HIGHLIGHT
Mycozole/Mycozole IV

Mycozole/Mycozole IV

fluconazole

Manufacturer:

Cathay Drug

Distributor:

Cathay Drug
Concise Prescribing Info
Contents
Fluconazole
Indications/Uses
Systemic infections including systemic candidiasis, coccidioidomycosis & cryptococcosis; blastomycosis, histoplasmosis & sporotrichosis; fungal skin infections.
Dosage/Direction for Use
Mycozole cap Systemic candidiasis 400 mg on day 1, followed by 200 mg daily for 28 days. Cryptococcal meningitis 400 mg for acute & 200 mg for relapse on day 1, followed by 200 mg daily for 10-12 wk after CSF culture becomes -ve. Superficial mucosal candidiasis 50 mg daily, if necessary, 100 mg may be given. Treatment usually continues for 7-14 days in oropharyngeal candidiasis (except in severely immunocompromised patients), 14 days in atrophic oral candidiasis associated w/ dentures & mucosal candidal infections including esophagitis for 14-30 days. Vag candidiasis 150 mg as single dose. Dermatophytosis, pityriasis versicolor & Candida infections 50 mg daily for up to 6 wk. Immunocompromised patient at risk of fungal infections Prophylactic dose: 50-400 mg daily. Childn >4 wk Superficial infection 3 mg/kg daily. Loading dose: 6 mg/kg may be used on the 1st day if necessary. Systemic infections 6-12 mg/kg daily. Prophylaxis in immunocompromised childn 3-12 mg/kg daily. Infants 2-4 wk Administer every 48 hr, >2 wk Administer every 72 hr. Mycozole IV soln for infusion 2 mg/mL at a rate of 5-10 mL/min (300-600 mL/hr). Max: 100 mL/hr. Childn >4 wk Systemic infections 6-12 mg/kg daily. Prophylaxis in immunocompromised childn 3-12 mg/kg daily. Infant <2 wk All doses should be given once every 72 hr; 2 & 4 wk Doses should be given every 48 hr. Max of 400 mg daily in childn or 12 mg/kg in infant.
Administration
May be taken with or without food.
Special Precautions
Hepatic or renal impairment. Abnormalities in hematologic, hepatic & renal function have been observed in patients w/ serious underlying disease eg, AIDS or malignancy. Cases of torsade de pointes & QT prolongation in patients w/ proarrhythmic conditions. Pregnancy & lactation.
Adverse Reactions
Abdominal pain, diarrhea, flatulence, nausea & vomiting, taste disturbance, headache, dizziness, leucopenia, thrombocytopenia, hyperlipidaemia, increased liver enzyme, exfoliative cutaneous reactions eg, toxic epidermal necrolysis, Stevens-Johnson syndrome (common in patients w/ AIDS), rashes, dyspepsia, hepatic disorders, angioedema, anaphylaxis, seizures, alopecia, pruritus, hypokalemia.
Drug Interactions
Decreased plasma conc w/ rifampicin. Increased plasma conc w/ hydrochlorothiazide. Increased plasma conc of bosentan, ciclosporin, midazolam, nevirapine, amitriptyline, phenytoin, rifabutin, sulfonylurea hypoglycemics & nateglinide. May inhibit the formation of a toxic metabolite of sulfamethoxazole w/ selective cyclooxygenase-2-inhibitors eg, celecoxib & parecoxib, tacrolimus, triazolam, warfarin & zidovudine. Risk of cardiac arrhythmias w/ terfenadine, astemizole & cisapride. Reduced clearance of theophylline. Increase conc of amitriptyline & contraceptive steroids.
MIMS Class
ATC Classification
J02AC01 - fluconazole ; Belongs to the class of triazole derivatives. Used in the systemic treatment of mycotic infections.
Presentation/Packing
Form
Mycozole cap 150 mg
Packing/Price
20's (P8,106.56/box)
Form
Mycozole cap 50 mg
Packing/Price
20's (P2,759.68/box)
Form
Mycozole IV soln for IV infusion 200 mg/100 mL
Packing/Price
100 mL x 1's (P2,377.76/box)
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