Medication info

Daewon Ketotifen Syrup (Ketotifen Fumarate)

Prescription medication경구
Ingredient · strength
Ketotifen Fumarate›27.6mg / 100mL
Manufacturer / importer
대원제약(주)
Appearance
A clear liquid with a colorless to pale yellow hue, flavored with aromatic sweetness, contained in a white plastic bottle.
Packaging
Domestic use: 500mL/bottle, Export use: 500mL/bottle
Approval status
Active

MFDS item code 199201515 · Notified 1992.04.15 · Insurance code 671800931

Summary

Main use
Prevention and treatment of bronchial asthma (asthma symptoms) and allergic diseases (such as rhinitis and skin disorders).
Who takes it
Adults · Children
Adult dose
For adults and children over 3 years old, administer 1mg of ketotifen orally, twice daily (morning and evening meals). For those over 10 years old, the dose may be increased to 2mg as needed. If sensitivity to sedative effects occurs, start with 0.5mg twice daily during the first week or 1mg at bedtime, gradually increasing to 2mg daily.
Child dose
For children aged 6 months to under 3 years, administer 0.5mg orally, twice daily (morning and evening meals). Adjust the dosage appropriately according to age and symptoms.

Ingredients

Manufacturer
대원제약(주)

Efficacy & effects

Prevention and treatment of bronchial asthma (asthma symptoms) and allergic diseases (such as rhinitis and skin disorders).

  • 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 used for the prevention of asthma symptoms caused by bronchial asthma and allergic bronchitis. It is also effective for the prevention and treatment of allergic rhinitis, atopic dermatitis, eczema, urticaria, and other allergic skin diseases, as well as systemic multiple allergic diseases. It helps alleviate allergic reactions in patients and reduces the recurrence of symptoms. Therefore, it is used to prevent and manage various allergy-related symptoms.

How to take

Adult dose

For adults and children over 3 years old, administer 1mg of ketotifen orally, twice daily (morning and evening meals). For those over 10 years old, the dose may be increased to 2mg as needed. If sensitivity to sedative effects occurs, start with 0.5mg twice daily during the first week or 1mg at bedtime, gradually increasing to 2mg daily.

Child dose

For children aged 6 months to under 3 years, administer 0.5mg orally, twice daily (morning and evening meals). Adjust the dosage 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 components. Patients with epilepsy or convulsive disorders should avoid this drug as it may trigger seizures. It should not be used as a substitute for steroid medications used to treat asthma. Women who are breastfeeding are advised not to take this medication, and if necessary, should discontinue breastfeeding. Patients taking oral hypoglycemic agents should be cautious as the platelet count may decrease when used with this drug. Patients with genetic issues such as fructose intolerance should not take the syrup formulation of this drug. Patients who are already on other medications for asthma should not suddenly stop their existing medication and should transition slowly to this drug. This drug may cause drowsiness or dizziness during the first few days of use, so caution is advised when operating machinery or driving. Patients undergoing long-term steroid treatment should taper off steroids slowly when starting this medication and be mindful of adrenal insufficiency. This medication does not stop an ongoing seizure, so separate treatment is necessary if seizure symptoms are present. When discontinuing the medication, it should be tapered off gradually over 2 to 4 weeks. Caution is needed as the effects may be enhanced when taken with central nervous system depressants, antihistamines, or alcohol. The safety of this drug during pregnancy has not been established, so it should only be taken when absolutely necessary. Children and infants may experience central nervous system side effects such as seizures or agitation, so they should be monitored closely while on this medication. In case of overdose, symptoms such as drowsiness, confusion, and seizures may occur, and immediate medical attention is required. It is recommended to stop taking this drug 3 to 5 days prior to allergy testing. Keep out of reach of children and store in the original container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

  • Erythema multiforme
  • Stevens-Johnson syndrome
  • severe skin reactions
  • hepatitis
  • increased liver enzymes
  • seizures.

Mild side effects

  • Cystitis
  • weight gain
  • excitement
  • irritability
  • insomnia
  • nervousness
  • dizziness
  • sedation
  • dry mouth
  • nausea
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  • vomiting
  • diarrhea
  • rash
  • urticaria
  • drowsiness
  • headache
  • disorientation
  • nystagmus
  • tachycardia
  • hypotension.

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 and moisture and is best kept at room temperature. This helps maintain the drug's efficacy and prevent deterioration.

Appearance and packaging

Appearance

A clear liquid with a colorless to pale yellow hue, flavored with aromatic sweetness, contained in a white plastic bottle.

Package unit

Domestic use: 500mL/bottle, Export use: 500mL/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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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.