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

Logo MOLIPAXIN® 50 mg Capsules
MOLIPAXIN® 100 mg Capsules

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

MOLIPAXIN® 50 mg Capsules
MOLIPAXIN
® 100 mg Capsules

COMPOSITION:
50 mg capsule:
trazodone hydrochloride 50 mg.
100 mg capsule: trazodone hydrochloride 100 mg.

PHARMACOLOGICAL CLASSIFICATION:
A. 1.2 Psychoanaleptics (antidepressants).

PHARMACOLOGICAL ACTION:
Trazodone hydrochloride is a triazolopyridine anxiolytic/anti-depressant, psychotropic agent.

INDICATIONS:
Molipaxin is indicated in the treatment of depression, mixed anxiety and depression.

CONTRA-INDICATIONS:
Combined use with other psychotropic drugs should only be undertaken with due recognition of the possibility of potentiation.
Pregnancy and lactation: The safety of Molipaxin in human pregnancy has not been established.

DOSAGE AND DIRECTIONS FOR USE:
The dosage is dependent upon the diagnosis and the severity of the condition and the individual patient's response. The daily dosage is usually administered in three divided doses.
Adults:
Depression
- The optimal dosage is between 300 - 400 mg/day. It is suggested that a starting dose of 150 mg/day is given for the first week, increasing to 300 mg/day or higher according to the clinical response (600 mg/day dosage has been reported).
Mixed anxiety and depression - The recommended starting dose is between 100 - 150 mg/day. When depression is the predominant symptom, a dose of 300 - 400 mg daily may be required to obtain a satisfactory response.
Children:
Molipaxin is not recommended for use in children.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Molipaxin should be administered with care to patients receiving barbiturates, muscle relaxants and volatile anaesthetics, since it has been shown to potentiate the action of these substances. Patients should be warned about the possibility of their judgement being impaired when handling dangerous machinery and when driving. The following side-effects have been noted: headache, dizziness, drowsiness, nausea and vomiting, weakness, decreased alertness, weight loss, tremor, dry mouth, tachycardia, constipation, diarrhoea, hypertension, blurred vision, excitement, restlessness, irritability, confusional states, insomnia, skin rashes and priapism.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
There is no specific antidote to Molipaxin. The stomach should be emptied as quickly as possible and symptomatic and supportive therapy given.

IDENTIFICATION:
Capsules:
50 mg - opaque violet cap and opaque green body with R365B printed on one half and the company logo on the other half.
100 mg - opaque violet cap and opaque fawn body with R365C printed on one half and the company logo on the other half.

PRESENTATION:
Molipaxin capsules (all strengths) are presented in blister packs each containing 20 capsules.
The 50 mg and 100 mg capsules are packed in cartons of 100 capsules. Sample packs (both strengths) are packed in cartons of 10 capsules.

STORAGE INSTRUCTIONS:
Store in a cool, dry place, below 25°C
Protect from light.
Keep out of reach of children.

REGISTRATION NUMBER:
Molipaxin 50 mg Capsules ––E/1.2/9
Molipaxin 100 mg Capsules ––E/1.2/10

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Hoechst Marion Roussel Limited
16th Road, Midrand

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
11 April, 1985.

Hoechst Marion Roussel Ltd.
16th Road,
Midrand

        MN2-A0098
               
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Updated on this site: December 2000

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