INNOVACE Tablet Ref.[6785] Active ingredients: Enalapril

Posology

The absorption of Innovace Tablets is not affected by food.

The dose should be individualised according to patient profile (see section 4.4) and blood pressure response.

Paediatric Population

There is limited clinical trial experience of the use of Innovace in hypertensive paediatric patients (see sections 4.4, 5.1 and 5.2).

Hypertension

The initial dose is 5 to maximally 20 mg, depending on the degree of hypertension and the condition of the patient (see below). Innovace is given once daily. In mild hypertension, the recommended initial dose is 5 to 10 mg. Patients with a strongly activated renin-angiotensin-aldosterone system (e.g. renovascular hypertension, salt and/or volume depletion, cardiac decompensation, or severe hypertension) may experience an excessive blood pressure fall following the initial dose. A starting dose of 5 mg or lower is recommended in such patients and the initiation of treatment should take place under medical supervision.

Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with enalapril. A starting dose of 5 mg or lower is recommended in such patients. If possible, diuretic therapy should be discontinued for 2-3 days prior to initiation of therapy with Innovace. Renal function and serum potassium should be monitored.

The usual maintenance dose is 20 mg daily. The maximum maintenance dose is 40 mg daily.

Heart Failure/Asymptomatic Left Ventricular Dysfunction

In the management of symptomatic heart failure, Innovace is used in addition to diuretics and, where appropriate, digitalis or beta-blockers. The initial dose of Innovace in patients with symptomatic heart failure or asymptomatic left ventricular dysfunction is 2.5 mg, and it should be administered under close medical supervision to determine the initial effect on the blood pressure. In the absence of, or after effective management of, symptomatic hypotension following initiation of therapy with Innovace in heart failure, the dose should be increased gradually to the usual maintenance dose of 20 mg, given in a single dose or two divided doses, as tolerated by the patient. This dose titration is recommended to be performed over a 2 to 4 week period. The maximum dose is 40 mg daily given in two divided doses.

Table 1. Suggested Dosage Titration of Innovace in Patients with Heart Failure/Asymptomatic Left Ventricular Dysfunction:

* Special precautions should be followed in patients with impaired renal function or taking diuretics (see section 4.4).

Blood pressure and renal function should be monitored closely both before and after starting treatment with Innovace (see section 4.4) because hypotension and (more rarely) consequent renal failure have been reported. In patients treated with diuretics, the dose should be reduced if possible before beginning treatment with Innovace. The appearance of hypotension after the initial dose of Innovace does not imply that hypotension will recur during chronic therapy with Innovace and does not preclude continued use of the drug. Serum potassium and renal function also should be monitored.

Dosage in Renal Insufficiency

Generally, the intervals between the administration of enalapril should be prolonged and/or the dosage reduced.

Table 2. Dosage in Renal Insufficiency:

^* See section 4.4. Enalaprilat is dialysable. Dosage on nondialysis days should be adjusted depending on the blood pressure response.

Use in Elderly

The dose should be in line with the renal function of the elderly patient (see section 4.4).

Use in Paediatrics

For patients who can swallow tablets, the dose should be individualised according to patient profile and blood pressure response. The recommended initial dose is 2.5 mg in patients 20 to <50 kg and 5 mg in patients ≥50 kg. Innovace is given once daily. The dosage should be adjusted according to the needs of the patient to a maximum of 20 mg daily in patients 20 to <50 kg and 40 mg in patients ≥50 kg (see section 4.4).

Innovace is not recommended in neonates and in paediatric patients with glomerular filtration rate <30 ml/min/1.73 m², as no data are available.

Method of administration

Oral use.

Limited data are available for overdosage in humans. The most prominent features of overdosage reported to date are marked hypotension, beginning some six hours after ingestion of tablets, concomitant with blockade of the renin-angiotensin system, and stupor. Symptoms associated with overdosage of ACE inhibitors may include circulatory shock, electrolyte disturbances, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety, and cough. Serum enalaprilat levels 100- and 200-fold higher than usually seen after therapeutic doses have been reported after ingestion of 300 mg and 440 mg of enalapril, respectively.

The recommended treatment of overdosage is intravenous infusion of normal saline solution. If hypotension occurs, the patient should be placed in the shock position. If available, treatment with angiotensin II infusion and/or intravenous catecholamines may also be considered. If ingestion is recent, take measures aimed at eliminating enalapril maleate (e.g. emesis, gastric lavage, administration of absorbents, and sodium sulfate). Enalaprilat may be removed from the general circulation by haemodialysis (see section 4.4). Pacemaker therapy is indicated for therapy-resistant bradycardia. Vital signs, serum electrolytes and creatinine concentrations should be monitored continuously.

2 years.

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

Innovace 2.5 mg: All-aluminium blister packages containing 2, 11, 20, 28, 30, 40, 49 × 1, 50, or 100 tablets.

Innovace 5 mg: All-aluminium blister packages containing 2, 14, 20, 28, 28 × 1, 30, 49 × 1, 50, 60, 98, or 100 tablets.

Innovace 10 mg: All-aluminium blister packages containing 28, 49 × 1, 30, 50, 98 or 100 tablets.

Innovace 20 mg: All-aluminium blister packages containing 10, 14, 20, 28, 28 × 1, 30, 49 × 1, 50, 56, 60, 84, 90, 98, 100 or 500 tablets.

Not all pack sizes may be marketed.

No special requirements.