Hymol Injection 20 mg (Morphine Sulfate Hydrate)

Adult administration

Intrathecal administration The starting dose of this medicine should be determined individually based on the patient's response to sequential single rapid intrathecal injections of morphine sulfate hydrate injection at 0.5 or 1 mg/mL, the patient's condition before insertion of a continuous microinfusion device, and careful assessment of adverse reactions. The recommended initial dose of this medicine ranges from 0.2～1 mg per day for patients who are not opioid-tolerant to 1∼10 mg per day for patients with some degree of opioid tolerance. The maximum daily dose should be determined individually. Limited experience with continuous intrathecal administration of this medicine indicates that the daily dose required to maintain adequate analgesia continues to increase over time, with considerable variation in the rate of increase. Myoclonus has been reported in patients receiving doses exceeding 20 mg per day. Use doses of 20 mg or more per day with caution because of the increased likelihood of serious adverse reactions. Epidural administration The starting dose of this medicine should be determined individually based on the patient's response to sequential single rapid intrathecal injections of morphine sulfate hydrate injection at 0.5 or 1 mg/mL, the patient's condition before insertion of a continuous microinfusion device, and careful assessment of adverse reactions. The recommended initial dose of this medicine ranges from 3.5～7.5 mg per day for patients who are not opioid-tolerant to 4.5∼10 mg per day for patients with some degree of opioid tolerance. During treatment, the dose requirement may often increase to 20～30 mg per day. The maximum daily dose should be determined individually.

This medication carries a risk of severe adverse reactions, so patients should be closely monitored for at least 24 hours after administration begins, preferably for several days, in a setting equipped with emergency facilities and professionals. Extreme caution is required when used in combination with other central nervous system depressants or alcohol, as it may lead to severe sedation, respiratory depression, coma, or death. For ampoule injections, care should be taken as glass shards may enter the solution when cutting the container, especially when used on children or the elderly. Patients with hypersensitivity to this drug, infections at the injection site, those on anticoagulants, or patients with severe respiratory depression should not be administered this drug. It should be used cautiously in patients with conditions such as elevated intracranial pressure, liver or kidney dysfunction, gallbladder disease, or prostate enlargement, and those with a history of drug dependency or alcoholism should be aware of dependency risks. Long-term use of this medication can lead to drug dependence, so withdrawal symptoms should be closely monitored when reducing or discontinuing the dosage abruptly. Respiratory depression symptoms may occur, so the patient's respiratory condition should be continuously checked, and appropriate measures should be taken as needed. Various side effects such as hypotension, exacerbation of head injuries, constipation, nausea, vomiting, etc., may arise, necessitating careful monitoring of the patient's condition. This medication should only be used in pregnant women or those who may become pregnant when there are no other treatment options available, and it should not be used as a labor analgesic. Breastfeeding women should stop nursing since this drug can be passed into breast milk. Safety and effectiveness in children have not been established, and it is recommended not to use it. Elderly patients may exhibit a wider range of reactions and side effects, so they should be used cautiously starting with lower doses. In cases of overdose, severe symptoms such as respiratory depression, loss of consciousness, and hypotension may occur, so immediate emergency treatment is required, and narcotic antagonists should be administered if necessary. Before administration, the solution should be checked for any precipitate or discoloration, and if abnormalities are found, it should not be used. This medication requires strict management: store it away from light in a room temperature environment and do not freeze. Unused medication should be disposed of safely, and if it comes into contact with the skin, it should be washed off immediately. This drug is only used for patients who have difficulty in pain control, and if new neurological symptoms or adverse reactions appear during administration, the doctor should be consulted immediately. Additionally, it is advisable to control diet properly and use laxatives as needed to prevent constipation.

Drug dependence, yawning, sneezing, tearing, sweating, nausea, vomiting, diarrhea, abdominal pain, pupil dilation, headache, insomnia, anxiety, hallucination, 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, hypotension, shock, generalized muscle spasm of the lower limbs, convulsions, discomfort, toxic psychosis, drowsiness, euphoria, anxiety, dysentery, hyperalgesia, sweating, headache, itching, urticaria, rash, local tissue irritation response, urinary retention, oliguria, constipation, biliary colic, dry mouth, pancreatitis, spasm of the Oddi sphincter, peripheral edema, swelling of male genitalia, acute generalized pustular rash, central sleep apnea syndrome, cough reflex suppression, thermoregulation disorder, intestinal obstruction, nausea, loss of appetite, fatigue, weakness, dizziness, hypotension, decreased libido, erectile dysfunction, amenorrhea, hyperalgesia, sleep apnea syndrome, hypoxemia, dysfunction of the Oddi sphincter, spasm, acute chest syndrome, paralysis, severe neurological adverse reactions, inflammatory lesions, skeletal muscle relaxation, cool skin, miosis, bradycardia, hypotension, apnea, cardiovascular collapse, cardiac arrest, death, aspiration pneumonia

This medication is sensitive to light and should be stored in a container that prevents light exposure. Additionally, it should be kept at a temperature between 15 to 30 degrees Celsius, avoiding excessively hot or cold places.

Appearance

A colorless, transparent solution contained in a brown glass ampoule.

Package unit

10 ampoules/box [2ml/1 ampoule]