Medication info

Nazalen Syrup (Ketotifen Fumarate)

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

MFDS item code 199000819 · Notified 1990.01.10 · Insurance code 643200051

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 over 3 years, ketotifen is administered orally at a dose of 1 mg twice a day (morning and evening during meals). For those over 10 years, a dose of up to 2 mg may be taken if necessary. If sensitivity to sedation or similar effects occurs, start with 0.5 mg twice a day during the first week of treatment or 1 mg at bedtime, gradually increasing to 2 mg per day.
Child dose
For children aged 6 months to under 3 years, this medication is administered orally at a dose of 0.5 mg twice a day (morning and evening during meals). Adjustments may be made based on age and symptoms.

Ingredients

Manufacturer
동성제약(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 allergic diseases.
View approved original text

This medication is used to prevent asthma symptoms caused by bronchial asthma and allergic bronchitis. It is also helpful in the prevention and treatment of allergic rhinitis, eczema, atopic dermatitis, urticaria, and skin itching. In addition, it is effective in preventing and treating systemic allergic diseases. Overall, it is used to manage various allergic diseases and improve symptoms.

How to take

Adult dose

For adults and children over 3 years, ketotifen is administered orally at a dose of 1 mg twice a day (morning and evening during meals). For those over 10 years, a dose of up to 2 mg may be taken if necessary. If sensitivity to sedation or similar effects occurs, start with 0.5 mg twice a day during the first week of treatment or 1 mg at bedtime, gradually increasing to 2 mg per day.

Child dose

For children aged 6 months to under 3 years, this medication is administered orally at a dose of 0.5 mg twice a day (morning and evening during meals). Adjustments may be made based on age and symptoms.

Precautions

This medication should not be used by patients who are allergic to this medication or its components or have experienced hypersensitivity reactions. Patients with a history of epilepsy or other seizure disorders should be cautious as seizures may occur during the use of this medication. This medication cannot be used as a substitute for corticosteroids used in asthma treatment, so patients currently taking corticosteroids for asthma should be aware of this. Lactating women are advised not to take this medication and should stop breastfeeding if necessary. Patients taking oral hypoglycemic agents should consult with healthcare personnel and undergo blood tests as platelet count may decrease when taken with this medication. It is not safe for patients with genetic issues like fructose intolerance to take this medication due to the maltitol component in the syrup formulation. Patients taking other medications for asthma prevention and treatment should not suddenly discontinue their existing medications and should start this medication with careful monitoring. Initial use of this medication may cause symptoms such as drowsiness, dry mouth, and dizziness, but these generally resolve naturally over time. Especially in children, symptoms such as agitation, insomnia, and hyperactivity may occur, so their condition should be closely monitored during use. Caution is needed when engaging in activities requiring concentration, such as driving or operating machinery, during the initial use of this medication. Patients undergoing long-term steroid therapy should gradually decrease their steroid dosage when taking this medication, being careful of adrenal function impairment. If accompanied by infection, appropriate antibacterial treatment should be provided, and this medication is not an anticonvulsant, so this should be understood. Seasonal allergy patients are advised to take this medication in advance to prevent symptoms from worsening. When discontinuing this medication, gradual tapering over 2 to 4 weeks is recommended. Caution is needed as it may enhance the effects when taken with sedatives, sleeping pills, antihistamines, or alcohol. Women who are pregnant or may become pregnant should consult with a doctor before taking this medication. Children, especially infants, may experience central nervous system symptoms such as seizures or agitation, so careful observation is necessary during use. Generally, elderly patients do not require dosage adjustment, but caution is advised considering their diminished physical function. Overdose may result in symptoms such as drowsiness, confusion, headache, and severe sedation, while children may experience hyperactivity or seizures and should receive immediate medical attention. This medication may interfere with allergy skin reaction tests, so it is advisable to discontinue use 3 to 5 days before testing. This medication should be stored out of reach of children and kept in its original container to ensure safety and maintain 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 air ingress, ideally at room temperature between 1 to 30 degrees Celsius. This storage method helps maintain the medication's efficacy over time.

Appearance and packaging

Appearance

A transparent liquid with a colorless to pale yellow hue and aromatic sweetness contained 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.

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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.