APO-MOXONIDINE

What it is

APO-MOXONIDINE is an immediate release film-coated tablet for oral use containing 0.2 mg or 0.4 mg moxonidine. The 0.2 mg tablets are pink round biconvex tablets 5 mm in diameter, while the 0.4 mg tablets are pink round biconvex tablets 7 mm in diameter.

Approved indications

— Treatment of hypertension.

Dosing overview

Treatment should be started with 0.2 mg in the morning. The dose may be titrated after two weeks to 0.4 mg 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 0.6 mg in divided doses (morning and evening). A single daily dose of 0.4 mg and a divided daily dose of 0.6 mg should not be exceeded. APO-MOXONIDINE may be taken with or without food. In patients with moderate renal impairment (GFR 30–60 mL/min), the single dose should not exceed 0.2 mg and the daily dose should not exceed 0.4 mg.

Key safety warnings

Abrupt cessation of combination therapy with moxonidine 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 moxonidine stopped after a few days have elapsed. During cessation of therapy blood pressure should be regularly monitored. Cases of varying degrees of atrioventricular block have been reported in the post-marketing setting in patients undergoing moxonidine treatment. Based on these 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 AV block. When moxonidine is used in patients with 1st degree AV block, special care should be exercised to avoid bradycardia. Moxonidine must not be used in higher degree AV blocks. Moxonidine should be used with caution in patients with a history of angioneurotic oedema. As with other centrally acting antihypertensives, moxonidine should be used with caution in patients with severe coronary artery disease and unstable angina, where there is limited experience. It is advised not to interrupt the intake of moxonidine abruptly. Moxonidine should be withdrawn gradually over a period of days.

Contraindications

Hypersensitivity to any of the ingredients. Heart failure (NYHA Class I–IV). Patients aged 75 years or older. Bradycardia (HR < 50 beats/minute) or severe bradyarrhythmia, including sick sinus syndrome, or second or third degree atrioventricular block. Malignant arrhythmias. Severe renal impairment (GFR < 30 mL/min, serum creatinine concentration >160 µmol/L).

Regulatory history

APO-MOXONIDINE received initial ARTG registration on 15 December 2017. Two variants were first listed on the ARTG on 16 January 2018: the 0.4 mg film-coated tablet (ARTG 285632) and the 0.2 mg film-coated tablet (ARTG 285640), both in blister packs under licence category RE.