PentaRabakcal Tablets 600 micrograms (Fentanyl Citrate)

Adult dose

1. Initial dose This drug is not bioequivalent to other formulations containing fentanyl. Do not switch from other fentanyl-containing formulations on a dose-for-dose (mcg-for-mcg) basis. There are no guidelines for switching between this drug and other fentanyl-containing formulations other than ACTIQ (including oral, transdermal, and parenteral formulations of fentanyl). All patients must be titrated starting at 100 mcg. 1) Patients currently using ACTIQ The initial dose of this drug is always 100 mcg, except in patients who are 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 in Table 1 below. The doses of this drug in Table 1 are starting doses and do not represent equivalent analgesic doses of ACTIQ. Instruct patients to discontinue use of ACTIQ and dispose of any remaining product. Table 1. Recommended initial dose 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 being switched from ACTIQ doses of 600 mcg or higher should start with 200 mcg of this drug and proceed using multiples of this tablet strength. 2) Other patients The initial dose of this drug 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 of the same strength for that episode of pain. Therefore, a patient 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 closely monitor the patient starting with 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 using this drug during several episodes of cancer 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 (applying one 100 mcg tablet to each buccal mucosa) for the next episode of cancer breakthrough pain. If this dose is not successful, the patient may be instructed to apply 2 tablets of 100 mcg to each 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 of the same strength for that episode of pain. Therefore, a patient 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 be 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 previously prescribed tablets before receiving a prescription for the next strength. If they are unable to do so, any unused medication must be disposed of safely (see Precautions for Storage and Handling). Any dispensed, unopened medication that is no longer needed should be disposed of as soon as possible. 3. Maintenance dose ① Once titrated to an effective dose, patients must use only 1 tablet of this drug at the appropriate strength for breakthrough pain. ② If breakthrough pain does not subside within 30 minutes, the patient may take one 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 Dose adjustment may be necessary in some patients. 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 per day, the dose of the around-the-clock opioid used for persistent pain should be reassessed. ⑥ If pain is not adequately controlled, the possibility of hyperalgesia, tolerance, and progression of the underlying disease should be considered.

This medication is to be used only in patients who are undergoing treatment for persistent pain due to cancer and have developed a tolerance to opioid analgesics. In patients without opioid tolerance, the use of this medication can lead to severe respiratory depression and should not be administered. This medication should only be used by healthcare professionals with specialized knowledge and experience for the purpose of treating pain in cancer patients. If swallowed by a child, this drug can be fatal, so it must always be stored in a safe place out of the reach of children, and any unused medication must be disposed of properly. Taking this medication along with other central nervous system depressants or alcohol can lead to respiratory depression or severe sedation; caution should be exercised when co-administering. This medication may increase blood concentration and risk of side effects when used in conjunction with certain antibiotics or antifungals that interfere with drug metabolism in the liver. During pregnancy, it can affect the fetus, so it must only be administered after consulting a physician, and breastfeeding women should be cautious as it may affect their newborn. The safety and efficacy in children under 18 have not been established, and it should not be used in this age group. Elderly patients may experience more frequent adverse reactions; therefore, dosage adjustments and careful monitoring are necessary. In case of overdose, severe respiratory depression and decreased consciousness can occur, necessitating immediate emergency treatment, and opioid antagonists may be required in some cases. Patients using this medication should be closely monitored for their condition and maintain appropriate dosing while being cautious of the risk of addiction or abuse. When driving or operating machinery, be careful as the effects of this medication may increase the risk of accidents.

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

This medication must be stored in a tightly sealed container to prevent exposure to air or moisture. It is best stored at room temperature between 15 and 30 degrees Celsius.

Appearance

Flat round white tablet

Package unit

28 tablets (4 tablets/blister x 7)