Bioprexum Dosage/Direction for Use

The dose should be individualised according to the patient profile (see Precautions) and blood pressure response.
Hypertension: Bioprexum may be used in monotherapy or in combination with other classes of antihypertensive therapy. Recommended Dose: 5 mg once daily in the morning.
Patients with a strongly activated renin-angiotensin-aldosterone system (in particular, renovascular hypertension, salt- and/or volume-depletion, cardiac decompensation or severe hypertension) may experience an excessive drop in blood pressure following the initial dose. A starting dose of 2.5 mg is recommended in such patients and the initiation of treatment should take place under medical supervision. The dose may be increased to 10 mg once daily after 1 month of treatment.
Symptomatic hypotension may occur following initiation of therapy with Bioprexum; this is more likely in patients who are being treated concurrently with diuretics. Caution is therefore recommended since these patients may be volume- and/or salt-depleted.
If possible, the diuretic should be discontinued 2-3 days before beginning therapy with Bioprexum (see Precautions).
Hypertensive Patients in Whom the Diuretic Cannot be Discontinued: Therapy with Bioprexum should be initiated with a 2.5-mg dose. Renal function and serum potassium should be monitored. The subsequent dosage of Bioprexum should be adjusted according to blood pressure response. If required, diuretic therapy may be resumed.
Elderly: Treatment should be initiated at a dose of 2.5 mg which may be progressively increased to 5 mg after 1 month, then to 10 mg if necessary depending on renal function.
Symptomatic Heart Failure: It is recommended that Bioprexum, generally associated with a nonpotassium-sparing diuretic and/or digoxin and/or a β-blocker, be introduced under close medical supervision with a recommended starting dose of 2.5 mg taken in the morning. This dose may be increased after 2 weeks to 5 mg once daily if tolerated. The dose adjustment should be based on the clinical response of the individual patient.
In severe heart failure and in other patients considered to be at high risk (patients with impaired renal function and a tendency to have electrolyte disturbances, patients receiving simultaneous treatment with diuretics and/or treatment with vasodilating agents), treatment should be initiated under careful supervision (see Precautions).
Patients at high risk of symptomatic hypotension eg, patients with salt depletion with or without hyponatraemia, patients with hypovolaemia or patients who have been receiving vigorous diuretic therapy, should have these conditions corrected, if possible, prior to therapy with Bioprexum. Blood pressure, renal function and serum potassium should be monitored closely, both before and during treatment with Bioprexum (see Precautions).
Stable Coronary Artery Disease: Initially 5 mg once daily for 2 weeks, then increased to 10 mg once daily, depending on renal function and provided that the 5 mg dose is well tolerated.
Elderly: Elderly patients should receive 2.5 mg once daily for 1 week, then 5 mg once daily the next week, before increasing the dose up to 10 mg once daily depending on renal function. The dose should be increased only if the previous lower dose is well tolerated.
Renal Impairment: Dosage in patients with renal impairment should be based on creatinine clearance (CrCl).
CrCl ≥60 mL/min: 5 mg/day, >30 to <60 mL/min: 2.5 mg/day, >15 to <30 mL/min: 2.5 mg every other day.
Haemodialysed Patients* (CrCl <15 mL/min): 2.5 mg on the day of dialysis.
*Dialysis clearance of perindoprilat is 70 mL/min. For patients on haemodialysis, the dose should be taken after dialysis.
Hepatic Impairment: No dosage adjustment is necessary in patients with hepatic impairment (see Pharmacokinetics under Actions and Precautions).
Administration: It is recommended that Bioprexum be taken once daily in the morning before a meal.