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Monopril (Fosinopril Sodium) - Indications and Dosage

 
 



INDICATIONS AND USAGE

MONOPRIL (fosinopril sodium tablets) is indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics.

MONOPRIL is 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 MONOPRIL, 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 MONOPRIL does not have a similar risk (see WARNINGS).

In considering use of MONOPRIL, 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).

DOSAGE AND ADMINISTRATION

Hypertension

Adults

The recommended initial dose of MONOPRIL (fosinopril sodium tablets) is 10 mg once a day, both as monotherapy and when the drug is added to a diuretic. Dosage should then be adjusted according to blood pressure response at peak (2-6 hours) and trough (about 24 hours after dosing) blood levels. The usual dosage range needed to maintain a response at trough is 20-40 mg but some patients appear to have a further response to 80 mg. In some patients treated with once daily dosing, the antihypertensive effect may diminish toward the end of the dosing interval. If trough response is inadequate, dividing the daily dose should be considered. If blood pressure is not adequately controlled with MONOPRIL alone, a diuretic may be added.

Concomitant administration of MONOPRIL with potassium supplements, potassium salt substitutes, or potassium-sparing diuretics can lead to increases of serum potassium (see PRECAUTIONS).

In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally can occur following the initial dose of MONOPRIL. To reduce the likelihood of hypotension, the diuretic should, if possible, be discontinued two to three days prior to beginning therapy with MONOPRIL (see WARNINGS). Then, if blood pressure is not controlled with MONOPRIL alone, diuretic therapy should be resumed. If diuretic therapy cannot be discontinued, an initial dose of 10 mg of MONOPRIL should be used with careful medical supervision for several hours and until blood pressure has stabilized. (See WARNINGS ; PRECAUTIONS: Information for Patients and Drug Interactions.)

Since concomitant administration of MONOPRIL with potassium supplements, or potassium-containing salt substitutes or potassium-sparing diuretics may lead to increases in serum potassium, they should be used with caution (see PRECAUTIONS).

Pediatrics

In children, doses of MONOPRIL between 0.1 and 0.6 mg/kg have been studied and shown to reduce blood pressure to a similar extent (see Pharmacodynamics and Clinical Effects). Based on this, the recommended dose of MONOPRIL in children weighing more than 50 kg is 5 to 10 mg once per day as monotherapy. An appropriate dosage strength is not available for children weighing less than 50 kg.

Heart Failure

Digitalis is not required for MONOPRIL to manifest improvements in exercise tolerance and symptoms. Most placebo-controlled clinical trial experience has been with both digitalis and diuretics present as background therapy.

The usual starting dose of MONOPRIL should be 10 mg once daily. Following the initial dose of MONOPRIL, the patient should be observed under medical supervision for at least two hours for the presence of hypotension or orthostasis and, if present, until blood pressure stabilizes. An initial dose of 5 mg is preferred in heart failure patients with moderate to severe renal failure or those who have been vigorously diuresed.

Dosage should be increased, over a several week period, to a dose that is maximal 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 (creatinine clearances <80 mL/min/1.73m2), including end-stage renal failure (creatinine clearance <10 mL/min/1.73m2). 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.)

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 - 30° C (59° F - 86° F) [see USP Controlled Room Temperature]. Protect from moisture by keeping bottle tightly closed.

Bristol-Myers Squibb Company
Princeton, NJ 08543 USA

J4-502Q
0158DIM-13
1081010A7
015895DIMP-4
1132205A3
Revised July 2003

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