Medication info

Zaditen Tablets (Ketotifen Fumarate)

Prescription medicationApproval withdrawn
Ingredient · strength
Ketotifen Fumarate›Strength being verified
Manufacturer / importer
한국노바티스(주)
Appearance
White or yellowish circular tablets
Packaging
60 tablets (10Tabs/PTP x 6)
Approval status
Approval withdrawn

MFDS item code 200307815 · Notified 2003.03.21

This product's status changed to Approval withdrawn on 2023.06.14. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Prevention and treatment of bronchial asthma (asthma symptoms) and allergic diseases (rhinitis, skin diseases)
Who uses it
Adults · Children
Adult dosage
For adults, administer 1 mg of ketotifen orally twice daily (morning and evening with meals). In patients over 10 years, 2 mg may be administered if necessary. In the first week of treatment, start with 0.5 mg orally twice daily or 1 mg at bedtime, then gradually increase to 2 mg daily. Adjust according to age and symptoms.
Children's dosage
For children over 3 years, administer 1 mg of ketotifen orally twice daily (morning and evening with meals).

Ingredients

Importer
한국노바티스(주)

Efficacy & effects

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

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

This medication is used to prevent symptoms of asthma related to bronchial asthma and allergic bronchitis. It is also effective in the prevention and treatment of allergic rhinitis, eczema, atopic dermatitis, urticaria, skin itching, and systemic multi-allergic diseases. Therefore, it helps improve various allergic reactions and alleviate symptoms.

Dosage and Administration

Adult dosage

For adults, administer 1 mg of ketotifen orally twice daily (morning and evening with meals). In patients over 10 years, 2 mg may be administered if necessary. In the first week of treatment, start with 0.5 mg orally twice daily or 1 mg at bedtime, then gradually increase to 2 mg daily. Adjust according to age and symptoms.

Children's dosage

For children over 3 years, administer 1 mg of ketotifen orally twice daily (morning and evening with meals).

Precautions

This medicine should never be used by patients who are allergic to this medicine or any of its components or who have shown hypersensitivity reactions to them. Patients with a history of epilepsy or convulsive disorders should avoid this medication, as it may induce seizures. This medicine cannot replace corticosteroids used for asthma treatment and should not be combined with or substituted for drugs that are used solely for asthma treatment. Women who are breastfeeding should avoid taking this medicine, and if unavoidable, breastfeeding should be stopped. Patients taking oral hypoglycemic agents should be cautious as the platelet count may decrease when this medicine is taken with them. Syrup forms of this medicine should not be administered to patients with certain genetic metabolic disorders such as fructose intolerance. This medicine contains lactose, so patients with lactose intolerance or related genetic diseases should avoid taking it. Patients who have already been on other medications for asthma should not abruptly stop their current medication when switching to this medicine, especially steroid-dependent patients should gradually reduce their intake. When taking this medicine, drowsiness or dizziness may occur during the first few days, so caution should be taken while driving or operating machinery. Patients who are on long-term steroid therapy are at risk of adrenal insufficiency when taking this medicine, so dosage reduction should be done slowly. If there is an infection, appropriate antibacterial treatment should be undertaken, and this medicine is not for treating already occurred seizures. Seasonal allergy patients are advised to start taking this medicine before symptoms worsen and continue taking it throughout the symptom duration. When discontinuing this medicine, the dosage should be gradually reduced over 2 to 4 weeks to minimize side effects. Caution and dosage adjustments are necessary when taking this medicine with sedatives, sleeping pills, antihistamines, alcohol, etc., as their effects can be enhanced. The safety of this medicine has not been established in pregnant women, so it should only be taken as deemed necessary by a physician's judgment. Children, especially infants, should be observed closely for signs of seizures or central nervous system symptoms when taking this medicine. Elderly patients generally do not need dosage adjustments, but should take it cautiously as they may have diminished physical function. In case of overdose, symptoms of drowsiness, confusion, seizures, and respiratory depression may occur, necessitating immediate medical assistance. This medicine can affect the results of allergy skin tests, so it is advisable to discontinue it at least 3 to 5 days prior to testing. Finally, keep this medicine out of the reach of children, and store it in its original container to prevent deterioration in quality and misuse.

Side effects and when to seek care immediately

Serious side effects

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

Mild side effects

  • Cystitis
  • weight gain
  • excitement
  • 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 medicine should be stored in a tightly closed container to protect it from air and moisture, and it is advisable to keep it at room temperature between 1 degree and 30 degrees Celsius. By storing it this way, you can maintain the effectiveness of the medicine and use it safely.

Appearance and packaging

Appearance

White or yellowish circular tablets

Package unit

60 tablets (10Tabs/PTP x 6)

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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.