Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
FOSINOPRIL SODIUM (UNII: NW2RTH6T2N) (FOSINOPRILAT - UNII:S312EY6ZT8)
Rising Pharma Holdings, Inc.
ORAL
PRESCRIPTION DRUG
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
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 90 NDC 16571-770-09 Bottles of 1,000 NDC 16571-770-10 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 90 NDC 16571-771-09 Bottles of 1,000 NDC 16571-771-10 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 90 NDC 16571-772-09 Bottles of 1,000 NDC 16571-772-10 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: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Made in India Code: TS/DRUGS/19/1993 Issued: 03/2021
Abbreviated New Drug Application
FOSINOPRIL SODIUM - FOSINOPRIL SODIUM TABLET RISING PHARMA HOLDINGS, INC. ---------- 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 tablets. Inactive ingredients include: anhydrous lactose, crospovidone, microcrystalline cellulose, povidone, and sodium stearyl fumarate. 30 45 7 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, mea Baca dokumen lengkapnya