Sporinazol Tablets (Itraconazole Solid Dispersion)

Adult dose

(Tablets) (Capsules) It is preferable to administer this medicine immediately after a meal to increase absorption. 1. Short-term treatment This medicine continues to exert a therapeutic effect in the skin tissues even after discontinuation. Therefore, the final clinical and mycological treatment effect should preferably be assessed 2～4 weeks after completion of the prescribed treatment. 1) Candidal vaginitis: Administer 200 mg of itraconazole twice daily (morning and evening) for 1 day, or 200 mg once daily for 3 days. 2) Pityriasis versicolor: Administer 200 mg once daily for 7 days. 3) Tinea corporis and tinea cruris: Administer 100 mg once daily for 15 days. 4) Tinea manuum (interdigital) and tinea pedis (interdigital): Administer 100 mg once daily for 15 days. 5) Tinea manuum (palmar) and tinea pedis (plantar): 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 3 weeks without treatment; this constitutes 1 cycle. Administer up to 2 cycles for infection limited to the fingernails and up to 3 cycles for toenail infection. Onychomycosis site 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 The oral bioavailability of this medicine 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. Indication Dose Average treatment duration Remarks Aspergillosis 200mg once daily 2～5 months For invasive or disseminated disease, increase to 200mg twice daily Candidiasis 100～200mg once daily 3 weeks～7 months Cryptococcal meningitis 200mg twice daily 2 months～1 year Maintenance therapy: 200mg once daily Paracoccidioidomycosis 100mg once daily 6 months (Oral solution) To increase absorption, do not take this medicine with food. Hold this medicine in the mouth for approximately 20 seconds to allow it to contact the entire oral cavity, then swallow. After swallowing, do not rinse the mouth so that the medicine remains in the mouth for as long as possible. 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 an additional 1 week. 2. Oral and esophageal candidiasis resistant to fluconazole 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 an additional 2 weeks. Even if symptoms do not improve, do not use 400 mg per day for more than 14 days.

Child dose

Administer 5 mg/kg body weight per day in 2 divided doses.

This medication may pose a risk to patients with impaired cardiac function, particularly in the case of congestive heart failure, so it should not be used unless for the treatment of serious infections. If symptoms of heart failure appear during treatment, administration should be stopped immediately. Patients with an allergic reaction to this medication or hypersensitivity to its components should not be treated with it. Additionally, this medication has numerous drug interactions, and concomitant use with certain medications can lead to serious side effects or changes in effectiveness, so it must be discussed with a physician. It is safest for women who are pregnant, potentially pregnant, or breastfeeding to avoid this medication. Patients with impaired liver or kidney function may be affected in the metabolism and elimination of this medication; therefore, careful monitoring and dosage adjustment may be necessary if required. Patients with weakened immunity or specific diseases may experience reduced effectiveness of this medication, necessitating close monitoring of treatment response. This medication may rarely cause side effects such as headache, nausea, abdominal pain, and others like liver dysfunction or severe allergic reactions, thus any abnormal symptoms should prompt immediate consultation with medical personnel. This medication can cause dizziness or vision disturbances; hence caution is advised during driving or operating machinery. During treatment, all other medications being taken should be disclosed to the physician, and the medication should not be taken with contraindicated drugs or those requiring caution. Absorption may be hindered in a state of low gastric acidity, so taking it with acidic beverages may be helpful. In the case of overdose, since there is no specific antidote, treatment according to symptoms is needed, and it should be kept out of reach of children.

Decreased myocardial contractility, headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory tract infection, leukopenia, hypersensitivity, dysgeusia, sensory impairment, paresthesia, tinnitus, constipation, diarrhea, dyspepsia, bloating, vomiting, liver dysfunction, hyperbilirubinemia, itching, rash, urticaria, nocturia, erectile dysfunction, menstrual disorders, edema, agranulocytosis, thrombocytopenia, anaphylaxis-like reaction, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, altered mental status, peripheral neuropathy, dizziness, drowsiness, tremor, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, speech impairment, cough, gastrointestinal disorders, liver failure, hepatitis, jaundice, erythematous rash, hyperhidrosis, myalgia, arthralgia, renal impairment, urinary incontinence, generalized edema, facial edema, chest pain, fever, pain, fatigue, chills, increased alanine aminotransferase, increased aspartate aminotransferase, increased serum alkaline phosphatase, increased serum lactate dehydrogenase, increased serum urea, increased gamma-glutamyl transferase, elevated liver enzymes, abnormal urinalysis, leukocytosis, eosinophilia, anemia, vascular edema, serum sickness, angioneurotic edema, anaphylaxis, anaphylactic shock, allergic reaction, diplopia, visual impairment, hearing loss, ventricular ectopic beats, atrial block, palpitations, increased bowel motility, belching, glossitis, stomatitis, abdominal and lumbar pain, pancreatitis, increased serum total protein, elevated total bilirubin, increased LAP, anorexia, malaise, dark urine, increased liver enzyme levels, Stevens-Johnson syndrome, toxic epidermal necrolysis, Riehl's syndrome, erythema multiforme, hair loss, photosensitivity reaction, exfoliative dermatitis, leukocytoclastic vasculitis, acute generalized exanthematous pustulosis, increased BUN, positive urine protein test, positive urine glucose test, decreased libido, drowsiness, malaise, shoulder stiffness, insomnia, chest pain, increased serum triglyceride level, burning sensation, increased serum uric acid level, increased serum potassium level, serum sickness, angioneurotic edema, anaphylactic reaction, hypertriglyceridemia, tremor, visual impairment, hearing loss, congestive heart failure, dyspnea, pancreatitis, severe hepatic toxicity, toxic epidermal necrolysis, Steven-Johnson syndrome, acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, hair loss, photosensitivity, increased serum creatine phosphokinase activity

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture, preferably at room temperature between 1 and 30 degrees Celsius. Proper storage will maintain the medication’s efficacy and ensure safe use.

Appearance

White or off-white round film-coated tablets

Package unit

200 tablets/bottle, 30 tablets/bottle, 28 tablets/bottle