BETAHISTINE

What it is

Setear is a 24 mg tablet containing betahistine dihydrochloride. The 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. Caution should be taken in the treatment of patients receiving antihistamines. 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. Common adverse effects include nausea and dyspepsia. Gastrointestinal disturbances may be relieved by reducing the dose or by taking betahistine with meals. Rare skin reactions including various types of rash, pruritus and urticarial/angio-neurotic oedema have been reported, which are probably related to the histamine-like structure of betahistine.

Contraindications

Betahistine 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.

Regulatory history

Setear received initial approval on 02 March 2017.