APO-CLONIDINE

What it is

APO-CLONIDINE contains clonidine hydrochloride. The registered tablet formulation contains 100 micrograms of clonidine hydrochloride.

Approved indications

— Acute hypertensive crisis. — Alternative to oral therapy where the oral route of administration is inappropriate.

Dosing overview

The dose is one to two ampoules (150–300 micrograms) by intramuscular injection undiluted, or given intravenously in 10 mL of normal saline over five minutes, and may be repeated at intervals of 3 to 6 hours as necessary. As clonidine is metabolised in the liver and excreted mainly by the kidneys, hepatic or renal impairment may require a reduction in dosage.

Key safety warnings

Sudden cessation of antihypertensive therapy is known to be associated in some instances with rebound hypertension which in some cases may be severe, particularly in patients receiving more than the maximum recommended dose of 900 micrograms per day. Following sudden discontinuation of clonidine after prolonged treatment with high doses, restlessness, palpitations, rapid rise in blood pressure, nervousness, tremor, headache or nausea have been reported. Special care should be exercised in treating patients who have a history of depression or who have advanced cerebrovascular disease, as reduction of blood pressure in the latter circumstances may itself cause mental changes. The use and safety of clonidine in children and adolescents has little supporting evidence in randomised controlled trials and therefore cannot be recommended for use in this population. In particular, when clonidine is used off-label concomitantly with methylphenidate in children with ADHD, serious adverse reactions, including death, have been observed. Therefore, clonidine in this combination is not recommended. Patients who wear contact lenses should be warned that treatment with APO-CLONIDINE may cause decreased lacrimation.

Contraindications

APO-CLONIDINE should not be used in patients with known hypersensitivity to clonidine hydrochloride, and in patients with severe bradyarrhythmia resulting from either sick sinus syndrome or AV block of second or third degree.

PBS listing

The 100 microgram tablet is listed on the PBS with 2 items at an ex-manufacturer price of A$11.47 under a restricted restriction type.

Regulatory history

APO-CLONIDINE (100 microgram tablet) was first listed on the ARTG on 24 November 2016.