MOXOTENS

What it is

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

Approved indications

— Treatment of hypertension.

Dosing overview

Treatment should be started with 200 µg MOXOTENS in the morning. The dose may be titrated after two weeks to 400 µg 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 µg in divided doses (morning and evening). A single daily dose of 400 µg and a divided daily dose of 600 µg of MOXOTENS should not be exceeded. MOXOTENS may be taken with or without food.

Key safety warnings

Abrupt cessation of combination therapy with MOXOTENS and a beta-blocker may result in rebound hypertension. If combination therapy with MOXOTENS and a beta-blocker is to be ceased, the beta-blocker should be stopped first and then MOXOTENS stopped after a few days have elapsed. MOXOTENS should not be interrupted abruptly and should be withdrawn gradually over a period of days. MOXOTENS should be used with caution in patients with a history of angioneurotic oedema, severe coronary artery disease and unstable angina. Cases of varying degrees of atrioventricular block have been reported in the post-marketing setting in patients undergoing moxonidine treatment, and 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 AV block. MOXOTENS 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 MOXOTENS concomitantly with alcohol or tricyclic antidepressants should be avoided. Common adverse effects include dry mouth, headache, dizziness, nausea, sleep disturbance, somnolence, asthenia, vasodilatation, and anxiety.

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 (glomerular filtration rate less than 30 mL/min, serum creatinine concentration greater than 160 µmol/L).

PBS listing

No information regarding PBS listing is contained in the provided documents.

Regulatory history

MOXOTENS received its first approval on 30 October 2019. The 200 microgram tablet formulation (ARTG 300132) and the 400 microgram tablet formulation (ARTG 300129) were first listed on the Australian Register of Therapeutic Goods on 2 July 2019.