Vaxcel Fluconazole

Vaxcel Fluconazole

fluconazole

Manufacturer:

Kotra Pharma

Distributor:

Kotra Pharma
Concise Prescribing Info
Contents
Fluconazole
Indications/Uses
Cyptococcosis including cryptococcal meningitis & pulmonary, cutaneous infections. Systemic candidiasis including candidemia, disseminated candidiasis & other invasive candidal infection. Mucosal candidiasis including oropharyngeal non-invasive bronchopulmonary infections, candiduria, mucocutaneous & chronic oral atrophic candidiasis. Genital candidiasis, acute or recurrent vag candidiasis; prophylaxis to incident reduction or recurrent vag candidiasis; candidal balanitis. Prevention of fungal infections in patients w/ malignancy predisposed to such infections as a result of cytotoxic chemotherapy or radiotherapy. Dermatomycosis including tinea pedis, corporis, cruris & versicolor & dermal candida infections. Maintenance therapy to prevent cyptococcal disease relapse & prevention of oropharyngeal candidiasis relapse in patients w/ AIDS.
Dosage/Direction for Use
Adult Oropharyngeal candidiasis 50-100 mg once daily for 7-14 days. Atrophic oral candidiasis associated w/ dentures 50 mg once daily for 14 days. Other mucosal candidal infections except genital candidiasis 50 mg daily for 14-30 days. Unusually difficult mucosal candidal infections May be increased to 100 mg daily. Tinea pedis, corporis, cruris, versicolor & dermal candida infections 50 mg once daily for 2-4 wk. Tinea pedis May require treatment up to 6 wk. Candidemia, disseminated candidiasis & other invasive candidal infections 400 mg on 1st day followed by 200 mg daily, may then be increased to 400 mg daily. Cyptococcal meningitis & other cyptococcal infections at other sites 400 mg on 1st day followed by 200-400 mg once daily for 6-8 wk. Prevention of cryptococcal meningitis relapse in patient w/ AIDS 200 mg daily dose. Prevention of fungal infections in immunocompromised patient 50-400 mg once daily. Patient at high risk of systemic infection 400 mg once daily. Childn Mucosal candidiasis 3 mg/kg daily. Loading dose: 6 mg/kg on 1st day. Systemic candidiasis & cryptococcal infection 6-12 mg/kg daily. Prevention of fungal infections in immunocompromised patient 3-12 mg/kg daily. Renal impairment Initial loading dose: 50-400 mg.
Contraindications
Hypersensitivity to fluconazole &/or other azole derivatives. Co-administration of terfenadine, cisapride, halofantrine. Pregnancy & lactation.
Special Precautions
Discontinue if clinical signs or symptoms consistent w/ liver disease develop. Severe cutaneous reactions, bullous lesions or erythema multiforme, anaphylaxis. QT interval prolongation, Torsade de pointes, structural heart disease, electrolyte abnormalities. Patients w/ proarrhythmic conditions.
Adverse Reactions
Headache; abdominal pain, diarrhea, flatulence, nausea; hepatic toxicity; rash; renal & hematological function changes.
Drug Interactions
Monitor prothrombin time w/ coumarin anticoagulants. Increased benzodiazepines conc. Monitor cyclosporin, rifabutin plasma conc. Increased phenytoin & tacrolimus serum levels. Increased risk of ventricular arrhythmia w/ pimozide. Decreased AUC w/ rifampicin. Prolonged sulfonylurea t½. Increased risk of theophylline toxicity. Increased AUC of zidovudine. Elevated serum levels of astemizole or other CYP450-metabolized drugs.
MIMS Class
ATC Classification
J02AC01 - fluconazole ; Belongs to the class of triazole derivatives. Used in the systemic treatment of mycotic infections.
Presentation/Packing
Form
Vaxcel Fluconazole soln for infusion 2 mg/mL
Packing/Price
50 mL x 1's
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