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

Logo MIPRALIN 10 mg TABLETS
MIPRALIN 25 mg TABLETS

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form)

MIPRALIN 10 mg TABLETS
MIPRALIN 25 mg TABLETS

COMPOSITION:
Tablets containing 10 mg and 25 mg
imipramine hydrochloride.

PHARMACOLOGICAL CLASSIFICATION:
A 1.2 Psychoanaleptics (antidepressants)

PHARMACOLOGICAL ACTION:
Imipramine hydrochloride is a
tricyclic antidepressant. It has weak anti-cholinergic and antihistaminic actions and prevents the uptake of catecholamines at adrenergic nerve endings. Its mode of action in depression is not fully understood. Its therapeutic effects are only evident after 2 - 3 weeks.

Imipramine is readily absorbed from the gastrointestinal tract and about 95 % becomes reversibly bound to plasma proteins.

INDICATIONS:
Endogenous depressive states and depression associated with other psychiatric conditions.
Mipralin has been reported to be of value in the treatment of enuresis in childhood.

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.

DOSAGE AND DIRECTIONS FOR USE:
In the treatment of depression:
25 to 75 mg thrice daily; elderly patients may require only 10 to 30 mg daily.
When a satisfactory response is obtained, the drug should be withdrawn gradually, but prolonged maintenance treatment may be necessary in some cases.

In the treatment of enuresis, the usual dose for children over 10 years of age is 50 mg at bedtime, and for children aged 4 to 10 years, 25 mg at bedtime.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Peripheral anticholinergic side effects; notably dry mouth, constipation, urinary retention and pupillary dilation with blurred vision and changes in visual accommodation. When anticholinergic effects are severe the medicine should be discontinued or reduced.

Drowsiness or excessive sedation in certain patients. On the other hand disorientation and agitation, insomnia and restlessness can also occur with normal doses. The risks of central nervous system depression are greater when administered together with other central nervous system depressants, e.g. alcohol, barbiturates.

Note: Elderly patients are more prone to all these effects, and therapy should be initiated at lower than standard doses in the elderly.

At the time of initiation of therapy patients should be advised not to drive a motor vehicle, climb dangerous heights or operate dangerous machinery for at least several days. In these situations impaired decision making could lead to accidents.

Cautions should be observed with patients suffering from a depressive phase of manic depressive psychosis, as occasionally hypomania or mania can be precipitated in such patients. Withdraw the drug if the depression turns into a manic phase.

In elderly male patients suffering from prostatism, urinary retention may be precipitated.

In patients suffering from cardiac disease special caution should be observed because of the occasional problems of tachycardia, dysrhythmia, orthostatic hypotension and other unwanted effects on blood pressure, aggravation of conduction disturbances, and electrocardiographic abnormalities. Regular cardiological and electrocardiographic examination is advised.

Epilepsy may be aggravated.

The medicine should not usually be given to patients receiving other central nervous system depressants, e.g. barbiturates and to patients receiving monoamine oxidase inhibitors only after a suitable interval (the drugs may be given together if the dosages are carefully controlled, preferably in hospital). The pressor effects of the direct acting sympathomimetic agents, adrenaline and noradrenaline, are enhanced, and the use of local anaesthetics containing these vasoconstrictors should be avoided as hypertensive reactions may occur. The simultaneous administration of anticholinergic agents may be dangerous. The hypotensive effects of certain antihypertensive agents may be reduced.

Narrow-angle glaucoma may be aggravated.

The drug should be withdrawn if allergic skin reactions appear.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage and poisoning may be characterised by central nervous system depression or excitation, severe anticholinergic effects and cardiotoxicity.

The following symptoms and signs are characteristic of acute overdosage:- drowsiness, restlessness, ataxia, stupor, coma, pyrexia, palpitations, tachycardia, cardiac arrhythmias, hypotension and in severe cases, respiratory depression. Epileptiform seizures may occur. Mixed poisoning with other central nervous system depressants is not uncommon.

Treatment of overdosage is symptomatic.

IDENTIFICATION:
10 mg: Light brown coated tablet with a diameter of 5 mm.
25 mg: Burnt orange coated tablet with a diameter of 6 mm.

PRESENTATION:
Packs of 50, 100 and 500 tablets

STORAGE INSTRUCTIONS:
Store below 25 °C.
Protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN,
SINCE EVEN SMALL DOSES MAY BE FATAL TO THEM.

REGISTRATION NUMBER:
10 mg: M/1.2/l7
25 mg: M/1.2/18

NAME AND BUSINESS ADDRESS OF APPLICANT:
Lennon Limited,
7 Fairclough Road,
PORT ELIZABETH
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
23/09/1993 G063A
  Tradepak P.E.

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