Medication info

Astifen Syrup (Ketotifen Fumarate)

Prescription medication경구
Ingredient · strength
Ketotifen Fumarate›27.6mg / 100mL
Manufacturer / importer
이연제약(주)
Appearance
A colorless to pale yellow transparent liquid with a sweet aromatic flavor in a white plastic bottle.
Packaging
500mL/bottle
Approval status
Active

MFDS item code 200100164 · Notified 2001.07.27 · Insurance code 658600591

Summary

Main use
Prevention and treatment of bronchial asthma (asthma symptoms) and allergic diseases (rhinitis, skin diseases, etc.).
Who takes it
Adults · Children
Adult dose
For adults and children over 3 years: Administer 1 mg of ketotifen orally 2 times a day (morning and evening meals). For those over 10 years, 2 mg may be given if necessary. If sedation or similar sensitivity occurs when taking ketotifen, begin with 0.5 mg orally 2 times a day or 1 mg at bedtime during the first week of treatment, then gradually increase to 2 mg per day.
Child dose
For children aged 6 months to under 3 years: Administer 0.5 mg of this medication orally 2 times a day (morning and evening meals). Adjust dosage as appropriate based on age and symptoms.

Ingredients

Manufacturer
이연제약(주)

Efficacy & effects

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

  • Bronchial asthma
  • allergic bronchitis
  • asthma symptoms
  • allergic rhinitis
  • allergic skin diseases
  • eczema
  • atopic dermatitis
  • hives
  • itching
  • systemic 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 and various allergic skin diseases, such as eczema, atopic dermatitis, hives, and itching, as well as systemic allergic diseases. This medication helps to suppress allergic reactions to alleviate symptoms and prevent recurrence. Therefore, it is useful in managing respiratory and skin diseases caused by allergies.

How to take

Adult dose

For adults and children over 3 years: Administer 1 mg of ketotifen orally 2 times a day (morning and evening meals). For those over 10 years, 2 mg may be given if necessary. If sedation or similar sensitivity occurs when taking ketotifen, begin with 0.5 mg orally 2 times a day or 1 mg at bedtime during the first week of treatment, then gradually increase to 2 mg per day.

Child dose

For children aged 6 months to under 3 years: Administer 0.5 mg of this medication orally 2 times a day (morning and evening meals). Adjust dosage as appropriate based on age and symptoms.

Precautions

This medication should not be used in patients with hypersensitivity to this medication or its components, or those with a history of such reactions. Additionally, it is not safe for patients with epilepsy or seizure disorders, as this medication may induce seizures. This medication cannot replace corticosteroids used for asthma treatment, so patients on corticosteroid therapy should not switch to this medication. Breastfeeding women are advised not to take this medication, and if necessary, it is preferable to discontinue breastfeeding. Patients taking oral hypoglycemic agents should be cautious as the number of platelets may decrease when using this medication together. Patients with genetic conditions like fructose intolerance should not take this medication in syrup form, in particular. Patients taking other medications for asthma should not suddenly stop existing medications when starting long-term treatment with this medication, and should reduce them gradually. Initially, drowsiness, dizziness, and dry mouth may occur in the first few days of taking this medication, but these symptoms typically resolve on their own over time. Particularly in children, symptoms of excitation, insomnia, and nervousness may occur, so careful monitoring is required. When operating machinery or driving while taking this medication, caution is advised as patients' reaction times may slow down. Patients undergoing long-term steroid therapy should be careful with this medication, as there is a risk of adrenal insufficiency during medication reduction. If there is a concurrent infection, appropriate antibacterial treatment should be administered as well. This medication does not suppress already occurring seizures, and patients should be adequately informed of this fact. Patients with seasonal allergies are advised to start taking this medication before the symptoms worsen and to continue during the symptomatic period. It is safe to gradually discontinue this medication over a period of 2 to 4 weeks rather than stopping abruptly. Taking this medication along with sedatives, sleeping pills, antihistamines, or alcohol may enhance their effects, so careful dosage adjustments and monitoring are necessary. The safety of this medication has not been established in pregnant women, so it should only be used if the benefits outweigh the risks. Children and the elderly require special monitoring while taking this medication, as children in particular may easily show symptoms of seizures or central nervous system abnormalities, necessitating thorough observation. In case of overdose, symptoms like drowsiness, confusion, headache, and in severe cases, seizures or respiratory depression may occur, requiring immediate medical assistance. It is advisable to discontinue this medication before allergy testing, and it should be stored out of reach of children and kept in its original container.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • erythema multiforme
  • Stevens-Johnson syndrome
  • severe skin reactions
  • hepatitis
  • seizures.

Mild side effects

  • Cystitis
  • weight gain
  • excitement
  • irritability
  • insomnia
  • nervousness
  • dizziness
  • sedation
  • dry mouth
  • elevated liver enzymes
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  • drowsiness
  • headache
  • nausea
  • vomiting
  • diarrhea
  • rash.

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 air or moisture from entering. Avoid storing in extremely hot or cold places, and it is best to keep it at a normal room temperature.

Appearance and packaging

Appearance

A colorless to pale yellow transparent liquid with a sweet aromatic flavor in a white plastic bottle.

Package unit

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.