AVLOIRE

What it is

Avloire is a medicine containing carbamazepine . It is available as tablets containing 100 mg or 200 mg of carbamazepine, and as controlled release (CR) tablets containing 200 mg or 400 mg of carbamazepine .

Approved indications

— Complex or simple partial seizures (with or without loss of consciousness) with or without secondary generalisation . — Generalised tonic-clonic seizures . — Mixed seizure patterns incorporating complex or simple partial seizures and generalised tonic-clonic seizures . — Relief of pain in idiopathic trigeminal neuralgia and trigeminal neuralgia due to multiple sclerosis . — Idiopathic glossopharyngeal neuralgia . — Treatment of mania and maintenance treatment of bipolar affective disorders to prevent or attenuate recurrence .

Dosing overview

For adults and children over 15 years with epilepsy, the initial dose is 100 to 200 mg once or twice daily, slowly raised until optimal response is obtained—generally at 400 mg two or three times daily, though in some patients 1600 mg or even 2000 mg daily may be required in rare instances . For trigeminal neuralgia, the recommended initial dose is 200 to 400 mg daily in two divided doses, increasing by 200 mg each day in divided doses until pain relief is obtained, usually achieved with doses up to 800 mg daily, with a maximum dose not exceeding 1200 mg daily . For mania and maintenance treatment of bipolar affective disorder, the dosage range is 400 to 1600 mg daily, with a starting dose of 200 to 400 mg daily in two divided doses when used alone in mania, increased to 800 to 1000 mg during the first week by daily increments of 200 mg and up to 1600 mg if no response is found after a second week .

Key safety warnings

Serious dermatological reactions, including toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS), have been reported very rarely with Avloire and may require hospitalisation as these conditions may be life-threatening and fatal, with most cases appearing in the first few months of treatment . HLA-A*3101 may be a risk factor for the development of hypersensitivity syndrome and cutaneous adverse drug reactions such as SJS, TEN, DRESS, AGEP and maculopapular rash . HLA-B*1502 is strongly correlated with SJS/TEN skin reactions in patients of Han Chinese and Thai origin, with higher reporting rates in some Asian countries where the allele is more prevalent . Aplastic anaemia and agranulocytosis (in some cases fatal) have been reported in association with the use of Avloire . Complete blood counts, including platelets, should be obtained before treatment as a baseline and periodically thereafter, and Avloire should be discontinued if any evidence of significant bone-marrow depression appears . Hyponatraemia is known to occur with carbamazepine; in patients with pre-existing renal conditions associated with low sodium or in patients treated concomitantly with sodium-lowering medicinal products, serum sodium levels should be measured prior to initiating therapy and thereafter after approximately two weeks and then at monthly intervals for the first three months . Antiepileptic drugs, including carbamazepine, increase the risk of suicidal thoughts or behaviour in patients taking these drugs for any indication, and patients treated with any antiepileptic drug should be monitored for the emergence or worsening of depression, suicidal thoughts or behaviour, and any unusual changes in mood or behaviour .

Contraindications

Avloire is contraindicated in patients with known hypersensitivity to carbamazepine or structurally related drugs (such as tricyclic antidepressants) or to any other component of the formulations, atrioventricular block, systemic lupus erythematosus, and history of hepatic porphyrias (including acute intermittent porphyria, variegate porphyria, and porphyria cutanea tarda) . Avloire is contraindicated in patients with a history of bone marrow depression and is contraindicated in combination with monoamine-oxidase inhibitors . Avloire is contraindicated in hepatic failure . Avloire is contraindicated in neonates below 4 weeks of age .

PBS listing

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

Regulatory history

Avloire carbamazepine 100 mg and 200 mg tablets were first listed on the ARTG on 12 March 2024, with licence category RE . Avloire CR 200 mg and 400 mg controlled release tablets were first listed on the ARTG on 4 February 2026, with licence category RE .