Abstral Sublingual Tablet 200 Micrograms (Fentanyl Citrate)

Adult dose

A dose that provides adequate analgesia and minimizes adverse reactions must be established for each individual patient. 1. Dose titration 1) Initiation of treatment The initial dose of this drug 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 another fentanyl product. * Because absorption patterns differ, when switching from another fentanyl product to this drug, the strength must not be converted at a 1:1 ratio; dose titration as described below must be followed. 2) Additional dosing for a single pain episode Until an appropriate dose is established, the patient may need to take an additional dose of this drug for a single pain episode. If adequate analgesia 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. This drug should be administered for another episode of breakthrough pain no sooner than 2 hours later. 3) Dose escalation If adequate analgesia is not achieved with the initial dose of 100㎍, the dose may be increased in 100㎍ increments 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, a repeat 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 the same time. Once an appropriate dose has been established for an individual patient, administer one tablet at the established dose; for doses of 600 ㎍ and 800㎍, administer 2 tablets of 300㎍ and 400㎍, respectively. If adequate analgesia is not achieved, a repeat dose may be taken after 30 minutes. However, do not exceed 2 doses for a single episode of breakthrough pain, and administer a dose for another episode no sooner than 2 hours later. Initial dose titration process Initial sublingual tablet dose (㎍) used for an episode of breakthrough pain 100: Additional dose (㎍) to be taken 30 minutes after the initial dose 100 Initial sublingual tablet dose (㎍) used for an episode of breakthrough pain 200: Additional dose (㎍) to be taken 30 minutes after the initial dose 100 Initial sublingual tablet dose (㎍) used for an episode of breakthrough pain 300: Additional dose (㎍) to be taken 30 minutes after the initial dose 100 Initial sublingual tablet dose (㎍) used for an episode of breakthrough pain 400: Additional dose (㎍) to be taken 30 minutes after the initial dose 200 Initial sublingual tablet dose (㎍) used for an episode of breakthrough pain 600: Additional dose (㎍) to be taken 30 minutes after the initial dose 200 Initial sublingual tablet dose (㎍) used for an episode of breakthrough pain 800: Additional dose (㎍) to be taken 30 minutes after the initial dose - 4) Daily dose limit If 4 or more episodes of breakthrough pain occur per day, the dose of the long-acting opioid used for persistent cancer pain should be readjusted. Administration of this drug should be limited to no more than 4 times per day. 2. Dose readjustment If there is a significant change in response to the titrated dose of this drug, dose adjustment may be needed to identify the optimal dose. If the patient experiences 4 or more episodes of breakthrough pain during any consecutive 4-day period, the dose of the regularly taken opioid should be reassessed. In addition, if the dose of the regularly taken opioid changes, the dose of this drug should also be reassessed and readjusted. If pain is not adequately controlled, the possibility of hyperalgesia, tolerance, and progression of the underlying disease should be considered. 3. Duration and goals of treatment Before starting treatment with this drug, the treatment strategy, including the duration of treatment, treatment goals, and plan for discontinuation, should be agreed upon with the patient. During treatment with this drug, the physician and patient should have frequent contact to assess the need for ongoing treatment, consider discontinuation, and adjust the dose if necessary. If pain is not adequately controlled, the possibility of pain hypersensitivity, tolerance, and progression of the underlying disease should be considered. This drug should not be used for longer than necessary. 4. Discontinuation If breakthrough pain no longer occurs, administration of this drug should be discontinued immediately. Treatment of persistent background pain should be maintained. If it is necessary to discontinue all opioid medications, the patient should be closely monitored to avoid sudden withdrawal effects.

This medication is a powerful opioid analgesic used to treat breakthrough pain in cancer patients. It should not be used in patients without tolerance to opioids or those with acute pain or postoperative pain. This drug should only be used under the guidance of a healthcare professional for cancer pain management and should be kept out of the reach of children. Caution is needed when taken with central nervous system depressants such as narcotics, benzodiazepines, or alcohol as it may lead to severe respiratory depression or coma. Additionally, concomitant use with certain antibiotics, antifungals, or other medications may increase drug concentration and the risk of side effects, so it is essential to consult a physician. During treatment, symptoms such as drowsiness, dizziness, and blurred vision may occur; therefore, it is advisable to avoid driving or operating machinery. This medication may lead to physical dependence or drug tolerance, so careful dosage adjustment and attention to withdrawal symptoms during cessation are necessary. Patients with respiratory diseases, heart diseases, or liver or kidney dysfunction should use this medication with caution, and pregnant or nursing women should consult a professional before taking it. In case of overdose, severe respiratory depression and coma may occur, so contact a medical institution immediately and receive appropriate treatment in emergencies. This medication should be safely used according to a specialist's prescription and instructions for pain control in cancer patients.

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

Store this medication in a sealed container to prevent exposure to air or moisture, and keep it in a cool place at or below 25 degrees Celsius. Storing it this way helps maintain its effectiveness.

Appearance

White oval tablet

Package unit

30 tablets