ACCUPRO Film-coated tablet Ref.[7065] Active ingredients: Quinapril

Posology

Adults

Hypertension

Monotherapy:

The recommended initial dosage is 10 mg once daily in uncomplicated hypertension. Depending upon clinical response, patient’s dosage may be titrated (by doubling the dose allowing adequate time for dosage adjustment) to a maintenance dosage of 20 mg/day to 40 mg/day given as a single dose or divided into 2 doses. Long-term control is maintained in most patients with a single daily dosage regimen. Patients have been treated with dosages up to 80 mg/day. Take either with or without food. The dose should always be taken at about the same time of day to help increase compliance.

Concomitant Diuretics:

In order to determine if excess hypotension will occur, an initial dosage of 2.5 mg of Accupro is recommended in patients who are being treated with a diuretic. After this the dosage of Accupro should be titrated (as described above) to the optimal response (see sections 4.3, 4.4, 4.5 and 5.1).

Congestive Heart Failure

In order to closely monitor patients for symptomatic hypotension, a single 2.5 mg initial dosage is recommended. After this, patients should be titrated to an effective dose: (up to 40 mg/day) given in 1 or 2 doses with concomitant diuretic and/or cardiac glycoside therapy. Patients are usually maintained effectively on doses of 10 mg/day to 20 mg/day given with concomitant therapy. Take either with or without food. The dose should always be taken at about the same time of day to help increase compliance.

In the treatment of severe or unstable congestive heart failure, Accupro should always be initiated in hospital under close medical supervision.

Other patients who may also be considered to be at higher risk and should have treatment initiated in hospital include: patients who are on high dose loop diuretics (e.g. >80 mg furosemide) or on multiple diuretic therapy, have hypovolemia, hyponatremia (serum sodium <130 mgEq/l) or systolic blood pressure <90 mmHg, are on high dose vasodilator therapy, have a serum creatinine >150 µmol/l or are aged 70 years or over.

Elderly/Renal Impairment

In elderly patients and in patients with a creatinine clearance of less than 40 mL/min, an initial dosage in essential hypertension of 2.5 mg is recommended followed by titration to the optimal response (see section 4.4).

Paediatric population

Currently available data are described in sections 5.1 and 5.2 but no recommendation on a posology can be made.

Method of administration

For oral use. The tablets should not be chewed, crushed or divided.

The oral LD₅₀ of quinapril in mice and rats ranges from 1440 to 4280 mg/kg.

No data are available with respect to overdosage in humans. The most likely clinical manifestation would be symptoms attributable to severe hypotension, which should normally be treated by intravenous volume expansion.

Haemodialysis and peritoneal dialysis have little effect on the elimination of quinapril and quinaprilat.

Treatment is symptomatic and supportive consistent with established medical care.

3 years.

Do not store above 25°C. Store in the original package in order to protect from moisture.

Tampertainers with desiccant containing 56 or 100 tablets.

Polyamide/aluminium/PVC blister strip containing 7, 28, 56 or 100 tablets.

Not all pack sizes may be marketed.

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.