Medication info

Sama Ketotifen Syrup (Ketotifen Fumarate)

Prescription medicationSyrup경구
Ingredient · strength
Ketotifen Fumarate›27.6mg / 100mL
Manufacturer / importer
삼아제약(주)
Appearance
Colorless, transparent, viscous syrup
Packaging
200mL, 500mL (bottle)
Approval status
Active

MFDS item code 199800892 · Notified 1998.09.29 · Insurance code 645700761,645700762

Summary

Main use
Prevention and treatment of bronchial asthma and allergic diseases (rhinitis, skin diseases)
Who takes it
Adults · Children
Adult dose
Adults and children 3 years and older: Take 1 mg of ketotifen orally twice a day (morning and evening meals). For children over the age of 10, a dose of up to 2 mg may be given if needed. If sedation or other sensitive effects occur upon ketotifen administration, it is recommended to start with 0.5 mg twice a day or 1 mg at bedtime during the first week of treatment, gradually increasing to 2 mg per day.
Child dose
Children aged 6 months to less than 3 years: For this medication, take 0.5 mg orally twice a day (morning and evening meals). Adjust dose appropriately according to age and symptoms.

Ingredients

Manufacturer
삼아제약(주)

Efficacy & effects

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

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

This medication is used to prevent asthma symptoms associated with bronchial asthma and allergic bronchitis. It is also effective in the prevention and treatment of various allergic skin diseases such as allergic rhinitis, eczema, atopic dermatitis, urticaria, skin itching, as well as systemic multiple allergic disorders. It helps in efficiently managing these various allergic diseases and alleviating symptoms. Therefore, it is used to improve various symptoms associated with allergies.

How to take

Adult dose

Adults and children 3 years and older: Take 1 mg of ketotifen orally twice a day (morning and evening meals). For children over the age of 10, a dose of up to 2 mg may be given if needed. If sedation or other sensitive effects occur upon ketotifen administration, it is recommended to start with 0.5 mg twice a day or 1 mg at bedtime during the first week of treatment, gradually increasing to 2 mg per day.

Child dose

Children aged 6 months to less than 3 years: For this medication, take 0.5 mg orally twice a day (morning and evening meals). Adjust dose appropriately according to age and symptoms.

Precautions

This medication should not be used in patients who have had an allergic reaction to this medication or its components. Patients with a history of epilepsy or convulsive disorders should use this medication with caution as there is a risk of seizures occurring during treatment. This medication cannot be used as a substitute for corticosteroid drugs used in the treatment of asthma, and it is recommended that breastfeeding women do not take it. Patients taking oral hypoglycemic agents or those with genetic issues such as fructose intolerance must consult a physician before using this medication. Patients already taking other medications for the purpose of preventing or treating asthma should not abruptly stop their existing medications but should gradually adjust them under medical supervision. Initial use of this medication may cause symptoms such as drowsiness, dry mouth, and dizziness, but these usually resolve naturally with time. Particularly in children, central nervous system symptoms such as excitability, insomnia, and nervousness may occur, so careful monitoring is necessary. When driving or operating machinery, caution is required as the reaction time may slow down after taking this medication. Patients who have been receiving long-term steroid treatment should be very cautious when reducing the steroid dosage while taking this medication, and it is crucial to taper down gradually. This medication may interact with other drugs, so especially when taken with hypoglycemic agents, sedatives, sleeping pills, antihistamines, or alcohol, consultation with a doctor or pharmacist is recommended. Pregnant women or women of childbearing potential should use this medication only when the therapeutic benefits outweigh the risks, and breastfeeding women are advised to avoid taking it or to stop breastfeeding. In the case of overdose, symptoms such as drowsiness, confusion, seizures, and respiratory depression may occur, necessitating immediate medical attention for appropriate treatment. It is recommended to discontinue this medication before allergy tests and to store it in a safe place out of reach of children. Also, removing the medication from its original container and storing it in another container may lead to degradation of the drug’s quality or misuse, so it should be stored in its original container.

Side effects and when to seek care immediately

Serious side effects

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

Mild side effects

  • Cystitis
  • weight gain
  • excitability
  • irritability
  • insomnia
  • nervousness
  • dizziness
  • sedation
  • dry mouth
  • increased 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 is sensitive to light, so it should be stored in a special container that blocks light. Additionally, it is recommended to keep it at room temperature, avoiding extremely hot or cold environments.

Appearance and packaging

Appearance

Colorless, transparent, viscous syrup

Package unit

200mL, 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.