INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
SOLATRAN 15 (capsules);
SOLATRAN 30 (capsules).

SCHEDULING STATUS:
S5

PROPRIETARY NAMES
(and dosage form):

SOLATRAN 15 (capsules);
SOLATRAN 30 (capsules).

COMPOSITION :
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.

PHARMACOLOGICAL CLASSIFICATION:
A.2.6 Tranquillizers.

PHARMACOLOGICAL ACTION:
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.

INDICATIONS:
Solatran is indicated for the treatment of anxiety, tension, irritability and similar stress related symptoms.

CONTRA-INDICATIONS :
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.

IDENTIFICATION:
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".

PRESENTATION:
Solatran 15: Cartons containing 30 or 100 blister packed capsules.
Solatran 30: Cartons containing 30 or 100 blister packed capsules.

STORAGE INSTRUCTIONS:
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.

REGISTRATION NUMBERS:
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,
Johannesburg 2090

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
12.11.1985.

Solatran and the SB logo are trademarks.
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