Actiq Buccal Tablet 400 Micrograms (Fentanyl Citrate)

Adult dose

The blister package should be opened with scissors immediately before use. The patient should place 1 tablet of this medicine in the mouth and position it between the cheek and lower gum, then occasionally move the medication from one side to the other using the applicator. This medicine should be allowed to dissolve, not chewed. If 1 tablet of this medicine is chewed and swallowed, the peak plasma concentration and bioavailability may be lower than when it is taken as directed. This medicine 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 the effects of the opioid become excessive before 1 tablet has been fully administered, remove the medication immediately and reduce the dose for subsequent administrations. 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 starting dose of this medicine for the treatment of breakthrough cancer pain is 200㎍. Patients should be prescribed the titration pack containing 6 tablets of 200㎍ to limit the number of units of the product used at home during the titration period. Patients should not increase the dose before taking all of the prescribed tablets of this medicine. Patients should strictly follow these starting-dose instructions. The dose should be changed until the patient reaches a dose that provides adequate analgesia with a single administration of this medicine for an episode of breakthrough cancer pain while minimizing adverse reactions. To determine whether dose adjustment has been appropriate, patients should record the dose of this medicine used for several episodes of breakthrough cancer pain and review these records with their physician. 2) Repeat administration for a single pain episode Until an appropriate dose is reached, the patient may need to take an additional dose of this medicine for a single pain episode. Repeat administration may begin 15 minutes after completion of the preceding tablet (30 minutes after starting the preceding tablet). While the patient is undergoing titration and taking an individually selected dose for treatment, no more than 2 tablets should be administered for each episode of breakthrough cancer pain. 3) Dose increases If, after administration of this medicine for several consecutive episodes of breakthrough pain, more than 1 tablet per pain episode is needed, an increase of 1 dose level should be considered. It is recommended that 6 tablets of the new dose of this medicine be prescribed during the initial titration process. Each new dose of this medicine 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 established. 4) Daily maximum After a successful dose has been found (for example, treatment of each pain episode with 1 tablet), the patient's daily dose should be limited 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 titration process Start with 200㎍ (Do not dispense more than 6 tablets initially.) ↓ 1 - Take this medicine 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 medicine for several episodes of breakthrough pain. ↓ Does 1 tablet provide adequate relief? Yes No ↙ ↘ ↓ ↓ Effective dose established Increase dose* by 1 level *Available dose range: 200㎍, 400㎍, 600㎍, 800㎍, 1200㎍, 1600㎍ 2. Dose adjustment Results from studies of long-term administration of this medicine for the treatment of breakthrough cancer pain indicate that, in some patients, both the dose of this medicine and the dose of the regularly scheduled opioid analgesic may need to be adjusted to continue to achieve adequate relief of breakthrough cancer pain. In general, if administration of this medicine for several consecutive episodes of breakthrough pain results in the need for more than 1 tablet per pain episode, the dose should be increased. During adjustment 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 per day, the physician should consider increasing the dose of the opioid that the patient takes regularly 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 medicine Because it is not known at what dose opioid therapy can be stopped without the sudden appearance of withdrawal symptoms, gradual dose reduction is recommended for patients who need to discontinue opioid therapy.

This medication is an opioid analgesic used to treat breakthrough pain in cancer patients. It should only be administered to patients who are tolerant to opioids and should not be used in patients who are opioid-naive or for treating acute pain or post-surgical pain. Serious side effects such as respiratory depression may occur, and it must be used under strict supervision by a specialist. It is very dangerous for children, so it must be stored out of reach of children, and any unused medication should be disposed of safely. This medication can cause increased respiratory depression and sedation if taken with central nervous system depressants or alcohol, so caution is needed. Also, when combined with certain antibiotics or antifungal agents that affect drug metabolism in the liver, the effects may change, necessitating dosage adjustments. Pregnant or breastfeeding women should carefully consider the administration of this medication. Elderly patients or those with impaired liver or kidney function may be more sensitive to the medication, and dosage adjustments should be made accordingly. This medication can cause addiction, dependence, and withdrawal symptoms, so signs of drug abuse should be carefully monitored during treatment. Overdose can lead to life-threatening symptoms such as respiratory depression, so immediate emergency treatment is needed. During treatment, avoid hazardous activities like driving or operating machinery, and regularly consult with a doctor to manage dosage and side effects. Store the medication in a tightly sealed container to prevent exposure to air or moisture. The storage temperature should be maintained between 15 and 30 degrees Celsius.

• Asthenia
• headache
• accidental injury
• muscle hypertonicity
• pain
• fever
• abdominal pain
• chills
• back pain
• chest pain

This medication must be stored in a tightly sealed container to avoid exposure to air or moisture. It is recommended to maintain a storage temperature between 15 and 30 degrees Celsius.

Appearance

A white cylindrical buccal tablet attached to a white plastic support, with a flat bottom and a dome-shaped top.

Package unit

30 tablets (3 tablets/PTP packaging x 10)