Myungmoon Guyeonsan Fentanyl Injection

Adult administration

The dose should be determined individually, taking into consideration age, body weight, physical condition, disease state, use of other drugs, and the type and duration of surgery and anesthesia. Reduce the dose in elderly or debilitated patients. For obese patients (20 % or more above standard body weight), determine the dose based on lean body weight. 1. Adults and adolescents 12 years of age and older 1) Preanesthetic medication: Inject 50∼100 ㎍ (1∼2 mL) intramuscularly 30∼60 minutes before surgery (adjust the dose as appropriate in elderly or debilitated patients or patients receiving other CNS depressants.). 2) Analgesic adjunct for general anesthesia: Refer to the adult dosage table 3) Analgesic adjunct for local anesthesia: When additional analgesia is needed, slowly inject 50∼100 ㎍(1∼2 mL) intravenously over 1∼2 minutes or administer intramuscularly. 4) Postoperative (recovery room): If pain control is needed or tachypnea or delirium occurs, inject 50∼100 ㎍(1∼2 mL) intramuscularly. The dose may be repeated after 1∼2 hours if needed. 5) General anesthetic: When it is important to reduce stress caused by surgery, administer 50∼100 ㎍/kg(1∼2 mL/kg) with oxygen and a neuromuscular blocking agent. In some cases, up to 150 ㎍/kg(3 mL/kg) may be needed to achieve this anesthetic effect. (Adult dosage table) Total dose, low dose: 2 ㎍/kg(0.04 mL/kg) Total dose, moderate dose: 2∼20 ㎍/kg(0.04∼0.4 mL/kg) Total dose, high dose: 20∼50 ㎍/kg(0.4∼1 mL/kg) Administer 20∼50 ㎍/kg(0.4∼1.0 mL/kg) with N2O/O2 Maintenance dose, low dose: 2 ㎍/kg(0.04 mL/kg) Maintenance dose, moderate dose: 2∼20 ㎍/kg(0.04∼0.4 mL/kg) 25∼100 ㎍/kg(0.5∼2 mL/kg) may be administered intravenously or intramuscularly. Maintenance dose, high dose: 20∼50 ㎍/kg(0.4∼1 mL/kg) Administer from 25 ㎍ up to 1/2 of the initial dose.

Child administration

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

This medication may have glass fragments when using the ampule injection, so the container should be handled very carefully when being cut. Extra caution is required when used on children or the elderly. This drug can cause severe sedation, respiratory depression, coma, and even death when used in combination with narcotics, benzodiazepines, or alcohol that affect the central nervous system, therefore combined administration must be strictly limited to the minimal dose and duration under the judgment of a specialist. It should not be administered to patients with known allergies to this medication or to those contraindicated for certain neuromuscular blocking agents, patients with elevated intracranial pressure, patients with convulsive disorders, infants under 2 years, asthma patients, patients with severe respiratory depression, and patients taking MAO inhibitors. Patients with impaired respiratory function, liver or kidney dysfunction, cardiac arrhythmia, the elderly, severe myasthenia gravis, patients with blood coagulation disorders, patients with a history of drug dependence or alcohol addiction should be administered cautiously as the risk of side effects is increased and careful monitoring is necessary. This medication may cause serious side effects such as dependence, severe respiratory depression, muscle rigidity, anaphylaxis, hypotension, and arrhythmia; therefore, the patient's condition must be closely monitored during administration, and immediate appropriate treatment should be provided if abnormal symptoms occur. This medication should only be administered by healthcare professionals capable of providing specialized anesthesia management, and emergency equipment such as airway devices, oxygen supply devices, and opioid antagonists must be readily available. Respiratory depression may persist for several hours after administration, so the patient's vital signs should be checked regularly, and appropriate monitoring of respiratory maintenance should be carried out after surgery. When used with other central nervous system depressants, the sedative effect may be enhanced, potentially leading to serious side effects; therefore, dosage adjustments and patient monitoring are essential. Administration is restricted for pregnant or nursing mothers, particularly during delivery due to the risk of respiratory depression in neonates. Nursing should be avoided for 24 hours after administration. Safety and efficacy have not been established for infants under 2 years, so administration is generally not recommended. For the elderly or frail patients, due to the decline in body function, the risk of side effects is increased, so dosage should be adjusted and careful monitoring performed. In cases of overdose, severe respiratory depression, loss of consciousness, and cardiac arrest may occur, necessitating immediate emergency treatment measures such as airway security, oxygen supply, and, if necessary, artificial respiration and opioid antagonists. Ensure to check for discoloration or foreign substances before using this medication and use it safely.

Dependency, respiratory distress, slow breathing, irregular breathing, apnea, trunk muscle stiffness, respiratory distress following rigidity of neck and limb skeletal muscles, anaphylactic reaction, shock, hypotension, arrhythmia, ectopic beats, cardiac arrest, bradycardia, itching, rash, erythema, urticaria, orthostatic hypotension, tachycardia, hypertension, visual disturbances, abnormal euphoria, drowsiness, excessive talking, paralysis, headache, tremors, extrapyramidal symptoms, psychiatric symptoms, insomnia, agitation, dizziness, delirium, mood swings, rigidity, hallucinations, paresthesia, delirium tremens, hypersensitivity to pain, harmless stimulation pain, nausea, vomiting, postoperative secondary respiratory depression, laryngeal stridor, sweating, urinary retention, sneezing, sore throat, excessive mucus secretion, increased sputum production, difficulty in sputum expulsion, hypothermia, coldness, limb coldness, cyanosis, wheezing, hiccups, miosis, thirst, hoarseness, fever, sexual dysfunction, withdrawal syndrome, fatigue, involuntary muscle contractions, anaphylaxis reaction, anaphylactic shock, nausea, diarrhea, anxiety, chills, tremors, sweating, coldness, restlessness, postoperative hallucinations, muscle tone abnormalities, restless legs syndrome, ocular motor seizure, drowsiness, hypotension, cardiovascular depression, respiratory depression, unconsciousness, coma, skeletal muscle relaxation, cool skin, miosis, hypotension

This medication is sensitive to light; it should be stored in a container that does not allow light to enter. Additionally, to maintain the drug's effectiveness, it is important to store it at room temperature, between 1 and 30 degrees Celsius.

Appearance

Colorless transparent solution in brown glass ampules or brown glass vials

Package unit

For intramuscular use - 2 milliliters/ampule [1 ampule (2 mL) × 10], For intramuscular use - 2 milliliters/vial [1 vial (2 mL) × 10], For intramuscular use - 10 milliliters/vial [1 vial (10 mL) × 10], For intramuscular use - 20 milliliters/vial [1 vial (20 mL) × 10]