Medication info
Narcosulha-jung 100 Micrograms (Fentanyl Citrate)

Narcosulha-jung 100 Micrograms (Fentanyl Citrate)

Prescription medicationSublingual TabletOral
Ingredient · strength
Fentanyl Citrate›157.1μg / 1 tablet
Manufacturer / importer
BC World Pharmaceutical Co., Ltd.
Appearance
White round tablet
Packaging
30 tablets (10 tablets/PTP x 3)
Approval status
Active

MFDS item code 201707583 · Approved 2017.10.24 · Insurance code 653103320

Summary

Main use
Relief of breakthrough pain in opioid-tolerant adult cancer patients
Who takes it
Adults
Adult dose
The initial dose of this medicine for the treatment of breakthrough cancer pain is 100㎍. Because of pharmacokinetic characteristics and individual variability, the initial dose should be 100㎍ even in patients previously treated with another fentanyl product. When switching from another fentanyl product to this medicine, do not convert the strength at a 1:1 ratio; dose titration is required. Until an appropriate dose is reached, the patient may need to take an additional dose of this medicine for an episode of pain. If adequate analgesia is not achieved within 30 minutes, a second dose may be taken. Do not take more than 2 doses for a single episode of breakthrough pain. The next dose of this medicine for another episode of breakthrough pain should be given at least 2 hours later. If adequate analgesia is not achieved with the initial dose of 100㎍, the dose may be increased in increments of 100㎍ up to 400㎍ to achieve adequate analgesia; if this is insufficient, the next doses are 600㎍ and 800㎍, respectively. If adequate analgesia is not achieved, the dose may be repeated after 30 minutes. During dose titration, 100㎍ or 200㎍ tablets may be used, but no more than 4 tablets should be used at one time. Once an appropriate dose has been established for an individual patient, administer one tablet at the established dose; for 600 ㎍ and 800㎍, administer 2 tablets of 300㎍ and 400㎍, respectively. If adequate analgesia is not achieved, the dose may be repeated after 30 minutes. However, do not take more than 2 doses for a single episode of breakthrough pain, and administer a dose for another episode of breakthrough pain at least 2 hours later. Initial sublingual tablet dose (㎍) used for an episode of breakthrough pain 100: Additional dose (㎍) to be taken 30 minutes after the initial dose 100 Initial sublingual tablet dose (㎍) used for an episode of breakthrough pain 200: Additional dose (㎍) to be taken 30 minutes after the initial dose 100 Initial sublingual tablet dose (㎍) used for an episode of breakthrough pain 300: Additional dose (㎍) to be taken 30 minutes after the initial dose 100 Initial sublingual tablet dose (㎍) used for an episode of breakthrough pain 400: Additional dose (㎍) to be taken 30 minutes after the initial dose 200 Initial sublingual tablet dose (㎍) used for an episode of breakthrough pain 600: Additional dose (㎍) to be taken 30 minutes after the initial dose 200 Initial sublingual tablet dose (㎍) used for an episode of breakthrough pain 800: Additional dose (㎍) to be taken 30 minutes after the initial dose - If 4 or more episodes of breakthrough pain occur per day, the dose of the long-acting opioid used for persistent cancer pain should be readjusted. Use of this medicine should be limited to no more than 4 times daily. If there is a significant change in the response to the titrated dose of this medicine, dose adjustment may be needed to identify the optimal dose. If the patient experiences 4 or more episodes of breakthrough pain during any 4 consecutive days, the dose of the regularly taken opioid should be reassessed. The dose of this medicine should also be reassessed and readjusted if the dose of the regularly taken opioid changes. If breakthrough pain no longer occurs, discontinue this medicine immediately. Treatment for persistent background pain should be maintained. If all opioid treatment must be discontinued, the patient should be monitored closely to avoid sudden withdrawal effects.

Ingredients

Manufacturer
BC World Pharmaceutical Co., Ltd.

Efficacy & effects

Relief of breakthrough pain in opioid-tolerant adult cancer patients

  • Persistent pain
  • breakthrough pain in cancer patients with tolerance
View approved original text

Used to relieve breakthrough pain in adult cancer patients aged 18 and older who are undergoing treatment with opioid analgesics for persistent pain and have developed tolerance to the treatment.

How to take

Adult dose

The initial dose of this medicine for the treatment of breakthrough cancer pain is 100㎍. Because of pharmacokinetic characteristics and individual variability, the initial dose should be 100㎍ even in patients previously treated with another fentanyl product. When switching from another fentanyl product to this medicine, do not convert the strength at a 1:1 ratio; dose titration is required. Until an appropriate dose is reached, the patient may need to take an additional dose of this medicine for an episode of pain. If adequate analgesia is not achieved within 30 minutes, a second dose may be taken. Do not take more than 2 doses for a single episode of breakthrough pain. The next dose of this medicine for another episode of breakthrough pain should be given at least 2 hours later. If adequate analgesia is not achieved with the initial dose of 100㎍, the dose may be increased in increments of 100㎍ up to 400㎍ to achieve adequate analgesia; if this is insufficient, the next doses are 600㎍ and 800㎍, respectively. If adequate analgesia is not achieved, the dose may be repeated after 30 minutes. During dose titration, 100㎍ or 200㎍ tablets may be used, but no more than 4 tablets should be used at one time. Once an appropriate dose has been established for an individual patient, administer one tablet at the established dose; for 600 ㎍ and 800㎍, administer 2 tablets of 300㎍ and 400㎍, respectively. If adequate analgesia is not achieved, the dose may be repeated after 30 minutes. However, do not take more than 2 doses for a single episode of breakthrough pain, and administer a dose for another episode of breakthrough pain at least 2 hours later. Initial sublingual tablet dose (㎍) used for an episode of breakthrough pain 100: Additional dose (㎍) to be taken 30 minutes after the initial dose 100 Initial sublingual tablet dose (㎍) used for an episode of breakthrough pain 200: Additional dose (㎍) to be taken 30 minutes after the initial dose 100 Initial sublingual tablet dose (㎍) used for an episode of breakthrough pain 300: Additional dose (㎍) to be taken 30 minutes after the initial dose 100 Initial sublingual tablet dose (㎍) used for an episode of breakthrough pain 400: Additional dose (㎍) to be taken 30 minutes after the initial dose 200 Initial sublingual tablet dose (㎍) used for an episode of breakthrough pain 600: Additional dose (㎍) to be taken 30 minutes after the initial dose 200 Initial sublingual tablet dose (㎍) used for an episode of breakthrough pain 800: Additional dose (㎍) to be taken 30 minutes after the initial dose - If 4 or more episodes of breakthrough pain occur per day, the dose of the long-acting opioid used for persistent cancer pain should be readjusted. Use of this medicine should be limited to no more than 4 times daily. If there is a significant change in the response to the titrated dose of this medicine, dose adjustment may be needed to identify the optimal dose. If the patient experiences 4 or more episodes of breakthrough pain during any 4 consecutive days, the dose of the regularly taken opioid should be reassessed. The dose of this medicine should also be reassessed and readjusted if the dose of the regularly taken opioid changes. If breakthrough pain no longer occurs, discontinue this medicine immediately. Treatment for persistent background pain should be maintained. If all opioid treatment must be discontinued, the patient should be monitored closely to avoid sudden withdrawal effects.

Precautions

This medicine is a powerful opioid analgesic used to relieve breakthrough pain in cancer patients. It should only be used for patients who have developed tolerance to opioids and should not be used for patients who are new to opioids or for acute pain and postoperative pain treatment. This drug must be administered under strict professional supervision and stored out of the reach of children. Caution is needed as serious respiratory depression or coma can occur if taken with central nervous system depressants or alcohol. Particular caution is required when used along with certain antibiotics or antifungals, as drug concentration may increase, leading to a higher risk of side effects, and consultation with healthcare professionals is advised. During treatment, symptoms such as drowsiness, dizziness, and blurred vision may occur, so driving or operating machinery should be avoided. There is a risk of drug abuse or addiction during use, so the prescribed dosage and administration must be strictly followed, and any abnormal symptoms should be reported to healthcare professionals immediately. Pregnant or breastfeeding women are advised not to use this drug, as it can have serious effects on the fetus and newborn, especially during childbirth. Elderly patients or those with impaired liver or kidney function may be more sensitive to side effects, requiring dosage adjustments and careful observation. In case of overdose, severe respiratory depression and reduced consciousness can occur, necessitating emergency treatment, and immediate hospitalization is required. This drug must only be used for the management of breakthrough pain in cancer patients and should be stored in a cool place below 25 degrees Celsius, with opened products not to be used.

Side effects

  • Nausea
  • constipation
  • drowsiness
  • headache
  • hypersensitivity reaction
  • anaphylactic reaction
  • anaphylactic shock
  • loss of appetite
  • appetite decline
  • depression
Show 67 more
  • paranoia
  • confusion
  • sense of direction loss
  • changes in mental state
  • anxiety
  • euphoria
  • discomfort
  • emotional instability
  • distractibility
  • insomnia
  • hallucinations
  • drug abuse
  • drug tolerance
  • dizziness
  • forgetfulness
  • olfactory disturbances
  • taste disturbances
  • tremors
  • weakness
  • sensory impairment
  • sleep disorders
  • convulsions
  • hyperalgesia
  • allodynia
  • blurred vision
  • tachycardia
  • bradycardia
  • hypotension
  • respiratory distress
  • pharyngeal pain
  • pharyngeal rigidity
  • respiratory depression
  • stomatitis
  • vomiting
  • dry mouth
  • oral ulcers
  • gum ulcers
  • lip ulcers
  • gastric emptying disorder
  • abdominal pain
  • dyspepsia
  • gastric discomfort
  • tongue abnormalities
  • aphthous stomatitis
  • tongue swelling
  • diarrhea
  • hyperhidrosis
  • skin lesions
  • rash
  • allergic pruritus
  • pruritus
  • diaphoresis
  • bruising
  • joint pain
  • musculoskeletal rigidity
  • joint stiffness
  • erectile dysfunction
  • fatigue
  • drug withdrawal syndrome
  • weakness
  • lethargy
  • flushing and warmth
  • peripheral edema
  • fever
  • neonatal withdrawal syndrome
  • accidental overdose
  • falls

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

Storage

Store this medicine in a sealed container to prevent air or moisture from entering, and it is recommended to keep it in a cool place below 25 Degrees Celsius. Doing so will help maintain the drug's effectiveness over time.

Appearance and packaging

Appearance

White round tablet

Package unit

30 tablets (10 tablets/PTP x 3)

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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.