Medication info

EdiPen Syrup (Ketotifen Fumarate)

Prescription medicationSyrup경구Approval withdrawn
Ingredient · strength
Ketotifen Fumarate›27.6mg / 100mL
Manufacturer / importer
대우제약(주)
Appearance
Colorless, transparent aromatic syrup
Packaging
500mL/bottle, 1000mL/bottle
Approval status
Approval withdrawn

MFDS item code 199400573 · Notified 1994.04.02

This product's status changed to Approval withdrawn on 2025.02.06. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Prevention of bronchial asthma (asthma symptoms), treatment of allergic diseases (rhinitis, skin diseases, etc.)
Who takes it
Adults · Children
Adult dose
For adults and children 3 years and older: take 1 mg of ketotifen orally twice a day (morning, evening meals). For those over 10 years old, a dose of up to 2 mg may be taken if necessary. If sensitivity to sedation occurs during ketotifen use, start with 0.5 mg twice a day in the first week of treatment or 1 mg at bedtime, slowly increasing to 2 mg daily.
Child dose
For children aged 6 months or older and under 3 years: take 0.5 mg orally twice a day (morning, evening meals). Adjust appropriately according to age and symptoms.

Ingredients

Manufacturer
대우제약(주)

Efficacy & effects

Prevention of bronchial asthma (asthma symptoms), treatment of allergic diseases (rhinitis, skin diseases, etc.)

  • Bronchial asthma
  • allergic bronchitis
  • asthma symptoms
  • allergic rhinitis
  • allergic skin diseases
  • eczema
  • atopic dermatitis
  • urticaria
  • skin itching
  • systemic multiple allergic diseases
View approved original text

This medication is effective in preventing asthma symptoms related to bronchial asthma and allergic bronchitis. It also helps to prevent and treat allergic rhinitis and various allergic skin conditions, for example, eczema, atopic dermatitis, urticaria, and skin itching. Additionally, it can be used for systemic multiple allergic diseases to alleviate and prevent symptoms. This medicine effectively manages various allergic symptoms, contributing to the quality of life for patients. Therefore, it is widely used for the management and prevention of respiratory and skin-related allergic diseases.

How to take

Adult dose

For adults and children 3 years and older: take 1 mg of ketotifen orally twice a day (morning, evening meals). For those over 10 years old, a dose of up to 2 mg may be taken if necessary. If sensitivity to sedation occurs during ketotifen use, start with 0.5 mg twice a day in the first week of treatment or 1 mg at bedtime, slowly increasing to 2 mg daily.

Child dose

For children aged 6 months or older and under 3 years: take 0.5 mg orally twice a day (morning, evening meals). Adjust appropriately according to age and symptoms.

Precautions

This medication should not be used in patients who have had an allergic reaction to this drug or its ingredients. Patients with epilepsy or convulsive disorders should be cautious, as there is a risk of seizures occurring while taking this medication. This medication should not be used as a substitute for corticosteroid drugs used to treat asthma. Breastfeeding women are advised not to take this medication; if unavoidable, breastfeeding should be discontinued. Patients taking oral hypoglycemic agents should have regular tests while using this medication, as it may reduce platelet count. It is safer for patients with genetic issues such as fructose intolerance to avoid this syrup-form medication. Patients already taking other medications for asthma should not stop their existing medications suddenly but should adjust them gradually. During the initial days of taking this medication, symptoms such as drowsiness or dizziness may occur, so caution is needed when driving or operating machinery. Patients undergoing long-term steroid treatment should be cautious of adrenal function suppression when taking this medication, and medication tapering should be done gradually. Appropriate antibacterial treatment should be given if an infection is present. This medication is not for treating existing seizures; patients should be adequately informed of this. For those with seasonal allergies, it is advisable to start taking this medication before symptoms begin. When discontinuing this medication, it should be gradually reduced over 2 to 4 weeks to minimize side effects. Caution is required when taking this medication with sedatives, sleeping pills, antihistamines, or alcohol, as their effects may be enhanced. There is no established safety during pregnancy; this medication should only be used when the benefits outweigh the risks. Especially in infants, central nervous system side effects may occur, so their condition should be closely monitored during use. Elderly patients may have decreased physiological functions, so careful attention is needed when taking this medication. In case of overdose, symptoms such as drowsiness, confusion, convulsions, and respiratory depression may occur, requiring immediate medical attention. Patients should not take this medication prior to allergy testing, as it may affect the test results. This medication should be stored out of reach of children and maintained in its original container to preserve quality.

Side effects and when to seek care immediately

Serious side effects

  • Erythema multiforme
  • Stevens-Johnson syndrome
  • severe skin reactions
  • hepatitis
  • seizures

Mild side effects

  • Cystitis
  • weight gain
  • agitation
  • irritability
  • insomnia
  • nervousness
  • dizziness
  • sedation
  • dry mouth
  • increased liver enzymes
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  • drowsiness
  • headache
  • nausea
  • vomiting
  • diarrhea
  • rash
  • urticaria

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. The storage temperature should be maintained between 15 and 25 degrees Celsius.

Appearance and packaging

Appearance

Colorless, transparent aromatic syrup

Package unit

500mL/bottle, 1000mL/bottle

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.