CIZINATE

What it is

CIZINATE is a tablet containing cinnarizine 20 mg and dimenhydrinate 40 mg. CIZINATE tablets are white to almost white, round, biconvex uncoated tablets 8 mm in diameter.

Approved indications

— Short-term, symptomatic treatment of vertigo of various causes, in adults who have not responded to alternative treatments.

Dosing overview

The recommended dose for adults is one tablet three times daily. The lowest dose for the shortest duration to achieve symptom control should be used. CIZINATE tablets should be swallowed without chewing with some liquid after meals to minimise any gastric irritation. In general, the duration of treatment should not exceed four weeks.

Key safety warnings

Extrapyramidal effects including tremor, dyskinesia, parkinsonism, tardive dyskinesia and akathisia have been reported rarely with cinnarizine, and are more likely to occur in older patients (over 60 years), women, those on high doses (over 150 mg daily) and those with prolonged exposure to cinnarizine. Patients should be advised to cease treatment with CIZINATE immediately and seek medical advice if any abnormal movements such as shaking, twitching or twisting movements, muscle stiffness, restless legs, stiff posture, slowed shuffling walk or a need to be in constant motion arise. CIZINATE may cause drowsiness, especially at the start of treatment, and patients affected in this way should not drive or operate machinery. Cinnarizine/dimenhydrinate should be used with caution in hypotensive patients and in patients with conditions that might be aggravated by anticholinergic therapy, such as raised intra-ocular pressure, pyloro-duodenal obstruction, prostatic hypertrophy, hypertension, hyperthyroidism or severe coronary heart disease.

Contraindications

CIZINATE is contraindicated in patients with hypersensitivity to cinnarizine, dimenhydrinate, diphenhydramine, other antihistamines of a similar structure, or to any of the excipients. CIZINATE is contraindicated in patients with a creatinine clearance of ≤25 mL/min (severe renal impairment). CIZINATE is contraindicated in patients with severe hepatic impairment. CIZINATE is contraindicated in patients with angle-closure glaucoma, convulsions, suspicion of raised intracranial pressure, alcohol abuse or urine retention due to urethroprostatic disorders. CIZINATE is contraindicated for use in children under 6 years of age because of the potential for fatal respiratory depression, psychiatric and CNS events.

Regulatory history

CIZINATE (cinnarizine 20 mg/dimenhydrinate 40 mg uncoated tablets) was first listed on the ARTG on 8 January 2019. The TGA approval decision was made on 21 December 2018. The TGA's evaluation concluded that the product met chemistry and quality control standards, and bioequivalence to an overseas reference product was demonstrated.