Oramorph Special Precautions

This medicine should be used carefully in the following conditions: In patients with obstructive respiratory disorders, reduced respiratory reserve (e.g. kyphoscoliosis, emphysema or severe adiposis), anoxia, hypercapnia, respiratory insufficiency (patients may become comatose because of carbon dioxide retention), pulmonary disorders; Cor pulmonale; Impaired consciousness, shock, CNS depression; Known opioid dependency. Patients dependent on opioids may be prescribed with morphine if this appears essential for the treatment of pain, particularly in case of acute conditions. Special monitoring of treatment is recommended; Within the first 24 hours post-surgery; Hypovolemia; In patients with chronic kidney or liver disorders, pancreatitis, myxoedema, adrenocortical insufficiency, hypothyroidism, pheochromocytoma, prostatic hypertrophy with residual urine (risk of bladder rupture secondary to urinary retention); Fulminant ulcerative colitis; In patients with obstructive bile or urinary tract diseases or spasms of bile ducts and urinary tract secondary to stone formation, since morphine may worsen these symptoms; After surgery affecting the biliary system, since morphine may cause abdominal pain; Epilepsy or increased propensity to seizures. Morphine lowers the threshold for onset of epileptic syndromes. Morphine should be administered under strict medical control in patients suffering from epilepsy and the dosage should be adjusted individually.
Abdominal conditions: Morphine sulfate pentahydrate must not be given if paralytic ileus is likely to occur (see Contraindications), or if the patient has bowel or obstructive biliary disease. Should paralytic ileus be suspected or occur during use, Oramorph should be discontinued immediately.
Caution should be exercised where there is an obstructive bowel disorder, biliary colic, operations on the biliary tract, acute pancreatitis or prostatic hyperplasia.
If constipation occurs this may be treated with the appropriate laxatives.
Care should be exercised in patients with inflammatory bowel disease.
Morphine may obscure the diagnosis or clinical course of patients with acute abdominal conditions and complications following abdominal surgery.
Hypotensive effect: The administration of morphine may result in severe hypotension in individuals whose ability to maintain homeostatic blood pressure has already been compromised by depleted blood volume or the concurrent administration of drugs such as phenothiazine or certain anaesthetics (see Interactions). Careful dosing is needed in elderly patients, patients with heart insufficiency and with impaired liver or kidney function, respectively (dose reduction if needed).
Dependence and withdrawal (abstinence) syndrome: Use of opioid analgesics may be associated with the development of physical and/or psychological dependence or tolerance. The risk increases with the time the drug is used, and with higher doses. Symptoms can be minimised with adjustments of dose or dosage form, and gradual withdrawal of morphine. For individual symptoms, see Adverse Reactions.
Tolerance to the analgesic, respiratory depressant, sedative and euphoric effects of morphine usually develops on long-term use. However, tolerance to all side effects does not develop at an equal rate; therefore, muscle twitching, tremor, mental confusion, hallucinations and convulsions can occur. Cross-tolerances with other opioids occur.
Adrenal insufficiency: Opioid analgesics may cause reversible adrenal insufficiency requiring monitoring and glucocorticoid replacement therapy. Symptoms of adrenal insufficiency may include e.g. nausea, vomiting, loss of appetite, fatigue, weakness, dizziness, or low blood pressure.
In case of pre-existing adrenocortical insufficiency (e.g. Morbus Addison) plasma cortisol concentration should be monitored and if needed corticoids should be substituted.
Acute chest syndrome (ACS) in patients with sickle cell disease (SCD): Due to a possible association between ACS and morphine use in SCD patients treated with morphine during a vaso-occlusive crisis, close monitoring for ACS symptoms is warranted.
Decreased sex hormones and increased prolactin: Long-term use of opioid analgesics may be associated with decreased sex hormone levels and increased prolactin. Symptoms include decreased libido, impotence or amenorrhea.
Hyperalgesia: Hyperalgesia that does not respond to a further dose increase of morphine may occur in particular in high doses. A morphine dose reduction or change in opioid may be required.
Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs: Concomitant use of Oramorph and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe Oramorph concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.
The patients should be followed closely for signs and symptoms of respiratory depression and sedation. In this respect, it is strongly recommended to inform patients and their caregivers to be aware of these symptoms (see Interactions).
Use with rifampicin: Plasma concentrations of morphine may be reduced by rifampicin. The analgesic effect of morphine should be monitored and doses of morphine adjusted during and after treatment with rifampicin (see Interactions).
Oral P2Y12 inhibitor antiplatelet therapy: Within the first day of concomitant P2Y12 inhibitor (e.g. clopidogrel, prasugrel, ticagrelor) and morphine treatment, reduced efficacy of P2Y12 inhibitor treatment has been observed (see Interactions).
Interference with diagnostic tests: Morphine interferes with the diagnostic determination of cerebrospinal fluid pressure, the concentrations of plasma amylase, plasma lipase, serum alanine aminotransferase (SGPT), serum aspartate aminotransferase (SGOT), serum bilirubin and serum alkaline phosphatase.
Excipients related warnings: Methyl parahydroxybenzoate and propyl parahydroxybenzoate can cause allergic reactions (also delayed hypersensitivity reactions).
This medicine contains 0.105 ml alcohol (ethanol) per ml solution which is equivalent to about 10% v/v, and it must not be given to patients suffering from alcoholism. The alcohol content needs to be considered in patients with higher risk due to liver disease.
This medicine contains 100 mg glucose liquid per ml solution. Patients with the rare glucose-galactose malabsorption should not take this medicine.
This medicine contains 300 mg sucrose per ml solution. Patients with rare hereditary conditions of fructose/galactose intolerance, glucose-galactose malabsorption or sucrase isomaltase insufficiency should not take this medicine.
Note for diabetic patients: 5 ml solution corresponds to 0.17 bread exchange.
Effects on ability to drive and use machines: Even if the recommendations for use are adhered to morphine sulfate pentahydrate can have an impact on the capability to react to such an extent that the ability to drive or to use machines is impaired. This is to be expected especially upon initiation of treatment, dose increase and change in medication as well as in combination with alcohol and centrally depressing substances.