Product Description.:
C 85
tablet , peach , scored , round round
DebossedBiconvex
Fosinopril sodium is a white to off-white crystalline powder, soluble ( > 100 mg/mL) in water, in ethanol, and in methanol, and slightly soluble in hexane. Fosinopril sodium is designated chemically as L-proline, 4-cyclohexyl-1-[[[2-methyl-1-(1-oxopropoxy)propoxy](4-phenylbutyl)phosphinyl]acetyl]-, sodium salt,
Fosinoprilat, the active metabolite of fosinopril, is a non-sulfhydryl angiotensin-converting enzyme inhibitor. Fosinopril is converted to fosinoprilat by hepatic cleavage of the ester group.
Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide sparingly soluble in methanol and insoluble in ether, in chloroform, and in dilute mineral acids.
MONOPRIL?-HCT (fosinopril sodium-hydrochlorothiazide tablets) is a combination of fosinopril sodium and hydrochlorothiazide, USP. It is available for oral use in two tablet strengths: MONOPRIL-HCT 10/12.5, containing 10 mg of fosinopril sodium and 12.5 mg of hydrochlorothiazide, USP and MONOPRIL-HCT 20/12.5, containing 20 mg of fosinopril sodium and 12.5 mg of hydrochlorothiazide, USP. The inactive ingredients of the tablets include lactose, croscarmellose sodium, povidone, sodium stearyl fumarate, and iron oxide.
INDICATIONS
MONOPRIL-HCT (fosinopril sodium-hydrochlorothiazide tablets) is indicated for the treatment of hypertension.
These fixed dose combinations are not indicated for initial therapy. (See DOSAGE AND ADMINISTRATION.)
In using MONOPRIL-HCT, 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 does not have a similar risk (see WARNINGS: Neutropenia/Agranulocytosis).
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).
SIDE EFFECTS
MONOPRIL-HCT (fosinopril sodium-hydrochlorothiazide tablets) has been evaluated for safety in over 660 patients with hypertension approximately 137 of these patients were treated for more than one year. The observed adverse events were generally mild, transient, and similar to those seen with fosinopril and hydrochlorothiazide taken separately. There was no relationship between the incidence of side effects and age.
In placebo-controlled clinical trials of MONOPRIL-HCT, the usual duration of therapy was two months. Adverse clinical or laboratory events led to discontinuation of therapy by 4.3% of 368 placebo-treated patients and by 3.5% of 660 MONOPRIL-HCT-treated patients.
The most common reasons for discontinuation of therapy with MONOPRIL-HCT in U.S. studies were headache (0.3%), cough (0.3% see PRECAUTIONS), and fatigue (0.2%).
