Spora Calm (Itraconazole Solid Dispersion)

Adult dosage

To increase absorption, this medicine should preferably be administered immediately after meals. 1. Short-term treatment This medicine continues to exert a therapeutic effect in skin tissue even after treatment is discontinued. Therefore, final clinical and mycological outcomes should preferably be assessed 2～4 weeks after completing the prescribed treatment. 1) Candida vaginitis: Administer 200 mg of itraconazole 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 of the hands (interdigital type), tinea of the feet (interdigital type): Administer 100 mg once daily for 15 days. 5) Tinea of the hands (palms), tinea of the feet (soles): Administer 100 mg once daily for 30 days or 200 mg 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 Administer 200 mg twice daily for 1 week, followed by a 3-week treatment-free period; this constitutes 1 cycle. Administer up to 2 cycles for fingernail infection only and up to 3 cycles for toenail infection. Site of onychomycosis Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Toenails (with or without concurrent fingernail infection) Treatment No treatment Treatment No treatment Treatment Fingernails Treatment No treatment Treatment Or 2) Continuous therapy Administer 200 mg once daily for 3 months. The therapeutic effect continues for 3 months for fingernails and 6 months for toenails after the end of treatment. 3. Systemic fungal infections In patients with impaired immune function, such as those with neutropenia, AIDS, or organ transplant recipients, oral bioavailability of this medicine may be reduced; therefore, double the dose when necessary. Aspergillosis: 200mg once daily; average treatment duration 2～5 months. For invasive or disseminated disease, increase the dose to 200mg 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.

This drug should not be used in patients with impaired heart function. Particularly, individuals with congestive heart failure or a history of impaired heart function should avoid administering this medication. If symptoms of heart failure occur while taking this drug, usage should be stopped immediately and healthcare personnel should be consulted. This medication can weaken the contractile strength of the heart muscle. Patients with allergies to this drug or a history of hypersensitivity should not use it. Severe side effects may occur when taken with certain specific drugs, especially when combined with heart-related medications, analgesics, antipsychotics, and anticoagulants, so it is essential to consult with a doctor or pharmacist before usage. It is advisable for pregnant women, those who may become pregnant, and nursing mothers to avoid using this drug due to potential effects on the fetus or newborn. Patients with poor liver function should have regular liver function tests while using this drug and should avoid it if liver damage is suspected. Caution is also necessary for patients with impaired kidney function, and dosage adjustments may be required. Patients with weakened immunity, such as AIDS patients or organ transplant recipients, should take this drug under the direction of healthcare personnel, as its effectiveness may vary. This medication has a high potential for drug interactions, so patients should inform healthcare personnel if they are taking other medications. Symptoms such as dizziness, vision disturbances, and hearing loss may occur, requiring caution during driving or operating machinery. It should be administered cautiously to children and the elderly, and only when the benefits outweigh the risks. In the case of overdose, there is no specific antidote, and immediate hospital visit for appropriate treatment is necessary. This drug should be stored out of reach of children, and maintained in its original container to preserve quality.

Decreased myocardial contractility, headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory infection, leukopenia, hypersensitivity, taste disorder, sensory decrease, sensory abnormality, tinnitus, constipation, diarrhea, dyspepsia, distension, vomiting, liver dysfunction, hyperbilirubinemia, pruritus, rash, urticaria, urinary frequency, erectile dysfunction, menstrual disorders, edema, agranulocytosis, thrombocytopenia, anaphylactic-like reaction, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, altered mental status, peripheral neuropathy, dizziness, drowsiness, tremor, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, voice disorders, cough, gastrointestinal disorders, liver failure, hepatitis, jaundice, erythematous rash, hyperhidrosis, myalgia, arthralgia, kidney impairment, urinary incontinence, generalized edema, facial edema, chest pain, fever, pain, fatigue, chills, elevated alanine aminotransferase, elevated aspartate aminotransferase, increased serum alkaline phosphatase, increased serum lactate dehydrogenase, increased serum urea, elevated gamma-glutamyl transferase, increased liver enzymes, abnormal urinalysis, leukocytosis, eosinophilia, anemia, vascular edema, serum sickness, angioedema, anaphylaxis, anaphylactic shock, allergic reaction, diplopia, visual impairment, hearing loss, ventricular ectopic beats, atrioventricular block, palpitations, increased bowel motility, belching, glossitis, stomatitis, abdominal pain in the lumbar region, pancreatitis, elevated serum total protein, increased total bilirubin, elevated LAP, anorexia, malaise, brown urine, increased liver enzyme levels, mucous membrane syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Reiter'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, somnolence, shoulder stiffness, insomnia, chest pain, elevated serum triglycerides, flushing, elevated serum uric acid, elevated serum potassium, serum sickness, angioedema, anaphylactic reaction, hypertriglyceridemia, tremor, visual impairment, transient or permanent hearing loss, congestive heart failure, dyspnea, pancreatitis, significant hepatotoxicity, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, hair loss, photosensitivity, increased serum creatine phosphokinase

This drug should be stored in a sealed container to prevent exposure to air or humidity. It is recommended to maintain storage temperatures between 1 degree and 30 degrees at room temperature.

Appearance

White or pale yellow round film-coated tablet

Package unit

30 tablets, 100 tablets