PentaKanSuhha Tablet 267 Micrograms (Fentanyl Citrate)

Adult dose

[Administration] After removing this medicine from the blister, 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. If any of this medicine remains after 30 minutes, it may be swallowed. Patients with dry mouth should moisten the mouth with water before taking this medicine. [Dosage] For each patient, determine a dose that provides adequate analgesia while minimizing adverse reactions. This medicine has a different pharmacokinetic profile and dosage regimen from other rapid-acting fentanyl products used for cancer breakthrough pain; therefore, it cannot be converted on a dose-for-dose (㎍) basis. Patients should not use two different fentanyl products simultaneously to treat breakthrough pain. When switching to this medicine, the other fentanyl product should be discontinued. To prevent confusion and the possibility of overdose, always minimize the number of tablets available at each strength. 1. Dose titration 1) Initiation of treatment The initial dose of this medicine for the treatment of cancer breakthrough pain is 133㎍. This medicine has a different absorption profile from other fentanyl products and should not be converted at a 1:1 ratio; follow the dose titration below. 2) Repeat dosing for a single episode of pain If adequate analgesia is not achieved within 15 ∼ 30 minutes, a second dose may be administered. Patients should not take more than 2 tablets of this medicine for a single episode of breakthrough pain. This medicine should not be administered for another episode of breakthrough pain until at least 2 hours later. 3) Dose escalation If more than one dose is required to treat breakthrough pain, consider increasing to the next dose according to the table below. Continue sequential dose escalation until adequate analgesia is achieved. At 533㎍, increase the additional (second) dose to 133㎍~267㎍. Once an adequate dose has been identified, maintain that dose. Titration process Start with 133㎍ Is adequate pain relief achieved within 15~30 minutes· Yes Use this dose for subsequent episodes of breakthrough pain No Administer a second dose* (See table below) Increase to the next higher dose for the next episode of breakthrough pain. * Administration of the second dose Initial sublingual tablet dose (㎍) used for the episode of breakthrough pain / Additional dose (㎍) to be taken 15∼30 minutes after the initial dose 133 / 133 267 / 133 400 / 133 533 / 267 800 / - 4) Maximum daily dose If breakthrough pain occurs more than 4 times per day, the dose of the long-acting opioid used for persistent cancer pain should be readjusted. Use of this medicine should be limited to no more than 4 times per day. 2. Dose readjustment If there is a significant change in the response to the adjusted dose of this medicine, dose adjustment may be necessary to identify the optimal dose. (For dose adjustment, see 3) Dose escalation.) If breakthrough pain occurs more than 4 times per day, the dose of the regularly taken opioid should be reassessed. The dose of this medicine should also be reassessed and retitrated if there is a change in the regularly taken opioid or its dose. If pain is not adequately controlled, consider the possibility of hyperalgesia, tolerance, and progression of the underlying disease. 3. Discontinuation If breakthrough pain no longer occurs, discontinue this medicine immediately. Treatment for persistent background pain should be maintained. If it is necessary to discontinue all opioid medicines, closely monitor the patient to avoid sudden withdrawal effects.

This medicine is a powerful analgesic used to relieve breakthrough pain in cancer patients and should only be used in patients with tolerance to opioid medications. Patients without tolerance to opioid medications must not use this drug due to the severe risk of respiratory depression or death. It must be prescribed and managed by a physician who has specialized knowledge and experience in cancer pain treatment. Keep it safely stored away from children and those who do not take this medication, and properly discard any remaining medication. Co-administration with other central nervous system depressants or alcohol can lead to severe sedation, respiratory depression, or coma, so it should be avoided or used with extreme caution. Especially, this medication should not be given to patients who have recently taken MAO inhibitors, as there is a risk of serious side effects such as serotonin syndrome. This medication has risks of tolerance, dependence, and drug abuse, so these symptoms should be monitored closely during use. Patients with impaired respiratory function, chronic lung disease, head trauma or elevated intracranial pressure, heart disease, or impaired kidney and liver function require special attention when using this drug. Pregnant or nursing women should consult with a physician before using this medicine due to potential risks to the fetus or newborn, and breastfeeding must be paused for a certain period after dosing. Elderly patients may be more sensitive to this medication and may require dosage adjustments and monitoring of their condition. In case of overdose, severe respiratory depression may occur and immediate emergency treatment is necessary, which may include administering opioid antagonists and securing the airway. Patients using this medication should avoid engaging in hazardous activities such as driving or operating machinery, and should consult medical personnel immediately if symptoms of drug abuse or dependence appear. Due to the high potential for drug interactions, it is essential to inform healthcare providers of any medications currently being taken. Always adhere to the prescribed dosing regimen and do not arbitrarily discontinue or increase the dosage.

• Respiratory depression
• apnea
• respiratory arrest
• blood circulation disorders
• hypotension
• shock
• anaphylactic reaction
• nausea
• vomiting
• constipation

This medication should be stored in a sealed container protected from light, as it is sensitive to light. It is recommended to maintain a storage temperature between 1°C and 30°C, ideally at room temperature.

Appearance

White, convex triangular film-coated tablet

Package unit

30 tablets (3 tablets * 10 PTP) / box