 10 mg are white to off-white, flat, capsule shaped, uncoated tablets with notched sides at double bisect and debossed with ‘X’ and ‘77’ on either side of the score line on one side and plain on the other side.             Bottles of 30                           NDC 65862-471-30             Bottles of 90                           NDC 65862-471-90             Bottles of 1,000                       NDC 65862-471-99 Fosinopril Sodium Tablets USP, 20 mg are white to off-white, round, biconvex, uncoated tablets debossed with ‘X’ on one side and ‘84’ on the other side.             Bottles of 30                           NDC 65862-472-30             Bottles of 90                           NDC 65862-472-90             Bottles of 1,000                       NDC 65862-472-99 Fosinopril Sodium Tablets USP, 40 mg are white to off-white, round, biconvex, uncoated tablets debossed with ‘X’ on one side and ‘69’ on the other side.             Bottles of 30                           NDC 65862-473-30             Bottles of 90                           NDC 65862-473-90             Bottles of 1,000                       NDC 65862-473-99 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture by keeping bottle tightly closed. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 038, India Revised: 07/2019

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

FOSINOPRIL SODIUM - FOSINOPRIL SODIUM TABLET
AUROBINDO PHARMA LIMITED
----------
FOSINOPRIL SODIUM TABLETS, USP
RX ONLY
WARNING: FETAL TOXICITY
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
DESCRIPTION
Fosinopril sodium tablets, USP 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, USP is a white to almost white powder. It is
soluble in water
(100 mg/mL), methanol, and ethanol and slightly soluble in hexane.
Its structural formula is:
Its molecular formula is C
H
NNaO P, and its molecular weight is 585.65.
Fosinopril sodium, USP is available for oral administration as 10 mg,
20 mg, and 40 mg
30
45
7
tablets. Inactive ingredients include: anhydrous lactose,
crospovidone, 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 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 inc