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

Logo INTRAMED MEPYRAMINE MALEATE INJECTION

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

INTRAMED MEPYRAMINE MALEATE INJECTION

COMPOSITION:
Injection: Each 2,0 mL contains
Mepyramine Maleate 50 mg

PHARMACOLOGICAL CLASSIFICATION:
A 5.7.1 Antihistaminics

PHARMACOLOGICAL ACTION:
Mepyramine maleate is a histamine antagonist and thus has antihistaminic properties.

INDICATIONS:
Mepyramine maleate is indicated in disorders known to respond to antihistamine therapy e.g. urticaria, rhinitis, anaphylactic shock. Mepyramine maleate is used to ameliorate or even abort the effects of histamine release e.g. antihistaminics are taken prior to sun bathing and procaine penicillin ia administered together with a potent antihistaminic.

CONTRA-INDICATIONS:
Hypersensitivity to mepyramine maleate.
Antihistaminics are contra-indicated in epileptics

WARNINGS:
This medicine may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other central nervous system depressant agents. Patients should be warned against taking charge of vehicles or machinery or performing potentially hazardous tasks where loss of concentration may lead to accidents.

DOSAGE AND DIRECTIONS FOR USE:
Injection: 25 mg to 50 mg intramuscularly or intravenously.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The most common side-effect of mepyramine maleate is sedation which can vary from slight drowsiness to deep sleep, and including inability to concentrate, lassitude, dizziness, hypotension, muscular weakness and inco-ordination.
Other side-effects include gastro-intestinal disturbances such as nausea, vomiting, diarrhoea or constipation and epigastric pain.
Headache, tinnitus, elation and depression, irritability, nightmares, anorexia, difficulty in micturition, dryness of the mouth, tightness of the chest and tingling, heaviness and weakness of the hands may occur.
In infants and children it may act as a cerebral stimulant. Symptoms of stimulation in adults include insomnia, nervousness, tachycardia, tremors, muscle twitching and convulsions.
Large doses may precipitate fits in epileptics.
Allergic reactions and anaphylaxis may occur. Blood dyscrasias including agranulocytosis and haemolytic anaemia may occur.
Mepyramine maleate has anticholinergic properties and should be used with care in conditions such as glaucoma and prostatic hypertrophy. The anticholinergic effects of atropine and tricyclic antidepressants may be enhanced by mepyramine maleate.
Mepyramine maleate may mask the warning symptoms of damage caused by ototoxic medicines and may effect the metabolism of other medicines in the liver. It may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The dominant effect of overdosage includes drowsiness followed by hallucinations, excitement, ataxia, inco-ordination, convulsions and athetosis. Fixed dilated pupils with a flushed face and fever are common in children.
In case of overdosage, the patient should be kept quiet and convulsions and marked central nervous system stimulation should preferably be treated with diazepam or phenobarbitone intramuscularly.

IDENTIFICATION:
Clear solution in 2 mL amber ampoules.

PRESENTATION:
Boxes containing 10 and 100 ampoules.

STORAGE INSTRUCTIONS:
Keep out of reach of children. Protect from light.
Store below 25°C.

REGISTRATION NUMBER:
C791 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF APPLICANT:
INTRAMED (PTY) LTD.
6 Gibaud Rd
Korsten
PORT ELIZABETH 6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
June 1974 12-225/3-93
Hoogland 3213

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