Betaserc 24mg

betahistine dihydrochloride

Scored, white tablets, for oral administration containing 24 mg betahistine dihydrochloride.

Excipients : microcrystalline cellulose, mannitol, citric acid monohydrate, colloidal anhydrous silica and talc.

Indications

Meniere's Syndrom as defined by the following trias of core symptoms :

-- vertigo ( with nausea/vomiting )

-- hearing loss ( hardness of hearing )

-- tinnitus

Symptomatic treatment of vestibular vertigo.

Dosage and administration

The dosage for adults is 1 tablet 2 times/day. The dosage should be individually adapted according to the response. Improvement can sometimes only be observed after a couple of weeks of treatment. The best results are sometimes obtained after a few months. There are indications that treatment from the onset of the disease prevents the progression of the disease and/or the loss of hearing in later phases of the disease.

Contraindications

Hypersensitivity to any component of the product.

Warnings and special precautions for use

Patients suffering from phaeochromocytoma and patients with bronchial asthma need to be carefully monitored during the therapy. Caution should be taken in the treatment of patients with a history of peptic ulcer.

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Interactions

No interactions are known.

Pregnancy and lactation

There is insufficient data on the use of this drug during pregnancy to evaluate possible harmful effects. There are no indications for harmful effects in animal testing.

Effect on ability to drive and use machines

Research has shown that betahistine does not influence the ability to drive and to use machines.

Undesirable effects

In some cases mild gastric complaints have been observed. These can normally be dealt with by taking the dose during meals or by lowering the dose. In very rare cases skin hypersensitivity reactions have been reported, in particular rash, pruritus and urticaria.

Overdose

A few cases of overdose ( up to 728 mg ) with mild to moderate symptoms have been reported. At a dose of 728 mg a convulsion was reported.

In all cases recovery was complete. Treatment of overdose should include standard supportive measures.

Pharmacodynamics

The mechanism of action of betahistine is not known. Pharmacological testing in animals has shown that the blood circulation in the inner ear improves, probably by means of a relaxation of the precapillary sphincters. In pharmacological studies, betahistine was found to have weak H₁ receptor agonistic and considerate H₃ antagonistic properties in the CNS and autonomic nervous system. Betahistine was also found to have a dose dependent inhibiting effect on spike generation of neurons in lateral and medial vestibular nuclei. The importance of this observation in the action against Meniere's syndrome or vestibular vertigo, however, remains unclear.

Pharmacokinetics

Betahistine dihydrochloride is completely absorbed after oral administration. Only one metabolite, 2-pyridylacetic acid which is excreted in the urine, is known.

Shelf life and storage conditions

5 years at temperatures not exceeding 25°C and

3 years at temperatures not exceeding 30°C.