DBL MORPHINE SULFATE INJECTION 10 MG/ML [SIN00757P]

Product Info

DBL MORPHINE SULFATE INJECTION 10 MG/ML

[SIN00757P]

4.1 Therapeutic Indications

DBL Morphine Sulfate is indicated for the relief of moderate to severe pain not responsive to non-opioid analgesics. It may also be used as a pre-operative medication and as an analgesic adjunct in general anaesthesia.

4.2 Dose and Method of Administration

NOTE: Opioid antagonists and facilities for administration of oxygen and control of respiration should be available during, and immediately following parenteral administration.

Subcutaneous, intramuscular and slow intravenous administration

DBL Morphine Sulfate may be given by the subcutaneous, intramuscular or intravenous route. The subcutaneous route is not suitable for oedematous patients.

Adults: DBL Morphine Sulfate is usually administered by intramuscular or subcutaneous injection, in the range of 5 to 20 mg, depending on the cause of pain and the patient response. Doses may be repeated every 4 to 6 hours.

DBL Morphine Sulfate may also be given intravenously when a rapid onset of action is desired. The dose is usually in the range of 2.5 to 15 mg diluted in 4 to 5 mL of Water for Injections given slowly over 4 to 5 minutes.

Children: DBL Morphine Sulfate is given by intramuscular or subcutaneous injection in doses of 0.1 to 0.2 mg/kg bodyweight to a maximum of 15 mg. Injection may be repeated every 4 to 6 hours.

When a rapid onset of action is desirable, in a closely monitored environment, morphine may be titrated intravenously with caution, in a dose of 0.05 to 0.1 mg/kg, incrementally over 5 to 15 minutes. Repeat intravenous dosing is unsubstantiated as a method of analgesic therapy in children.

DBL Morphine Sulfate is not usually given pre-operatively in children under 1 year, and it should be given with extreme care to neonates. It should not be given to premature infants (see section 4.3 Contraindications).

Continuous intravenous infusion

The dosage of morphine should be titrated according to the patient’s analgesic requirements and previous opiate experience. For the management of acute pain via intravenous infusion, most adults with no previous history of opioid intake can be continued on 0.5 to 2.0 mg/h after adequate analgesic therapy has been established.

In children, an infusion dose of 0.01 to 0.05 mg/kg/h morphine to a maximum intravenous dose of 4 mg/h is recommended.

It is recommended that an opioid antagonist and equipment for artificial ventilation be available.

Patient-controlled analgesia (PCA)

PCA allows patients to assess their own level of pain and consequently titrate the amount of morphine they require for adequate pain control against sedation and other side effects.

The dosages and time intervals are preset into a microprocessor-controlled infusion pump. When the patient experiences pain, a button is depressed by the patient and a dose of morphine is administered intravenously. If the patient should depress the button before the preset time interval (lockout interval) has elapsed, no extra drug is administered. For adults, demand doses of 0.5 to a maximum of 1.5 mg morphine have been given via PCA using a lockout interval of 6 to 10 minutes. Along with the self-administered dose of morphine, some syringe pumps also deliver a background continuous infusion of morphine at a basal rate. If a background infusion is adopted, a dose of 1 mg/h morphine is often used in adults. Some PCA pumps allow a maximum dosage over a defined period to be preset in order to avoid patient overdosage.

There is limited clinical experience of the use of PCA in children. However, a demand dose of 0.01 to 0.025 mg/kg morphine has been used successfully in children and adolescents between the ages of 7 and 19 years with a lockout interval of 6 to 10 minutes. If a background infusion is employed, an infusion dose of 0.015 mg/kg/h morphine may be used in children.

The demand dosage and lockout interval should be determined according to the patient’s analgesic requirements. Patients receiving a background infusion of morphine should generally receive a smaller demand dose relative to equivalent patients utilising a demand dose only.

Techniques such as PCA with background continuous infusion are associated with a higher rate of adverse effects and require close monitoring.

General information for cancer pain

When morphine is administered by continuous intravenous or subcutaneous infusion for relief of severe, chronic pain associated with cancer, the dosage of morphine must be individualised according to the response and tolerance of the patient. In some patients with exceptionally severe, chronic pain it may be necessary to exceed the usual dosage. Reduced dosage is indicated in poor-risk patients, in very young or very old patients, and in patients receiving other CNS depressants.

Orally administered morphine should be used in preference to parenteral morphine whenever adequate pain control can be achieved by this route. However, oral morphine is often inadequate or impractical in the terminally ill patient.

Patients being converted from oral morphine to either intramuscular, intravenous or subcutaneous morphine require dosage reduction (about one-sixth), since about 60% of oral morphine is metabolised in first-pass metabolism (i.e., 1 mg of either intramuscular, subcutaneous or intravenous morphine for every 6 mg of oral morphine). The dose should then be titrated according to the patient’s clinical response.

For cancer pain, DBL Morphine Sulfate should be given regularly around the clock, in most instances every 4 hours. The basis of pain control with DBL Morphine Sulfate should be regular scheduling rather than on an ‘as required’ or PRN narcotic order. Patients requiring high doses of morphine usually need to be awakened for medication during the night to prevent morning pain.

Morphine dosage increases

Dosage increases for intravenous, subcutaneous or intramuscular administration of morphine should not be made more frequently than every 24 hours, since it will take approximately 4 to 5 morphine half-lives to attain a new steady state concentration in a patient with normal liver and kidney function.

Following all dosage increases, the patient must be monitored closely for side effects, the most common being sedation, nausea, vomiting, constipation and hypotension.

Treatment goals and discontinuation

Before initiating treatment with morphine, a treatment strategy including treatment duration and treatment goals, and a plan for end of the treatment, should be agreed together with the patient, in accordance with pain management guidelines. During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed.

When a patient no longer requires therapy with morphine, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal. In absence of adequate pain control, the possibility of hyperaesthesia, drug tolerance and progression of underlying disease should be considered (see section 4.4 Special Warnings and Precautions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Duration of treatment

Morphine should not be used longer than necessary.

Warning: As with all parenteral drug products, intravenous admixtures should be visually inspected for clarity, particulate matter, precipitate and leakage prior to administration, whenever solution and container permit. Solutions showing haziness, particulate matter, precipitate or leakage should not be used. Development of a yellow colour in morphine solutions does not indicate toxicity or loss of potency or efficacy.

4.3 Contraindications

DBL Morphine Sulfate is contraindicated in the following situations:

• patients with known hypersensitivity to morphine or other opioids;

• patients with severe respiratory disease, acute respiratory disease, respiratory depression or failure, especially in the presence of cyanosis and/or increased bronchial secretion;

• patients with asthma or other obstructive airways disease;

• other 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, 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 who are taking or who have taken monoamine oxidase (MAO) inhibitors within the previous fourteen days;

• phaeochromocytoma (due to risk of pressor response to histamine release);

• arrhythmia;

• cardiac failure secondary to pulmonary disease;

• alcoholism or delirium tremens;

• comatose patients;

• head injury;

• brain tumour;

• increased intracranial or cerebrospinal pressure and in convulsive states such as status epilepticus, tetanus or strychnine poisoning (see section 4.4 Special Warnings and Precautions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Morphine is contraindicated in premature infants or during labour for delivery of premature infants.

The administration of morphine via PCA to children less than six years of age and adults with poor cognitive function is contraindicated.

The continuous intravenous infusion of morphine in patients with hepatic or renal disease is contraindicated (see section 4.4 Special Warnings and Precautions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).