Medication info

Brontifen Syrup (Ketotifen Fumarate)

Prescription medication경구
Ingredient · strength
Ketotifen Fumarate›27.6mg / 100mL
Manufacturer / importer
(주)에이프로젠바이오로직스
Appearance
A transparent liquid with a colorless to pale yellow hue and a fragrant sweet taste in a white plastic bottle
Packaging
500 milliliters/bottle
Approval status
Active

MFDS item code 199701092 · Notified 1997.07.03 · Insurance code 645200961

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 of ketotifen orally, twice a day (morning and evening meals). For those aged 10 years and older, administer up to 2 mg if necessary. If sedation or similar sensitivity occurs during ketotifen treatment, start with 0.5 mg orally, twice a day in the first week of treatment, or 1 mg at bedtime, and gradually increase to 2 mg daily.
Child dose
Children aged 6 months to less than 3 years: administer 0.5 mg of this drug orally, twice a day (morning and evening meals). Adjust dosage appropriately according to age and symptoms.

Ingredients

Manufacturer
(주)에이프로젠바이오로직스

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 allergic diseases
View approved original text

This medication helps to prevent asthma symptoms related to bronchial asthma and allergic bronchitis. It is also used for the prevention and treatment of allergic rhinitis and atopic dermatitis, eczema, urticaria, itching skin, as well as systemic allergic diseases. Through these effects, various symptoms related to allergies can be managed effectively.

How to take

Adult dose

Adults and children aged 3 years and older: administer 1 mg of ketotifen orally, twice a day (morning and evening meals). For those aged 10 years and older, administer up to 2 mg if necessary. If sedation or similar sensitivity occurs during ketotifen treatment, start with 0.5 mg orally, twice a day in the first week of treatment, or 1 mg at bedtime, and gradually increase to 2 mg daily.

Child dose

Children aged 6 months to less than 3 years: administer 0.5 mg of this drug orally, twice a day (morning and evening meals). Adjust dosage appropriately according to age and symptoms.

Precautions

This medication should not be used by patients who are allergic to this drug or its components, or have experienced hypersensitivity reactions. Patients with epilepsy or convulsive disorders, or a history of such diseases, should avoid this medication as it may induce seizures. This drug should not be used as a substitute for corticosteroid medications utilized for asthma treatment, and patients currently taking corticosteroids for asthma should exercise caution. Breastfeeding women are advised not to take this medication, and if necessary, should discontinue breastfeeding. Patients taking oral hypoglycemic agents, especially those of the biguanide class, should confirm platelet counts through blood tests due to a possible decrease in platelets and exercise caution when combining treatments. Patients with genetic issues like fructose intolerance should avoid this medication's syrup formulation containing maltitol. Patients who are already taking other medications for asthma prevention or treatment should not abruptly discontinue their existing medications if using this drug for an extended period; they should gradually adjust their treatments. When taking this medication, drowsiness, dizziness, or dry mouth may occur during the initial days, so caution is needed while driving or operating machinery. Patients undergoing long-term steroid treatment should be particularly cautious when taking this medication and reducing steroid doses, as adrenal insufficiency may occur. If there is an infection, appropriate antimicrobial treatment should be administered alongside this medication. This drug is not intended to treat already occurred seizures or symptoms, which should be understood clearly. It is recommended for patients with seasonal allergies to start taking this medication before symptoms worsen and to continue throughout the symptom duration. When discontinuing, it should be tapered down over 2 to 4 weeks to minimize side effects. This medication may enhance the effects of central nervous system depressants, antihistamines, and alcohol when taken together, so dose adjustments and caution are required. Safety during pregnancy has not been established; therefore, pregnant women or those who may become pregnant should use this medication with caution. Children, especially infants, may experience central nervous system side effects such as seizures and agitation, so they should be closely monitored during treatment. Elderly patients do not require special dosage adjustment but should be cautious due to potentially reduced bodily functions. In cases of overdose, severe symptoms such as drowsiness, confusion, seizures, and respiratory depression may occur, requiring immediate medical attention, and possibly gastric lavage or drug detoxification treatment. It is advisable to discontinue this medication before allergy testing and not take it 3 to 5 days prior to ensure accurate results. Store in a safe place out of reach of children, and keep in the original container to maintain the quality and safety of the medication.

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
  • agitation
  • sensitivity
  • 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 air or moisture from entering. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius to preserve the drug's effectiveness and safety for a long time.

Appearance and packaging

Appearance

A transparent liquid with a colorless to pale yellow hue and a fragrant sweet taste in a white plastic bottle

Package unit

500 milliliters/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.