Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: Pfizer Laboratories (Pty) Ltd, 85 Bute Lane, Sandton 2196, South Africa Tel: +27(0)11 320 6000 / 0860 734 937 (Toll-free South Africa)
Short-term relief of anxiety-tension states resulting from stressful circumstances, anxiety associated with anxiety neurosis and other psychoneuroses, and as an adjunct in other disease states in which anxiety is manifested. DEMETRIN is only indicated when the disorder is severe, disabling or subjecting the individual to extreme stress.
DEMETRIN is administered orally, usually in divided doses. The usual daily dose is 30 mg. The dose should be adjusted gradually within the range of 20 to 60 mg daily in accordance with the response of the patient. Drowsiness and fatigue may occur in some patients with moderate anxiety receiving higher doses on a daily basis.
In elderly or debilitated patients, it is advisable to initiate treatment at a daily dose of 10 to 15 mg (see section 4.4). A single, daily dose at bedtime usually ranges between 20 to 40 mg.
Treatment should be started with the lowest recommended dose. The maximum dose should not be exceeded.
Treatment should be as short as possible. The patient should be reassessed regularly and the need for continued treatment should be evaluated, especially in the case of a patient being symptom free.
The overall duration of treatment should, generally, not be more than 6 – 8 weeks, including a tapering-off process. In certain cases, extension beyond the maximum treatment period may be necessary; if so, it should not take place without re-evaluation of the patient’s status.
The safety and efficacy of DEMETRIN in children have not been investigated.
For oral use.
Manifestations of overdosage include somnolence, confusion, coma, respiratory and cardiovascular depression and hypotension. Vomiting should be induced. General supportive care with close observation is indicated. Hypotension may be controlled with noradrenaline or another suitable vasopressors e.g. levarterenol bitartrate, or metaraminol bitartrate.
Flumazenil (as an adjunct to, not as a substitute for, overdosage treatment) is indicated for the complete or partial reversal of the sedative effects of the medicine. Patients treated with flumazenil should be monitored for resedation, respiratory depression, and other residual benzodiazepine effects for an appropriate period after treatment. The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose. Consult the complete flumazenil package insert prior to use.
36 months.
Store in a cool, dark (at or below 25ºC) dry place.
Clear PVC/Aluminium foil blisters of 100 tablets.
Not all pack sizes may be marketed.
No special requirements.
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