Abstral Sublingual Tablet 400 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. For patients with dry mouth, moisten the mouth with water before administering the tablet. The dose must be established individually for each patient to provide 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 pharmacokinetic characteristics and individual variability, the initial dose is 100㎍ even in patients previously treated with another fentanyl product. * Because absorption patterns differ, when switching from another fentanyl product to this medicine, do not switch on a 1:1 dose basis; follow the dose titration instructions below. 2) Additional dose for a single episode of pain Until an appropriate dose is reached, the patient may need to take an additional dose of this medicine for a single episode of pain. If adequate pain relief is not achieved within 30 minutes, a second dose may be administered. Do not administer more than 2 doses for a single episode of breakthrough pain. Wait at least 2 hours before administering this medicine 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 relief; if this is insufficient, the next doses are 600㎍ and 800㎍, respectively. If adequate pain relief is not achieved, another dose may be administered after 30 minutes. During dose titration, 100㎍ or 200㎍ tablets may be used, but do not use more than 4 tablets at one time. Once the appropriate dose has been established for the individual patient, administer a single tablet at the established dose; for 600 ㎍ and 800㎍ doses, administer 2 tablets of 300㎍ and 400㎍, respectively. If adequate pain relief is not achieved, another dose may be administered after 30 minutes. However, do not administer more than 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 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) Daily maximum If 4 or more episodes of breakthrough pain occur in a day, readjust the dose of the long-acting opioid used for persistent cancer pain. Limit administration of this medicine to no more than 4 times daily. 2. Dose readjustment If there is a significant change in response to the titrated 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 4 consecutive days, reassess the dose of the regularly administered opioid. Also reassess and readjust the dose of this medicine if the dose of the regularly administered opioid changes. If pain is not adequately controlled, consider the possibility of hyperalgesia, tolerance, and progression of the underlying disease. 3. Duration and goals of treatment Before starting treatment with this medicine, agree with the patient on a treatment plan, including treatment duration, treatment goals, and a plan for ending treatment. During treatment with this medicine, the physician and patient should maintain frequent contact to assess the need for continued treatment, consider discontinuation, and adjust the dose as necessary. If pain is not adequately controlled, consider the possibility of hyperalgesia, tolerance, and progression of the underlying disease. Do not use this medicine for longer than necessary. 4. Discontinuation If breakthrough pain no longer occurs, discontinue this medicine immediately. Continue treatment for persistent background pain. If all opioid treatment must be discontinued, monitor the patient closely to avoid sudden withdrawal effects.

This medication is used to relieve breakthrough pain in cancer patients who have developed tolerance to opioid analgesics. Individuals who have not used opioid analgesics for a long time should not use this medication, as it may cause serious respiratory depression. This medication should only be prescribed by healthcare professionals with expertise and experience in cancer pain management, and it should be stored in a safe place out of the reach of children. Additionally, caution is needed when this medication is taken with narcotics, central nervous system depressants, alcohol, etc., as it may lead to severe respiratory depression, coma, or even death. Particularly, if taken with certain antibiotics, antifungals, heart medications, etc., the effects of this medication may be intensified, or side effects may become more severe, so consultation with a physician is necessary. During the use of this medication, drowsiness or dizziness may occur, so it is advisable to avoid driving or operating machinery. Moreover, this medication should be used cautiously in patients with weak kidney or liver function, respiratory diseases, heart diseases, head injuries, etc., and it is recommended that women who are pregnant or breastfeeding do not use it unless in special circumstances. In the case of an overdose, severe respiratory depression and loss of consciousness may occur, requiring immediate emergency care, and withdrawal symptoms or drug dependence may arise, so caution is required during use. The safety and efficacy of this medication in children under 18 years of age have not been established. Finally, this medication should only be used to relieve pain in cancer patients, and it is important to continuously consult with healthcare professionals about side effects and drug interactions during use.

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

This medication should be stored in a sealed container to prevent air or moisture from entering, preferably in a cool place below 25 degrees Celsius. Storing it this way can help maintain the medication's effectiveness for a longer period.

Appearance

White diamond-shaped tablet

Package unit

30 tablets