INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo MEDOPAM 10 mg TABLETS
MEDOPAM 15 mg TABLETS
MEDOPAM 30 mg TABLETS

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

MEDOPAM 10 mg TABLETS
MEDOPAM 15 mg TABLETS
MEDOPAM 30 mg TABLETS

COMPOSITION:
Each tablet contains 10 mg, 15 mg or 30 mg
oxazepam as active ingredient.

PHARMACOLOGICAL CLASSIFICATION:
2.6 Tranquillizers.

PHARMACOLOGICAL ACTION:
Oxazepam is a metabolic derivative of diazepam with anticonvulsant, sedative, muscle relaxant and amnesic properties. Oxazepam is less active than diazepam in high doses in causing muscle relaxation. The compound exhibits a mild tranquillising action. Oxazepam is more active than chlordiazepoxide in causing sleep.

INDICATIONS:
Oxazepam is indicated for the control of anxiety, tension and fear. It may be used to alleviate the symptoms of alcohol withdrawal. It has no specific usefulness in the treatment of psychotic patients.

CONTRA-INDICATIONS:
Oxazepam should not be given to infants or depressive patients. It is contra-indicated in patients with a known hypersensitivity towards the drug. The effects of oxazepam may be enhanced by alcohol, barbiturates, narcotics, MAO inhibitors and other depressants of the central nervous system. The response to treatment with oral anticoagulants may be variable in patients taking oxazepam.

WARNINGS:
Alcohol may alter the response to oxazepam. It may enhance the effects of CNS depressants and may reduce the patients ability to undertake activities requiring mental alertness and judgement, such as driving a car and operating machinery.

Medopam 15 mg tablets contain FD and C Yellow No. 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of tartrazine sensitivity in the general population is currently thought to be low, it is frequently seen in patients who have aspirin-sensitivity.

DOSAGE AND DIRECTIONS FOR USE:
The average dose for adults is: 45 - 120 mg daily in divided doses.
Mild stress disturbances may respond to doses of 10 mg - 20 mg three times daily and this dosage should only be exceeded with caution in elderly or debilitated patients.
The following may serve as a guide to determine the correct dose for children:
7 years - 50% of the adult dose
10 years - 60% of the adult dose
12 years - 75% of the adult dose
14 years - 80% of the adult dose

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The side-effects of benzodiazepines are usually mild and infrequent. Drowsiness, light-headedness and ataxia are the most common and are often dose-dependent.
Elderly and debilitated patients are especially susceptible to these reactions.
Other side-effects that may be observed include hypotension, gastro-intestinal and visual disturbances, skin rashes, urinary retention, headache, confusion, vertigo and changes in libido. There have been occasional reports of blood dyscrasias and jaundice.

Special precautions:
Particular care should be exercised when giving benzodiazepines to elderly or debilitated patients who are at particular risk of oversedation, respiratory depression and ataxia. The initial oral dosage should be reduced in these patients. Care should also be exercised when giving oxazepam to patients with pulmonary disease and limited pulmonary reserve.

Although hypotension has occurred only rarely, oxazepam should be administered with caution to patients in whom a drop in blood pressure might lead to cardiac complications. Oxazepam should be used with caution in patients receiving barbiturates or other central nervous system depressants concomitantly with the benzodiazepines. Caution should be observed when giving oxazepam to patients with impaired hepatic or renal function.

Oxazepam should be used with caution in patients suffering from anxiety concomitant with an underlying depressive disorder and patients with closed angle glaucoma. With prolonged treatment periodic blood counts and liver function tests may be advisable. In severely disturbed patients, treatment with oxazepam sometimes results in paradoxical reactions, provoking excitement instead of sedation. The benzodiazepines should be used judiciously during pregnancy and they are preferably avoided. Given during labour the benzodiazepines cross the placenta and may cause the floppy infant syndrome characterised by central respiratory depression, hypothermia and poor sucking. The benzodiazepines should not be administered to lactating mothers.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage produces CNS depression and coma. There is no specific treatment. In recent severe overdosage with benzodiazepines the stomach should be emptied by aspiration and lavage. Recovery usually follows symptomatic treatment.

CONDITIONS OF REGISTRATION:
Advertise to the professions only.

IDENTIFICATION:
White tablets - 10 mg
Yellow tablets - 15 mg
Blue tablets - 30 mg

PRESENTATION:
White tablets 10 mg - bottles of 30, 100 and 500
Yellow tablets 15 mg - bottles of 30, 100 and 500
Blue tablets 30 mg - bottles of 30, 100 and 500

STORAGE INSTRUCTIONS:
Store in a cool, dry place (below 25°C). Store away from direct sunlight.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
10 mg        Q/2.6/249
15 mg        Q/2.6/250
30 mg        Q/2.6/251

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
GEO SCHWULST LABORATORIES LIMITED
17 Faraday St.,
Village Main,
JOHANNESBURG
2091

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
January 1984

PM 0631-8/94

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