Zaditen Syrup (Ketotifen Fumarate)

Adult dose

For adults and children aged 3 years and older: administer 1 mg orally twice a day (morning, evening meals) as Ketotifen. For those aged 10 or older, a dose of up to 2 mg may be given if needed. If sensitivity to sedative effects occurs, start with 0.5 mg orally twice a day during the first week of treatment, or 1 mg at bedtime, and gradually increase to 2 mg per day.

Child dose

For children aged 6 months to less than 3 years: administer 0.5 mg orally twice a day (morning, evening meals). Dosage may be adjusted according to age and symptoms.

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 convulsions should not take this medication as it may provoke seizures. This medication should not be used as a substitute for corticosteroid medications used in asthma treatment. Breastfeeding women should not take this medication, and if unavoidable, should discontinue breastfeeding. Patients taking oral hypoglycemic agents should exercise caution as platelet counts may decrease when used in conjunction with this medication. Patients with genetic problems such as fructose intolerance should avoid taking this medication in syrup form. Patients already on other medications for asthma should not suddenly stop those medications when starting this treatment but should gradually adjust. When first taking this medication, symptoms such as drowsiness, dry mouth, and dizziness may occur, but most will naturally subside over time. Particularly in children, central nervous system symptoms such as agitation, insomnia, and hyper-reactivity may occur, necessitating close observation. Caution is required during activities that require concentration, such as driving or operating machinery, while taking this medication. Patients undergoing long-term steroid treatment should gradually reduce steroid dosage when using this medication and be cautious of adrenal insufficiency. If an infection is present, appropriate antimicrobial therapy should also be provided. This medication is not intended for the treatment of already occurring seizures, so patients must be adequately informed of this. Seasonal allergy patients should start taking this medication before symptoms worsen and continue during the symptom period. Do not abruptly discontinue this medication; tapering should be done over 2-4 weeks to minimize side effects. Taking sedatives, sleeping pills, antihistamines, or alcohol can enhance effects; thus, caution is advised. The safety of this medication has not been established during pregnancy, so it should be used cautiously when needed. Children and the elderly may have different drug responses; therefore, special observation and caution are necessary during administration. In case of overdose, symptoms such as drowsiness, confusion, seizures, and respiratory depression may occur, requiring immediate treatment. This medication should be discontinued before allergy testing, as it may affect the test results. Keep out of reach of children and store in the original container to maintain the quality and safety of the medication.

Serious side effects

• Urticaria → severe allergic reaction.
• Erythema multiforme, Stevens-Johnson syndrome, severe skin reactions → serious skin adverse reactions.
• Hepatitis, increased liver enzymes → liver dysfunction (jaundice).
• Seizures → severe neurological symptoms.

Mild side effects

• Cystitis
• weight gain
• agitation
• hyper-reactivity
• insomnia
• nervousness
• dizziness
• sedation
• dry mouth
• drowsiness

This medication is sensitive to light and should be stored in a container that blocks light. Additionally, it is important to store it in a cool, dry place at a temperature below 25 degrees Celsius to maintain its effectiveness.

Appearance

A colorless to pale yellow transparent syrup in a brown glass bottle.

Package unit

100mL (1 bottle of 100mL)