Instanyl Nasal Spray 100 Micrograms (Fentanyl Citrate)

Adult use

This medicine must be administered by the nasal route only. It is recommended that this medicine be administered while sitting or standing upright. Before first use, spray 3 ~ 4 times into the air to ensure an even spray. If the medicine has not been used for 7 days or longer, spray once into the air before use to clear any residue. Clean the tip of the nasal spray after each dose. Each spray of this medicine contains 100 µg of fentanyl. Treatment with this medicine must be supervised by a clinician with specialized knowledge and skills in opioid therapy for cancer pain. The clinician should be alert to the potential for fentanyl abuse. The dose must be determined individually for each patient to provide adequate pain relief while minimizing adverse reactions. Patients should be carefully monitored during dose titration. Dose titration should be carried out at the discretion of a healthcare professional. If pain is not adequately controlled, hyperalgesia, tolerance, and progression of the underlying disease should be considered. This medicine may be administered for up to 4 episodes of breakthrough pain per day. For a single episode of breakthrough pain, no more than 2 doses of this medicine should be administered, with an interval of at least 10 minutes between doses. For another episode of breakthrough pain, administer this medicine no sooner than 4 hours later. 1. Dose titration Before starting this medicine, persistent pain must be controlled with opioid therapy, and breakthrough pain must occur no more than 4 times per day. The initial dose is 50 µg administered into one nostril. When breakthrough pain occurs, titrate the dose (50, 100, 200 µg) until a single dose of this medicine provides adequate pain relief while minimizing adverse reactions. If adequate pain relief is not achieved, the dose may be repeated after 10 minutes. Do not administer more than 2 doses of this medicine for a single episode of breakthrough pain. For another episode of breakthrough pain, administer this medicine no sooner than 4 hours later. To determine whether dose adjustment is appropriate, the patient should be assessed over several episodes (generally 1~2 days) of cancer-related breakthrough pain. 2. Maintenance therapy Once the dose has been established according to the steps described above, the patient should continue the corresponding dose of this medicine. If adequate pain relief is not achieved, the same dose may be repeated after at least 10 minutes. Do not administer more than 2 doses of this medicine for a single episode of breakthrough pain. For another episode of breakthrough pain, administer this medicine no sooner than 4 hours later. 3. Dose adjustment In general, if more than one dose is required for several consecutive episodes of breakthrough pain, increase the maintenance dose of this medicine. If breakthrough pain occurs more than 4 times per day, the dose of the opioid used as baseline treatment for persistent pain should be adjusted. If the patient cannot tolerate this medicine or adverse reactions persist, reduce the dose or replace this medicine with another analgesic. 4. Discontinuation of treatment If breakthrough pain no longer occurs, discontinue this medicine immediately. Treatment for persistent background pain should be maintained. If all opioid therapy needs to be discontinued, the dose should be tapered gradually as directed by a physician to avoid effects from abrupt discontinuation.

This drug is an opioid used for the treatment of breakthrough pain in cancer patients. It should only be used in patients with known tolerance to opioids, and should not be used in patients without opioid tolerance or for the treatment of acute pain or postoperative pain. This drug should only be administered by healthcare professionals with specialized knowledge and experience in cancer treatment. It must be kept out of reach of children to prevent accidental exposure, and any unused drug should be disposed of properly. Caution is necessary when combined with central nervous system depressants or alcohol, as it may lead to severe sedation, respiratory depression, coma, or death. Care must be taken when taking this drug with CYP3A4 enzyme inhibitors such as certain antibiotics or antifungals, as this can increase blood concentration and pose risks. It should only be administered in pregnancy when absolutely necessary due to potential effects on the fetus, and is not to be used during childbirth due to risks of respiratory depression in the newborn. Breastfeeding women should refrain from nursing for at least 5 days after taking this medication. It is not used in children and adolescents under 18 years of age as safety and efficacy have not been established. Elderly patients or patients with impaired kidney and liver function may be more sensitive to the effects and side effects of this drug, thus careful dosage adjustment and monitoring are needed. Overdosing can result in severe respiratory depression and loss of consciousness, requiring immediate medical intervention in emergencies. This drug may impair mental and physical functioning, so caution is advised when driving or operating dangerous machinery. Repeated use may lead to drug dependence, so strict adherence to medical guidance is necessary due to the risk of drug abuse and addiction. Maintain cleanliness of the nasal spray tip during use, and remove any residue before spraying if not used for more than 7 days. Store this medication out of reach of children, do not freeze it, and keep the bottle upright. Any unused medication should be stored in a safe packaging or returned to the hospital to prevent misuse.

• Dependence
• insomnia
• hallucinations
• drowsiness
• dizziness
• headache
• sedation
• myoclonic jerks
• perceptual distortion
• sensory abnormalities

This drug should be stored in a sealed container to protect it from air or moisture. Store at room temperature between 1 degree and 30 degrees Celsius.

Appearance

Colorless and transparent nasal spray liquid in a measurable brown glass bottle that sprays a fixed amount.

Package unit

10 doses (1.8 mL)