BC Morphine Sulfate Hydrate Injection 1 mg/mL (Vial)

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] Adult 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, an additional 1∼2 mg may be administered cautiously at an appropriate interval to allow the effect to be assessed. Do not administer more than 10 mg over 24 hours. When administered into the thoracic region, the incidence of early and delayed respiratory depression increases markedly, even at doses of 1∼2 mg. For continuous infusion, administer an initial dose of 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 in elderly patients. [Intrathecal administration] The usual intrathecal dose is 1/10 of the epidural dose. Adult dose: 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 the 0.05 % preparation or 0.2∼1 mL of the 0.1 % preparation). Do not inject more than 2 mL of the 0.05 % preparation or 1 mL of the 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 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 children. There is no information on administration to children.

This drug may cause severe adverse reactions when administered epidurally or intrathecally; therefore, patients should be monitored in a hospital capable of providing emergency treatment for at least 24 hours following the first dose. The ampule injection carries a risk of glass fragments, so caution is necessary when handling it, especially in children or the elderly during container breakage. Using it in conjunction with central nervous system depressants or alcohol may pose a severe risk of sedation, respiratory depression, coma, or death, thus caution is required during co-administration. It should not be administered to patients with hypersensitivity, ongoing asthma attacks, or severe respiratory depression. Avoid epidural or intrathecal administration in patients with infection at the injection site, bleeding tendencies, or those taking anticoagulants. Elderly, frail, or patients with impaired liver or kidney function may experience delayed metabolism and excretion of this drug, increasing the risk of side effects, so caution is advised. This drug can induce drug dependence and tolerance, necessitating close monitoring of patient condition with long-term use, as withdrawal symptoms may emerge upon discontinuation. Various adverse reactions may occur, such as respiratory depression, hypotension, worsening of head injuries, constipation, urinary retention, skin itching, etc., and healthcare professionals should be informed immediately of any symptoms. This drug may affect the fetus or neonate when administered to pregnant or breastfeeding women; therefore, consultation with a physician is essential if pregnant or breastfeeding. Safety in children is not established, and it is advisable to avoid use. In case of overdose, respiratory depression and loss of consciousness may occur, requiring immediate emergency treatment and appropriate care. Before administration, check for any precipitation or discoloration in the injection solution, and slow intravenous injection should be carried out to prevent side effects such as chest wall rigidity. This drug may increase the risk of side effects when used in conjunction with other central nervous system depressants; thus, dosage adjustment and careful observation of patient status are necessary during co-administration.

yawning, sneezing, tearing, sweating, nausea, vomiting, diarrhea, abdominal pain, pupil dilation, headache, insomnia, anxiety, hallucination, convulsion, tremor, pain in muscles and joints all over the body, respiratory distress, palpitations, dyspnea, bradypnea, irregular breathing, apnea, head injury, increased intracranial pressure, hypotension, shock, peripheral muscle spasms of the lower limbs, convulsion, discomfort, anxiety, toxic psychosis, unusual euphoria, confusion, headache, dysentery, hyperalgesia, hyperhidrosis, constipation, biliary colic, dry mouth, pancreatitis, sphincter of Oddi spasm, urinary retention, sepsis, oliguria, itching, acute generalized pustular exanthema, urticaria, localized tissue irritation response, central sleep apnea syndrome, cough reflex suppression, decreased libido, menstrual irregularities, amenorrhea, thermoregulation disorder, intestinal obstruction, coma, stupor, skeletal muscle relaxation, cold skin, miosis, bradycardia, hypotension, apnea, cardiovascular collapse, cardiac arrest, death, aspiration pneumonia, severe hypotension, bradycardia, cardiac asystole

This drug is sensitive to light, so it should be stored in a container that prevents light exposure. Additionally, it is important to store the drug between 1 to 30 degrees Celsius to maintain its efficacy.

Appearance

A colorless and transparent solution contained in a brown transparent vial.

Package unit

5 mL × 10 vials, 1 mL × 10 vials