Pentorabak Oral Tablet 200 Micrograms (Fentanyl Citrate)

Adult dose

1. Initial dose This medicine is not bioequivalent to other products containing fentanyl. Do not switch from other fentanyl-containing products on a mcg-for-mcg basis. There are no guidelines for switching between this medicine and other fentanyl-containing products, other than ACTIQ buccal tablets (including oral, transdermal, and parenteral fentanyl products). All patients must have their dose titrated starting at 100 mcg. 1) Patients who were using ACTIQ buccal tablets The initial dose of this medicine is always 100 mcg, except for patients already using ACTIQ buccal tablets. ① For patients switching from ACTIQ buccal tablets to this medicine, prescribe according to the initial dose recommendations for patients currently receiving ACTIQ buccal tablets in Table 1 below. The doses of this medicine in Table 1 are starting doses and do not represent doses equivalent in analgesic effect to ACTIQ buccal tablets. Patients must be instructed to stop using ACTIQ buccal tablets and discard any remaining product. Table 1. Recommended initial dose for patients currently receiving ACTIQ buccal tablets Current dose of ACTIQ buccal tablets (mcg) Initial dose of this medicine* 200 100 mcg 400 100 mcg 600 200 mcg 800 200 mcg 1200 2X200 mcg 1600 2X200 mcg *Start with the initial dose and titrate to the effective dose. ② Patients switching from a dose of ACTIQ buccal tablets of 600 mcg or higher should start with 200 mcg of this medicine and proceed using multiples of this tablet strength. 2) Other patients The initial dose of this medicine is 100 mcg. 3) Repeat dosing for a single pain episode ① If breakthrough pain has not subsided after 30 minutes, the patient may take one additional dose for that episode of pain, using a product of the same strength. Therefore, a patient may take a maximum of 2 doses of this medicine for a single episode of breakthrough pain. ② The patient must wait at least 4 hours before treating another episode of breakthrough pain with this medicine. 2. Dose titration ① The physician should closely monitor the patient from the initial dose and adjust the dose until an appropriate analgesic effect is achieved with tolerable adverse reactions. To determine whether dose adjustment is appropriate, patients should record their experience using this medicine for several episodes of cancer-related breakthrough pain and discuss it with their physician. ② For patients whose initial dose is 100 mcg and who require an increase, they may be instructed to use 2 tablets of 100 mcg (apply 1 tablet of 100 mcg to each side of the buccal mucosa) for the next episode of cancer-related breakthrough pain. If this dose is not successful, the patient may be instructed to apply 2 tablets of 100 mcg to each side of the buccal mucosa (a total of 4 tablets of 100 mcg). For doses of 400 mcg or higher, titrate using multiples of the 200 mcg tablet. However, do not use more than 4 tablets at the same time. ③ If breakthrough pain has not subsided after 30 minutes, the patient may take one additional dose for that episode of pain, using a product of the same strength. Therefore, a patient may take a maximum of 2 doses of this medicine for an episode of breakthrough pain. During the titration period, a single dose of this medicine may consist of 1-4 tablets of the same strength (100 mcg or 200 mcg). ④ The patient must wait at least 4 hours before treating another episode of breakthrough pain with this medicine. During the titration period, only 1 product strength should be used at a time to prevent overdose. ⑤ The patient should use all tablets previously prescribed before being prescribed the next product strength. If this is not possible, unused medicine must be disposed of safely (see Precautions for storage and handling). Any prescribed, unopened medicine that remains should be discarded as soon as it is no longer needed. 3. Maintenance dose ① Once the effective dose has been titrated, the patient must use only 1 tablet of this medicine of the appropriate strength for breakthrough pain. ② If breakthrough pain has not subsided within 30 minutes, the patient may take 1 additional dose of the same strength. ③ The patient must wait at least 4 hours before treating another episode of breakthrough pain with this medicine. ④ Some patients may require dose adjustment of this medicine. In general, the dose should be adjusted only if the dose being used fails to control several consecutive episodes of breakthrough pain. ⑤ If a patient experiences breakthrough pain more than 4 times a day, the dose of the around-the-clock opioid used for persistent pain should be reviewed. ⑥ If pain is not adequately controlled, the possibility of hyperalgesia, tolerance, and progression of the underlying disease should be considered. Immediately after removing the tablet from the blister, place this medicine in the mouth (above the rearmost molar, between the upper cheek and gum). Do not split the tablet. Do not suck, chew, or swallow this medicine, as this may result in lower blood levels than when taken as directed. This medicine must be left between the cheek and gum for approximately 14~25 minutes until it disintegrates. If any of this medicine remains in the mouth after 30 minutes, it may be swallowed with a glass of water. For the next dose, it is recommended that this medicine be applied to the opposite side of the mouth. As an alternative method of administration, it may be administered sublingually (under the tongue).

This medication is a powerful opioid analgesic used to relieve breakthrough pain in cancer patients. It should only be used in patients tolerant to opioid analgesics; administration to those without tolerance can lead to serious respiratory depression. This medicine should only be prescribed for pain management in cancer patients by healthcare professionals with specialized knowledge and experience. It must be stored safely out of reach of children, and any leftover medication should be disposed of safely. This drug has strong central nervous system depressant effects, and concomitant use with benzodiazepines or alcohol may increase the risks of respiratory depression, coma, and death. Particular caution is needed when co-administering with drugs that inhibit or induce CYP3A4 enzyme, as this will significantly affect drug concentration and effects. Patients with respiratory diseases, head injuries, heart disease, or renal or liver dysfunction should be treated with special caution. Pregnant women should only use this medicine when absolutely necessary, as it may affect the fetus, and breastfeeding mothers should avoid it due to the possibility of transfer into breast milk affecting the newborn. Elderly patients may respond differently to the drug, and dosing should be adjusted carefully. In case of overdose, severe respiratory depression may occur, necessitating urgent medical attention, respiratory support, and the administration of opioid antagonists. This medication can cause addiction, abuse, and dependence, so patients should be closely monitored, and if drug use disorder is suspected, immediate consultation with healthcare providers is necessary. Caution is required when driving or operating machinery, as the sedative effects of this drug may increase the risk of accidents. During the use of this medication, do not use other opioid analgesics or central nervous system depressants concurrently; if co-administration is unavoidable, it should be for the minimum dose and for the shortest duration. This medication is not administered to children under 18 years of age, as safety and efficacy have not been established. Possible side effects during use include nausea, vomiting, dizziness, drowsiness, headache, constipation, fatigue, etc., and if any unusual symptoms persist or worsen, patients should inform their healthcare provider.

• Nausea
• vomiting
• fatigue
• dizziness
• drowsiness
• headache
• anemia
• neutropenia
• constipation
• diarrhea

This medicine should be stored in a tightly sealed container to protect it from air or moisture exposure. Furthermore, it is best stored at room temperature between 15 and 30 degrees Celsius to maintain its effectiveness and safety.

Appearance

White, flat, round oral tablet

Package unit

28 tablets (4 tablets/blister × 7)