Halim Fentanyl Injection (Fentanyl Citrate)

Adult administration

The dose should be determined 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 (more than 20 % above standard body weight), determine the dose based on lean body weight. 1. Adults and adolescents 12 years of age and older (see adult dosage table) 1) Premedication: 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 depressants). 2) Analgesic adjunct during general anesthesia: See adult dosage table. 3) Analgesic adjunct during local anesthesia: If additional analgesia is needed, inject 50∼100 ㎍(1∼2 mL) slowly over 1∼2 minutes intravenously or 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 the stress of surgery, administer 50∼100 ㎍/kg (1∼2 mL/kg) with oxygen and a neuromuscular blocking agent. It has been reported that this technique can induce 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. (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) Maintenance dose Low dose 2 ㎍/kg(0.04 mL/kg) Moderate dose 2∼20 ㎍/kg(0.04∼0.4 mL/kg) If there are signs of a decrease in 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∼1 mL/kg) If there are signs of a decrease in anesthetic effect or changes in vital signs indicating surgical stress, administer 25 ㎍ up to one-half of the initial dose.

Child administration

Young 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 should be handled with care to avoid glass particles from the injection container upon opening. Extra caution is required, especially when used in children and elderly patients. It should not be used in combination with opioid analgesics, benzodiazepines, or alcohol as it may lead to severe drowsiness, respiratory depression, coma, or even death. If unavoidable, the lowest effective dose should be used for a limited duration with careful monitoring of the patient's respiratory status and consciousness. This medication should not be used by individuals allergic to this drug or its components, or to other opioids. It should also not be administered to patients who cannot receive neuromuscular blocking agents, those with elevated intracranial pressure, individuals with a history of seizures, infants under 2 years of age, asthma patients, severe respiratory depression patients, and those taking MAO inhibitors. Caution is advised for patients with compromised respiratory function, liver or kidney impairment, arrhythmias, the elderly, myasthenia gravis patients, hypothyroidism, coagulation disorders, a history of drug or alcohol dependence, and those with cardiovascular diseases. Continuous monitoring of the patient's condition is essential during administration due to the possibility of serious side effects such as dependence, respiratory depression, muscle rigidity, anaphylaxis, hypotension, and arrhythmias. This medication may also cause various minor side effects such as itching, rash, drowsiness, dizziness, nausea, and vomiting. It should be administered only by medical personnel who are capable of providing professional anesthetic management in an environment equipped with necessary respiratory support and emergency equipment. When anesthetizing, ensure that the patient is fasting and maintain the depth of anesthesia at the minimal level required for the procedure. Respiratory depression may persist for several hours post-administration, hence the patient should be monitored closely. The combination with other central nervous system depressants or alcohol may exacerbate side effects, so dosage should be reduced and close observation is necessary during concurrent use. In pregnant women or those who may become pregnant, it should only be administered judiciously when necessary, and not during labor. Furthermore, as this drug is secreted in breast milk, breastfeeding should be avoided for 24 hours post-administration. Safety and efficacy in infants under 2 years have not been established, thus it is advisable not to use it in this age group. Elderly or frail patients may require cautious dose adjustments due to increased risk of side effects due to weakened physiological functions. In case of overdose, severe respiratory depression, loss of consciousness, hypotension, and cardiac issues can occur requiring immediate emergency measures, including potential administration of narcotic antagonists and respiratory support. Always check for discoloration or contamination before administration.

Dependence, respiratory distress, slow breathing, irregular breathing, apnea, body muscle rigidity, respiratory distress following skeletal muscle rigidity of the neck and limbs, anaphylactic reactions, shock, hypotension, arrhythmia, ectopic beats, cardiac arrest, bradycardia, itching, rash, erythema, urticaria, orthostatic hypotension, tachycardia, hypertension, visual disturbances, unusual euphoria, drowsiness, excessive talking, paralysis, headache, tremors, extrapyramidal symptoms, psychiatric symptoms, insomnia, agitation, dizziness, delirium, mood swings, rigidity, hallucinations, numbness, delirium, hypersensitivity to pain, non-harmful stimulus pain, nausea, vomiting, secondary respiratory depression after surgery, laryngospasm, sweating, urinary retention, sneezing, sore throat, excessive mucus secretion, increased sputum discharge, difficulty in sputum discharge, hypothermia, coldness, cold feeling in limbs, cyanosis, wheezing, hiccups, miosis, thirst, hoarseness, fever, sexual dysfunction, withdrawal syndrome, fatigue, involuntary muscle contraction, anaphylactic reactions, anaphylactic shock, nausea, diarrhea, anxiety, chills, tremors, sweating, withdrawal symptoms, apnea, unconsciousness, coma, skeletal muscle relaxation, cool skin, miosis, hypotension

This drug is sensitive to light and should be stored in a sealed container that prevents light exposure. The storage temperature should be maintained between 1 and 30 degrees Celsius at room temperature. Proper storage conditions will ensure the drug’s efficacy is safely preserved.

Appearance

[For Internal Use 1] Brown ampoule or brown vial containing a colorless transparent liquid [For Internal Use 2] Injection in a plastic aqueous injection container with a colorless transparent liquid

Package unit

[For Internal Use 1] 1mL/ampoule x 10 ampoules, 2mL/ampoule x 10 ampoules, 10mL/ampoule x 10 ampoules, 10mL/vial x 10 vials, 20mL/vial x 5 vials [For Internal Use 2] 2mL/ampoule x 10 ampoules, 10mL/ampoule x 10 ampoules, 20mL/ampoule x 10 ampoules