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Monopril

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Monopril

Indications
Dosage
How Supplied

INDICATIONS

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

MONOPRIL (fosinopril sodium) 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 (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 MONOPRIL does not have a similar risk (see WARNINGS).

In considering use of MONOPRIL (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).

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 (fosinopril sodium) alone, a diuretic may be added.

Concomitant administration of MONOPRIL (fosinopril sodium) 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 (fosinopril sodium) . To reduce the likelihood of hypotension, the diuretic should, if possible, be discontinued 2 to 3 days prior to beginning therapy with MONOPRIL (see WARNINGS). Then, if blood pressure is not controlled with MONOPRIL (fosinopril sodium) alone, diuretic therapy should be resumed. If diuretic therapy cannot be discontinued, an initial dose of 10 mg of MONOPRIL (fosinopril sodium) should be used with careful medical supervision for several hours and until blood pressure has stabilized. (See WARNINGS and PRECAUTIONS: Information for Patients and DRUG INTERACTIONS.)

Since concomitant administration of MONOPRIL (fosinopril sodium) 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 (fosinopril sodium) between 0.1 and 0.6 mg/kg have been studied and shown to reduce blood pressure to a similar extent (see CLINICAL PHARMACOLOGY: Pharmacodynamics and Clinical Effects). Based on this, the recommended dose of

MONOPRIL (fosinopril sodium) 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 (fosinopril sodium) 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 (fosinopril sodium) should be 10 mg once daily. Following the initial dose of MONOPRIL (fosinopril sodium) , the patient should be observed under medical supervision for at least 2 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/1.73 m2), including end-stage renal failure (creatinine clearance < 10 mL/min/1.73 m2). 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 (fosinopril sodium) 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 (fosinopril sodium) 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 (fosinopril sodium) 40” on the other. They are supplied in bottles of 90 (NDC 0087-1202-13). Bottles contain a desiccant canister.

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. Rev July 2008.

Last reviewed on RxList: 6/30/2009
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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