DESCRIPTION:
The active ingredient of sere is betahistine dihydrochloride or 2-(2-methyiamino-ethyl] pyridine dihydrochloride. Betahistine Is a synthetic and orally active analogue of histamine. The major application of sere is in the treatment of Meniere's disease and Meniere-like syndrome characterized by severe attacks of vertigo, tinnitus and progressive loss of hearing, frequently accompanied by nausea and vomiting.
INDICATIONS:
1. Meniere's disease.
2. Meniere-iike syndrome characterized by attacks of vertigo, tinnitus and / or progressive hearing loss, usually accompanied by nausea and vomiting.
DOSAGE:
The recommended dosage of sere Is 24 mg to 48 mg per day to be taken in three divided doses. Thus for the 8 mg tablet one or two tablets to be taken three times dally. For 16mg, one tablet three times daily. Prolonged treatment is necessary for optimal results.
CONTRAINDICATIONS & PRECAUTIONS:
No contra-indications are known. Patients with phaeochromocytoma or bronchial asthma should be treated with caution. Caution is advised also in the treatment of patients with a history of peptic ulcer.
PHARMACOLOGY AND TOXICOLOGY:
sere exerts a relaxant action on the pre-capillary sphincters of the microcirculation of the inner ear and tnerapy increases the blood supply to the stria vascularis of the labyrinth. Investigations into the acute, sub-acute and chronic effects of betahistine in animals and widespread applications of Sere in humans has demonstrated low toxicity and safety of the drug.
PREGNANCY AND LACTATION:
In animal tests with high doses of betahistine no teratogenic effects have been demonstrated. In rats no teratogenic propertiat. have been demonstrated, nevertheless its use during pregnancy should be discouraged.
CLINICAL EXPERIENCE:
The effect of sere has been widely investigated in controlled trials, sere has been shown to reduce both the frequency and the severity of vertigo attacks, to have a favorable influence on tinnitus and on hearing loss especially if treatment is started early.
Although progress can usually be seen within a few days, the onset of improvement is sometimes very gradual and clearly noticeable only after several weeks of treatment. Therefore, continued treatment is recommended as optimal results are usually obtained after a few months. sere is very well tolerated in long term treatment.
SIDE 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 cutaneous reactions have been reported, in particular rash, pruritus and urticaria.
OVERDOSAGE:
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.
PRESENTATION:
sere {betahistine dihydrochloride) tablets are available in following forms and packs:
1. Round white scored 8 mg tablets in a blister pack of 30's.
2. Round white plain 16 mg tablets in a blister pack of 30's.
STORAGE AND DISPOSAL:
Store in a cool, dry place, & protect from light.
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