Medication info

Cough Pen Syrup (Ketotifen Fumarate)

Prescription medication경구
Ingredient · strength
Ketotifen Fumarate›27.6mg / 100mL
Manufacturer / importer
조아제약(주)
Appearance
A transparent solution with a colorless to light yellow aromatic sweetness contained in a white plastic bottle
Packaging
500 milliliters/bottle
Approval status
Active

MFDS item code 201906227 · Notified 2019.09.02 · Insurance code 644603991

Summary

Main use
Prevention and treatment of bronchial asthma (asthma symptoms) and allergic diseases (rhinitis, skin diseases, etc.)
Who takes it
Adults · Children
Adult dose
Adults and children over 3 years: 1 mg of ketotifen orally twice a day (morning and evening with meals). For those over 10 years, dosage may be increased to 2 mg if needed. If sedation occurs when taking ketotifen, start at 0.5 mg twice a day or 1 mg at bedtime during the first week and gradually increase to 2 mg per day.
Child dose
Children aged 6 months to under 3 years: 0.5 mg orally twice a day (morning and evening with meals). Adjust according to age and symptoms.

Ingredients

Manufacturer
조아제약(주)

Efficacy & effects

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

  • Bronchial asthma
  • allergic bronchitis
  • asthma symptoms
  • allergic rhinitis
  • allergic skin diseases
  • eczema
  • atopic dermatitis
  • urticaria
  • pruritus
  • systemic multiple allergic diseases
View approved original text

This medication helps prevent asthma symptoms related to bronchial asthma and allergic bronchitis. It is also used to prevent and treat various allergic skin diseases and systemic multiple allergic diseases such as allergic rhinitis, eczema, atopic dermatitis, urticaria, and pruritus. Through these effects, it contributes to alleviating allergy-related symptoms and maintaining a healthy lifestyle for patients.

How to take

Adult dose

Adults and children over 3 years: 1 mg of ketotifen orally twice a day (morning and evening with meals). For those over 10 years, dosage may be increased to 2 mg if needed. If sedation occurs when taking ketotifen, start at 0.5 mg twice a day or 1 mg at bedtime during the first week and gradually increase to 2 mg per day.

Child dose

Children aged 6 months to under 3 years: 0.5 mg orally twice a day (morning and evening with meals). Adjust according to age and symptoms.

Precautions

This medication should not be used in patients who have had an allergic reaction to this drug or its ingredients. Patients with epilepsy or other seizure disorders or a history of such should exercise caution while taking this medication since the risk of seizures may increase. This medication cannot replace corticosteroid drugs used for asthma treatment, so patients on steroid therapy should not substitute this medication for their current treatment. Women who are breastfeeding should preferably avoid taking this medication; if unavoidable, breastfeeding should be discontinued. Patients taking oral hypoglycemic agents should monitor their blood count, as this medication may reduce platelet counts. Patients with genetic issues such as fructose intolerance should avoid syrup formulations of this medication due to its maltitol content. Patients already taking other medications for asthma should not abruptly discontinue those medications upon starting this treatment but should taper off gradually. Initial side effects may include drowsiness, dry mouth, and dizziness, but these typically resolve over time. Particularly in children, central nervous system symptoms such as excitability, irritability, and insomnia may occur, necessitating careful observation. Caution is required when operating machinery or driving, as response times may be slower. Patients undergoing steroid treatment should reduce their steroid dosage gradually and cautiously while taking this medication. If an infection is present, appropriate antimicrobial treatment should accompany this therapy, as this medication is not intended to treat seizures or symptoms that have already occurred. For seasonal allergy patients, it is advisable to start this medication before symptoms begin and continue until the end of symptoms. When discontinuing this medication, it should be tapered off gradually over 2 to 4 weeks to reduce side effects. This medication may enhance the effects of sedatives, sleep aids, antihistamines, and alcohol, so dosage adjustments and caution are necessary. The safety of this medication during pregnancy is not well established; therefore, if medication is necessary, it should be used only after consulting a physician and confirming that the benefits outweigh the risks. Although no special dosage adjustments are typically necessary for children or the elderly, careful monitoring is advised for those with impaired physical function. In cases of overdose, symptoms may include drowsiness, confusion, headache, and changes in heart rate, and immediate medical attention should be sought. It is recommended to discontinue this medication before allergy testing, and it should be stored in a sealed container out of reach of children and kept in its original container.

Side effects and when to seek care immediately

Serious side effects

  • Erythema multiforme
  • Stevens-Johnson syndrome
  • severe skin reactions
  • hepatitis
  • elevated liver enzymes
  • seizures

Mild side effects

  • Cystitis
  • weight gain
  • excitability
  • irritability
  • insomnia
  • nervousness
  • dizziness
  • sedation
  • dry mouth
  • sedation
Show 7 more
  • nausea
  • vomiting
  • diarrhea
  • drowsiness
  • headache
  • rash
  • urticaria

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

Storage

This medication should be stored in a sealed container to prevent exposure to air or moisture and kept at room temperature away from direct sunlight. This will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

A transparent solution with a colorless to light yellow aromatic sweetness contained 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.

Questions about this medicine

No questions yet.

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

Related searches

Search tags

Suggested searches

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.