Narcoselhajung 200 Micrograms (Fentanyl Citrate)

Adult dose

The dose must be individualized for each patient to provide adequate pain relief while minimizing adverse reactions. 1. Dose titration 1) Starting treatment The initial dose of this drug for the treatment of breakthrough cancer pain is 100㎍. Because of pharmacokinetic characteristics and individual variability, the initial dose is 100㎍ even in patients previously treated with another fentanyl product. * Because the absorption patterns differ, when switching from another fentanyl product to this drug, do not convert the strength at a 1:1 ratio; follow the dose titration below. 2) Repeat dosing for a single pain episode Until an appropriate dose is reached, the patient may need to take an additional dose of this drug for a pain episode. If adequate pain relief has not been achieved within 30 minutes, a second dose may be taken. Do not exceed 2 doses for a single episode of breakthrough pain. Wait at least 2 hours before administering this drug for another episode of breakthrough pain. 3) Dose escalation If adequate pain relief is not achieved with the initial dose of 100㎍, the dose may be increased in 100㎍ increments up to 400㎍ to achieve adequate pain relief; if this is insufficient, the next doses are 600㎍ and 800㎍, respectively. If adequate pain relief is not achieved, a dose may be repeated after 30 minutes. During dose titration, 100㎍ or 200㎍ tablets may be used, but do not use more than 4 tablets at a time. Once an appropriate dose has been established for an individual patient, administer one tablet at the established dose; for 600 ㎍ and 800㎍, administer 2 tablets of 300㎍ and 400㎍, respectively. If adequate pain relief is not achieved, a dose may be repeated after 30 minutes. However, do not exceed 2 doses for a single episode of breakthrough pain, and wait at least 2 hours before administering a dose for another episode of breakthrough pain. Initial dose-finding process Initial sublingual tablet dose (㎍) used for an episode of breakthrough pain / Additional dose (㎍) to be taken 30 minutes after the initial dose 100 / 100 200 / 100 300 / 100 400 / 200 600 / 200 800 / - 4) Maximum daily dose If 4 or more episodes of breakthrough pain occur in 1 day, the dose of the long-acting opioid used for persistent cancer pain should be readjusted. Use of this drug should be limited to 4 times daily or less. 2. Dose readjustment If there is a marked change in response to the titrated dose of this drug, dose adjustment may be necessary to determine the optimal dose. If the patient experiences 4 or more episodes of breakthrough pain during any 4 consecutive days, reassess the dose of the regularly administered opioid. Also reassess and readjust the dose of this drug if the dose of the regularly administered opioid is changed. If pain is not adequately controlled, consider the possibility of hyperalgesia, tolerance, and progression of the underlying disease. 3. Discontinuation Discontinue this drug immediately if breakthrough pain no longer occurs. Treatment for persistent background pain should be continued. If all opioid therapy must be discontinued, monitor the patient closely to avoid sudden withdrawal effects.

This medication is an opioid used to relieve breakthrough pain in cancer patients. It should only be used in patients who have developed tolerance to opioids. It should not be used in patients without tolerance as it can cause severe respiratory depression that may be life-threatening. This medication is for the treatment of breakthrough pain in patients who have been on opioids for a long time and is not appropriate for acute pain or postoperative pain. It can be very dangerous for children, so it should be stored in a safe place out of reach of children. Concurrent administration of this medication with central nervous system depressants such as benzodiazepines or alcohol can lead to serious sedation, respiratory depression, or coma. In particular, co-administration with drugs that inhibit CYP3A4 enzymes can increase the effects of this medication, raising the risk of respiratory depression and hypotension. It is recommended not to administer this medication to patients who have taken MAO inhibitors within the past 14 days. During treatment with this medication, symptoms such as sedation, drowsiness, and blurred vision may occur, so driving or operating dangerous machinery should be avoided. With long-term use, there is a risk of drug abuse or dependence, so patients and caregivers should strictly adhere to the dosing guidelines and immediately consult medical staff if any abnormal symptoms occur. During pregnancy, this medication may affect the fetus, and it should only be administered when absolutely necessary; in nursing mothers, breastfeeding must be discontinued for at least 5 days after administration. Elderly patients or patients with impaired liver or kidney function may be affected in the metabolism and excretion of this medication, necessitating dose adjustments and careful monitoring. In case of overdose, severe respiratory depression may occur, and immediate medical attention should be sought. This medication must be used under the guidance of healthcare professionals experienced in cancer pain management and should be kept in a cool place below 25 degrees Celsius, protected from moisture and freezing.

• Nausea
• constipation
• drowsiness
• headache
• hypersensitivity reaction
• anaphylactic reaction
• anaphylactic shock
• loss of appetite
• decreased appetite
• depression

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture and must be kept in a cool place below 25 degrees Celsius. Proper storage will help maintain the effectiveness of the medication.

Appearance

White oval tablet

Package unit

30 tablets (10 tablets/PTP X 3)