Bitra Tablet 100mg (Itraconazole Solid Dispersion)

Adult dosage

This medicine should preferably be taken immediately after a meal to increase its absorption. 1. Short-term treatment This medicine continues to exert a therapeutic effect in skin tissue even after treatment is discontinued. Therefore, the final clinical and mycological therapeutic effect should preferably be assessed 2 ～ 4 weeks after completing the prescribed course of treatment. 1) Candidal vaginitis: Administer itraconazole 200 mg per dose twice a day (morning and evening) for 1 day, or 200 mg once a day for 3 days. 2) Tinea versicolor: Administer 200 mg once a day for 7 days. 3) Tinea corporis, tinea cruris (jock itch): Administer 100 mg once a day for 15 days. 4) Tinea manuum (interdigital type), tinea pedis (interdigital type): Administer 100 mg once a day for 15 days. 5) Tinea manuum (palmar), tinea pedis (plantar): Administer 100 mg once a day for 30 days or 200 mg per dose twice a day for 7 days. 6) Oral candidiasis: Administer 100 mg once a day for 15 days. 7) Fungal keratitis: Administer 200 mg once a day for 21 days. 2. Onychomycosis 1) Pulse therapy: Administer 200 mg per dose twice a day for 1 week, followed by a 3-week treatment-free interval. This constitutes one cycle. Administer up to 2 cycles for infection of the fingernails only, and up to 3 cycles for infection of the toenails. Affected area of onychomycosis Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Toenails (with or without fingernail infection) Treatment Treatment-free Treatment Treatment-free Treatment Fingernails Treatment Treatment-free Treatment or 2) Continuous therapy: Administer 200 mg once a day for 3 months. After treatment ends, the therapeutic effect continues for 3 months for fingernails and 6 months for toenails. 3. Systemic fungal infections In patients with impaired immune function, such as those with neutropenia, AIDS, or organ transplant recipients, the oral bioavailability of this medicine may be reduced. If necessary, double the dose. Aspergillosis: 200 mg once a day; average treatment duration 2 ∼ 5 months. For invasive or disseminated disease, increase to 200 mg per dose twice a day. Candidiasis: 100 ∼ 200 mg once a day; average treatment duration 3 weeks ∼ 7 months. Cryptococcal meningitis: 200 mg twice a day; average treatment duration 2 months ∼ 1 year. Maintenance therapy: 200 mg once a day. Paracoccidioidomycosis: 100 mg once a day; average treatment duration 6 months

This drug should not be administered to patients with impaired ventricular function or a history of congestive heart failure, unless in life-threatening situations. If symptoms of congestive heart failure occur during treatment, the administration should be discontinued immediately. Serious side effects may occur if this drug is used with specific medications, so contraindicated drugs must be strictly avoided. Patients with allergies to this drug or its components, pregnant women or those who may become pregnant, nursing mothers, and individuals with lactose intolerance should not use this medication. Patients with reduced liver or kidney function, those with weakened immune systems, and patients who have previously had hypersensitivity reactions to this drug or similar medications should use this drug cautiously, with regular monitoring of liver function and patient condition. Common side effects may include headache, nausea, abdominal pain; serious side effects such as severe liver toxicity, cardiac abnormalities, and skin reactions may occur. If any unusual symptoms appear, consultation with healthcare providers is advised. Symptoms such as dizziness, visual disturbances, and hearing loss may occur, so caution is needed when driving or operating machinery. This drug interacts with many other medications, so all current medications must be disclosed to healthcare providers, especially when used with heart medications, anticoagulants, cancer drugs, or antipsychotics. Women who are pregnant or planning to become pregnant must use effective contraceptive methods while taking this drug, and nursing mothers should avoid using it. Special caution is needed for children and the elderly, and this medication should only be administered if the benefits outweigh the risks. There is no specific antidote for overdose, treatment is symptomatic, and this drug is not removed by hemodialysis. This drug must be kept out of reach of children and stored in its original container to maintain quality.

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory tract infection, leukopenia, hypersensitivity, taste disturbance, sensory decrease, abnormal sensation, tinnitus, constipation, diarrhea, dyspepsia, bloating, vomiting, liver dysfunction, hyperbilirubinemia, itching, rash, urticaria, polyuria, erectile dysfunction, menstrual disorders, edema, agranulocytosis, thrombocytopenia, anaphylactoid reaction, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, confusion, peripheral neuropathy, dizziness, drowsiness, tremors, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, voice disorders, cough, gastrointestinal disturbances, liver failure, hepatitis, jaundice, erythematous rash, hyperhidrosis, myalgia, arthralgia, renal impairment, urinary incontinence, generalized edema, facial swelling, chest pain, fever, pain, fatigue, chills, leukocytosis, eosinophilia, anemia, vascular edema, serum sickness, angioedema, anaphylaxis, anaphylactic shock, allergic reaction, diplopia, visual impairment, temporary hearing loss, permanent hearing loss, ventricular extrasystole, atrioventricular block, palpitations, increased bowel motility, belching, glossitis, stomatitis, abdominal and lumbar pain, pancreatitis, elevated serum total protein, increased total bilirubin, elevated LAP, loss of appetite, malaise, brown urine, increased liver enzyme levels, Stevens-Johnson syndrome, toxic epidermal necrolysis, Lyell's syndrome, erythema multiforme, hair loss, photosensitivity, exfoliative dermatitis, leukocytoclastic vasculitis, acute generalized exanthematous pustulosis, elevated BUN, positive urine protein test, positive urine glucose test, decreased libido, drowsiness, malaise, shoulder stiffness, insomnia, chest pain, elevated serum triglyceride levels, warmth sensation, elevated serum uric acid levels, elevated serum potassium levels, serum sickness, angioedema, anaphylactic reaction, hypertriglyceridemia, tremors, blurred vision, congestive heart failure, dyspnea, significant hepatotoxicity, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, increased serum creatine phosphokinase

Store this drug in a tightly closed container to prevent air exposure, and it is recommended to keep it at room temperature between 1 to 30 degrees Celsius. Proper storage maintains the drug's efficacy.

Appearance

White or off-white round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle