Betahistine

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Description

Betahistine 16

COMPOSITION:

Betahistine dihydrochloride ... 16 mg

Excipients q.s ....................... 1 tablet

(Avicel, mannitol, aerosil, talc, magnesium stearate, kollidon CL - M).

DOSAGE FORM: Tablets. 

PRESENTATION: Box of 3 blisters x 10 tablets.

PHARMACODYNAMICS:

Betahistine is an antivertigo drug. It relaxes the precapillary sphincters resulting in improvement of microcirculation of the inner ear, cerebral circulation, blood flow in internal carotid and vertebral arteries.

Betahistine affects the histaminergic system: Betahistine acts both as a partial histamine H1-receptor agonistic and histamine H3-receptor antagonist also in neuronal tissue. Its effect on H2-receptor activity is negligible. Betahistine increases histamine metabolism and release by blocking presynaptic H3-receptors and inducing H3-receptor downregulation.

PHARMACOKINETICS:

Betahistine is rapidly and completely absorbed from the gastrointestinal tract. The drug is excreted mainly via urine under metabolite forms. Its elimination half-life is about 3.5 hours. The dose is almost completely excreted in the urine in about 24 hours.

INDICATIONS:

Treatment of vestibular vertigo.

Méniere's syndrome: vertigo, tinnitus, vomiting, headache and sometimes associated with hearing loss.

CONTRAINDICATIONS:

Hypersensitivity to any components of the drug. Pheochromocytoma.

PRECAUTIONS:

Patients suffered from asthma, gastric ulcer or a known history of gastric ulcer.

Children aged under 12 years because the drug has not been proved its safety on children.

PREGNANCY AND LACTATION:

Because of insufficient dada about using the drug during pregnancy and lactation, the drug should only be indicated to these subjects if clearly needed.

VEHICLE DRIVERS AND MACHINERY OPERATORS:

The drug does not affect the ability to drive vehicles and operate machinery.

INTERACTIONS:

The interaction between betahistine and antihistamines exists in theory; however, no documents have been found.

ADVERSE EFFECTS: Gastrointestinal disturbances, headache, urticaria, and itching have been reported.

Inform your physician about any adverse effects occur during the treatment.

OVERDOSAGE:

Overdosage symptoms of betahistine are similar to those induced by histamines: gastric hypersecretion, allergic, urticaria, asthma, diarrhea due to intestinal spasm, vasolidation, hypotension. The symptoms have been treated by H1-antihistamines

DOSAGE & ADMINISTRATION:

Adults and children over 12 years of age: 1 tablet x 3 times daily. The dose may be adjusted following the severity of disease. It is advisable to take the drug after meals.

Or as directed by the physician.

Read the directions carefully before use.

Consult the physician for more information.

This drug is for prescriptions only.

Shelf-life: 36 months from the manufacturing date.

Storage conditions: Store in dry places, not exceeding 30oC, protect from light.

Specifications: Manufacturer's.

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