Hana Fentanyl Citrate Injection

Adult administration

Determine the dose individually, taking into consideration 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 ideal 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) Preoperative medication: Administer 50∼100 ㎍ (1∼2 mL) intramuscularly 30∼60 minutes before surgery (adjust the dose as appropriate for elderly or debilitated patients or patients receiving other depressants.). 2) Analgesic adjunct during general anesthesia: Refer to the adult dosage table. 3) Analgesic adjunct during local anesthesia: If additional analgesia is required, administer 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, administer 50∼100 ㎍(1∼2 mL) intramuscularly. The dose may be repeated after 1∼2 hours if needed. 5) General anesthetic: If it is important to reduce stress caused by surgery, administer 50∼100 ㎍/kg(1∼2 mL/kg) in combination with oxygen and a neuromuscular blocking agent. In some cases, up to 150 ㎍/kg(3 mL/kg) may be required to achieve this anesthetic effect. 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) High dose: Administer this medicine 20∼50 ㎍/kg(0.4∼1.0 mL/kg) in combination with N2O/O2. Maintenance dose, low dose: 2 ㎍/kg(0.04 mL/kg) Maintenance dose, moderate dose: This medicine 25∼100 ㎍/kg(0.5∼2 mL/kg) may be administered intravenously or intramuscularly. Maintenance dose, high dose: Administer 25 ㎍ up to 1/2 of the initial dose.

Child administration

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

Care must be taken to avoid introducing glass fragments when using ampule injections. Extra caution is advised when using the drug in children or the elderly. This drug can significantly depress respiration when used with central nervous system depressors, benzodiazepines, or alcohol, leading to deep sedation. When used with such drugs, it should only be applied in necessary cases at the minimum dosage for the shortest duration, with close monitoring of the patient's condition. It should not be used in patients with allergies to this medication, those who cannot use neuromuscular blockers, patients with elevated intracranial pressure, a history of seizures, infants under 2 years, asthmatics, severely respiratory depressed patients, and patients on specific medications (like MAO inhibitors). Patients with compromised respiratory or liver and kidney function, those with cardiac arrhythmias, elderly, frail patients, severe myasthenia gravis patients, patients with bleeding disorders, and those with a history of drug dependence or alcohol abuse should be treated with enhanced caution, observing closely for possible side effects. This medication can cause a range of serious side effects including respiratory depression, muscle rigidity, allergic reactions, hypotension, arrhythmias, neurological disturbances, etc. Therefore, continuous monitoring of the patient's condition is essential during administration. This medication should only be used by healthcare professionals equipped with specialized knowledge and technology, in an environment capable of maintaining airway and respiratory management. Fasting is required before anesthesia, and dosages should be carefully adjusted downward during the recovery phase. After administration of this drug, drowsiness or dizziness may occur, and driving or operating hazardous machinery should be avoided for 24 hours. This drug can interact with several medications that include central nervous system depressants; therefore, dosage adjustments and patient monitoring are required when used in conjunction with other medications. Women who are pregnant or breastfeeding should exercise caution when using this drug and should particularly avoid its use during labor, and breastfeeding should be suspended for 24 hours after administration. The safety and efficacy of this drug in infants under 2 years have not been established and its use is not recommended. Elderly or frail patients often have compromised physiological functions, making them more susceptible to side effects, so it is essential to verify the patient’s condition meticulously and adjust dosages accordingly. In cases of overdose, severe respiratory depression, loss of consciousness, hypotension, and cardiac issues may occur, necessitating immediate appropriate emergency treatment including securing the airway and providing oxygen, and if necessary, administering artificial respiration and opioid antagonists. Before administering, ensure there is no discoloration or foreign particles present in the drug; if abnormalities are found, it should not be used.

Dependence, respiratory distress, slow breathing, irregular breathing, apnea, body muscle rigidity, respiratory distress following skeletal muscle rigidity in the neck and limbs, anaphylactic reaction, shock, hypotension, arrhythmia, extrasystole, cardiac arrest, bradycardia, itching, rash, erythema, hives, orthostatic hypotension, tachycardia, hypertension, visual disturbances, abnormal euphoria, drowsiness, excessive talking, paralysis, headache, tremors, extrapyramidal symptoms, psychiatric symptoms, insomnia, agitation, dizziness, hallucinations, mood swings, rigidity, hallucinations, paresthesia, delirium, hypersensitivity to nociceptive pain, non-painful stimulus pain, nausea, vomiting, postoperative secondary rebound respiratory depression, laryngospasm, sweating, urinary retention, sneezing, sore throat, excessive mucus secretion, increased sputum production, difficulty in sputum expulsion, hypothermia, cold, peripheral coldness, cyanosis, wheezing, hiccups, miosis, thirst, hoarseness, fever, sexual dysfunction, withdrawal syndrome, lethargy, involuntary muscle contractions, anaphylactic reaction, anaphylactic shock, nausea, diarrhea, anxiety, chills, tremors, sweating, withdrawal symptoms, apnea, unconsciousness, coma, skeletal muscle relaxation, cold skin, miosis, bradycardia, hypotension, apnea, cardiovascular collapse, cardiac arrest, toxic leukoencephalopathy

This drug is sensitive to light and should be stored in a container that is shielded from light. Additionally, it is best stored at room temperature, not too hot or cold, between 1 to 30 degrees Celsius.

Appearance

Brown glass ampule, brown glass vial, or plastic aquatic injection container with a colorless transparent solution.

Package unit

1mL, 2mL, 10mL X 10 ampules, 1mL, 2mL, 10mL X 10 ampules (PP), 20mL, 30mL X 3 ampules (PP)