SETEAR

What it is

SETEAR is a tablet containing 24 mg of betahistine dihydrochloride. SETEAR 24 mg tablets are white flat tablets with bevelled edges and a break line on one side.

Approved indications

— Meniere's syndrome as defined by the following core symptoms: vertigo (with nausea/vomiting); hearing loss (hardness of hearing); tinnitus.

Dosing overview

The recommended starting dose in adults is one 24 mg tablet taken two times a day. The maximum recommended daily dosage is 48 mg, which may be taken as 16 mg three times daily or 24 mg twice daily. The tablets may be taken with or without food; however, if gastrointestinal upset occurs, it is recommended that the tablets be taken with meals. The dosage should be individually adapted according to the response. Improvement in symptoms may be observed in the first few days to weeks of treatment.

Key safety warnings

Patients with bronchial asthma need to be carefully monitored during therapy. In vitro data indicate an inhibition of betahistine metabolism by drugs that inhibit monoamine-oxidase (MAO) including MAO subtype B (e.g. selegiline), and caution is recommended when using betahistine and MAO inhibitors concomitantly. Skin reactions including various types of rash, pruritus and urticarial/angio-neurotic oedema have been reported rarely and are probably related to the histamine-like structure of betahistine; a single case of Stevens Johnson syndrome has been reported. Nausea and dyspepsia are common; vomiting, diarrhoea, abdominal distension, bloating and epigastric pain have been reported rarely and were usually mild. Dyspnoea, asthma and bronchospasms are very rare, and hypersensitivity reactions including anaphylaxis have been reported.

Contraindications

SETEAR is contraindicated during pregnancy and lactation; in children less than 18 years; in patients suffering from phaeochromocytoma; in patients with active peptic ulcer or a history of this condition; and in patients with hypersensitivity to any component of the product.

PBS listing

No source document contains information about PBS listing.

Regulatory history

SETEAR betahistine dihydrochloride 24 mg tablet was first listed on the Australian Register of Therapeutic Goods on 2 March 2017. A 16 mg tablet variant was subsequently registered on 12 August 2021.