SEVREDOL

What it is

SEVREDOL is available in isotonic preparations of morphine sulfate pentahydrate in strengths of 2 milligram per 1 mL, 5 milligram per 1 mL, 10 milligram per 1 mL, 15 milligram per 1 mL and 30 milligram per 1 mL. These are sterile solutions of morphine sulfate pentahydrate and sodium chloride in water for injections. SEVREDOL is a solution for injection presented as a clear colourless to slightly yellow solution.

Approved indications

— Short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain. — Pre-operative medication and as an analgesic adjunct in general anaesthesia.

Dosing overview

For adults, SEVREDOL is usually administered by intramuscular or subcutaneous injection in the range of 5 to 20 milligrams depending on the cause of pain and patient response, with doses repeated every 4 to 6 hours. SEVREDOL may also be given intravenously when rapid onset of action is desired, usually in the range of 2.5 to 15 milligrams diluted in 4 to 5 mL of Water for Injections given slowly over 4 to 5 minutes. For children, SEVREDOL is given by intramuscular or subcutaneous injection in doses of 0.1 to 0.2 milligram per kilogram bodyweight to a maximum of 15 milligrams, with injection repeated every 4 to 6 hours. When rapid onset is desirable in a closely monitored environment, morphine may be titrated intravenously with caution in doses of 0.05 to 0.1 milligram per kilogram incrementally over 5 to 15 minutes.

Key safety warnings

Serious, life-threatening or fatal respiratory depression may occur with the use of SEVREDOL. Situations which increase the risk of respiratory depression should be identified, dosing modified in patients at risk, and patients monitored closely, especially on initiation or following a dose increase. Concomitant use of SEVREDOL with other opioid analgesics, benzodiazepines, gabapentinoids, sedatives, hypnotics, antipsychotics, antihistamines, tricyclic antidepressants, centrally-active anti-emetics, general anaesthetics, tranquilisers, beta blockers, cannabis or other central nervous system depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Dosages and durations should be limited to the minimum required; patients should be monitored for signs and symptoms of respiratory depression and sedation; and patients should be cautioned not to drink alcohol while taking SEVREDOL. SEVREDOL contains an opioid that is a potential drug of abuse, misuse and dependence. Dependence can occur in patients appropriately prescribed SEVREDOL at recommended doses. The risk of dependence is increased in patients with a personal or family history of substance abuse, in current tobacco users or in patients with a personal history of mental illness, and increases the longer the drug is used and with higher doses. Serious, life-threatening or fatal respiratory depression can occur with the use of SEVREDOL even when used as recommended. It can occur at any time during use but the risk is greatest during initiation of therapy or following an increase in dose, and patients should be monitored closely for respiratory depression at these times.

Contraindications

SEVREDOL is contraindicated in patients with known hypersensitivity to morphine or other opioids; severe respiratory disease, acute respiratory disease and respiratory depression or failure, especially in the presence of cyanosis and/or increased bronchial secretion; asthma or other obstructive airways disease; conditions where respiratory reserve is depleted such as emphysema, chronic bronchitis or kyphoscoliosis; cor pulmonale; severe depressed level of consciousness; Diabetic Ketoacidosis where there is a danger of coma; severe liver disease or incipient hepatic encephalopathy; following biliary tract surgery or surgical anastomosis; biliary colic; gastrointestinal obstruction or paralytic ileus; suspected surgical abdomen; acute diarrhoeal conditions associated with antibiotic-induced pseudomembranous colitis; diarrhoea caused by poisoning until the toxic material has been eliminated; in patients taking or who have taken MAO inhibitors within the previous fourteen days; phaeochromocytoma; arrhythmias; cardiac failure secondary to pulmonary disease; acute alcoholism or delirium tremens; comatose patients; head injuries or brain tumour; and increased intracranial or cerebrospinal pressure and in convulsive states such as status epilepticus, tetanus or strychnine poisoning. SEVREDOL is contraindicated in premature infants or during labour for delivery of premature infants. The administration of SEVREDOL via patient-controlled analgesia to children less than six years of age and adults with poor cognitive function is contraindicated. The continuous intravenous infusion of SEVREDOL in patients with hepatic or renal disease is contraindicated.