Gujupentanyl Citrate Injection (Vial)

Adult administration

The dose should be determined individually, taking into consideration age, body weight, physical condition, pathological condition, use of other medicines, and the type and duration of surgery and anesthesia. Reduce the dose in elderly or debilitated patients. In obese patients (20 % or more above standard body weight), determine the dose based on lean body weight. Regularly monitor vital signs during administration. 1. Adults and adolescents aged 12 years or older (see adult dosage table) 1) Preanesthetic medication: Inject 50∼100㎍ (1∼2mL) intramuscularly 30∼60 minutes before surgery (adjust the dose as appropriate in elderly or debilitated patients or patients receiving other depressants.). 2) Analgesic adjunct during general anesthesia: See adult dosage table 3) Analgesic adjunct during local anesthesia: If additional analgesia is required, slowly inject 50∼100㎍(1∼2mL) intravenously over 1∼2 minutes or administer intramuscularly. 4) Postoperative (recovery room): If pain control is required or tachypnea or delirium occurs, inject 50∼100㎍(1∼2mL) intramuscularly. The dose may be repeated after 1∼2 hours if necessary. 5) General anesthetic: When it is important to reduce stress caused by surgery, administer 50∼100㎍/kg(1∼2mL/kg) in combination with oxygen and a neuromuscular blocking agent. This technique has been reported to produce anesthesia without the use of other anesthetics. In some cases, up to 150㎍/kg(3mL/kg) may be required to achieve this anesthetic effect. It is used particularly in open-heart surgery, complex neurosurgery, and orthopedic surgery when protection of the myocardium from excessive oxygen demand is needed. This technique may be used only in a setting with facilities and qualified healthcare professionals capable of managing respiratory depression. (Adult dosage table) Total dose Low dose 2㎍/kg(0.04mL/kg) Useful for minor but painful surgery. Administration of this medicine can reduce not only pain during surgery but also pain immediately after surgery. Moderate dose 2∼20㎍/kg(0.04∼0.4mL/kg) The dose increases as the complexity of surgery increases. Administration of this medicine can reduce not only pain during surgery but also stress to some extent. However, a mechanical ventilator is required because of respiratory depression during anesthesia, and respiration must be carefully monitored after surgery. High dose 20∼50㎍/kg(0.4∼1mL/kg) Used for open-heart surgery, complex neurosurgical and orthopedic procedures of long duration, and when the anesthesiologist judges that surgical stress may be harmful to the patient. Stress associated with increased blood levels of growth hormone, catecholamines, ADH, and prolactin may be reduced by administering this medicine at 20∼50㎍/kg(0.4∼1.0mL/kg) in combination with N2O/O2. When this high dose is used during surgery, respiratory depression persists after surgery, so postoperative respiratory management is essential. This method is used to reduce stress caused by surgery. Maintenance dose Low dose 2 ㎍/kg(0.04 mL/kg) Additional administration is rarely required for minor surgery. Moderate dose 2∼20㎍/kg(0.04∼0.4 mL/kg) If there are signs of reduced anesthetic effect, changes in vital signs indicating surgical stress, or movement, 25∼100㎍/kg(0.5∼2 mL/kg) of this medicine may be administered intravenously or intramuscularly. High dose 20∼50㎍/kg(0.4∼1mL/kg) If there are signs of reduced anesthetic effect or changes in vital signs indicating surgical stress, administer from 25㎍ up to 1/2 of the initial dose. If little time remains before the end of surgery, the additional dose should be determined particularly on an individual basis.

Child administration

2. Infants and children aged 2∼12 years: Use a low dose of approximately 2∼3㎍ per kg of body weight for induction and maintenance of anesthesia.

This medication can contain glass fragments when the injection vial is opened, so care should be taken, especially when used in children or elderly patients. This medicine should be used with extreme caution when combined with central nervous system depressants, narcotics, benzodiazepines, or alcohol, as it can severely inhibit respiration, potentially leading to coma or death. Patients allergic to this medicine or unable to use certain neuromuscular blockers, those with elevated intracranial pressure, patients with a history of seizures, asthmatic patients, and others should not use this medicine. Patients with impaired respiratory function, liver and kidney issues, elderly patients, or myasthenia gravis patients should exercise particular caution when using this medication, closely monitoring for potential side effects. This medication can cause dependence, so the state of the patient should be carefully monitored during use, and in cases of serious side effects such as respiratory distress or muscle rigidity, appropriate treatment should be administered immediately. While administering, vital signs such as respiration, blood pressure, and heart rate must be checked regularly, and close observation should continue until the respiratory condition stabilizes post-surgery. This medication may pose risks for pregnant or breastfeeding women and should only be used cautiously when necessary, and should not be administered during childbirth. Use of this medication should be avoided in infants under 2 years of age, as its efficacy and safety have not been established for this group. Elderly or frail patients may present a higher risk of side effects due to diminished physical function, so dosage should be reduced, and their condition should be observed closely. Overdose may result in respiratory arrest or loss of consciousness, and if such symptoms occur, immediate emergency measures such as airway management and oxygen supply, and if necessary, artificial respiration should be administered. Use of this medicine in combination with other central nervous system depressants or certain antidepressants and tranquilizers may exacerbate side effects, so in such cases, dosing should be adjusted according to a physician's instructions and monitored carefully. Drowsiness or dizziness may occur for 24 hours post-administration, so avoid driving vehicles or operating hazardous machinery.

Dependence, respiratory distress, slow breathing, irregular breathing, apnea, truncal rigidity, respiratory distress following skeletal muscle rigidity of the neck and limbs, anaphylactic reaction, shock, hypotension, arrhythmia, ectopic beats, cardiac arrest, bradycardia, pruritus, rash, erythema, urticaria, orthostatic hypotension, tachycardia, hypertension, visual disturbances, abnormal euphoria, drowsiness, talkativeness, paralysis, headache, tremors, extrapyramidal symptoms, psychiatric symptoms, insomnia, agitation, dizziness, delusions, mood swings, rigidity, hallucinations, paresthesia, delirium, hypersensitivity to pain, allodynia, nausea, vomiting, postoperative secondary respiratory depression, laryngospasm, sweating, urinary retention, sneezing, sore throat, excessive mucus secretion, increased sputum production, difficulty expectorating phlegm, hypothermia, coldness, cold extremities, cyanosis, wheezing, hiccups, miosis, thirst, hoarseness, fever, sexual dysfunction, decreased libido, withdrawal syndrome, lethargy, involuntary muscle contractions, anaphylaxis reaction, anaphylactic shock, respiratory depression, unresponsiveness, coma, skeletal muscle relaxation, cool skin, miosis, hypotension, apnea, cardiovascular collapse, cardiac arrest, toxic white matter encephalopathy

This medicine is sensitive to light and should be stored in a tightly closed container that prevents light exposure. It is important to maintain a storage temperature between 1 and 30 degrees Celsius. Proper storage can help preserve the efficacy of the medication for longer.

Appearance

Brown vial containing a colorless and transparent liquid

Package unit

2 milliliters/vial, 10 vials/box [2 milliliters/vial X 10], 10 milliliters/vial, 10 vials/box [10 milliliters/vial X 10]