Frankagen 50 mg (Franlucast Hydrate)

Adult dose

Adults: Administer 50mg of pranlukast hydrate orally twice daily, after breakfast and dinner. Adjust the dose as appropriate according to symptoms.

This medication should not be used in patients with hypersensitivity to this drug or its components. Additionally, it contains lactose, thus it should not be administered to patients with genetic conditions such as galactose intolerance, congenital lactose deficiency, or glucose-galactose absorption disorders. While using this drug, serious allergic reactions such as shock or anaphylaxis may occur, so symptoms should be monitored closely. If blood pressure drops, consciousness disturbances, respiratory difficulties, or rashes appear, administration should be stopped immediately and appropriate treatment should be received. Blood-related adverse reactions such as leukopenia or thrombocytopenia may occur; therefore, if symptoms such as fever, sore throat, fatigue, petechiae, nosebleeds, or tendency to bleed occur, administration must be stopped. Liver dysfunction may occur, so if jaundice or increased liver enzyme levels appear, administration should be stopped and appropriate measures taken. Respiratory system anomalies such as interstitial pneumonia or eosinophilic pneumonia may infrequently occur, thus if symptoms such as fever, cough, or difficulty breathing are present, the medication should be suspended and treatment (e.g., administration of corticosteroids) is required. Muscle-related anomalies such as rhabdomyolysis can occur; if symptoms like muscle pain, weakness, or elevated muscle enzymes appear, administration should be stopped and treated accordingly. Allergic reactions such as rash, urticaria, itching, and erythema multiforme can occur, so if abnormal symptoms appear, administration should be suspended. Neurological symptoms such as tremors, seizures, agitation, anxiety, headaches, drowsiness, dizziness, insomnia, numbness, and taste disturbances have been reported. Gastrointestinal symptoms may include nausea, abdominal pain, discomfort in the upper abdomen, diarrhea, vomiting, heartburn, loss of appetite, constipation, and stomatitis. Cardiovascular anomalies such as arrhythmias, palpitations, and flushing may rarely occur. Genitourinary symptoms such as proteinuria, hematuria, and urinary disorders have been rarely reported. Other symptoms may include stiffness, weakness, weight gain, hair loss, menstrual irregularities, edema, and fatigue. This medication does not relieve already occurring asthma attacks unlike bronchodilators or steroids, so this must be fully explained to the patient. If an acute asthma attack occurs during administration, bronchodilators or steroids should be used. When a patient undergoing long-term steroid treatment receives this medication and reduces the steroid dosage, it must be done slowly and cautiously. If a patient reduces the steroid maintenance dose while discontinuing this medication, attention should be paid to the risk of recurrence of the original condition. Serious adverse reactions such as vasculitis may occur during the use of this medication, so eosinophil levels and symptoms of vasculitis should be closely monitored. Psychiatric symptoms such as depression, suicidal thoughts, and aggressive behavior have been reported; thus, the patient's condition should be closely monitored after administration. Care should be taken not to administer this drug for long periods if no effect is observed. This medication may interact with enzymes (CYP3A4) metabolizing in the liver, so concomitant use with drugs that inhibit or compete with this enzyme may increase blood concentration levels. Women who are pregnant or of childbearing potential should only receive this medication when the therapeutic benefits outweigh the risks, as safety during pregnancy has not been established. The safety for low-birth-weight infants, newborns, infants, and children has not been sufficiently confirmed. Elderly patients may have decreased bodily functions, so caution is needed by reducing the dose during administration. This medication should be kept out of reach of children, and transferring it to another container should be avoided as this may lead to accidental risks and quality degradation.

• Shock
• anaphylaxis-like symptoms
• hypotension
• altered consciousness
• shortness of breath
• rash
• leukopenia
• fever
• sore throat
• general malaise

This medication should be stored in a tightly sealed container to avoid exposure to air or humidity. Furthermore, it should be stored at room temperature between 1°C and 30°C, avoiding extremes of temperature.

Appearance

White oval film-coated tablets

Package unit

30 tablets/bottle, 300 tablets/bottle