Pentacan Sulha Tablet 533 micrograms (Fentanyl Citrate)

Adult dose

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 medication is an opioid analgesic intended for the treatment of breakthrough pain in cancer patients. It should only be used in patients with tolerance to opioids; administration to patients without tolerance can lead to severe respiratory depression and risk of death. This medication must be prescribed by a healthcare professional experienced in cancer pain management. It can be fatal to children; therefore, it should be stored out of reach of children and non-patients. Co-administration with narcotics, benzodiazepines, or alcohol may increase the risk of severe sedation, respiratory depression, coma, and death, so such combinations should be avoided. Particular caution is necessary when taken with drugs that inhibit or induce the CYP3A4 enzyme, as this may alter the drug's concentration in the blood. Patients should refrain from driving or operating hazardous machinery while on this medication, as drowsiness or dizziness may occur. It may pose risks to fetuses during pregnancy; hence it should only be used when necessary. During breastfeeding, administration should be avoided as sedation and respiratory depression may occur in newborns. Elderly patients or those with impaired liver or kidney function may be more sensitive to the drug's effects and side effects, requiring careful dose adjustment and monitoring. Overdose may lead to severe respiratory depression and decreased consciousness, necessitating immediate medical attention. Due to the characteristics of this opioid analgesic, there is a risk of tolerance, dependence, and abuse. Therefore, the patient's condition should be closely monitored. While taking this medication, avoid other central nervous system depressants or alcohol, and consult a healthcare provider immediately if abnormal symptoms arise.

• Respiratory depression
• apnea
• respiratory arrest
• circulatory disorder
• hypotension
• shock
• anaphylactic reaction
• nausea
• vomiting
• constipation

This medication is sensitive to light and should be stored in a container that does not allow light penetration. Additionally, it is important to store it at room temperature, between 1 and 30 degrees Celsius, to maintain its efficacy.

Appearance

White, convex triangular film-coated tablet

Package unit

15 tablets (3 tablets * 5 PTP) / box