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

Logo ETHIPRAMINE 10 mgTablets
ETHIPRAMINE 25 mg Tablets

SCHEDULING STATUS
S5

PROPRIETARY NAME
(and dosage form)

ETHIPRAMINE 10 mgTablets
ETHIPRAMINE 25 mg Tablets

COMPOSITION
Each tablet contains:
Imipramine hydrochloride         10 mg
Imipramine hydrochloride         25 mg

PHARMACOLOGICAL CLASSIFICATION
A 1.2 Psychoanaleptics (antidepressants)

PHARMACOLOGICAL ACTION
ETHIPRAMINE (Imipramine hydrochloride) is a tricyclic antidepressant with weak anticholinergic and antihistaminic actions.

INDICATIONS
Endogenous depression, Parkinsonism, chronic alcoholism, behavioural disorders in children

CONTRA-INDICATIONS
The acute phase of myocardial infarction.
Administration is not advised during the first trimester of pregnancy, unless there are compelling reasons for its use.

WARNINGS
This medicine should at all times be kept out of reach of children, as even small doses may be fatal to them.

DOSAGE AND DIRECTIONS FOR USE
Usual dosage:
75 to 150 mg daily in divided doses or as prescribed
Elderly patients:
Not more than 10 to 30 mg per day
Children:
6 to 12 years: 25 mg at bedtime
Over 12 years: 50 mg at bedtime

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Peripheral anticholinergic side-effects:
Dry mouth, constipation, urinary retention and pupillary dilation with blurred vision and changes in visual accommodation. If these effects are severe, the medication should be withdrawn.
Central nervous system side-effects:
Drowsiness, excessive sedation, disorientation, agitation, insomnia and restlessness.
Note:
All these side-effects occur more commonly in elderly patients, hence therapy should be initiated at lower than normal dosages in these cases.
Precautions:
1. Patients are advised that the use of this medicine may lead to impaired decision-making and hence the driving of motor vehicles, climbing of dangerous heights or operation of dangerous machinery, etc. should be avoided for several days after initiation of therapy.
2. In the depressive phase of manic depressive psychoses, its use may precipitate mania or hypomania, in which case the drug should be immediately withdrawn.
3. In elderly male patients with prostatism it may precipitate urinary retention.
4. In cardiac disease, regular cardiological and electrographic examinations are advised, as it may occasionally produce tachycardia, dysrhythmias, orthostatic hypotension, blood pressure disturbances and electrocardiographic abnormalities.
5. Epilepsy and narrow angle glaucoma may be aggravated.
6. The risks of central nervous system depression are increased when it is taken in conjunction with other central nervous system depressants, e.g. alcohol and barbiturates. It should not be given together with MAOI or within 2 weeks of such treatment. (The above mentioned drugs may only be given in conjunction with a tricyclic antidepressant if dosages are very carefully monitored, preferably in hospital). The pressor effects of adrenaline and noradrenaline are enhanced and the use of local anaesthetics containing these should be avoided. Simultaneous administration of anticholinergic agents may be dangerous. The hypotensive effects of certain antihypertensive agents may be reduced.
7. If allergic skin reactions occur the drug should be withdrawn.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Overdosage and poisoning may result in central nervous system depression, excitation, severe anticholinergic effects and cardiotoxicity which may be characterised by the following signs and symptoms; drowsiness, restlessness, ataxia, stupor, coma, pyrexia, palpitations, tachycardia, cardiac arrhythmias, hypotension and, in severe cases, respiratory depression.
Epileptiform seizures may occur. Mixed poisoning with central nervous system depressants is not uncommon.
Treatment includes emptying of the stomach by aspiration and lavage.
Diazepam should be given i.v., or paraldehyde i.m., to control convulsions. Fluid intake should be maintained by infusions of electrolyte solutions. Respiration may need to be assisted and corticosteroids administered.
Cardiac irregularities should be corrected.

IDENTIFICATION
10 mg: Yellow, shiny, sugar-coated tablet
25 mg: Orange, sugar-coated tablet

PRESENTATION
10 mg: 50', 100’, 250', 500’, 1 000’, 5 000'
25 mg: 50', 100’, 250', 500’, 1 000’, 5 000'

STORAGE INSTRUCTIONS
Store below 25°C and protect from light.
KEEP OUT OF REACH OF CHILDREN.

REFERENCE NUMBERS
10 mg: B695 (Act 101/1965)
25 mg: B694 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF APPLICANT
Pharmacare Ltd
Building 12
Healthcare Park
Woodlands Drive
Woodmead
Sandton
2148

DATE OF PUBLICATION OF THIS PACKAGE INSERT
20 November 1969

308535        031205        Harry's Printers K31081 C04

Updated on this site: January 2005
Source: Community Pharmacy

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