SOLATRAN 15 (capsules);
SOLATRAN 30 (capsules).
(and dosage form):
SOLATRAN 15 (capsules);
SOLATRAN 30 (capsules).
Solatran 15 contains l5 mg 11-Chloro-(8, 12b-Dihydro)-2,8-dimethyl-12b-phenyl-4H-1,3 oxazino 3,2-d 1,4 benzodiazepine-4,7 (6H)-dione (ketazolam) per capsule.
Solatran 30 contains 30 mg 11-Chloro-(8, 12b-Dihydro)-2,8-dimethyl-12b-phenyl-4H-1,3 oxazino 3,2-d 1,4 benzodiazepine-4,7 (6H)-dione (ketazolam) per capsule.
Solatran is a benzodiazepine and shares the general characteristics of this group of products.
Absorption: Solatran is absorbed from the gastro-intestinal tract giving peak serum levels of ketazolam after approximately 3,2 hours. It is excreted mainly by the renal and hepatic pathways.
Distribution: Solatran is distributed to most tissues of the body, crosses the placental barrier and is excreted in the milk.
Solatran is indicated for the treatment of anxiety, tension, irritability and similar stress related symptoms.
Solatran is contra-indicated in patients with known hypersensitivity to this drug and acute narrow-angle glaucoma.
Solatran is contra-indicated during pregnancy, labour and lactation as its safety in these situations has not been established.
DOSAGE AND ADMINISTRATION:
Usual adult dosage: For most patients it is recommended that treatment should commence with a single 30 mg dose taken before retiring.
The effective dosage is usually in the range of 15 - 60 mg per day taken either as a single dose before retiring or in divided doses. When treating elderly or debilitated patients (e.g. those with cerebral disorders or cardiorespiratory insufficiency) a reduced dosage should be used initially until tolerance and efficacy can be assessed.
Patients undergoing therapy with centrally active products should be periodically reviewed.
Children: Insufficient data is available to recommend the administration of Solatran to children.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The side effects most commonly encountered are drowsiness and over-sedation. Drowsiness is more common in elderly and debilitated patients and in patients receiving high dosages. In clinical studies Solatran taken as a single daily dose, causes less drowsiness than diazepam taken in divided doses and was equally efficacious. A less common side effect is depression of mood and affect, disorientation or confusion, lethargy and ataxia. Paradoxical reactions such as acute hyper-excitable states with rage may occur. If these occur the medication should be discontinued.
There is a potential for abuse. Withdrawal symptoms (including convulsions) have occurred following abrupt cessation, especially in patients receiving large doses for prolonged periods.
Special precautions: Particular caution should be exercised in: the elderly and debilitated - who are at particular risk of over-sedation, respiratory depression and ataxia (initial oral dose should be reduced in these patients); patients with pulmonary disease and limited pulmonary reserve, patients suffering from impairment of renal or hepatic function, patients suffering from anxiety accompanied by an underlying depressive disorder; patients receiving barbiturates or other central nervous system depressants. There is an additive risk of central nervous system depression when these medicines are taken together; patients should be cautioned regarding the additive effect of alcohol.
Patients should be advised particularly at the initiation of therapy, not to drive a motor vehicle climb dangerous heights or operate dangerous machinery. In these situations, impaired decision-making could lead to accidents.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Manifestations of overdosage include somnolence confusion coma, respiratory and cardio-vascular depression :and hypertension. Gastric lavage may be useful if performed soon after ingestion.
Solatran 15: Dark pink/light pink capsules containing 15 mg ketazolam, overprinted "Solatran 15".
Solatran 30: Dark pink/light pink capsules containing 30 mg ketazolam, overprinted "Solatran 30".
Solatran 15: Cartons containing 30 or 100 blister packed capsules.
Solatran 30: Cartons containing 30 or 100 blister packed capsules.
Capsules of Solatran 15 and Solatran 30 are stable for two years if containers are kept tightly closed, protected from light and stored in a dry place at less than 25°C.
Keep out of reach of children.
Solatran 15 : P/2.6/251.
Solatran 30 : P/2.6/252.
NAME AND BUSINESS ADDRESS OF THE: APPLICANT:
SmithKline Beecham Pharmaceuticals (Pty) Ltd.,
6 Carey Street,
Wynberg Ext. 6,
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
Solatran and the SB logo are trademarks.
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