Medication info
Nazalen Tablets (Fumarate Ketotifen)

Nazalen Tablets (Fumarate Ketotifen)

Prescription medicationTabletOral
Ingredient · strength
Ketotifen Fumarate›1.38mg
Manufacturer / importer
Dongsung Pharmaceutical Co., Ltd.
Appearance
White round tablet
Packaging
30 tablets/bottle, 500 tablets/bottle
Approval status
Active

MFDS item code 199000820 · Notified 1990.01.10 · Insurance code 643200060

Summary

Main use
Prevention and treatment of allergic diseases (including rhinitis, skin diseases, and systemic multiple allergies) and prevention of asthma symptoms
Who takes it
Adults · Children
Adult dose
Adults: Administer 1 mg of ketotifen orally per dose twice daily (with breakfast and dinner). If sensitivity occurs during ketotifen treatment, start with 0.5 mg twice daily or 1 mg at bedtime during the first week of treatment, then gradually increase to 2 mg daily. Adjust the dose as appropriate according to age and symptoms.
Child dose
Children aged 3 years and older: Administer 1 mg of ketotifen orally per dose twice daily (with breakfast and dinner). Age 10 years and older: The dose may be increased to 2 mg per dose if needed.

Ingredients

Manufacturer
Dongsung Pharmaceutical Co., Ltd.

Efficacy & effects

Prevention and treatment of allergic diseases (including rhinitis, skin diseases, and systemic multiple allergies) and prevention of asthma symptoms

  • Bronchial asthma
  • allergic bronchitis
  • asthma symptoms
  • allergic rhinitis
  • allergic skin diseases
  • eczema
  • atopic dermatitis
  • hives
  • skin itching
  • systemic multiple allergy conditions
View approved original text

This medication helps to prevent asthma symptoms caused by bronchial asthma and allergic bronchitis. It is also used for the prevention and treatment of various allergy-related symptoms such as allergic rhinitis and allergic skin conditions, including eczema, atopic dermatitis, hives, skin itching, and others. It works effectively on systemic multiple allergy conditions, alleviating symptoms. Thus, it is useful for improving both bronchial and skin allergy symptoms.

How to take

Adult dose

Adults: Administer 1 mg of ketotifen orally per dose twice daily (with breakfast and dinner). If sensitivity occurs during ketotifen treatment, start with 0.5 mg twice daily or 1 mg at bedtime during the first week of treatment, then gradually increase to 2 mg daily. Adjust the dose as appropriate according to age and symptoms.

Child dose

Children aged 3 years and older: Administer 1 mg of ketotifen orally per dose twice daily (with breakfast and dinner). Age 10 years and older: The dose may be increased to 2 mg per dose if needed.

Precautions

This medication should not be used by patients who have allergies to this medication or its components, or previously experienced hypersensitivity reactions. Patients with seizure disorders or a history of such disorders should use caution when taking this medication, as seizures may occur. This medication should not be used as a substitute for corticosteroid drugs used in the treatment of asthma. It is recommended that this medication not be administered to nursing women. Patients taking oral hypoglycemic agents should undergo blood tests, as platelet counts may decrease when combined with this medication. The syrup form of this medication contains maltitol, so it should not be used by patients with genetic issues such as fructose intolerance. Additionally, since it contains lactose, patients with galactose intolerance, lactose deficiency, or glucose-galactose malabsorption should not take this medication. During the initial days of taking this medication, mental clouding or slowed reaction times may occur, so caution is needed when operating machinery or driving. Patients undergoing long-term steroid treatment should taper off steroids slowly while taking this medication, being cautious of adrenal insufficiency. If an infection is present, appropriate antibacterial treatment should be pursued in conjunction. This medication is not intended to treat already occurring seizures, and this understanding is crucial. Seasonal allergy patients are advised to start taking this medication before or during peak symptom periods. Do not abruptly discontinue this medication; taper off gradually over a period of 2 to 4 weeks. Caution is needed as taking tranquilizers, sleeping pills, antihistamines, and alcohol together may enhance each other's effects. The safety of this medication during pregnancy is not established, so it should only be taken when absolutely necessary, and nursing women should avoid its use or stop breastfeeding. Particularly in young children, neurological symptoms such as seizures or agitation may occur, so they should be carefully monitored while taking this medication. In case of overdose, drowsiness, confusion, headache, and in severe cases seizures or respiratory depression may occur, requiring immediate medical attention. It is advisable to discontinue this medication before allergy testing, and it should be kept out of the reach of children in its original container.

Side effects

  • cystitis
  • erythema multiforme
  • Stevens-Johnson syndrome
  • severe skin reactions
  • weight gain
  • agitation
  • irritability
  • insomnia
  • nervousness
  • dizziness
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  • sedition
  • thirst
  • hepatitis
  • increased liver enzymes
  • seizures
  • drowsiness
  • headache
  • nausea
  • vomiting
  • diarrhea
  • rash
  • urticaria
  • sleepiness
  • confusion
  • disorientation
  • headache
  • nystagmus
  • tachycardia
  • hypotension
  • hyperexcitability
  • coma
  • bradycardia
  • respiratory depression

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. Additionally, it is recommended to store it at room temperature, avoiding extreme heat or cold.

Appearance and packaging

Appearance

White round tablet

Package unit

30 tablets/bottle, 500 tablets/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.