Country: United States
Language: English
Source: NLM (National Library of Medicine)
FOSINOPRIL SODIUM (UNII: NW2RTH6T2N) (FOSINOPRILAT - UNII:S312EY6ZT8)
AvPAK
ORAL
PRESCRIPTION DRUG
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
Fosinopril sodium tablets USP, 10 mg: White to off-white, capsule-shaped tablets, both sides scored, debossed with “S|10” on one side and “|” on the other side. They are supplied as follows: NDC 50268-327-15 (10 tablets per card, 5 cards per carton). Fosinopril sodium tablets USP, 20 mg: White to off-white, round tablets debossed with “S 20” on one side and plain on the other side. They are supplied as follows: NDC 50268-328-15 (10 tablets per card, 5 cards per carton). Fosinopril sodium tablets USP, 40 mg: White to off-white, round tablets debossed with “S 40” on one side and plain on the other side. They are supplied as follows: NDC 50268-329-15 (10 tablets per card, 5 cards per carton). For Institutional Use Only. Dispensed in Unit Dose Package.
Abbreviated New Drug Application
FOSINOPRIL SODIUM- FOSINOPIRL SODIUM TABLET AVPAK ---------- 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 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 30 45 7 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 increase Read the complete document