BC Pentanyl Citrate Injection

Adult administration

The dose should be individualized based on age, body weight, physical condition, pathological condition, use of other drugs, 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), calculate the dose based on lean body weight. Monitor vital signs regularly during administration. 1. Adults and adolescents 12 years of age or older (see Adult Dosage Table) 1) Preanesthetic medication: Administer 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 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. The dose may be repeated after 1∼2 hours if necessary. 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. This technique has been reported to produce anesthesia without the use of other anesthetics. In some cases, doses up to 150 ㎍/kg (3 mL/kg) may be required to achieve this anesthetic effect. Use for open-heart surgery, where protection of the myocardium from excessive oxygen demand is especially important, and for complex neurosurgical or orthopedic procedures. This technique may be used only in a setting equipped to manage respiratory depression and staffed by qualified healthcare professionals. (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 waning anesthetic effect, changes in vital signs indicating surgical stress, or movement, 25∼100 ㎍/kg (0.5∼2 mL/kg) of this drug may be administered intravenously or intramuscularly. High dose 20∼50 ㎍/kg (0.4∼1 mL/kg): If there are signs of waning anesthetic effect or changes in vital signs indicating surgical stress, administer from 25 ㎍ up to 1/2 of the initial dose.

Child administration

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

This medication can have glass fragments if the container is broken during injection; therefore, extra caution must be taken when cutting the container, especially for children and the elderly. Using this drug with central nervous system depressants or alcohol can cause severe sedation, respiratory depression, coma, or even death; therefore, it should only be used at the minimum dosage necessary and patients must be closely monitored. This drug should not be used in certain patients, such as those allergic to opioids, patients with elevated intracranial pressure, infants under the age of 2 years, patients with severe asthma, or those with significant respiratory depression. Patients with poor respiratory function, liver or kidney dysfunction, elderly patients, or those with heart disease should use this medication with caution, as adverse reactions may occur. Continuous monitoring is essential. This drug can lead to dependence and poses a risk of respiratory depression; therefore, respiratory status must be continuously monitored during administration. Various adverse effects may occur, including muscle rigidity, allergic reactions, hypotension, arrhythmias, drowsiness, dizziness, nausea, vomiting, and more; any unusual symptoms should be reported immediately. This drug should only be used in an environment where qualified medical personnel can secure the airway and manage respiration; it is not to be used for purposes other than anesthesia. Patients must be fasting during anesthesia and the dosage should be reduced and administered cautiously during recovery. During administration, vital signs such as blood pressure, heart rate, respiration, and level of consciousness should be regularly checked, and respiratory depression may appear late after surgery, so observation is necessary. This drug can cause drowsiness or dizziness; therefore, operation of vehicles or dangerous machinery should be avoided for 24 hours post-administering. Chronic repeated use may result in withdrawal symptoms and there is a risk of drug abuse or dependence; therefore, careful management is necessary. This medication, when taken with other central nervous system depressants or narcotic analgesics, or alcohol, can greatly enhance side effects, necessitating dosage adjustments and monitoring. Women who are pregnant or may become pregnant should carefully consider the risks versus benefits of using this medication, and it should not be used during childbirth. In breastfeeding, this drug can be transmitted to breast milk, hence breastfeeding should be stopped for 24 hours after administration. Safety for infants under 2 years has not been established; thus, it is best to avoid use. Elderly or frail patients may have diminished physical function, increasing the risk of side effects; therefore, dosage should be reduced and closely monitored. In cases of overdose, severe respiratory depression, loss of consciousness, hypotension, and heart issues may occur, requiring immediate emergency treatment, and narcotic antagonists may need to be administered if necessary. Before administration, ensure the drug is not discolored or contaminated with foreign substances.

Dependence, respiratory distress, slow breathing, irregular breathing, apnea, truncal muscle rigidity, respiratory distress following skeletal muscle rigidity of the neck and limbs, anaphylactic reaction, shock, hypotension, arrhythmia, ectopic beats, cardiac arrest, bradycardia, itching, rash, erythema, urticaria, orthostatic hypotension, tachycardia, hypertension, vision disturbances, unusual excitation, drowsiness, excessive talking, paralysis, headache, trembling, extrapyramidal symptoms, psychiatric symptoms, insomnia, agitation, dizziness, nonsensical speech, mood swings, rigidity, hallucinations, paresthesia, delirium, hypersensitivity to pain, non-harmful irritant pain, nausea, vomiting, secondary rebound respiratory depression after surgery, laryngeal spasms, sweating, urinary retention, sneezing, sore throat, excessive mucus secretion, increased sputum production, difficulty expectorating sputum, hypothermia, coldness, cold extremities, cyanosis, wheezing, hiccups, miosis, thirst, hoarseness, fever, sexual dysfunction, withdrawal syndrome, lethargy, involuntary muscle contractions, anaphylactic reactions, anaphylactic shock, respiratory depression, unconsciousness, coma, skeletal muscle relaxation, cold skin, miosis, bradycardia, hypotension, apnea, cardiovascular collapse, cardiac arrest, toxic white matter encephalopathy

This medication should be stored in a tightly sealed container that protects it from light, and the storage temperature should be maintained between 1 to 30 degrees Celsius. Storing it this way helps ensure the drug's efficacy and prevents degradation.

Appearance

Colorless and transparent liquid in brown glass ampules and brown glass vials.

Package unit

2ml×10 ampules, 2ml×10 vials, 10ml×10 ampules, 10ml×10 vials, 20ml×1 vial, 20ml×10 vials, 30ml×1 vial, 30ml×10 vials