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 its 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 10s and 100s 25 mg/mL
Boxes of 1 mL Ampoules in 10s and 100s 50 mg/mL
Boxes of 2 mL Ampoules in 10s and 100s 100 mg/2 mL
STORAGE INSTRUCTIONS: Store below 25°C. Protect from light.
Keep out of the reach of children.
25 mg/1 mL =
50 mg/1 mL =
100 mg/2 mL =
NAME AND BUSINESS ADDRESS OF APPLICANT:
7 Fairclough Road
Marketed by: Intramed, Division of Pharmacare
6 Gibaud Road
DATE OF PUBLICATION OF THIS LEAFLET: Nov. 1969
KOHLER C&P P.E.