Pekpent Nasal Spray 400 Micrograms (Fentanyl Citrate)

Adult dosage

One dose of this medicine corresponds to either 1 spray (100 µg or 400 µg) or 2 sprays (200 µg or 800 µg) of the same strength (100 µg or 400 µg). Patients should not use more than 4 doses per day. After the first dose of this medicine, wait at least 4 hours before using this medicine to treat another breakthrough pain episode. Required dose (µg) 100: Product strength (µg) 100, administer 1 spray into one nostril Required dose (µg) 200: Product strength (µg) 100, administer 1 spray into each nostril Required dose (µg) 400: Product strength (µg) 400, administer 1 spray into one nostril Required dose (µg) 800: Product strength (µg) 400, administer 1 spray into each nostril The initial dose of this medicine for treating a breakthrough pain episode is always 100 µg (1 spray), including for patients switching to this medicine from another fentanyl-containing product for breakthrough pain treatment. Before using this medicine to treat another breakthrough pain episode, patients must wait at least 4 hours. The initial dose is 100 µg. For patients who require titration to a higher dose because of insufficient effect, administer a 200 μg spray (1 spray of 100μg into each nostril) for the next breakthrough pain episode. If this dose is insufficient, prescribe one bottle of this medicine at 400 μg/spray to the patient and instruct them to administer 1 spray of 400 μg/spray for the next pain episode. If this dose is insufficient, the dose may be increased to 800 μg (1 spray of 400μg into each nostril). Patients should be monitored closely, and the dose should be titrated until an effective dose is reached and confirmed for 2 consecutive breakthrough pain episodes. Once an effective dose has been established during titration, patients should continue using that dose up to a maximum of 4 times per day. In general, the maintenance dose of this medicine should be increased only if the current dose has not adequately treated several consecutive breakthrough pain episodes. If a patient consistently has more than 4 breakthrough pain episodes in 24 hours, the dose of the background opioid therapy may need to be reviewed. If the patient does not tolerate this medicine or adverse reactions persist, reduce the dose or replace this treatment with another analgesic. Do not use this medicine for longer than necessary. One bottle of this medicine contains 8 sprays. If the opened bottle has not been used for 5 days, prime it with one test spray before use.

This drug is an opioid analgesic used to treat breakthrough pain in cancer patients. It should only be used in patients who have tolerance to opioid analgesics; it should not be used in patients without tolerance, for acute pain, or post-surgical pain. This medication is to be used solely for cancer pain management under the supervision of a qualified professional and must be kept out of reach of children. Care should be taken when taken with other central nervous system depressants or alcohol, as severe sedation, respiratory depression, or coma may occur. It is especially recommended to avoid this medication within 14 days of taking an MAO inhibitor. This medication should not be administered to patients who are allergic to fentanyl or its components, those with severe respiratory depression, or those without tolerance to opioid analgesics. Patients with respiratory diseases, increased intracranial pressure, cardiac disease, or impaired renal or liver function should use this medication with caution. Concurrent use of serotonin-based medications can lead to life-threatening serotonin syndrome, so caution is advised. Additionally, this medication carries a risk of dependence or addiction. It must be taken exactly as directed by healthcare personnel to prevent misuse or abuse. Drowsiness, dizziness, or visual disturbances may occur during treatment, so driving or operating machinery should be avoided. Women who are pregnant or breastfeeding are advised not to use this medication, particularly during labor and delivery. In the event of an overdose, serious respiratory depression and coma may occur, requiring immediate emergency treatment. This medication is for intranasal use only; other routes of administration may pose risks. If not used for more than 5 days, it should be prepared by spraying once before resuming use. After use, close the protective cap and store it safely in a child-proof container, and any unused medication should be safely returned to a pharmacy or hospital.

• pneumonia
• coin-throat inflammation
• pharyngitis
• rhinitis
• neutropenia
• hypersensitivity reaction
• anaphylactic reaction
• anaphylactic shock
• dehydration
• hyperglycemia

This medication is sensitive to light and should be stored in a container that does not allow light to enter. Additionally, to maintain the efficacy of the drug, it is recommended to store it in a cool place between 1 and 25 degrees Celsius.

Appearance

Colorless, transparent nasal spray solution in a clear glass bottle with a pump showing the number of sprays.

Package unit

8 doses (1.55 mL)