Narcosal Ha-jeong 300 Micrograms (Fentanyl Citrate)

Adult dose

Remove this medicine from the blister and place it under the tongue. Do not chew, suck, or swallow it; allow the tablet to dissolve completely. Do not eat or drink until the tablet has completely dissolved. Patients with dry mouth should moisten their mouth with water before taking the tablet. A dose must be established for each individual patient that provides adequate pain relief while minimizing adverse reactions. 1. Dose titration 1) Initiation of treatment The initial dose of this medicine for the treatment of breakthrough cancer pain is 100㎍. Because of its pharmacokinetic properties and individual variability, the initial dose should be 100㎍ even in patients who have been receiving other fentanyl products. * Because absorption patterns differ, when switching from another fentanyl product to this medicine, the dose must not be changed on a 1:1 basis; the dose should be titrated as described below. 2) Repeat administration for a single pain episode Until an appropriate dose is reached, patients may need to take an additional dose of this medicine for a single pain episode. If adequate analgesia is not achieved within 30 minutes, a second dose may be taken. Do not administer more than 2 doses for a single episode of breakthrough pain. Allow at least 2 hours before administering this medicine for another episode of breakthrough pain. 3) Dose escalation If adequate analgesia is not achieved with the initial dose of 100㎍, the dose may be increased in increments of 100㎍ up to 400㎍ to achieve adequate analgesia. If this is insufficient, the next doses are 600㎍ and 800㎍, respectively. If adequate analgesia is not achieved, another dose may be taken after 30 minutes. During dose titration, 100㎍ or 200㎍ tablets may be used, but no more than 4 tablets should be used at one time. Once an appropriate dose has been established for an individual patient, administer one tablet at the established dose. For 600㎍ and 800㎍ doses, administer two tablets of 300㎍ and 400㎍, respectively. If adequate analgesia is not achieved, another dose may be taken after 30 minutes. However, do not administer more than 2 doses for a single episode of breakthrough pain, and allow at least 2 hours before administering a dose for another episode of breakthrough pain. Initial sublingual tablet dose (㎍) 100: Additional dose (㎍) to be taken 30 minutes after the initial dose 100 Initial sublingual tablet dose (㎍) 200: Additional dose (㎍) to be taken 30 minutes after the initial dose 100 Initial sublingual tablet dose (㎍) 300: Additional dose (㎍) to be taken 30 minutes after the initial dose 100 Initial sublingual tablet dose (㎍) 400: Additional dose (㎍) to be taken 30 minutes after the initial dose 200 Initial sublingual tablet dose (㎍) 600: Additional dose (㎍) to be taken 30 minutes after the initial dose 200 Initial sublingual tablet dose (㎍) 800: Additional dose (㎍) to be taken 30 minutes after the initial dose - 4) Daily limit 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. Administration of this medicine should be limited to no more than 4 times per day. 2. Dose readjustment If there is a marked change in response to the adjusted dose of this medicine, dose adjustment may be necessary to identify the optimal dose. If the patient experiences 4 or more episodes of breakthrough pain during any period of 4 consecutive days, the dose of the regularly administered opioid should be reassessed. The dose of this medicine should also be reassessed and readjusted if the dose of the regularly administered opioid is changed. If pain is not adequately controlled, the possibility of hyperalgesia, tolerance, and progression of the underlying disease should be considered. 3. Discontinuation If breakthrough pain no longer occurs, discontinue this medicine immediately. Treatment for persistent background pain should be continued. If it is necessary to discontinue all opioid therapy, the patient should be monitored closely to avoid sudden withdrawal effects.

This medication is a potent opioid analgesic used for the relief of breakthrough pain in cancer patients. It should be used only in patients who have developed tolerance to opioid medications, as it can cause severe respiratory depression that may be life-threatening in patients without tolerance. This medication should be prescribed by an experienced professional in cancer pain management and stored in a safe place out of reach of children. The risk of respiratory depression or coma increases when used in combination with central nervous system depressants such as narcotics, benzodiazepines, and alcohol, so extreme caution is necessary. Additionally, it should be noted that combining with CYP3A4 inhibitors, such as certain antibiotics or antifungals, may increase the concentration of this medication, raising the risk of side effects, so professional guidance is required. This medication is not suitable for the treatment of acute pain or postoperative pain and should be administered with caution in patients with severe respiratory depression, lung disease, heart disease, or kidney or liver dysfunction. Symptoms such as drowsiness, dizziness, and blurred vision may occur while taking this medication, so driving or operating hazardous machinery should be avoided. During the use of this medication, the potential for drug abuse or addiction must be monitored closely, and it is important to discuss dosage adjustments and treatment plans with a healthcare professional. In cases of overdose, severe respiratory depression and impaired consciousness may occur, and immediate emergency care should be sought; administration of opioid antagonists may be necessary. Caution is advised when using this medication during pregnancy as it may affect the fetus, and breastfeeding should be suspended for at least 5 days after administration. The safety and efficacy of this medication have not been established in pediatric patients under 18 years of age, so its use is not recommended. Older adults may be more sensitive to this medication, so dosage adjustments and careful monitoring for side effects are necessary. This medication should be stored in a cool, dry place below 25 degrees Celsius, and any remaining medication after opening should not be taken and should be disposed of safely.

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

This medication may be sensitive to air and moisture, so it should be stored in a sealed container. Additionally, it is important to keep it in a cool place, namely at or below 25 degrees Celsius, to maintain its effectiveness.

Appearance

White round tablet

Package unit

30 tablets (10 tablets/PTP X 3)