Spotra Tablets (Itraconazole Solid Dispersion)

Adult dose

(Tablets) (Capsules) It is preferable to administer immediately after a meal. 1. Short-term treatment 1) Vulvovaginal candidiasis: Administer 200 mg of itraconazole per dose twice daily (morning and evening) for 1 day, or 200 mg once daily for 3 days. 2) Tinea versicolor: Administer 200 mg once daily for 7 days. 3) Tinea corporis, tinea cruris: Administer 100 mg once daily for 15 days. 4) Tinea manuum (interdigital), tinea pedis (interdigital): Administer 100 mg once daily for 15 days. 5) Tinea manuum (palmar), tinea pedis (plantar): Administer 100 mg once daily for 30 days or 200 mg per dose twice daily for 7 days. 6) Oral candidiasis: Administer 100 mg once daily for 15 days. 7) Fungal keratitis: Administer 200 mg once daily for 21 days. 2. Onychomycosis 1) Pulse therapy One cycle consists of administering 200 mg per dose twice daily for 1 week, followed by a 3-week drug-free interval. Treat for up to 2 cycles if only the fingernails are infected and up to 3 cycles if the toenails are infected. 2) Continuous therapy Administer 200 mg once daily for 3 months. 3. Systemic fungal infections Oral bioavailability of this drug may be reduced in patients with impaired immune function, such as those with neutropenia or AIDS and organ transplant recipients; if necessary, double the dose. Aspergillosis: 200mg once daily; average treatment duration 2～5 months. For invasive or disseminated disease, increase to 200mg per dose twice daily. Candidiasis: 100～200mg once daily; average treatment duration 3 weeks～7 months. Cryptococcal meningitis: 200mg twice daily; average treatment duration 2 months～1 year. Maintenance therapy: 200mg once daily. Paracoccidioidomycosis: 100mg once daily; average treatment duration 6 months. (Oral solution) Do not take with food. 1. Oral and esophageal candidiasis Take 200 mg (20 mL) per day in 1～2 divided doses for 1 week. If there is no effect after 1 week, continue for 1 more week. 2. Fluconazole-resistant oral and esophageal candidiasis Take 200～400 mg (20～40 mL) per day in 1～2 divided doses for 2 weeks. If there is no effect after 2 weeks, continue for 2 more weeks. Do not use 400 mg per day for more than 14 days, even if symptoms have not improved. 3. Prevention of fungal infections Administer 5 mg/kg body weight per day in 2 divided doses.

This medication can pose a serious risk to patients with impaired cardiac function, particularly those with congestive heart failure, and should not be used except in special cases. If heart failure symptoms occur while using this drug, it should be discontinued immediately. Patients with a history of hypersensitivity to this medication or those with specific heart diseases, as well as those taking multiple medications that could interact with it, should not use this drug. Women who are pregnant or may become pregnant, as well as nursing mothers, should not take this medication, and effective contraceptive measures should be taken if there is a possibility of pregnancy while on this drug. Patients with impaired liver or kidney function should consult their physician and be monitored closely as the metabolism and excretion of this drug may be affected. This medication has strong interactions with many other drugs, so it is essential to consult a healthcare professional when taking other medications, especially avoiding combinations with specific analgesics, antiarrhythmics, anticoagulants, anticancer drugs, antipsychotics, and calcium channel blockers. Regular liver function tests should be conducted during treatment, and any unusual symptoms should be reported to healthcare professionals immediately. Side effects such as dizziness, visual disturbances, and hearing loss may occur, requiring caution when driving or operating machinery. All precautions should be taken when administering to children and the elderly, using only if the benefits of treatment outweigh the risks. In the event of overdose, symptom-specific treatment should be sought, as there is no specific antidote for this drug, and it is not removed by hemodialysis. Finally, this medication should be kept out of reach of children and stored in its original container.

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory infection, leukopenia, hypersensitivity, taste disorder, sensory impairment, abnormal perception, tinnitus, constipation, diarrhea, dyspepsia, distension, vomiting, abnormal liver function, hyperbilirubinemia, itching, rash, urticaria, pollakiuria, erectile dysfunction, menstrual disorders, edema, granulocytopenia, thrombocytopenia, anaphylactoid reactions, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, altered mental status, peripheral neuropathy, dizziness, drowsiness, tremors, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, voice disorders, cough, gastrointestinal disorders, liver failure, hepatitis, jaundice, erythematous rash, hyperhidrosis, muscle pain, joint pain, renal impairment, urinary incontinence, systemic edema, facial edema, chest pain, fever, pain, fatigue, chills, leukocytosis, eosinophilia, anemia, vascular edema, serum sickness, angioedema, anaphylaxis, anaphylactic shock, allergic reaction, diplopia, temporary or permanent hearing loss, ventricular ectopic beats, atrioventricular block, palpitations, increased bowel motility, belching, glossitis, stomatitis, abdominal and lumbar pain, pancreatitis, elevated serum total protein, increased total bilirubin, elevated LAP, decreased appetite, malaise, brown urine, increased liver enzyme levels, mucous membrane syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Reye's syndrome, erythema multiforme, hair loss, photosensitivity, exfoliative dermatitis, leukocytoclastic vasculitis, acute generalized exanthematous pustulosis, elevated BUN, positive urine protein, positive urine glucose, decreased libido, drowsiness, shoulder stiffness, insomnia, chest pain, elevated serum triglycerides, burning sensation, elevated serum uric acid, increased serum potassium, serum sickness, angioedema, anaphylactic reaction, hypertriglyceridemia, tremors, visual impairment, temporary or permanent hearing loss, congestive heart failure, dyspnea, pancreatitis, significant hepatotoxicity, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, hair loss, photosensitivity, increased serum creatine phosphokinase

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, and should be kept at room temperature, between 1 to 30 degrees Celsius, for best preservation of effectiveness.

Appearance

White or light yellow circular film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle