RENITEC Tablet Ref.[51094] Active ingredients: Enalapril

Essential hypertension

In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally may occur following the initial dose of RENITEC. The diuretic should, if possible, be discontinued for two to three days before beginning therapy with RENITEC to reduce the likelihood of hypotension (See Section 4.4 Special Warnings and Precautions for Use). If the patient’s blood pressure is not controlled with RENITEC alone, diuretic therapy may be resumed.

If the diuretic cannot be discontinued an initial dose of 2.5 mg (break the 5 mg tablet) should be used under medical supervision for at least one hour to determine whether excess hypotension will occur (See Section 4.4 Special Warnings and Precautions for Use and Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

The recommended initial dose in patients not on diuretics is 5 mg once a day. Dosage should be adjusted according to blood pressure response. The usual dosage range is 10 to 40 mg per day administered in a single dose or two divided doses. In some patients treated once daily, the antihypertensive effect may diminish toward the end of the dosing interval. In such patients, an increase in dosage or twice daily administration should be considered. If blood pressure is not controlled with RENITEC alone, a diuretic may be added.

Concomitant administration of RENITEC with potassium supplements, potassium salt substitutes, or potassium-sparing diuretics may lead to increases of serum potassium (see Section 4.4 Special Warnings and Precautions for Use).

To date there is insufficient experience with RENITEC in the treatment of accelerated or malignant hypertension. RENITEC, therefore, is not recommended in such situations.

Dosage in the Elderly (over 65 years)

The starting dose should be 2.5 mg. Some elderly patients may be more responsive to RENITEC than younger patients.

Renovascular Hypertension

Since blood pressure and renal function in such patients may be particularly sensitive to ACE inhibition, therapy should be initiated with a lower starting dose (e.g., 5 mg or less). The dosage should then be adjusted according to the needs of the patient. Most patients may be expected to respond to 20 mg taken once daily. For patients with hypertension who have been treated recently with diuretics, caution is recommended (see next paragraph).

Congestive Heart Failure

Therapy with RENITEC must be started under close medical supervision.

Blood pressure and renal function should be monitored closely both before and after starting treatment with RENITEC (see Section 4.4 Special Warnings and Precautions for Use) because severe hypotension and (more rarely) consequent renal failure have been reported.

Initiation of therapy requires consideration of recent diuretic therapy and the possibility of severe salt/volume depletion. If possible, the dose of diuretic should be reduced before beginning treatment.

The initial dose of RENITEC in patients with congestive heart failure (especially renally impaired or sodium- and/or volume-depleted patients) should be lower (2.5 mg or less), and it should be administered under close medical supervision to determine the initial effect on the blood pressure. The appearance of hypotension after the initial dose of RENITEC does not imply that hypotension will recur during chronic therapy with RENITEC and does not preclude continued use of the drug.

In the absence of, or after effective management of, symptomatic hypotension following initiation of therapy with RENITEC in congestive heart failure, the dose should be gradually increased, depending on the patient’s response, to the usual maintenance dose (10-20 mg) given in a single or divided dose. This dose titration may be performed over a 2 to 4 week period, or more rapidly if indicated by the presence of residual signs and symptoms of heart failure. In clinical trials in which mortality and morbidity was reduced, dosage was divided in two doses.

Left Ventricular Dysfunction Without Symptoms of Overt Heart Failure

In the SOLVD-Prevention trial, the initial dose was 2.5 mg twice daily and titrated, as above (see Section 4.2 Dose and Method of Administration, Congestive Heart Failure), to the usual maintenance dose of 20 mg in two divided doses.

Dosage Adjustment in Renal Impairment

The usual dose of enalapril is recommended for patients with a creatinine clearance >30 mL/min (serum creatinine of up to approximately 3 mg/dL). For patients with creatinine clearance ≤30 mL/min (serum creatinine ≥3 mg/dL), the first dose is 2.5 mg once daily. The dosage may be titrated upward until blood pressure is controlled or to a maximum of 40 mg daily.

Table 1:

^* Dosage on non dialysis days should be adjusted depending on blood pressure response.

Limited data are available with regard to overdosage in humans. The most likely manifestation of overdosage would be hypotension, beginning approximately six hours after ingestion of tablets, concomitant with blockade of the renin-angiotensin system, and stupor, which can be treated, if necessary, by intravenous infusion of normal saline solution. Several hypertensive patients in clinical studies have received as much as 80 mg of enalaprilat intravenously over a fifteen minute period. No adverse effects, other than those associated with recommended dosages, were observed. Enalaprilat may be removed from the general circulation by haemodialysis.

For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

The expiry date can be found on the packaging. In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG).

Store below 25°C.

Supplied in blister packs of 30 tablets.

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.