TinaDerm 200 mg Tablet (Itraconazole)

Adult dosage

(Tablets)(Capsules) Administration immediately after a meal is preferred. 1. Short-term treatment 1) Vulvovaginal candidiasis: Administer itraconazole 200 mg 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, tinea cruris (jock itch): Administer 100 mg once daily for 15 days. 4) Tinea manuum (interdigital type), tinea pedis (interdigital type): Administer 100 mg once daily for 15 days. 5) Tinea manuum (palms), tinea pedis (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 drug-free period; this constitutes 1 cycle. Administer 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 In patients with impaired immune function, double the dose if necessary. Aspergillosis: 200mg once daily for 2～5 months. For invasive or disseminated disease, increase the dose to 200mg twice daily. Candidiasis: 100～200mg once daily for 3 weeks～7 months. Cryptococcal meningitis: 200mg twice daily for 2 months～1 year. Maintenance therapy: 200mg once daily. Paracoccidioidomycosis: 100mg once daily for 6 months. (Oral solution) Do not take 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) daily in 1～2 divided doses for 1 week. If there is no effect after 1 week, continue treatment for another week. 2. Fluconazole-resistant oral and esophageal candidiasis Take 200～400 mg (20～40 mL) daily in 1～2 divided doses for 2 weeks. If there is no effect after 2 weeks, continue treatment for another 2 weeks. Even if symptoms do not improve, do not use 400 mg daily for more than 14 days. 3. Prevention of fungal infections Administer 5 mg/kg of body weight daily in 2 divided doses.

This medication is not recommended for patients with impaired heart function. If heart failure symptoms appear during treatment, the medication should be discontinued immediately. Patients who have a history of allergy or hypersensitivity to this drug should not use it. Additionally, pregnant or potentially pregnant women, and nursing mothers should not use this medication. Since this medication is mainly metabolized in the liver, patients with poor liver function should use it cautiously and undergo regular liver function tests during treatment. Patients with impaired renal function may also require dose adjustments. Due to many possible interactions with other medications, extra caution is necessary when taken with specific heart medications, analgesics, chemotherapy agents, and antipsychotics. Given the number of contraindicated drugs, patients should inform their doctor or pharmacist of any other medications they are taking. While taking this medication, side effects such as headaches, nausea, abdominal pain, and diarrhea may occur, and in rare cases, liver function abnormalities, skin rashes, and neurological symptoms may be observed. Consult medical personnel immediately should any abnormal symptoms arise. Additionally, dizziness or visual disturbances may occur while driving or operating machinery, so caution is advised. This medication’s absorption may decrease when gastric acidity is reduced, so when taken in conjunction with acid-reducing drugs, it’s advisable to adjust the timing of doses or take it with acidic beverages. In case of overdose, there is no specific antidote, therefore symptomatic treatment should be applied, and it is important to keep it out of reach of children.

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory tract infection, leukopenia, hypersensitivity, taste disorder, sensory impairment, sensory abnormalities, tinnitus, constipation, diarrhea, dyspepsia, bloating, vomiting, abnormal liver function, hyperbilirubinemia, itching, rash, urticaria, polyuria, erectile dysfunction, menstrual disorders, edema, granulocytopenia, thrombocytopenia, anaphylactic-like reactions, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, confusion, peripheral neuropathy, dizziness, drowsiness, tremors, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, voice disorders, cough, gastrointestinal disorders, liver failure, hepatitis, jaundice, erythema, hyperhidrosis, myalgia, arthralgia, renal impairment, urinary incontinence, generalized edema, facial edema, chest pain, fever, pain, fatigue, chills, leukocytosis, eosinophilia, anemia, vascular edema, serum sickness, angiogenic edema, anaphylaxis, anaphylactic shock, allergic reactions, diplopia, transient or permanent hearing loss, ventricular extrasystole, atrial block, palpitations, increased intestinal motility, belching, tongue inflammation, stomatitis, abdominal and lumbar pain, pancreatitis, increased serum total protein, increased total bilirubin, increased LAP, decreased appetite, malaise, brown urine, elevated liver enzyme levels, mucous membrane syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, hair loss, photosensitivity reactions, exfoliative dermatitis, leukocytoclastic vasculitis, acute generalized exanthematous pustulosis, increased BUN, positive urine protein reaction, positive urine glucose reaction, decreased libido, drowsiness, shoulder stiffness, insomnia, chest pain, elevated serum triglyceride levels, burning sensation, elevated serum uric acid levels, elevated serum potassium levels, serum sickness, angiogenic edema, anaphylactic reactions, hypertriglyceridemia, tremors, visual impairment, transient 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 levels

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. The storage temperature should be kept between 1 degree and 30 degrees Celsius to safely maintain the drug's efficacy.

Appearance

White or yellowish rectangular tablet

Package unit

100 tablets [(10 tablets/PTP) × 10], 30 tablets/bottle, 100 tablets/bottle, 300 tablets/bottle