国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
FOSINOPRIL SODIUM (UNII: NW2RTH6T2N) (FOSINOPRILAT - UNII:S312EY6ZT8)
Physicians Total Care, Inc.
FOSINOPRIL SODIUM
FOSINOPRIL SODIUM 10 mg
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 than in non-black patients
Fosinopril sodium tablets USP, 10 mg: White to off-white, scored, rectangular-shaped tablet embossed “9” on one side of the score and “3” on the other side of the score. On the opposite side of the tablet embossed “72” on one side of the score and “22” on the other side of the score. They are supplied in Fosinopril sodium tablets USP, 20 mg: White to off-white, capsule-shaped tablet embossed “93” on one side and “7223” on the other side. They are supplied in Fosinopril sodium tablets USP, 40 mg: White to off-white, round tablet, embossed “93” on one side and “7224” on the other side. They are supplied in Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture by keeping bottle tightly closed. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 91010, Israel Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. H 4/2009 Distributed by: Physicians Total Care, Inc. Tulsa, OK 74146
Abbreviated New Drug Application
FOSINOPRIL SODIUM - FOSINOPRIL SODIUM TABLET PHYSICIANS TOTAL CARE, INC. ---------- FOSINOPRIL SODIUM TABLETS USP, 10 MG, 20 MG, AND 40 MG 7222 7223 7224 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 tablets should be discontinued as soon as possible. See WARNINGS, FETAL/NEONATAL MORBIDITY AND MORTALITY. 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 is available for oral administration as 10 mg, 20 mg, and 40 mg tablets. Inactive ingredients include: crospovidone, glyceryl behenate, isopropyl alcohol, lactose anhydrous, NF, microcrystalline cellulose, povidone, and sodium lauryl sulfate. CLINICAL PHARMACOLOGY MECHANISM OF ACTION In animals and humans, fosinopril sodium is hydrolyzed by esterases to the pharmacologically active 30 45 7 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 阅读完整的文件