PHYSIOTENS

What it is

PHYSIOTENS contains moxonidine. It is available in two strengths: 200 microgram and 400 microgram tablets. PHYSIOTENS is a film-coated tablet.

Approved indications

— Treatment of hypertension.

Dosing overview

Treatment should be started with 200 microgram in the morning. The dose may be titrated after two weeks to 400 microgram given as one dose or as divided doses (morning and evening) until a satisfactory response is achieved. If the response is still unsatisfactory after a further 2 weeks treatment, the dosage can be increased up to a maximum of 600 microgram in divided doses (morning and evening). A single daily dose of 400 microgram and a divided daily dose of 600 microgram should not be exceeded. In patients with moderate renal impairment (GFR 30–60 mL/min), the single dose should not exceed 200 microgram and the daily dose should not exceed 400 microgram. PHYSIOTENS may be taken with or without food.

Key safety warnings

Abrupt cessation of combination therapy with PHYSIOTENS and a beta-blocker may result in rebound hypertension. If combination therapy is to be ceased, the beta-blocker should be stopped first and then PHYSIOTENS stopped after a few days have elapsed. Cases of varying degrees of atrioventricular block have been reported in the post-marketing setting in patients undergoing moxonidine treatment. Based on case reports, the causative role of moxonidine in delaying atrioventricular conduction cannot be completely ruled out. Caution is recommended when treating patients with a possible predisposition to developing an atrioventricular block. PHYSIOTENS should not be used because of lack of experience in cases of intermittent claudication, Raynaud's Disease, Parkinson's Disease, epileptic disorders, glaucoma, and depression. Due to lack of therapeutic experience, the use of PHYSIOTENS concomitantly with alcohol or tricyclic antidepressants should be avoided. It is advised not to interrupt the intake of PHYSIOTENS abruptly. PHYSIOTENS should be withdrawn gradually over a period of days.

Contraindications

Hypersensitivity to any of the ingredients of this product. Heart failure (NYHA Class I–IV). Patients aged 75 years or older. Bradycardia (heart rate less than 50 beats per minute) or severe bradyarrhythmia, including sick sinus syndrome, or second or third degree atrioventricular block. Malignant arrhythmias. Severe renal impairment (GFR less than 30 mL/min, serum creatinine concentration greater than 160 micromol per litre).

Regulatory history

PHYSIOTENS moxonidine tablets were first listed on the ARTG on 10 November 2004.