Medication info

Instanyl Nasal Spray 50 Micrograms (Fentanyl Citrate)

Prescription medicationExternal use
Ingredient · strength
Fentanyl Citrate›0.785mg / 1mL
Manufacturer / importer
Daewoong Pharmaceuticals
Appearance
Colorless and transparent nasal spray solution contained in a measurable brown glass bottle that dispenses a specific amount.
Packaging
10 doses (1.8mL)
Approval status
Active

MFDS item code 201400641 · Approved 2014.02.13 · Insurance code 641605801

Summary

Main use
Relief of breakthrough pain in adult cancer patients tolerant to opioid medications
Who uses it
Adults
Adult use
Each spray of this medicine contains 50 µg of fentanyl. 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.

Ingredients

Importer
Daewoong Pharmaceuticals

Efficacy & effects

Relief of breakthrough pain in adult cancer patients tolerant to opioid medications

  • Persistent pain
  • breakthrough pain
View approved original text

This medication is used for breakthrough pain that occurs in patients over 18 years of age being treated with opioid medications, particularly for sudden pain in cancer patients. It helps effectively relieve severe pain that suddenly worsens during ongoing treatment for persistent pain due to cancer.

How to use

Adult use

Each spray of this medicine contains 50 µg of fentanyl. 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.

Precautions

This medication is a strong opioid analgesic used to relieve breakthrough pain in cancer patients. It should only be used in patients who are tolerant to opioid medications, as it may cause life-threatening respiratory depression in patients who have not used opioids for an extended period. It should be administered under the guidance of a healthcare professional experienced in cancer pain management, and stored in a safe place out of the reach of children. Additionally, it should not be combined with narcotic drugs, benzodiazepines, alcohol, etc., as this may result in severe respiratory depression and sedation. This medication may interact with certain drugs, so it is essential to inform healthcare providers about all medications being taken. Pregnant or breastfeeding women should avoid using this medication or make careful decisions after consulting with healthcare professionals. Elderly patients or those with impaired liver or kidney function should have their dosage adjusted, and patients with respiratory diseases should use it with caution. Overdosing this medication may cause severe respiratory depression, loss of consciousness, and impaired heart function, so dosage and administration intervals should be strictly adhered to. It is advisable to avoid activities requiring mental or physical function, such as driving or operating machinery, while using this medication. Lastly, this medication can cause addiction and dependence, so it is crucial to strictly follow healthcare providers' instructions and not to stop taking it or change the dosage arbitrarily.

Side effects

  • Dependence
  • insomnia
  • hallucination
  • drowsiness
  • dizziness
  • headache
  • sedation
  • convulsive syndrome
  • perceptual errors
  • sensory abnormalities
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  • taste abnormalities
  • vertigo
  • motion sickness
  • hypotension
  • flushing
  • facial flushing
  • throat irritation
  • respiratory depression
  • epistaxis
  • nasal ulcer
  • rhinorrhea
  • nasal septum perforation
  • nausea
  • vomiting
  • constipation
  • gastritis
  • dry mouth
  • hyperhidrosis
  • skin pain
  • itching
  • fever
  • drug withdrawal syndrome
  • drug abuse
  • drug tolerance
  • neonatal withdrawal syndrome
  • hypersensitivity
  • anaphylactic reaction
  • anaphylactic shock
  • hyperalgesia
  • non-harmful stimulus pain
  • respiratory failure
  • pneumonia
  • weakness
  • pain
  • decrease in neutrophils
  • increased alanine aminotransferase
  • increased aspartate aminotransferase
  • weight gain
  • increased serum creatine phosphokinase
  • weight loss
  • cough
  • hemoptysis
  • oropharyngeal pain
  • productive cough
  • hiccups
  • non-necrotizing vasculitis
  • pulmonary embolism
  • hyponatremia
  • decreased appetite
  • hypokalemia
  • hypercalcemia
  • hypocalcemia
  • hypoglycemia
  • thirst
  • bacterial infection
  • catheter site infection
  • herpes zoster
  • influenza
  • laryngitis
  • Pneumocystis pneumonia
  • dysuria
  • acute kidney injury
  • bladder dysfunction
  • hematuria
  • hydronephrosis
  • cerebral infarction
  • lower limb paralysis
  • polyneuropathy in malignant diseases
  • seizures
  • back pain
  • cervical pain
  • limb pain
  • penile edema
  • scrotal pain
  • vaginal bleeding
  • anemia
  • pancytopenia
  • jaundice
  • eyelid abrasion
  • neck injury
  • erythema
  • urticaria
  • myocardial infarction
  • delirium
  • respiratory depression
  • unresponsiveness
  • coma
  • skeletal muscle relaxation
  • cool skin
  • miosis
  • bradycardia
  • hypotension
  • apnea
  • cardiovascular collapse
  • cardiac arrest
  • death
  • toxic leukoencephalopathy
  • Cheyne-Stokes respiration

Not everyone experiences these, and they can vary from person to person.

Storage

This medication can be sensitive to air and moisture, so it should be stored in a tightly sealed container. A storage temperature between 1 and 30 degrees Celsius at room temperature is recommended to safely maintain the medication’s effectiveness.

Appearance and packaging

Appearance

Colorless and transparent nasal spray solution contained in a measurable brown glass bottle that dispenses a specific amount.

Package unit

10 doses (1.8mL)

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.