Morphine Injection 1 mg/mL (Morphine Sulfate Hydrate)

Adult administration

(Injection 0.5 mg/mL, 1 mg/mL) This medicine is administered intravenously, epidurally, or intrathecally. [Intravenous administration] Dose: The initial dose is 2∼10 mg per 70 kg of body weight. Administer with extreme caution in elderly patients. [Epidural administration] Epidural administration of this medicine must be performed by a physician experienced in epidural administration, in a facility where appropriate patient monitoring is available. Resuscitation equipment and opioid antagonists (such as naloxone) must be immediately available to manage complications and respiratory depression that may occur in the event of inadvertent intravascular or intrathecal injection (the usual intrathecal dose is 1/10 of the epidural dose). As respiratory depression may be delayed, monitor the patient for at least 24 hours after each administration. Before administering this medicine, confirm that the needle or catheter is correctly positioned in the epidural space. Appropriate confirmation methods are as follows: 1) aspiration should yield neither blood nor cerebrospinal fluid; or 2) after administration of 5 mL (3 mL for obstetric patients) of preservative-free 1.5 % lidocaine·epinephrine (1 : 200,000), observe the patient for the absence of tachycardia (indicating that the injection was not intravascular) and sudden segmental paralysis (indicating that the injection was not intrathecal). Adult dose: An initial dose of 5 mg injected into the lumbar region can provide satisfactory pain relief for up to 24 hours. If adequate pain relief does not occur within 1 hour, an additional 1∼2 mg may be administered cautiously at an appropriate interval to assess the effect. Do not administer more than 10 mg over 24 hours. When administered in the thoracic region, early and delayed respiratory depression increase markedly, even at doses of 1∼2 mg. For continuous infusion, the initial dose is 2∼4 mg over 24 hours. If adequate pain relief does not occur with the initial dose, an additional 1∼2 mg may be administered. Administer with caution in elderly patients. [Intrathecal administration] The usual intrathecal dose is 1/10 of the epidural dose. Intrathecal administration of this medicine must be performed by a physician experienced in intrathecal administration, in a facility where appropriate patient monitoring is available. Resuscitation equipment and opioid antagonists (such as naloxone) must be immediately available to manage complications and respiratory depression that may occur in the event of inadvertent intravascular injection. As respiratory depression may be delayed, monitor the patient for at least 24 hours after each administration. Early and delayed respiratory depression occur more frequently with intrathecal administration. Adult dose: A single injection of 0.2∼1 mg can 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 in the lumbar region; repeated intrathecal administration is not recommended. To reduce the incidence of potential adverse reactions, naloxone may be administered by continuous intravenous infusion at 0.6 mg per hour after this medicine has been administered for 24 hours. Administer with extreme caution in 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

There is no information on administration to patients under 18 years of age. There is no information on administration to pediatric patients. There is no information on administration to pediatric patients.

This drug may cause severe adverse reactions when administered epidurally or intrathecally; therefore, after the first administration, the patient must be admitted to a hospital capable of providing emergency care and monitored for at least 24 hours. When using ampoules, they should be carefully cut to avoid the risk of glass particles entering the solution; extra caution is needed when administering to children or the elderly. This drug should be used with caution in combination with central nervous system depressants, narcotics, benzodiazepines, and alcohol, as it could cause severe sedation, respiratory depression, coma, or even death. If possible, it should be used at the minimal effective dose for the shortest duration. This drug should not be administered to certain patients, such as those allergic to opioids or experiencing an asthma attack, and intravenous administration should be avoided in patients with severe respiratory depression. Also, administration is prohibited in patients with infection at the injection site, those on anticoagulants, or patients with bleeding tendencies. Elderly patients, those who are weak, patients with impaired liver or kidney function, respiratory depression, and those with a history of seizures should be administered this drug with caution, as there is a risk of drug dependence. This drug can lead to dependence with prolonged administration; therefore, do not abruptly reduce or discontinue the dose, but taper it gradually while closely monitoring the patient's condition. Monitor the patient's respiratory status carefully for signs of respiratory depression and administer appropriate emergency treatment, such as opioid antagonists if necessary. This drug can cause hypotension or shock, so it should be used cautiously in patients with cardiovascular shock. Common side effects may include constipation, nausea, vomiting, urinary retention, and pruritus; appropriate measures should be taken to prevent constipation. Pregnant or nursing women should be cautious, as administration may affect the fetus or newborn. It should only be used during pregnancy if the therapeutic benefits outweigh the risks, and nursing should be halted when administering this drug. Safety in children has not been established, thus pediatric administration should be approached with caution. In cases of overdose, severe symptoms, such as respiratory depression, decreased consciousness, and hypotension may occur, requiring immediate emergency intervention and close observation even after administering an opioid antagonist. This drug may enhance respiratory depression and sedation when used in combination with other central nervous system depressants; thus, careful dose adjustment and patient monitoring are necessary when administered together. Before administration, check the injection solution for discoloration or precipitation, and avoid rapid intravenous administration, administering it slowly instead.

yawning, sneezing, tearing, sweating, nausea, vomiting, diarrhea, abdominal pain, pupil dilation, headache, insomnia, anxiety, hallucinations, convulsions, tremors, pain in muscles and joints throughout the body, respiratory distress, palpitations, shortness of breath, slow breathing, irregular breathing, apnea, head injury, increased intracranial pressure, decreased blood pressure, shock, tonic-clonic muscle spasms of the lower limbs, convulsions, discomfort, anxiety, toxic psychosis, abnormal euphoria, confusion, headache, dysentery pain, hyperalgesia, sweating, constipation, biliary colic, dry mouth, pancreatitis, sphincter of Oddi spasm, urinary retention, septicemia, oliguria, itching, acute generalized pustular rash, hives, localized tissue irritation response, central sleep apnea syndrome, cough reflex suppression, decreased libido, menstrual irregularities, amenorrhea, temperature regulation disorder, intestinal obstruction, coma, unconsciousness, skeletal muscle relaxation, cold skin, miosis, bradycardia, hypotension, apnea, circulatory collapse, cardiac arrest, death, aspiration pneumonia

This drug should be stored in a tightly sealed container that prevents light exposure, and it is important to maintain a storage temperature between 15 to 30 degrees Celsius room temperature. Storing it this way helps to maintain the drug's efficacy and safety.

Appearance

A brown transparent ampoule containing a colorless, transparent liquid

Package unit

5 mL x 25 ampoules