Actiq Buccal Tablet 200 Micrograms (Fentanyl Citrate)

Adult dose

Immediately before use, open the blister package with scissors. The patient should place 1 tablet in the mouth between the cheek and lower gum, then use the applicator to move the tablet occasionally from one side to the other. The tablet should be allowed to dissolve; it should not be chewed. If 1 tablet is chewed and swallowed, the maximum plasma concentration and bioavailability may be lower than when it is taken as directed. This tablet should be taken over 15 minutes. If the administration time is shorter or longer, efficacy may be lower than that reported in clinical trials. If opioid effects become excessive before the full tablet has been administered, remove the medication immediately and reduce the dose for subsequent administrations. A dose that provides adequate pain relief and minimizes adverse reactions must be established for each patient. 1. Dose titration 1) Initiation The initial dose of this medication for the treatment of breakthrough cancer pain is 200㎍. The patient should be prescribed the initial titration pack containing 6 tablets of 200㎍ to limit the number of tablets available for use at home during the titration period. The patient should not increase the dose before taking all of the prescribed tablets of this medication. The patient must strictly follow these initial dosing instructions. The dose should be adjusted until a dose is reached that provides adequate pain relief and minimizes adverse reactions when this medication is administered as a single dose for an episode of breakthrough cancer pain. To determine whether dose adjustment has been adequate, the patient should record the dose of this medication taken for several episodes of breakthrough cancer pain and review the records with the physician. 2) Repeat administration for an episode of pain Before an appropriate dose has been established, the patient may need to take an additional dose of this medication for an episode of pain. A repeat dose may be started 15 minutes after the previous tablet has been completely administered (30 minutes after the previous tablet was started). While the patient is undergoing titration and taking an individually determined supplemental dose, no more than 2 tablets should be administered for each episode of breakthrough cancer pain. 3) Dose escalation If, over several consecutive episodes of breakthrough pain, more than 1 tablet per episode is needed, consider increasing the dose by one dose level. During initial dose titration, it is recommended that 6 tablets of the new dose be prescribed. Each new dose of this medication used during the initial titration period should be evaluated over several episodes of breakthrough cancer pain (generally 1~2 days) to determine whether it provides adequate efficacy with tolerable adverse reactions. Adverse reactions tend to occur more frequently during the initial titration phase than after the effective dose has been determined. 4) Maximum daily dose After a successful dose has been found (for example, treatment of each episode of pain with 1 tablet), limit the patient's daily dose to no more than 4 tablets. If the dose exceeds 4 tablets per day, the dose of the long-acting opioid used for persistent cancer pain should be readjusted. Initial dose titration process Start with 200㎍ (Do not dispense more than 6 tablets initially.) 1 - Take this medication over 15 minutes. 2 - Wait an additional 15 minutes after taking it. 3 - If needed, take a second tablet over 15 minutes. 4 - Administer this medication for several episodes of breakthrough pain. Does 1 tablet provide adequate relief? Yes No Effective dose established Increase the dose* by one dose level *Available dose strengths are 200㎍, 400㎍, 600㎍, 800㎍ 1200㎍ 1600㎍ 2. Dose adjustment Studies of long-term administration of this medication for the treatment of breakthrough cancer pain have shown that some patients need to adjust both the dose of this medication and the dose of the regularly scheduled opioid analgesic (administered at fixed intervals) to continue to obtain adequate relief of breakthrough cancer pain. In general, if more than 1 tablet per episode is needed over several consecutive episodes of breakthrough pain, the dose of this medication should be increased. During the process of adjusting to an appropriate dose, a small quantity (6 tablets) should be prescribed at each adjustment step. If the patient experiences breakthrough cancer pain more than 4 times a day, the physician should consider increasing the dose of the opioid regularly taken for persistent cancer pain. If pain is not adequately controlled, the possibility of hyperalgesia, tolerance, and progression of the underlying disease should be considered. 3. Discontinuation of this medication Because it is not known at what dose opioid treatment can be stopped suddenly without the occurrence of withdrawal symptoms, gradual dose reduction is recommended for patients who need to discontinue opioid treatment.

This medication is a powerful opioid analgesic used for the treatment of breakthrough pain in cancer patients. It should only be used in patients who are tolerant to opioids, and it must never be used in patients who have not been on opioids for a long time. It is particularly not suitable for the treatment of acute pain or postoperative pain. This medication should only be administered by healthcare professionals with expertise and experience; it must be kept out of reach of children. Caution should be exercised as concurrent use with narcotics, central nervous system depressants, or alcohol may lead to respiratory depression, deep sedation, coma, or even death. The potential for drug interactions while taking this medication must always be considered, especially with drugs that inhibit or induce metabolic enzymes in the liver, which may require dosage adjustments. Patients with respiratory depression, cardiovascular diseases, impaired liver or kidney function, or head trauma require special attention when using this medication. During use, symptoms such as drowsiness and dizziness may occur, so driving or operating dangerous machinery should be avoided. This medication has a potential for dependency and abuse, thus it should be taken exactly as prescribed by a physician, and dosages should not be changed or stopped arbitrarily. In the event of an overdose, emergency treatment is necessary, and quick medical intervention is crucial as serious side effects such as respiratory depression may occur. Any leftover medication after use should be disposed of safely to prevent access by children or others. Additionally, this medication may affect dental health, so regular oral hygiene and dental visits are recommended. Patients who are pregnant or breastfeeding should consult healthcare professionals before using this medication. Caution is necessary for elderly patients or those under 18, as the safety and appropriate dosage have not been sufficiently established.

• Asthenia
• headache
• incidental injury
• muscle rigidity
• pain
• fever
• abdominal pain
• chills
• back pain
• chest pain

This medication should be stored in a tightly sealed container to avoid exposure to air and moisture. It is best to maintain a storage temperature between 15 to 30 degrees Celsius at room temperature to preserve its effectiveness.

Appearance

A white cylindrical buccal tablet with a flat underside and a dome-shaped upper surface, attached to a white plastic support.

Package unit

30 tablets (3 tablets/PTP packaging x 10)