Pentorabak Kaljeong 800 Micrograms (Fentanyl Citrate)

Adult dose

1. Initial dose This drug is not bioequivalent to other fentanyl-containing products. Do not switch from another fentanyl-containing product on a mcg-for-mcg basis. There are no guidelines for switching between this drug and fentanyl-containing products other than ACTIQ buccal tablets (including oral, transdermal, and parenteral fentanyl products). All patients must be titrated starting at 100 mcg. 1) Patients currently using ACTIQ buccal tablets The initial dose of this drug is always 100 mcg, except in patients already using ACTIQ buccal tablets. ① For patients who are to be switched from ACTIQ buccal tablets to this drug, prescribe according to the recommended initial doses for patients currently receiving ACTIQ tablets in Table 1 below. The doses of this drug in Table 1 are starting doses and do not represent doses equivalent in analgesic effect to ACTIQ tablets. Instruct patients to discontinue use of ACTIQ buccal tablets and dispose of any remaining product. Table 1. Recommended initial doses for patients currently receiving ACTIQ buccal tablets Current dose of ACTIQ buccal tablets (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 For patients switching from doses of 600 mcg or higher of ACTIQ buccal tablets, start with 200 mcg of this drug and administer multiples of this tablet strength. 2) Other patients The initial dose of this drug is 100 mcg. 3) Repeat dosing for a single episode of pain ① If breakthrough pain has not resolved after 30 minutes, the patient may take one additional dose of the same strength 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 closely monitor the patient starting with the initial dose and adjust the dose until an appropriate dose is reached that provides adequate analgesia with tolerable adverse reactions. To determine whether dose adjustment is appropriate, patients should record their experience using this drug for 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, instruct them to use 2 tablets of 100 mcg (apply 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 a time. ③ If breakthrough pain has not resolved after 30 minutes, the patient may take one additional dose of the same strength for that episode of pain. Therefore, patients may take a maximum of 2 doses of this drug for an episode of breakthrough pain. During titration, 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 titration, only one product strength should be used at any time to prevent overdose. ⑤ Patients should use all previously prescribed tablets before receiving a prescription for the next strength. If they cannot do so, unused medication must be disposed of safely (see Precautions for storage and handling). Any prescribed, unopened medication remaining should be disposed of as soon as it is no longer needed. 3. Maintenance dose ① Once titrated to an effective dose, patients must use only 1 tablet of this drug of the appropriate strength for breakthrough pain. ② If breakthrough pain does not resolve 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 of this drug may be necessary for 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 a 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 a potent analgesic used for treating breakthrough pain in patients tolerant to opioids. It should not be used in patients who are not tolerant to opioids as it may cause severe respiratory depression. This medication must be prescribed by healthcare professionals with specialized knowledge in cancer pain management, and should not be used arbitrarily by the general public. Exposure to this drug by children can be fatal, so it must always be stored in a safe place out of reach of children. Caution is essential when this medication is combined with central nervous system depressants such as narcotics, benzodiazepines, or alcohol, as it may cause severe sedation and respiratory depression. In particular, concurrent use with other opioids, sedatives, sleeping pills, or antihistamines during treatment with this medication may increase the risk of side effects. Patients taking MAO inhibitors or those who have taken them within the last 14 days are advised not to use this medication. Due to significant pharmacokinetic differences between this and other fentanyl preparations, dosage should not be converted or substituted on the same basis. This medication has a high potential for abuse, requiring vigilance to prevent misuse or illegal use. Special caution is needed for patients with respiratory depression, chronic pulmonary disease, head injuries, heart disease, or kidney or liver dysfunction when administering this drug. Pregnant women should use this medication cautiously after consulting with a physician, as it may affect the fetus. Breastfeeding women are recommended to discontinue breastfeeding as this medication is secreted in breast milk. Safety for children under 18 has not been established, hence use is not recommended. Elderly patients are at higher risk for side effects and require careful monitoring and dosage adjustments. Overdosing may lead to respiratory depression and severe side effects, necessitating immediate medical attention. This medication should only be used for pain control in cancer patients, and special care should be taken regarding storage and disposal to prevent misuse. Additionally, this medication may impair mental and physical capabilities, so caution is required when driving or operating machinery. Given the potential for drug interactions, patients using other medications must inform their healthcare provider. During the use of this medication, careful monitoring for side effects is essential, and any abnormal symptoms should prompt immediate consultation with a healthcare provider.

• 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 a storage temperature between 15 and 30 degrees Celsius.

Appearance

White, flat, round tablets

Package unit

28 tablets (4 tablets/blister × 7)