LONITEN

What it is

LONITEN is minoxidil . It is available as 10 mg tablets . LONITEN is an orally active peripheral vasodilator . LONITEN selectively relaxes arteriolar smooth muscle which reduces peripheral vascular resistance and lowers systemic blood pressure .

Approved indications

— Adjunctive therapy in adults with severe refractory hypertension which has failed to respond to extensive multiple therapy .

Dosing overview

The usual adult dosage range of LONITEN is 5 to 40 mg per day . The maximum recommended dosage is 100 mg per day . Dosage adjustments should be made at intervals of 3 days or longer . Dosage requirements may be lower in patients with renal failure or undergoing chronic dialysis . For patients with hepatic impairment dosage adjustment should be considered, starting therapy at a reduced dose once daily and titrating up to the lowest effective dose to obtain desired therapeutic effect . Prior to introducing LONITEN, it is recommended that the antihypertensive therapy be adjusted to a regimen consisting of a diuretic and a beta-adrenergic blocking agent . LONITEN must be given with sufficient diuretic therapy to maintain salt and water balance in all patients who are not on dialysis .

Key safety warnings

If used alone, LONITEN can cause significant retention of salt and water, producing dependent oedema and puffiness of the face, eyes or hands. Haemodilution may occur leading to a temporary decrease in haematocrit, haemoglobin and erythrocyte count. Chest X-rays may show evidence of pulmonary vascular engorgement. The clinical condition of some patients with symptomatic heart failure may deteriorate under these circumstances . Reflex tachycardia and possibly angina pectoris may develop in patients with unsuspected coronary artery disease, unless protected against LONITEN-induced tachycardia with beta-adrenergic blocking drugs or other suitable sympathetic nervous system suppressants. Patients with unstable angina pectoris or angina pectoris of recent onset should be protected with these agents before starting LONITEN therapy . Elongation, thickening and enhanced pigmentation of fine body hair (hypertrichosis), unassociated with endocrine abnormalities, is seen in most patients. It is usually first noticed in the facial area 3 to 6 weeks after starting therapy, may recede slightly during prolonged therapy, and is reversed 1 to 3 months after LONITEN is discontinued. All patients should be fully informed of this possible effect before commencing LONITEN therapy . There have been multiple reports of pericarditis occurring in association with LONITEN. Pericardial effusion, and occasionally tamponade, has been detected in 3% to 4% of patients treated with a LONITEN containing regimen. LONITEN-treated patients should be closely monitored for any suggestion of a pericardial effusion and echocardiography should be carried out if suspicion arises .

Contraindications

LONITEN is contraindicated in phaeochromocytoma and pulmonary hypertension secondary to mitral stenosis . LONITEN is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation .

PBS listing

LONITEN 10 mg tablets are listed on the PBS as 2 items with restricted access at an ex-manufacturer price of A$28.76 .

Regulatory history

LONITEN was first approved on 2 August 1991 . ARTG registration 12309 for LONITEN minoxidil 10 mg tablet was first listed on 1991-08-02 .