MONOPRIL

Information about MONOPRIL
Composition:
Each tablet contain 10mg or 20mg fosinopril sodium.

Dosage:
Recommended dose and dosage schedule: Monopril is indicated in the treatment of hypertension and heart failure. - Hypertension, not being treated with diuretics: The dose range is 10 to 40 mg per day administered in a single dose and without regard to meals. The normal starting dose for patients is 10 mg once a day. Dosage may need to be adjusted after approximately 4 weeks according to blood pressure response. No additional blood pressure lowering is achieved with doses greater than 40 mg daily. If blood pressure is not adequately controlled with Monopril alone, adiuretic can be added.  Heart Failure: The initial dose of Monopril Is 10 mg once daily. If the Initial dose is well tolerated, it can be increased to 40 mg once daily, depending on clinical response. The possible appearance of hypotension after the Initial dose does not rule out a dose increase, but should obviously be carefully assessed and treated. Use with concomitant diuretic therapy. The diuretic should perfectly be discontinued for several days prior to beginning therapy with Monopril to reduce the risk of an excessive hypotensive response. If blood pressure is inadequately controlled after an observation period of approximately 4 weeks, diuretic therapy may be resumed. Alternatively, if diuretic therapy cannot be discontinued, an initial dose of 10 mg of Monopril should be used with careful medical supervision for several hours, until blood pressure has stabilized. In diuretic treated hypertensive patients, mean cerebral blood flow is maintained between 4 and 24 hours after Monopril, despite significant reduction in blood pressure. Use in the elderly (over 65 years): No dosage reduction is necessary in patients with clinically normal renal and hepatic function as no significant differences in the pharmacokinetic parameters or antihypertensive effect of fosinoprilat have been found compared with younge subjects. Use in impaired renal function: It is advisable to initiate treatment at a dose of 10 mg. Depending on the response, the dose should then be titrated to achieve the desired therapeutic effect. Absorption, bioavailability, protein binding, biotransformation and metabolism are not appreciably altered by reduced renal function. In patients with impaired renal function, the total body clearance of fosinoprilat is approximately 50% slower than that in patients with normal renal function. However since hepatobiliary elimination compensates at least partially for diminished renal elimination, the body clearance of fosinoprilat is not appreciably different over a wide range of renal insufficiency (creatinine clearances ranging from < 10 to 80 ml/min/ 1.73m2, i.e. Including end-stage renal failure). Clearance of fosinoprilat by haemodialysis and peritoneal dialysis averages 2% and 7% respectively, of urea clearances. Use in hepatic insufficiency (alcoholic or biliary cirrhosis): it is advisable to initiate treatment at a dose of 10 mg. Although the rate of hydrolysis may be slowed, the extent of hydrolysis is not appreciably reduced in patients with hepatic impairment. In this group of patients, there is evidence of reduced hepatic clearance of fosinoprilat with compensatory increase in renal excretion. Use in children: The paediatric use of Monopril has not been established.

Indications and usage:
Monopril is indicated in the treatment of hypertension where standard therapy is ineffective or inappropriate because of adverse effects. Monopril may be used alone as initial therapy or in combination with other antihypertensive agents. The antihypertens

Package:
Monopril 10 mg : Box of 10 or 20 tablets.

Monopril 20 mg : Box of 10or 20 tablets .

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