MORPHINE SULPHATE PF INJECTION INTRAMED 10 mg/mL; MORPHINE SULPHATE PF INJECTION INTRAMED 15 mg/mL; MORPHINE SULPHATE PF INJECTION INTRAMED 20 mg/mL

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

MORPHINE SULPHATE PF INJECTION INTRAMED 10 mg/mL
MORPHINE SULPHATE PF INJECTION INTRAMED 15 mg/mL
MORPHINE SULPHATE PF INJECTION INTRAMED 20 mg/mL

SCHEDULING STATUS:
S7

PROPRIETARY NAME
(and dosage form):

MORPHINE SULPHATE PF INJECTION INTRAMED 10 mg/mL
MORPHINE SULPHATE PF INJECTION INTRAMED 15 mg/mL
MORPHINE SULPHATE PF INJECTION INTRAMED 20 mg/mL

COMPOSITION:
Each 1 mL ampoule contains 10, 15 or 20 mg morphine sulphate.

PHARMACOLOGICAL CLASSIFICATION:
A 2.9 Other analgesics

PHARMACOLOGICAL ACTION:
Morphine acts as an agonist particularly at µ receptors, and also d and K-receptors. Its effects are diverse and include analgesia, drowsiness, changes in mood, respiratory depression, decreased gastrointestinal motility, nausea, vomiting and alterations of the endocrine and autonomic nervous systems. The development of tolerance and physical dependence is a characteristic feature. About one third is protein bound and it has a half-life of about 2 hours. It is eliminated mainly by glomerular filtration and small amounts are found in the faeces and urine.

INDICATIONS:
Relief of intractable pain not controlled with non-narcotic analgesics.

CONTRA-INDICATIONS:
Morphine is not usually administered to children under the age of one year and it should be given with extreme care to newborn or premature infants.
It is contra-indicated in:

–	respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion;
–	in the presence of acute alcoholism, head injuries and conditions in which intracranial pressure is raised;
–	during an attack of bronchial asthma or in heart failure secondary to chronic lung disease;
–	for biliary or renal colic, since sphincter constriction occurs.

WARNINGS:
The euphoric activity of morphine may lead to abuse. Dependence and tolerance to morphine may occur.

DOSAGE AND DIRECTIONS FOR USE:
Doses should generally be reduced in the elderly or debilitated or in patients with renal impairment.

Subcutaneous or intramuscular injection

Adults:	5 to 20 mg every 4 hours
Children:	1 to 5 years: 2,5 to 5 mg
	6 to 12 years: 5 to 10 mg

Slow intravenous injection or as loading dose for continuous or patient controlled infusions: Adults: up to 15 mg

Maintenance dose for continuous intravenous administration and continuous subcutaneous infusion: From 0,8 to 80 mg per hour.

Intrathecal dose ranges from 0,2 to 1,0 mg and must only be given as a single dose.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Normal doses: nausea, anorexia, vomiting, constipation, drowsiness and confusion. Micturition may be difficult and ureteric or biliary spasm as well as an anti-diuretic effect may occur. Dry mouth, sweating, facial flushing, vertigo, bradycardia, palpitation, orthostatic hypotension, hypothermia, restlessness, changes of mood, hallucinations and miosis. Raised intracranial pressure sometimes occurs. The euphoric activity of morphine leads to abuse and dependence.
Larger doses produce respiratory depression, hypotension with circulatory failure and deepening coma. Convulsions may occur, especially in infants and children. Rhabdomyolysis progressing to renal failure has been reported in overdosage. Death may occur from respiratory failure.
Due to the histamine-releasing effect, urticaria, pruritus and contact dermatitis occur. Pain and irritation may occur at the site of injection. Analphylactic reactions following intravenous injection have been reported, as well as muscle rigidity. The administration of morphine during labour may cause respiratory depression in the newborn infant.

Toxic doses vary considerably with the individual and regular users may tolerate large doses. The triad of coma, pinpoint pupils, and respiratory depression is considered indicative of overdosage; dilatation of the pupils occurs as hypoxia develops. Pulmonary oedema after overdosage is a common cause of fatalities among opioid addicts.

Special Precautions
Morphine should be used with extreme caution in patients with decreased respiratory reserve.
In the case of geriatric patients, and in patients with hypothyroidism, adrenocortical insufficiency, impaired kidney or liver function, prostatic hypertrophy, shock or inflammatory or obstructive bowel disorders, it should be used with caution and the dosage reduced. It should be used with caution in patients with myasthenia gravis and in patients taking monoamine oxidase inhibitors.
The administration of opioid analgesics during labour may cause respiratory depression in the newborn infant. The dosage should be reduced in elderly and debilitated patients.
The depressant effects of morphine are enhanced by central nervous system depressants such as alcohol, anaesthetics, hypnotics, sedatives, tricyclic antidepressants and phenothiazines.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Signs and symptoms of overdose indicating need for medical attention: Cold, clammy skin; confusion; convulsions; dizziness, severe; drowsiness, severe; low blood pressure; nervousness or restlessness, severe; pinpoint pupils of eyes; slow heartbeat; slow or troubled breathing; unconsciousness; weakness, severe.

See "side effects and special precautions".
Intensive supportive therapy may be required to correct respiratory failure and shock. The specific antagonist naloxone hydrochloride is used. A dose of 0,4 to 2 mg is given intravenously every 2 to 3 minutes, if necessary up to 10 mg. For children, the initial dose is 0,01 mg/kg. It may also be given by subcutaneous or intramuscular injection. Additional doses may be required to prevent relapse. The circulation should be maintained with infusions of Dextrose injection and suitable electrolyte solutions. Assisted respiration may be necessary.
The use of opioid antagonists such as naloxone, nalorphine, and levallorphan in persons physically dependent on morphine or related drugs may induce withdrawal symptoms.

IDENTIFICATION:
A sealed amber glass ampoule containing a clear colourless to slightly yellow solution.

PRESENTATION:
1 mL amber glass ampoules in containers of 10.

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

APPLICATION NUMBERS:
Morphine Sulphate PF Injection Intramed 10 mg/mL: B930 (Act 101/1965)
Morphine Sulphate PF Injection Intramed 15 mg/mL: B931 (Act 101/1965)
Morphine Sulphate PF Injection Intramed 20 mg/mL: B932 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF APPLICANT:
Intramed (Pty) Ltd
6 Gibaud Road
PORT ELIZABETH
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

May 1995	12-235/10-95
	KOHLER C&P P.E.