Safety Information for Using
Morphine Sulphate®

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.

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.