Rx Item-Fosinopril-Hctz 20/12.5MG 100 Tab by Glenmark Pharma USA

FOSINOPRIL SODIUM - fosinopril sodium tablet
Camber Pharmceuticals Inc.


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 Tablet should be discontinued as soon as possible. See WARNINGS: Fetal/Neonatal Morbidity and Mortality.

DESCRIPTION



Fosinopril sodium tablet is the sodium salt of fosinopril, the ester prodrug of an angiotensin coverting 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-oxopro-poxy)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:

29914956-figure-01
(click image for full-size original)
Its empirical formula is C30H45NNaO7P, and its molecular weight is 585.65.

Fosinopril Sodium is available for oral administrations as 10 mg, 20 mg, and 40 mg tablets. Inactive ingredients include: crospovidone, lactose, microcrystalline cellulose, magnesium stearate, and povidone.

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 l 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. INDICATIONS AND USAGE

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, 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 (see WARNINGS: Head and Neck Angioedema and Intestinal Angioedema).

Rx Item-Fosinopril-Hctz 20/12.5MG 100 Ta
Item No. RX694513, 694513, NDC No.: 68462-0555-01, 68462-555-01, 6846255501, 68462055501, 0555-01, 055501 UPC No. 3-68462-55501-9, 368462-555019, 368462555019

Rx Item-Fosinopril-Hctz 20/12.5MG 100 Ta
Item No. RX694513, 694513, NDC No.: 68462-0555-01, 68462-555-01, 6846255501, 68462055501, 0555-01, 055501 UPC No. 3-68462-55501-9, 368462-555019, 368462555019

Rx Item-Fosinopril-Hctz 20/12.5MG 100 Ta
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