Ketotent Syrup (Fumarate Ketotifen)
Ketotifen Fumarate 27.6mg
Prescription medication
Hanol Biopharma Co., Ltd.
MFDS item code 200100411 · Notified 2001.07.12
This product's status changed to Approval withdrawn on 2025.03.13. It may no longer be sold, so consult a doctor or pharmacist before taking it.
Prevention and treatment of allergic diseases (rhinitis, skin disorders, and systemic multisystem conditions); prevention of asthma symptoms
This medication helps prevent symptoms of bronchial asthma and allergic bronchitis. It is also used for the prevention and treatment of allergic rhinitis and various allergic skin diseases, such as eczema, atopic dermatitis, hives, and skin itching. Additionally, it can be expected to have preventive and therapeutic effects on various systemic allergic diseases, effectively acting on multiple allergy-related symptoms to improve the quality of life for patients.
Adults: Administer 1 mg of ketotifen orally twice daily (with breakfast and dinner). If sensitivity such as sedation 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 per day. Adjust the dose as appropriate according to age and symptoms.
Children 3 years and older: Administer 1 mg of ketotifen orally twice daily (with breakfast and dinner). For children 10 years and older, up to 2 mg per dose may be administered if needed. Children 6 months to under 3 years: Administer 0.5 mg of this drug orally twice daily (with breakfast and dinner).
This medication should not be used by patients who have had allergic reactions or hypersensitivity to this drug or its components. Patients with epilepsy or seizure disorders, or those with a history of such conditions, should be cautious as rare seizures may occur during treatment with this medication. This drug should not be used as a substitute for corticosteroids used to treat asthma. Breastfeeding women are advised not to take this medication, and if unavoidable, should stop breastfeeding. Patients taking oral hypoglycemic agents should be cautious as platelet counts may decrease when used together with this medication. Patients with genetic issues such as fructose intolerance should avoid this syrup due to the maltitol component. Patients already taking other medications for the prevention or treatment of asthma should not suddenly discontinue existing medications when starting this drug, especially those dependent on steroids should taper off slowly to avoid adrenal insufficiency. This medication may cause drowsiness, dry mouth, and dizziness during the first few days, which usually resolves over time. Children may have a more sensitive central nervous system, leading to excitability, irritability, and insomnia, so careful observation is necessary. During the first few days of driving or operating machinery, it is important to be cautious as reaction times may be slower. Patients undergoing long-term steroid therapy should taper off steroids slowly when taking this medication and be vigilant for signs of adrenal insufficiency. If an infection is accompanying symptoms, appropriate antibiotic treatment is necessary. This medication does not stop already occurring seizures, so it is important to inform patients of this fact adequately. Patients with seasonal allergies are advised to start taking this medication before their symptoms worsen and continue until symptoms resolve. This medication should not be suddenly discontinued; instead, the dosage should be gradually reduced over 2–4 weeks. Regular blood tests should be conducted when taking this medication with oral hypoglycemic agents, especially biguanides, as there may be a reduction in platelet count. Taking sedatives, sleeping pills, antihistamines, or alcohol together can enhance each other's effects, necessitating careful dose adjustments and usage. Food intake does not affect the absorption of this medication. The safety of this drug during pregnancy is uncertain; therefore, pregnant women or those who may become pregnant should carefully consider the benefits and risks. Breastfeeding mothers should ideally avoid this medication; should taking it be necessary, breastfeeding must be interrupted. There is no data regarding the effect of this drug on human reproductive ability, but no special abnormalities were found in animal studies. Particularly in infants, seizures or excitability may occur, so careful observation during administration is necessary. Pediatric doses per weight may be higher than in adults, but the total dosage should be adjusted to be lower than that for adults. Elderly patients may experience decreased physiological functions, so caution is warranted during administration, though there are no established reasons for dose adjustments. In cases of overdose, symptoms such as drowsiness, severe sedation, confusion, headache, tachycardia, and hypotension may occur, and particularly in children, signs of hyperexcitability or seizures, and coma may arise, necessitating prompt treatment. It is advisable to discontinue the medication before allergy tests, preferably not taking it for 3–5 days before testing. Keep this medication out of reach of children, and store medications in their original containers to prevent misuse or degradation of quality.
Not everyone experiences these, and they can vary from person to person.
This medication should be stored in a tightly sealed container to protect it from air and moisture. The recommended storage temperature is room temperature between 1 to 30 degrees Celsius. Following these guidelines will help maintain the efficacy of the medication.
Colorless to pale yellow transparent liquid with a sweet aromatic flavor
500ml/bottle
Even with the same ingredient, strength, dosage form and how it is taken can differ.
Ketotifen Fumarate 27.6mg
Prescription medication
Hanol Biopharma Co., Ltd.

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Tablet · Prescription medication
Dongsung Pharmaceutical Co., Ltd.
Ketotifen Fumarate
OTC medication
Cosmax Pharma Co., Ltd.
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.