Medication info

Gujuguyun-san Pentanyl Injection

Prescription medicationIntramuscular injection · Intravenous injection
Ingredient · strength
Fentanyl Citrate›0.0785mg / 1mL
Manufacturer / importer
Gujoo Pharmaceutical Co., Ltd.
Appearance
Brown ampoule containing a colorless transparent liquid
Packaging
10 ampoules/box[(2mL/ampoule x 10)], 10 ampoules/box[(10mL/ampoule x 10)], 5 ampoules/box[(20mL/ampoule x 5)]
Approval status
Active

MFDS item code 199604972 · Approved 1996.11.14 · Insurance code 669800033,669800043,669800051

Summary

Main use
Anesthetic adjunct and premedication; anesthesia for high-risk surgery; relief of pain before and after anesthesia and surgery
Who receives it
Adults · Children
Adult administration
Determine the dose individually, taking into account 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), determine the dose based on lean body weight. Regularly monitor vital signs during administration. Adults and adolescents aged 12 years and older Preoperative 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). Analgesic adjunct to general anesthesia: See the adult dosage table. Analgesic adjunct to local anesthesia: If additional analgesia is required, slowly administer 50∼100 ㎍ (1∼2 mL) intravenously over 1∼2 minutes or administer intramuscularly. 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 needed. General anesthesia: 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. 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. It is used particularly in open-heart surgery, complex neurosurgery, and orthopedic surgery when protection of the myocardium from excessive oxygen demand is required. This technique may be used only where facilities and qualified healthcare personnel are available to manage respiratory depression. Adult dosage table Total dose, low dose: 2 ㎍/kg(0.04 mL/kg) Useful for minor but painful surgery. Administration of this drug can reduce not only pain during surgery but also pain immediately after surgery. Total dose, moderate dose: 2∼20 ㎍/kg(0.04∼0.4 mL/kg) The dose increases as the complexity of surgery increases. Administration of this drug can provide intraoperative analgesia and reduce stress to some extent. However, respiratory depression during anesthesia may require mechanical ventilation, and respiration must be carefully monitored after surgery. Total dose, high dose: 20∼50 ㎍/kg(0.4∼1 mL/kg) Used for open-heart surgery, complex neurosurgery and orthopedic surgery of long duration, or when the anesthesiologist considers surgical stress harmful to the patient. The stress response, indicated by increased blood concentrations of growth hormone, catecholamines, ADH, and prolactin, can be reduced by administering this drug 20∼50 ㎍/kg(0.4∼1.0 mL/kg) in combination with N2O/O2. When such high doses are used during surgery, respiratory depression may persist postoperatively, making postoperative respiratory management essential; this method is used to reduce stress caused by surgery. Maintenance dose, low dose: 2 ㎍/kg(0.04 mL/kg) Additional doses are rarely required for minor surgery. Maintenance dose, moderate dose: 2∼20 ㎍/kg(0.04∼0.4 mL/kg) If there are signs of reduced 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. Maintenance dose, high dose: 20∼50 ㎍/kg(0.4∼1 mL/kg) If there are signs of reduced anesthetic effect or changes in vital signs indicating surgical stress, administer from 25 ㎍ up to 1/2 of the initial dose. If little time remains in the surgery, determine any additional dose particularly carefully for each patient.
Child administration
Children aged 2∼12 years: Use a low dose of approximately 2∼3 ㎍ per kg of body weight for induction and maintenance of anesthesia.

Ingredients

Manufacturer
Gujoo Pharmaceutical Co., Ltd.

Efficacy & effects

Anesthetic adjunct and premedication; anesthesia for high-risk surgery; relief of pain before and after anesthesia and surgery

View approved original text

This medication is used mainly in various situations related to anesthesia. First, it provides short-term analgesic effects during anesthesia induction and maintenance, as well as in the recovery room immediately after surgery. Additionally, it is used as an opioid analgesic adjuvant during general or local anesthesia to help relieve pain. When used in combination with the neuroleptic droperidol, it acts as a premedication for induction and maintenance of anesthesia. Finally, in high-risk patient populations such as those undergoing open-heart surgery or complicated neurosurgical or orthopedic procedures, it helps provide safe anesthesia when used alongside oxygen. This medication improves effective pain management and anesthesia in various anesthesia situations.

How it is given

Adult administration

Determine the dose individually, taking into account 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), determine the dose based on lean body weight. Regularly monitor vital signs during administration. Adults and adolescents aged 12 years and older Preoperative 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). Analgesic adjunct to general anesthesia: See the adult dosage table. Analgesic adjunct to local anesthesia: If additional analgesia is required, slowly administer 50∼100 ㎍ (1∼2 mL) intravenously over 1∼2 minutes or administer intramuscularly. 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 needed. General anesthesia: 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. 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. It is used particularly in open-heart surgery, complex neurosurgery, and orthopedic surgery when protection of the myocardium from excessive oxygen demand is required. This technique may be used only where facilities and qualified healthcare personnel are available to manage respiratory depression. Adult dosage table Total dose, low dose: 2 ㎍/kg(0.04 mL/kg) Useful for minor but painful surgery. Administration of this drug can reduce not only pain during surgery but also pain immediately after surgery. Total dose, moderate dose: 2∼20 ㎍/kg(0.04∼0.4 mL/kg) The dose increases as the complexity of surgery increases. Administration of this drug can provide intraoperative analgesia and reduce stress to some extent. However, respiratory depression during anesthesia may require mechanical ventilation, and respiration must be carefully monitored after surgery. Total dose, high dose: 20∼50 ㎍/kg(0.4∼1 mL/kg) Used for open-heart surgery, complex neurosurgery and orthopedic surgery of long duration, or when the anesthesiologist considers surgical stress harmful to the patient. The stress response, indicated by increased blood concentrations of growth hormone, catecholamines, ADH, and prolactin, can be reduced by administering this drug 20∼50 ㎍/kg(0.4∼1.0 mL/kg) in combination with N2O/O2. When such high doses are used during surgery, respiratory depression may persist postoperatively, making postoperative respiratory management essential; this method is used to reduce stress caused by surgery. Maintenance dose, low dose: 2 ㎍/kg(0.04 mL/kg) Additional doses are rarely required for minor surgery. Maintenance dose, moderate dose: 2∼20 ㎍/kg(0.04∼0.4 mL/kg) If there are signs of reduced 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. Maintenance dose, high dose: 20∼50 ㎍/kg(0.4∼1 mL/kg) If there are signs of reduced anesthetic effect or changes in vital signs indicating surgical stress, administer from 25 ㎍ up to 1/2 of the initial dose. If little time remains in the surgery, determine any additional dose particularly carefully for each patient.

Child administration

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

Precautions

This medication should be handled with extreme care when using the ampoules, as glass fragments may be present, particularly when administering to children or the elderly. Care must be taken when used with other central nervous system depressants or alcohol, as severe respiratory depression, coma, and even death can occur. This medication should not be administered to specific patients, such as those allergic to this drug or similar medications, patients with elevated intracranial pressure, asthmatic patients, and infants under 2 years old. Patients with compromised respiratory function, impaired liver or kidney function, elderly patients, and those with heart disease should use this medication with increased caution. This medication can cause dependency, so the patient's condition should be closely monitored during administration, and serious side effects such as respiratory distress, muscle rigidity, or anaphylaxis should be promptly addressed. This medication should only be used in a professional anesthesia setting, and the patient's respiratory and cardiac status should be monitored continuously. Pregnant or nursing women should avoid using this medication or carefully consider its use; particularly, it is safest not to administer it during childbirth. After administration, drowsiness or dizziness may occur for 24 hours, so driving or operating hazardous machinery should be avoided. When used with other central nervous system depressants, the dose should be reduced, and patients should be monitored closely; combinations with certain medications are prohibited. In case of overdose, severe respiratory depression and loss of consciousness may occur, so immediate emergency measures such as airway management and oxygen administration should be taken. Before administration, ensure that the medication has not changed color and that no foreign substances are present.

Side effects

Dependence, respiratory distress, slow breathing, irregular breathing, apnea, body stiffness, respiratory distress following muscle stiffness of the neck and limbs, anaphylactic reaction, shock, hypotension, arrhythmia, ectopic beats, cardiac arrest, bradycardia, itching, rash, erythema, urticaria, orthostatic hypotension, tachycardia, hypertension, visual disturbances, abnormal euphoria, drowsiness, talkativeness, paralysis, headache, tremor, extrapyramidal symptoms, psychiatric symptoms, insomnia, agitation, dizziness, hallucinations, mood swings, rigidity, hallucinations, paresthesia, delirium, hypersensitivity to pain, non-painful stimulus pain, nausea, vomiting, secondary rebound respiratory depression after surgery, laryngospasm, sweating, urine retention, sneezing, sore throat, excessive mucus secretion, increased sputum production, difficulty in expectoration, hypothermia, coldness, limb coldness, cyanosis, wheezing, hiccups, miosis, thirst, hoarseness, fever, sexual dysfunction, withdrawal syndrome, lethargy, involuntary muscle contractions, anaphylactic reaction, anaphylactic shock, withdrawal symptoms, diarrhea, anxiety, chills, tremor, sweating, involuntary muscle contractions, anaphylactic shock

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a light-restrictive, airtight container, preferably at room temperature. This is a method to maintain the drug's effectiveness and prevent deterioration.

Appearance and packaging

Appearance

Brown ampoule containing a colorless transparent liquid

Package unit

10 ampoules/box[(2mL/ampoule x 10)], 10 ampoules/box[(10mL/ampoule x 10)], 5 ampoules/box[(20mL/ampoule x 5)]

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.