Verahit

Each tablet contains: Betahistine hydrochloride 16 mg.

Betahistine is indicated for treatment of Ménière's syndrome, symptoms of which may include vertigo, tinnitus, hearing loss and nausea.

Adults: Initial oral treatment is 8 to 16 mg three times daily, taken preferably with meals.
Maintenance doses are generally in the range 24-48 mg daily. Daily dose should not exceed 48 mg. Dosage can be adjusted to suit individual patient needs. Sometimes improvement could be observed only after a couple of weeks of treatment.
There is no data available for patients with hepatic impairment.
There is no data available for patients with renal impairment.
There is limited data in the elderly, betahistine should be used with caution in this population.
Children and adolescents: Betahistine tablets are not recommended for use in children and adolescents below age 18 due to lack of data on safety and efficacy.

A few overdose cases have been reported. Some patients experienced mild to moderate symptoms with doses up to 640 mg (e.g. nausea, somnolence, abdominal pain). Other symptoms of betahistine overdose are vomiting, dyspepsia, ataxia and seizures. More serious complications (convulsion, pulmonary or cardiac complications) were observed in cases of intentional overdose of betahistine especially in combination with other overdosed drugs. No specific antidote. Gastric lavage and symptomatic treatment are recommended within one hour after intake.

Betahistine is contraindicated in patients with a pheochromocytoma and hypersensitivity to betahistine hydrochloride or any of the excipients.

Caution is advised in the treatment of patients with a history of peptic ulcer. Clinical intolerance to betahistine hydrochloride in bronchial asthma patients has been shown in a relatively few patients. These patients need to be carefully monitored during the therapy.

Pregnancy: There are insufficient data on the use of betahistine in pregnant women. Animal studies, though insufficient do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant therapeutic exposure. The potential risk for humans is unknown. As a precautionary measure, it is preferable to avoid the use of Betahistine during pregnancy.
Lactation: It is not known whether betahistine is excreted in breast milk in humans. Betahistine is excreted in rat milk. The effects post-partum seen in animal studies were limited to very high doses. The importance of taking the medicine by the mother must be weighed against the benefits of breastfeeding and the potential risk for the child.
Fertility: Animal studies show no influence on fertility in rats.

The following undesirable effects have been experienced with the following indicated frequencies in betahistine-treated patients in placebo-controlled clinical trials and in post-marketing reports: very common (1/10); common (1/100 to <1/10); uncommon (1/1,000 to <1/100); rare (1/10,000 to <1/1,000); very rare (<1/10,000); and not known (frequency cannot be estimated from the available data).
Immune system disorders: Not known: Hypersensitivity reactions, e.g., anaphylaxis.
Nervous system disorders: Common: Headache, occasional drowsiness.
Cardiac disorders: Not known: Palpitations.
Respiratory disorders: Not known: Bronchospasms may occur in patients with bronchial asthma.
Gastrointestinal disorders: Common: Dyspepsia*, nausea.
Skin and subcutaneous tissue disorders: Not known: Cutaneous and subcutaneous hypersensitivity reactions, in particular angioneurotic edema, urticarial, rash, and pruritus.
*Mild gastric complaints (e.g., vomiting, gastrointestinal pain, abdominal distension and bloating) have been observed. These can normally be dealt with by taking the dose during meals or by lowering the dose.

No in vivo interaction studies have been performed. Based on in vitro data no in vivo inhibition on Cytochrome P450 enzymes is expected.
In vitro data indicate an inhibition of betahistine metabolism by drugs that inhibit monoamine oxidase (MAO) including MAO subtype B (e.g. selegiline). Caution is recommended when using betahistine and MAO inhibitors (including MAO-B selective) concomitantly. As betahistine is an analogue of histamine, interaction of betahistine with antihistamines may in theory affect the efficacy of one of these drugs.

Store at temperatures not exceeding 30°C.

Antivertigo Drugs

N07CA01 - betahistine ; Belongs to the class of antivertigo preparations.

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