DaeWon Fentanyl Citrate Injection

Adult dosage

Determine the dose individually, taking into account age, body weight, physical condition, disease state, 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 and older (refer to the adult dosage table) 1) Premedication: Administer 50∼100 ㎍ (1∼2 mL) intramuscularly 30∼60 minutes before surgery (adjust the dose appropriately in elderly or debilitated patients, or patients receiving other depressants.). 2) Analgesic adjunct for general anesthesia: Refer to the adult dosage table 3) Analgesic adjunct for local anesthesia: If additional analgesia is required, administer 50∼100 ㎍ (1∼2 mL) slowly intravenously over 1∼2 minutes or intramuscularly. 4) Postoperative (recovery room): If pain control is required or tachypnea or delirium occurs, administer 50∼100 ㎍ (1∼2 mL) intramuscularly. Repeat after 1∼2 hours if necessary. 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. This technique has been reported to provide anesthesia without the use of other anesthetics. In some cases, up to 150 ㎍/kg (3 mL/kg) may be required to achieve this anesthetic effect. Use particularly in open-heart surgery requiring myocardial protection from excessive oxygen demand, and in complex neurosurgical and orthopedic surgery. (Adult dosage table) Total dose Low dose 2 ㎍/kg(0.04 mL/kg) Moderate dose 2∼20 ㎍/kg(0.04∼0.4 mL/kg) High dose 20∼50 ㎍/kg(0.4∼1 mL/kg) Stress may be reduced by administering this medicine at 20∼50 ㎍/kg(0.4∼1.0 mL/kg) with N2O/O2. Maintenance dose Low dose 2 ㎍/kg(0.04 mL/kg) Moderate dose 2∼20 ㎍/kg(0.04∼0.4 mL/kg) This medicine may be administered intravenously or intramuscularly at 25∼100 ㎍/kg(0.5∼2 mL/kg). High dose 20∼50 ㎍/kg(0.4∼1 mL/kg) Administer 25 ㎍ up to one-half of the initial dose.

Children's dosage

Children aged 2∼12 years: Use a low dose of approximately 2∼3 ㎍/kg for induction and maintenance of anesthesia.

Care must be taken when opening the injection container, as glass fragments may be present; particular caution should be exercised when administering to children or the elderly. Concurrent use with other central nervous system depressants or alcohol may severely inhibit respiration, potentially leading to coma or death; therefore, co-administration should only be done at the minimum required dosage and for the shortest duration necessary. This medication should not be used in patients with allergic reactions to it or contraindications for certain neuromuscular blocking agents, patients with increased intracranial pressure, patients with seizure disorders, asthmatic patients, infants under 2 years of age, patients with severe respiratory depression, or patients on MAO inhibitors. Patients with compromised respiratory function, impaired liver or kidney function, cardiac arrhythmias, elderly patients, myasthenia gravis patients, hypothyroid patients, patients with blood coagulation disorders, patients with a history of substance dependence or alcoholism, and patients with cardiovascular diseases should be particularly cautious when using this medication. This drug can cause dependence, requiring careful patient monitoring, as symptoms like respiratory depression, muscle rigidity, allergic reactions, hypotension, arrhythmias, and other side effects may occur, necessitating close management. This medication should be used by professionals for anesthesia or pain relief, and continuous monitoring of the patient’s respiration, blood pressure, heart rate, and consciousness is required. Additionally, fasting is necessary before anesthesia, and careful dose adjustments are required during recovery from anesthesia. This medication can induce muscle rigidity, so the use of neuromuscular blocking agents is recommended to reduce these side effects. After administration, drowsiness or dizziness may occur for at least 24 hours, so driving or operating hazardous machinery should be avoided. Women who are pregnant or may become pregnant should carefully consider the risks and benefits of this medication, and it is advisable not to use it during childbirth. Furthermore, this drug is excreted in breast milk, so breastfeeding should be temporarily discontinued for 24 hours following administration. Safety and efficacy have not been established for infants under 2 years of age, so it is preferable not to use this medication in this population. Elderly or frail patients who may experience increased side effects should have their dosages reduced and their conditions closely monitored. In case of overdose, symptoms such as respiratory depression, loss of consciousness, and decreased cardiac function may occur, requiring immediate emergency measures including airway management, oxygen supply, intubation if needed, and assisted ventilation. Opioid antagonists may be administered to alleviate respiratory depression, but continuous monitoring is required. Ensure to check for discoloration or foreign substances in the medication before administration.

Dependency, respiratory distress, slow breathing, irregular breathing, apnea, muscle rigidity of the trunk, respiratory distress following skeletal muscle rigidity of the neck and limbs, anaphylactic reaction, shock, hypotension, arrhythmia, ectopic beats, cardiac arrest, bradycardia, itching, rash, erythema, hives, orthostatic hypotension, tachycardia, hypertension, visual disturbances, abnormal euphoria, drowsiness, talkativeness, paralysis, headache, tremors, extrapyramidal symptoms, psychiatric symptoms, insomnia, agitation, dizziness, hallucinations, mood swings, rigidity, hallucinations, paresthesia, delirium, nausea, vomiting, postoperative secondary respiratory depression, laryngospasm, sweating, urinary retention, sneezing, sore throat, excessive mucus secretion, increased sputum production, difficulty expelling sputum, hypothermia, cold, cold sensations in the limbs, cyanosis, wheezing, hiccups, mydriasis, thirst, hoarseness, fever, sexual dysfunction, withdrawal syndrome, fatigue, involuntary muscle contractions

This medication should be stored in a tightly sealed container that blocks light, at room temperature between 15 and 30 degrees Celsius. This storage method helps maintain the effectiveness of the medication and prevent degradation.

Appearance

A brown ampoule containing a colorless, transparent liquid.

Package unit

2mL/ampoule X 10, 10mL/ampoule X 1