Hallym Morphine Sulfate Hydrate Injection

Adult administration

[Intravenous administration] The initial dose is 2∼10 mg per 70 kg of body weight. Administer with extreme caution to elderly patients. [Epidural administration] The usual intrathecal dose is 1/10 of the epidural dose. An initial dose of 5 mg injected into the lumbar region may provide satisfactory pain relief for up to 24 hours. If adequate pain relief is not achieved within 1 hour, additional doses of 1∼2 mg may be administered cautiously at appropriate intervals to assess the effect. Do not administer more than 10 mg over 24 hours. When administered into the thoracic region, the early and delayed onset of respiratory depression is markedly increased, even at doses of 1∼2 mg. For continuous infusion, the initial dose is 2∼4 mg over 24 hours. If adequate pain relief is not achieved with the initial dose, an additional 1∼2 mg may be administered. Administer with caution to elderly patients. [Intrathecal administration] The usual intrathecal dose is 1/10 of the epidural dose. Early and delayed onset of respiratory depression occurs more frequently with intrathecal administration. A single injection of 0.2∼1 mg may provide satisfactory pain relief for up to 24 hours (equivalent to 0.4∼2 mL of a 0.05 % preparation or 0.2∼1 mL of a 0.1 % preparation). Do not inject more than 2 mL of a 0.05 % preparation or 1 mL of a 0.1 % preparation intrathecally. Administer only into the lumbar region; repeated intrathecal administration is not recommended. To reduce the incidence of potential adverse reactions, naloxone may be administered by intravenous infusion at 0.6 mg per hour after this medicine has been administered over 24 hours. Administer with extreme caution to elderly patients; a lower dose is usually sufficient. If pain recurs, consider administering morphine by another route because experience with repeated intrathecal administration is limited.

Child administration

Intravenous administration: There is no information on use in patients under 18 years of age. Epidural administration: There is no information on use in children. Intrathecal administration: There is no information on use in children.

This medication may cause severe adverse reactions when administered epidurally or intrathecally; therefore, it is necessary to be hospitalized in a facility capable of emergency treatment for at least 24 hours after the first administration for observation. When using ampule-type injectable preparations, care must be taken when cutting the container due to the risk of glass fragments mixing in, and further caution is necessary when used in children or the elderly. This drug, when combined with central nervous system depressants such as narcotics, benzodiazepines, and alcohol, could lead to severe sedation, respiratory depression, coma, or death; thus, co-administration must be approached with extreme caution, and if necessary, should be used at the lowest dose for the shortest duration while closely monitoring the patient's condition. This medication should not be administered to patients who have hypersensitivity to opioids or to those experiencing prolonged asthma attacks or severe respiratory depression, and intrathecal or epidural administration is prohibited for patients with infections at the injection site or a tendency to bleed. Elderly or frail patients, those with impaired liver or kidney function, or those with a history of seizures should have extra caution when using this medication, and adverse reactions such as respiratory depression or decreased blood pressure should be closely monitored during administration. Prolonged use of this medication can lead to drug dependence, so it is crucial to minimize the duration and dosage and be prepared for withdrawal symptoms. Various side effects can occur, such as respiratory depression, decreased blood pressure, worsening of head trauma, constipation, urinary retention, skin itching, severe skin reactions, etc.; if abnormal symptoms arise, promptly inform the healthcare personnel. Women who are pregnant or breastfeeding may affect the fetus or neonate when this medication is administered, so it should only be given if the therapeutic benefit outweighs the risks, and it is recommended to discontinue breastfeeding. Safety in children has not been established, so caution is needed when used, and the elderly should start at a low dose due to reduced physiological function and closely observe their condition. In the case of overdose, severe symptoms such as respiratory depression, loss of consciousness, and decreased blood pressure may arise; therefore, immediate emergency treatment should be sought, and appropriate treatment with opioid antagonists should be administered if necessary. This medication may increase side effects when used in conjunction with other central nervous system depressants, so dosage adjustment and close monitoring of the patient’s condition are required during co-administration. Before administration, check for discoloration or precipitation in the injection solution, and during intravenous administration, avoid rapid infusion and administer slowly.

Yawning, sneezing, tearing, sweating, nausea, vomiting, diarrhea, abdominal pain, pupil dilation, headache, insomnia, anxiety, delirium, seizures, tremors, pain in muscles and joints throughout the body, shortness of breath, palpitations, difficulty breathing, slow breathing, irregular breathing, apnea, head injury, increased intracranial pressure, hypotension, shock, cramping of lower limbs, convulsions, discomfort, anxiety, toxic psychosis, euphoria, confusion, headache, dysentery, hyperalgesia, sweating, dry mouth, pancreatitis, constipation, biliary colic, anal sphincter spasm, urinary retention, oliguria, itching, acute generalized exanthematous pustulosis, urticaria, local tissue irritative reaction, central sleep apnea syndrome, cough reflex inhibition, decreased libido, menstrual irregularities, amenorrhea, thermoregulation disorder, intestinal obstruction, loss of consciousness, coma, skeletal muscle relaxation, cool skin, miosis, bradycardia, hypotension, apnea, cardiovascular collapse, cardiac arrest, death, aspiration pneumonia, chest wall rigidity

This medication is sensitive to light, so it should be stored in an opaque container. Additionally, it is important to maintain a cool temperature between 15 and 30 degrees Celsius when storing the medication to preserve its efficacy for a long time.

Appearance

Brown ampule containing a colorless transparent liquid

Package unit

5 mL/ampule × 5 ampules