Medication info

Raditen Syrup (Ketotifen Fumarate)

Prescription medication경구Expired
Ingredient · strength
Ketotifen Fumarate›27.6mg / 100mL
Manufacturer / importer
(주)라이트팜텍
Appearance
A colorless to pale yellow, aromatic, sweetened transparent liquid in a white translucent plastic bottle.
Packaging
500 mL/bottle
Approval status
Expired

MFDS item code 201903030 · Notified 2019.05.10

This product's status changed to Expired on 2024.05.10. 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 takes it
Adults · Children
Adult dose
Adults and children aged 3 years and older: Administer 1 mg orally, twice a day (morning and evening) of ketotifen. For those over 10 years old, dosages of up to 2 mg may be given if necessary. If sensitivity to sedative effects arises, start with 0.5 mg twice daily or 1 mg at bedtime during the first week of treatment, then gradually increase to 2 mg per day.
Child dose
Children aged 6 months to under 3 years: Administer 0.5 mg orally, twice a day (morning and evening) of this medication. Adjust as appropriate based on age and symptoms.

Ingredients

Manufacturer
(주)라이트팜텍

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
  • hives
  • skin itching
  • systemic allergic diseases.
View approved original text

This medication helps prevent asthma symptoms caused by bronchial asthma and allergic bronchitis. It is also used for the prevention and treatment of various systemic allergic diseases, including allergic rhinitis, eczema, atopic dermatitis, hives, and skin itching.

How to take

Adult dose

Adults and children aged 3 years and older: Administer 1 mg orally, twice a day (morning and evening) of ketotifen. For those over 10 years old, dosages of up to 2 mg may be given if necessary. If sensitivity to sedative effects arises, start with 0.5 mg twice daily or 1 mg at bedtime during the first week of treatment, then gradually increase to 2 mg per day.

Child dose

Children aged 6 months to under 3 years: Administer 0.5 mg orally, twice a day (morning and evening) of this medication. Adjust as appropriate based on age and symptoms.

Precautions

This medicine should not be used by individuals who have any allergic reactions to this drug or its components, or those with a history of such experiences. People with epilepsy or convulsive disorders, or those with a history of such conditions, should be cautious as seizures may occur upon taking this medication. This drug cannot replace corticosteroid medications used to treat asthma and should not be used solely for asthma treatment purposes. Breastfeeding women are advised not to take this medication; if it must be taken, it is preferable to discontinue breastfeeding. Patients using oral hypoglycemic agents should monitor blood conditions, as this medication can decrease platelet counts when used together. Individuals with genetic issues such as fructose intolerance should avoid this syrup formulation due to the presence of maltitol. Patients already undergoing other treatments for asthma should gradually adjust their existing medication when switching to this drug without abrupt discontinuation. Initial side effects such as drowsiness, dry mouth, and dizziness may occur but typically resolve on their own over time. Children should be monitored closely as they may exhibit central nervous system symptoms such as agitation, insomnia, and nervousness. Caution is necessary during driving or operating machinery, as response times may be slower after taking this medication. Patients who have been treated with steroids for a long time should gradually reduce their steroid dosage when using this drug, paying attention to adrenal function. In case of infection, appropriate antimicrobial treatment should be used concurrently. This medication does not stop already occurring seizures and should be used with this understanding. Seasonal allergy sufferers are recommended to start taking this drug before symptoms begin and to continue taking it consistently until symptoms worsen. This medication should not be abruptly discontinued and should be gradually reduced over 2 to 4 weeks. Taking this medication with sedatives, sleeping pills, antihistamines, or alcohol may enhance each other's effects, so dosage adjustments should be made when used together. The safety of this drug during pregnancy is not well established; it should be taken only when necessary, and women with the possibility of pregnancy should use it cautiously. Pediatric patients should be monitored carefully as they are more prone to side effects such as seizures or agitation, and appropriate dosages should be adjusted based on weight. Elderly patients typically do not require dosage adjustment but should be monitored due to potential decreased physical function. In cases of overdose, symptoms such as drowsiness, confusion, headache, irregular heartbeat, and hypotension may occur; seek immediate medical attention if such symptoms arise. It is advisable to stop taking this medication before allergy testing, and it is preferable not to take it 3 to 5 days prior to testing. Store out of the reach of children in a safe place, and ensure it is kept in its original container to maintain product quality and prevent misuse.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • 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.

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 exposure to air or moisture, and it is important to maintain storage temperatures that are neither too hot nor too cold, ideally at room temperature. This will help preserve the medication's effectiveness and prevent degradation.

Appearance and packaging

Appearance

A colorless to pale yellow, aromatic, sweetened transparent liquid in a white translucent plastic bottle.

Package unit

500 mL/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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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.