Citracapsule 100 mg (Itraconazole)

Adult dosage

To increase absorption, this medicine should preferably be administered immediately after meals. The capsule must be swallowed whole. 1. Short-term treatment This medicine continues to have a therapeutic effect in skin tissue even after discontinuation. Therefore, the final clinical and mycological response should preferably be assessed 2～4 weeks after completing the prescribed course of treatment. 1) Vulvovaginal candidiasis: Administer itraconazole 200 mg 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 and tinea cruris: Administer 100 mg once daily for 15 days. 4) Tinea of the hands (interdigital) and tinea of the feet (interdigital): Administer 100 mg once daily for 15 days. 5) Tinea of the hands (palmar) and tinea of the feet (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 Administer 200 mg per dose twice daily for 1 week, followed by a 3-week drug-free period; this constitutes 1 cycle. Administer up to 2 cycles for infection limited to the fingernails 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 fingernail infection) Treatment Drug-free Treatment Drug-free Treatment Fingernails Treatment Drug-free Treatment \ 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 or AIDS and organ transplant recipients, the oral bioavailability of this medicine may be reduced; therefore, increase the dose twofold if necessary. Indication Dose Average duration of treatment1 Remarks Aspergillosis 200mg once daily 2~5 months For invasive or disseminated disease, increase the dose to 200mg twice daily Candidiasis 100~200mg once daily 3 weeks~7 months Cryptococcal meningitis 200mg twice daily 2 months~1 year Maintenance therapy (for patients with AIDS only) : 200mg once daily2 Paracoccidioidomycosis 100mg once daily 6 months There are no data on the efficacy of this dosage regimen for the treatment of paracoccidioidomycosis in patients with ADIS. 1 The duration of treatment should be adjusted according to clinical response. 2 The duration of treatment should depend on immune recovery.

This medication may pose a life-threatening risk to patients with impaired cardiac function, particularly congestive heart failure, and should not be administered unless for the treatment of severe infections. If symptoms of heart failure occur during administration, it should be discontinued immediately. This medication may cause blood concentrations to increase or decrease to a hazardous level when used with certain drugs, so it should not be taken with contraindicated drugs. It is not to be administered to women with known drug allergies or who are pregnant or breastfeeding. Precaution is needed in patients with impaired liver function, and regular liver function tests should be conducted to identify indications of abnormalities early. Patients with impaired kidney function may also require careful monitoring due to the need for dose adjustment. In patients with weakened immune systems, the efficacy of the drug may be reduced, and adjustments should be made based on clinical responses. Rarely, this medication can cause severe side effects such as hepatotoxicity, heart abnormalities, neurological issues, and skin reactions, thus any abnormal symptoms should be consulted with healthcare professionals immediately. Exercise caution during driving or operating machinery because of the possibility of dizziness or visual disturbances as side effects. This medication may have reduced absorption in a low acidity state, and concurrent taking with acidic beverages is recommended when taking medicines that lower stomach acidity. Additionally, as this medication can interact with various drugs, patients should inform their healthcare providers about any other medications they are taking. In the case of overdose, there is no specific antidote, and appropriate treatment should be provided based on symptoms, as it cannot be removed by hemodialysis. Keep out of reach of children and store in the original container to prevent deterioration.

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory infection, leukopenia, hypersensitivity, taste disorder, sensory loss, sensory abnormality, tinnitus, constipation, diarrhea, indigestion, bloating, vomiting, liver dysfunction, hyperbilirubinemia, itching, rash, urticaria, polyuria, erectile dysfunction, menstrual disorder, edema, granulocytopenia, thrombocytopenia, anaphylaxis-like reaction, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, confusion, peripheral neuropathy, dizziness, drowsiness, tremor, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, speech disorder, cough, gastrointestinal disorder, 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 blood urea, increased gamma-glutamyl transferase, increased liver enzymes, abnormal urinalysis, increased white blood cells, increased eosinophils, anemia, vascular edema, serum sickness, angioedema, anaphylaxis, anaphylactic shock, allergic reaction, diplopia, visual impairment, hearing loss, ventricular extrasystole, atrioventricular block, palpitations, increased intestinal motility, belching, glossitis, stomatitis, abdominal pain in the flank, pancreatitis, elevated serum total protein, elevated total bilirubin, elevated LAP, decreased appetite, malaise, brown urine, mucous membrane syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Liel syndrome, erythema multiforme, hair loss, photosensitivity reaction, exfoliative dermatitis, leukocyte destructive vasculitis, acute generalized exanthematous pustulosis, elevated BUN, positive urine protein reaction, positive urine glucose reaction, decreased libido, drowsiness, shoulder stiffness, insomnia, chest pain, elevated serum triglycerides, burning sensation, elevated serum uric acid, elevated serum potassium, serum sickness, angioedema, anaphylactic reaction, hypertriglyceridemia, tremor, blurred vision, congestive heart failure, dyspnea, significant hepatotoxicity, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, increased serum creatine phosphokinase

This medication should be stored in a tightly sealed container to prevent air and moisture from entering. It is also advisable to store it at room temperature between 1 to 30 degrees Celsius.

Appearance

A hard capsule with a blue upper part and a pink lower part filled with white or grayish spherical pellets

Package unit

30 capsules/bottle, 100 capsules/bottle