Monopril

[Fosinopril]

Dosage should be increased, over a several week period, to a dose that is maxi-mal and tolerated but not exceeding 40 mg once daily. The usual effective dosage range is 20 to 40 mg once daily. The appearance of hypotension, orthostasis, or azotemia early in dose titration should not preclude further careful dose titration. Consideration should be given to reducing the dose of concomitant diuretic.

For Hypertensive or Heart Failure Patients With Renal Impairment:

In patients with impaired renal function, the total body clearance of fosinoprilat is approximately 50% slower than in patients with normal renal function. Since hepatobiliary elimination partially compensates for diminished renal elimination, the total body clearance of fosinoprilat does not differ appreciably with any degree of renal insufficiency (creati-nine clearances <80 mL/ min/ 1.73m 2 ), including end-stage renal failure (creatinine clearance <10 mL/ min/ 1.73m 2 ). This relative constancy of body clearance of active fosinoprilat, resulting from the dual route of elimination, permits use of the usual dose in patients with any degree of renal impairment. (See WARNINGS: Anaphylactoid reactions during membrane exposure and PRECAUTIONS: Hemodialysis.)

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HOW SUPPLIED

MONOPRIL (fosinopril sodium tablets)
10 mg tablets: White to off-white, biconvex flat-end diamond shaped, compressed partially scored tablets with "BMS" on one side and "Monopril 10" on the other. They are supplied in bottles of 90 (NDC 0087-0158-46), and 1000 (NDC 0087-0158-85). Bottles contain a desiccant canister.
20 mg tablets: White to off-white, oval shaped, compressed tablets with "BMS" on one side and "Monopril 20" on the other. They are supplied in bottles of 90 (NDC 0087-0609-42), and 1000 (NDC 0087-0609-85). Bottles contain a desiccant canister. 40 mg tablets: White to off-white, biconvex hexagonal shaped, compressed tablets with "BMS" on one side and "Monopril 40" on the other. They are supplied in bottles of 90 (NDC 0087-1202-13). Bottles contain a desiccant canister. UNIMATIC ® unit-dose packs containing 100 tablets are also available in 20 mg (NDC 0087-0609-45).

STORAGE

Store at 25° C (77° F): excursions permitted to 15° C Ð 30° C (59° F Ð 86° F). [see USP Controlled Room Temperature]. Protect from moisture by keeping bottle tightly closed.

F4-B001-05-03 0158DIM-12 Printed in USA Revised: May 2003

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