CLOBIUM

What it is

CLOBIUM contains 10 mg clobazam per tablet. Clobazam is the first anxiolytic drug which belongs to the class of 1,5 rather than 1,4-benzodiazepines, with nitrogen atoms in the 7-membered heterocyclic ring located at positions 1 and 5 and an oxo substituent at position 4. CLOBIUM tablets appear as white to off white oval shaped uncoated tablets with a functional score on one side and "C" and "10" debossed on other side.

Approved indications

— Short term use (up to one month) for the symptomatic management of acute anxiety and sleep disturbances associated with anxiety in adults. — As adjunctive therapy in children 4 years of age and over with partial refractory and Lennox-Gastaut epilepsy types who are not adequately stabilised with their current anticonvulsant therapy.

Dosing overview

The 10 mg tablets can be divided into equal halves of 5 mg.

Key safety warnings

Concomitant use of opioids and benzodiazepines, including CLOBIUM, may result in sedation, respiratory depression, coma and death. Patients should be advised that their tolerance for alcohol and other CNS depressants will be diminished and that these medications should either be eliminated or given in reduced dosage in the presence of CLOBIUM. Benzodiazepines should be prescribed for short periods only (for example 2–4 weeks), and continuous long-term use of CLOBIUM is not recommended. The use of benzodiazepines may lead to physical and psychological dependence, with the risk of dependence increasing with the dose and duration of treatment. After as little as one week of therapy, withdrawal symptoms can appear following the cessation of recommended doses. Serious skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported with CLOBIUM in both children and adults during the post-marketing experience. Patients should be closely monitored for signs or symptoms of SJS/TEN, especially during the first 8 weeks of treatment. As an antiepileptic drug, CLOBIUM may increase the risk of suicidal thoughts or behaviour in patients with any indication, and patients should be monitored for worsening of depression, suicidal thoughts or behaviour, and any unusual changes in mood or behaviour.

Contraindications

CLOBIUM is contraindicated in patients with hypersensitivity to clobazam or other benzodiazepines or excipients, history of drug or alcohol dependence, myasthenia gravis, severe respiratory insufficiency or chronic obstructive airways disease with incipient respiratory failure, sleep apnoea syndrome, severe impairment of liver function, and during pregnancy and lactation.

PBS listing

CLOBIUM clobazam 10 mg is registered on the ARTG in tablet form in both bottle and blister pack variants, with registration first listed on 2020-06-22. Information regarding PBS listing status, restriction type and ex-manufacturer price is not available in the provided source documents.

Regulatory history

CLOBIUM received its first approval on 03/03/2020. The product was first listed on the ARTG on 2020-06-22.