Pentorabakcal Tablet 400 Micrograms (Fentanyl Citrate)

Adult dose

1. Initial dose This drug is not bioequivalent to other products containing fentanyl. Do not switch from other fentanyl-containing products on a dose-for-dose (mcg-for-mcg) basis. There are no guidelines for switching between this drug and other fentanyl-containing products other than Actiq (including oral, transdermal, and parenteral fentanyl products). All patients must titrate the dose starting at 100 mcg. 1) Patients currently using Actiq The initial dose of this drug is always 100 mcg, except in patients already using Actiq. ① For patients who are to be switched from Actiq to this drug, prescribe according to the recommended initial doses for patients currently receiving Actiq, as shown in Table 1 below. The doses of this drug in Table 1 are starting doses and do not represent equivalent analgesic doses of Actiq. Patients must be instructed to discontinue use of Actiq and dispose of any remaining product. Table 1. Recommended initial doses for patients currently receiving Actiq Current Actiq dose (mcg) / Initial dose of this drug* 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 an Actiq dose of 600 mcg or higher should start with 200 mcg of this drug and titrate in multiples of this tablet strength. 2) Other patients The initial dose of this drug is 100 mcg. 3) Redosing for a single episode of pain ① If breakthrough pain does not resolve after 30 minutes, an additional single dose of the same strength may be taken for that episode of pain. Therefore, patients may take a maximum of 2 doses of this drug for a single episode of breakthrough pain. ② Patients must wait at least 4 hours before treating another episode of breakthrough pain with this drug. 2. Dose titration ① The physician should monitor patients closely from the initial dose and adjust the dose until a dose is reached that provides adequate pain relief with tolerable adverse reactions. To determine whether dose adjustment is appropriate, patients should record their experience with this drug during several episodes of breakthrough cancer pain and discuss it with their physician. ② For patients whose initial dose is 100 mcg and who require an increase, the patient may be instructed to use two 100 mcg tablets (one 100 mcg tablet applied to each buccal mucosa) for the next episode of breakthrough cancer pain. If this dose is not successful, the patient may be instructed to apply two 100 mcg tablets to each buccal mucosa (a total of four 100 mcg tablets). 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 does not resolve after 30 minutes, an additional single dose of the same strength may be taken for that episode of pain. Therefore, patients may take a maximum of 2 doses of this drug for an episode of breakthrough pain. During the titration period, a single dose of this drug may consist of 1-4 tablets of the same strength (100 mcg or 200 mcg). ④ Patients must wait at least 4 hours before treating another episode of breakthrough pain with this drug. During the titration period, only one product strength should be used at a time to prevent overdose. ⑤ Patients should use all tablets previously prescribed before being prescribed the next strength. If they cannot do so, any unused medication must be disposed of safely (see Precautions for storage and handling). Any prescribed medication that remains unopened should be disposed of as soon as it is no longer needed. 3. Maintenance dose ① Once the effective dose has been established by titration, patients must use only 1 tablet of this drug at the appropriate strength for breakthrough pain. ② If breakthrough pain does not resolve within 30 minutes, patients may take an additional dose of the same strength. ③ Patients must wait at least 4 hours before treating another episode of breakthrough pain with this drug. ④ Some patients may require dose adjustment of this drug. In general, the dose should be adjusted only when 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 reevaluated. ⑥ If pain is not adequately controlled, the possibility of hyperalgesia, tolerance, and progression of the underlying disease should be considered.

This medication is used to treat breakthrough pain in cancer patients who have developed tolerance to opioid analgesics. Caution is needed as severe respiratory depression may occur in those without tolerance to opioid analgesics or those receiving inappropriate doses. This medication should only be administered by professionals experienced in cancer pain management and stored safely out of the reach of children. Taking this medication with central nervous system depressants or alcohol may increase the risk of severe sedation, respiratory depression, coma, and death, therefore, it should be avoided or done with extreme caution. In particular, use of this medication with specific antifungals or antibiotics like CYP3A4 inhibitors can dangerously increase drug concentration, so caution is required. Pregnant women should only take this medication if absolutely necessary, as it can affect the fetus, and it should not be used during childbirth due to the risk of respiratory depression in the fetus or newborn. Nursing mothers should also avoid this medication as it can be excreted in breast milk and affect the baby. Elderly patients have a higher risk of adverse reactions and should use this medication cautiously with dosage adjustments. Overdose may result in severe respiratory depression, requiring immediate emergency medical care. This medication may impair the ability to perform hazardous tasks like driving or operating machinery. Additionally, there is a risk of drug abuse or addiction while using this medication, so it should be taken strictly according to medical advice. Lastly, any remaining medication after opening should be securely disposed of to prevent access by children.

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

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain the storage temperature between 15 and 30 degrees Celsius.

Appearance

White flat round tablet

Package unit

28 tablets (4 tablets/blister × 7)