Medication info

Nepofen Injection (Nepafen HCl)

Prescription medicationIntravenous injectionApproval withdrawn
Ingredient · strength
Nefopam Hydrochloride›10mg / 1mL
Manufacturer / importer
Kujoo Pharmaceutical Co., Ltd.
Appearance
A colorless, transparent, odorless liquid contained in a colorless, transparent glass ampoule.
Packaging
2 mL x 20 ampoules
Approval status
Approval withdrawn

MFDS item code 201605513 · Notified 2016.09.12

This product's status changed to Approval withdrawn on 2026.01.26. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of acute pain, particularly postoperative pain
Who receives it
Adults
Adult administration
Administer 20 mg of nefopam hydrochloride per dose by intramuscular or intravenous injection. If necessary, repeat every 6 hours, not exceeding 120 mg per day. Administer intravenous injections slowly over at least 15 minutes. After administration, it is advisable to have the patient lie down and rest for 15 - 20 minutes. When added to an infusion fluid such as an electrolyte or glucose solution, administer 30 mg over 4 hours or 40 mg over 6 - 8 hours, in proportion to the administration time. It is recommended to avoid mixing this drug with other drugs for injection. Adjust the dose appropriately according to age and symptoms.

Ingredients

Manufacturer
Kujoo Pharmaceutical Co., Ltd.

Efficacy & effects

Relief of acute pain, particularly postoperative pain

  • Acute pain
  • post-surgical pain
View approved original text

This medication is used to relieve acute pain, particularly pain that occurs after surgery.

How it is given

Adult administration

Administer 20 mg of nefopam hydrochloride per dose by intramuscular or intravenous injection. If necessary, repeat every 6 hours, not exceeding 120 mg per day. Administer intravenous injections slowly over at least 15 minutes. After administration, it is advisable to have the patient lie down and rest for 15 - 20 minutes. When added to an infusion fluid such as an electrolyte or glucose solution, administer 30 mg over 4 hours or 40 mg over 6 - 8 hours, in proportion to the administration time. It is recommended to avoid mixing this drug with other drugs for injection. Adjust the dose appropriately according to age and symptoms.

Precautions

This medication is in injection form, and care should be taken to carefully break the glass ampoule when using it. Caution is necessary as glass fragments may cause adverse reactions. This medication should not be used in certain patients, such as those with epilepsy or myocardial infarction, individuals taking specific antidepressants or central nervous system medications, those allergic to this medication or its components, children under 15 years of age, patients with a history of seizures, people with urinary or prostate problems, and patients with glaucoma. Additionally, elderly patients, women who are pregnant or breastfeeding, and individuals taking certain anticholinergic medications should exercise extra caution when using this medication. Administration of this medication may lead to reduced appetite, nausea, drowsiness, dizziness, increased heart rate, thirst, difficulty urinating, injection site pain, headache, blurred vision, fatigue, nervousness, sleep disturbances, hallucinations, drug dependence, seizures, and allergic reactions. The occurrence of these side effects may vary depending on the dosage of the medication, and they typically diminish gradually with repeated administration. This medication is used to alleviate symptoms rather than to fundamentally treat inflammation and pain. Therefore, care should be taken to consider the degree of inflammation or pain when administering, and long-term use should be avoided. When treating inflammation caused by infection, this medication should not be used alone but rather in conjunction with appropriate antibiotics or antifungals, while closely monitoring the patient's condition. Elderly patients have a higher risk of adverse reactions when using this medication, so it should be administered cautiously at the minimum effective dose. Patients with impaired liver or kidney functions may be affected by the drug's metabolism and excretion, requiring caution. This medication can cause drowsiness or decreased alertness, so it's safer not to use it during tasks that require attention, such as driving or operating machinery. When combined with other analgesics or specific central nervous system medications, the risk of side effects may increase, so consultation with a healthcare provider is essential. Pregnant or breastfeeding women are advised against using this medication, and it should not be used in children due to unresolved safety concerns. Exceeding the recommended dose may lead to serious side effects such as heart issues, seizures, and hallucinations, so immediate consultation with a doctor or pharmacist is necessary, and monitoring of heart and respiratory functions may be required if needed. This medication should be avoided from being mixed with other medications for injection and should be stored in a sealed container away from children's access, in a cool, dry place, away from direct sunlight. Care should also be taken not to transfer it to another container.

Side effects

  • Loss of appetite
  • gastrointestinal disorders
  • nausea
  • drowsiness
  • vomiting
  • hyperhidrosis
  • dizziness
  • tachycardia
  • palpitations
  • thirst
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  • urinary retention
  • sweating
  • pain at the injection site
  • headache
  • blurriness of vision
  • fatigue
  • irritability
  • sleep disturbances
  • insomnia
  • agitation
  • hypersensitivity
  • hallucinations
  • abuse
  • drug dependence
  • convulsions
  • urticaria
  • Quincke's edema
  • anaphylactic shock
  • pink urine
  • pallor

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

Storage

This medication should be stored in a sealed container to prevent exposure to air and should be kept at a temperature between 1 and 30 degrees Celsius (room temperature). By storing it this way, the effectiveness of the medication can be maintained for an extended period.

Appearance and packaging

Appearance

A colorless, transparent, odorless liquid contained in a colorless, transparent glass ampoule.

Package unit

2 mL x 20 ampoules

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

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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.