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

Logo PETHIDINE INJECTION INTRAMED 25 mg/mL
PETHIDINE INJECTION INTRAMED 50 mg/mL
PETHIDINE INJECTION INTRAMED 100 mg/2 mL

SCHEDULING STATUS:
S7

PROPRIETARY NAME
(and dosage form):

PETHIDINE INJECTION INTRAMED 25 mg/mL
PETHIDINE INJECTION INTRAMED 50 mg/mL
PETHIDINE INJECTION INTRAMED 100 mg/2 mL

COMPOSITION:
1 mL Ampoules containing 25 mg
Pethidine Hydrochloride.
1 mL Ampoules containing 50 mg Pethidine Hydrochloride.
2 mL Ampoules containing 100 mg Pethidine Hydrochloride.

PHARMACOLOGICAL CLASSIFICATION:
A 2.9 Other Analgesics

PHARMACOLOGICAL ACTION:
Pethidine has an analgesic potency approximately equal to one-fifth that of morphine. Pethidine binds to the opioid receptors in the central nervous system and exerts it’s main pharmacological action on the central nervous system and the neural elements of the bowel.

INDICATIONS:
Pethidine is indicated for the relief of pain. It is particularly useful for the relief of post-operative pain. It may be used in obstetric practice to relieve labour pain.

CONTRA-INDICATIONS:
Pethidine is contra-indicated in respiratory depression, obstructive pulmonary disease, hepatic insufficiency and pain following cholecystectomy and for the relief of pain associated with renal colic. Increased intracranial pressure is also a contra-indication. It must not be administered to patients receiving phenothiazines or meprobamates. Pethidine should not be given to patients who are being treated with monoamine oxidase inhibitors, or within 2 weeks of the discontinuation of such treatment.

WARNING:
Dependence can occur.

DOSAGE AND DIRECTIONS FOR USE:
Children: 1 to 1,5 mg per kg body-mass given intramuscular or subcutaneous, but not exceeding the adult dose.
Adults: 50 to 100 mg S.C., I.M. or in reduced doses I.V. repeated every 3 to 4 hours if required but not exceeding maximum of 150 mg as a single dose.
Obstetric Analgesia: 50 mg to 100 mg I.M./S.C. as soon as contractions occur at regular intervals. This dose may be repeated after 1 to 3 hours if necessary.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
It may give rise to dry mouth, dizziness, perspiration, vomiting, constipation, urinary retention, dysphoria and nausea. Monoamine oxidase inhibitors potentiate the action of pethidine and this may have severe consequences, such as collapse of or severe respiratory depression. Local reactions often follow injections of pethidine; general hypersensitivity reactions occur. Intravenous injection may produce vasodilation and hypotension. Pethidine should be given with caution to elderly patients and to patients with supraventricular tachycardia. If given in conjunction with meprobamate or phenothiazines hypotension may develop. Pethidine must be regarded as a drug of addiction. It may prolong labour and cause respiratory depression in the newborn.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage with pethidine causes muscular twitching, tremors, hyperactive reflexes, dilated pupils and convulsions followed by respiratory depression, hypotension with circulatory failure and deepening coma. Death may occur from respiratory failure.
Treatment of Toxic Effects:
The stomach should be emptied by aspiration and lavage if oral ingestion occurs. The antidote is naloxone hydrochloride 400 to 2000 µg given subcutaneously, intramuscularly or intravenously, repeated at intervals of 2 to 3 minutes if necessary. In children a dose of 5 to 10 µg/kg body-mass may be given, similarly repealed at intervals of 2 to 3 minutes. Further treatment is supportive and symptomatic. The circulation should be maintained with infusions of dextrose injection and suitable electrolyte solutions. Assisted respiration may be necessary.

IDENTIFICATION:
Clear solution in clear glass ampoules.

PRESENTATION:
Boxes of 1 mL Ampoules in 10’s and 100’s –25 mg/mL
Boxes of 1 mL Ampoules in 10’s and 100’s –50 mg/mL
Boxes of 2 mL Ampoules in 10’s and 100’s –100 mg/2 mL

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

REGISTRATION NUMBER:
25 mg/1 mL = B/2.9/928
50 mg/1 mL = B/2.9/925
100 mg/2 mL = B/2.9/1630

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited
7 Fairclough Road
PORT ELIZABETH
6001
Marketed by:
Intramed, Division of Pharmacare
6 Gibaud Road
PORT ELIZABETH
6001

DATE OF PUBLICATION OF THIS LEAFLET:
Nov. 1969
                        12-337/8
                        KOHLER C&P P.E.

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