Sama Ketotifen Tablets (Ketotifen Fumarate)

Adult dose

For adults and children over 10 years, 1 mg is taken orally, twice daily (in the morning and at dinner), and if necessary, 2 mg can be administered at once. If sensitivity occurs, start with 0.5 mg twice daily or 1 mg at bedtime during the first week of treatment, then slowly increase to 2 mg daily. Adjust the dose based on age and symptoms.

Child dose

Children over 3 years of age are given 1 mg orally, twice daily (in the morning and at dinner).

This medication should not be used by patients who have allergies to this drug or its constituents, or have a history of such reactions. Patients with epilepsy or seizure disorders, or a history of such conditions, should be cautious as they may be at risk of seizures when taking this medication. This medication cannot replace corticosteroids used in asthma treatment and should not be used solely for asthma treatment purposes. Breastfeeding women are advised not to take this medication; if necessary, it is preferable to discontinue breastfeeding. Patients taking oral hypoglycemic agents should have their platelet counts monitored as they may decrease when used in conjunction with this drug. Patients with hereditary metabolic disorders such as fructose intolerance should not take the syrup form of this medication due to the maltitol ingredient. Patients who have genetic problems that prevent the breakdown of lactose should also not take this medication. Patients who are already using other treatments to prevent or treat asthma should not abruptly discontinue their existing medication when starting this treatment, especially those who are steroid-dependent. During the first few days of taking this medication, symptoms such as drowsiness, dizziness, and dry mouth may occur but usually disappear naturally over time. Particularly in children, central nervous system symptoms such as agitation, irritability, and insomnia may appear, so careful observation is necessary. Activities requiring caution such as driving or operating machinery should be performed carefully while taking this medication. Patients undergoing long-term steroid treatment should gradually reduce the steroid dose when starting this medication, and careful management is needed as adrenal insufficiency may occur. If there is an infection, appropriate antimicrobial treatment should be administered concurrently. This medication is not effective in treating seizures that have already occurred, so caution and explanation about seizure symptoms are necessary. Seasonal allergy patients are advised to start taking this medication before symptoms worsen and continue until symptoms subside. Do not abruptly stop taking this medication; it should be gradually reduced over 2 to 4 weeks. Concurrent use with central nervous system depressants, antihistamines, and alcohol can enhance their effects, so dose adjustments and caution are necessary. Food intake does not affect the absorption of this medication. The safety of this medication during pregnancy has not been established, so it should only be used cautiously when necessary. In cases of overdose, symptoms such as drowsiness, confusion, headache, and heart rate abnormalities may occur, and in children, over-excitement or seizures may occur, so it is essential to visit a healthcare facility immediately. It is advisable not to administer this medication before allergy testing and to store it out of reach of children in its original container.

Serious side effects

• Hives
• erythema multiforme
• Stevens-Johnson syndrome
• severe skin reactions
• hepatitis
• seizures

Mild side effects

• Cystitis
• weight gain
• excitement
• irritability
• insomnia
• nervousness
• dizziness
• sedation
• dry mouth
• increased liver enzymes

This medication should be stored in a tightly closed container to prevent air or moisture from entering, away from direct sunlight, and at a general room temperature. This way, the efficacy of the medication can be maintained for a long time.

Appearance

White round tablets

Package unit

30 tablets, 500 tablets (bottle)