INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
Q-MED MORPHINE 10 mg Injection
Q-MED MORPHINE 15 mg Injection

SCHEDULING STATUS:
S7

PROPRIETARY NAME
(and dosage form):

Q-MED MORPHINE 10 mg Injection
Q-MED MORPHINE 15 mg Injection

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

PHARMACOLOGICAL CLASSIFICATION:
A 2.7 Narcotic Analgesics

PHARMACOLOGICAL ACTION:
Morphine is a narcotic analgesic and produces major effects on the central nervous system and the bowel by acting as an agonist particularly at µ receptors, it also has affinity for and K-receptors. Therapeutic concentrations of morphine in plasma is about one third protein bound. The half-life of morphine is about 2 hours, the half-life of morphine-6-glucoronide is longer. Morphine is eliminated by glomerular filtration mainly as morphine-3-gluconide.

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

CONTRA-INDICATIONS:
Hypersensitivity to morphine.
Morphine is not usually given pre-operatively to children under 1 year of age, and it should be given with extreme care to newborn or premature infants for other conditions. Morphine is generally contra-indicated in respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion. It is also contraindicated in the presence of acute alcoholism, head injuries, and in conditions in which intracranial pressure is raised. It should not be given during an attack of bronchial asthma or in heart failure secondary to chronic lung disease.

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

DOSAGE AND DIRECTIONS FOR USE:
Adults:
The usual dose by subcutaneous or intramuscular injection is 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

Doses of up to 15 mg have been given by slow intravenous injection, sometimes as a loading dose for continuous or patient-controlled infusion.
Continuous administration: Doses have generally ranged from 0,8 mg to 80 mg per hour.
Intraspinal doses are in the region of 5 mg for an initial epidural injection. Intrathecal dose ranges from 0,2 to 1 mg, and should only involve the administration of a single dose.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:

1.

Side-effects: In normal doses the commonest side-effects of morphine are nausea, vomiting, constipation, drowsiness and confusion. Micturition may be difficult and there may be ureteric or biliary spasm; there is also an anti-diuretic effect. Dry mouth, sweating, facial flushing vertigo, bradycardia, palpitations, orthostatic hypotension, hypothermia, restlessness, changes of mood and miosis also occur. Raised intracranial pressure occurs in some patients. Larger doses produce respiratory depression and hypotension, with circulatory failure and deepening coma. Convulsions may occur especially in infants and children. Death may occur from respiratory failure. Due to the histamine-releasing effect, reactions such as urticaria and pruritus, occur in some individuals. Contact dermatitis, pain and irritation may occur on injection. Anaphylactic reactions, following intravenous injection of morphine have been reported as well as muscle rigidity. The administration of morphine during labour may cause respiratory depression in the newborn infant.

2.

Special precautions: The dosage should be reduced in elderly and debilitated patients. Morphine should be given with extreme caution in patients with decreased cardiac reserve. It should be given with caution or in reduced doses to patients with hypothyroidism, adrenocortical insufficiency, impaired kidney or liver function, prostatic hypertrophy, or shock. It should be used with caution in patients with obstructive bowel disorders. Opioid analgesics should be used with caution in patients with myasthenia gravis and in patients receiving monoamine oxidase inhibitors. The depressant effects of morphine are enhanced by depressants of the central nervous system such as alcohol, anaesthetics, hypnotics and sedatives, tricyclic antidepressants, and phenothiazines.

KNOWN SYMPTOMS OF OVERDOSAGE AND ITS TREATMENT:
See side effects for symptoms.
Intensive supportive therapy may be required to correct respiratory failure and shock. In addition, the specific antagonist naloxone hydrochloride is used to counteract very rapidly the severe respiratory depression and coma produced by excessive doses of opioid analgesics. A dose of 0,4 mg to 2 mg is given intravenously, repeated at intervals of 2 to 3 minutes if necessary, up to 10 mg.
Naloxone may also be given by subcutaneous or intramuscular injection. The effect of naloxone may be of shorter duration than that of the opioid analgesic and additional doses may be required to prevent relapses. Respiration assistance may be necessary. Circulation should be maintained with infusions of Dextrose injection and suitable electrolyte solutions.

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

PRESENTATION:
1 mL amber ampoules in boxes of 10.

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

REGISTRATION NUMBER:
10 mg/mL : 29/2.7/0475
15 mg/mL : 29/2.7/0476

NAME AND BUSINESS ADDRESS OF APPLICANT:
Quatromed Limited
10 Lindley Street
BETHLEHEM
9700

DATE OF PUBLICATION:
February 1995        PMO 0051/6-96
SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996,1997,1998