Zocol Capsule

Zocol Capsule

fluconazole

Manufacturer:

SM Pharmaceuticals

Distributor:

SM Pharmaceuticals
Concise Prescribing Info
Contents
Fluconazole
Indications/Uses
Cryptococcosis ie, cryptococcal meningitis & infections of other sites eg, pulmonary, cutaneous. Maintenance therapy to prevent relapse of cryptococcal disease in patients w/ AIDS. Systemic candidiasis ie, candidemia, disseminated candidiasis & other forms of invasive candidal infection. Mucosal candidiasis ie, oropharyngeal, esophageal, non-invasive bronchopulmonary infections, candiduria, mucocutaneous & chronic oral atrophic candidiasis (denture sore mouth). Prevention of oropharyngeal candidiasis relapse in patients w/ AIDS. Acute or recurrent genital & vag candidiasis. Prophylaxis to reduce incidence of recurrent vag candidiasis. Candidal balanitis. Prevention of fungal infections in patients w/ malignancy predisposed to such infections as a result of cytotoxic chemo- or RT. Dermatomycosis ie, tinea pedis, corporis & cruris, pityriasis versicolor & candida infections.
Dosage/Direction for Use
Adult Cryptococcal meningitis & infections at other sites 400 mg on 1st day followed by 200-400 mg once daily. Duration of treatment for cryptococcal meningitis for 6-8 wk. Prevention of cryptococcal meningitis relapse in patient w/ AIDS 200 mg daily after receiving full course of primary therapy. Candidemia, disseminated candidiasis & other invasive candidal infections 400 mg on 1st day followed by 200 mg daily, may be increased to 400 mg daily. Oropharyngeal candidiasis 50 mg once daily for 7-14 days. Atrophic oral candidiasis associated w/ dentures 50 mg once daily for 14 days concurrently w/ local antiseptic. Other mucosal candidal infections (except vag candidiasis) 50-100 mg daily for 14-30 days. Prevention of oropharyngeal candidiasis relapse in patient w/ AIDS 150 mg once wkly after receiving full course of primary therapy. Vag candidiasis, candida balanitis 150 mg as single oral dose. Reduce incidence of recurrent vag candidiasis 150 mg once mthly for 4-12 mth. Prevention of candidiasis 50-400 mg once daily. Dermal infections eg, tinea pedis, corporis & cruris & candida infections 150 mg once wkly or 50 mg once daily for 2-4 wk. Tinea pedis Up to 6 wk. Tinea versicolor 300 mg once wkly for 2 wk or 300-400 mg single dose or 50 mg once daily for 2-4 wk. Patient w/ high risk of systemic infection 400 mg once daily. Renal impairment Initial loading dose: 50-400 mg.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to azole compd. Co-administration w/ terfenadine.
Special Precautions
Discontinue use if rash develops. Monitor closely & discontinue use if bullous lesions or erythema multiforme develops. Development of severe cutaneous reactions w/ AIDS patient. Co-administration w/ terfenadine. Hepatic toxicity. Avoid use in pregnancy. Not recommended during lactation.
Adverse Reactions
GI disturbances eg, nausea, abdominal discomfort, diarrhoea, flatulence; rash; headache.
Drug Interactions
Increased prothrombin time w/ coumarin-type anticoagulants. Prolonged serum t½ of sulfonylureas eg, chlorpropamide, glibenclamide, glipizide & tolbutamide. Increased plasma conc w/ hydrochlorothiazide. Increased phenytoin, zidovudine levels. Decreased AUC & t½ w/ rifampicin. Increased cyclosporin conc. Decreased plasma clearance of theophylline. Serious cardiac dysrhythmias secondary to prolonged QTc interval w/ terfenadine. Cardiac events eg, Torsade de pointes w/ cisapride. Increased serum levels of rifabutin, tacrolimus, cisapride, astemizole or CYP450-metabolized drugs.
MIMS Class
Antifungals
ATC Classification
J02AC01 - fluconazole ; Belongs to the class of triazole and tetrazole derivatives. Used in the systemic treatment of mycotic infections.
Presentation/Packing
Form
Zocol cap 100 mg
Packing/Price
4 × 7's
Form
Zocol cap 150 mg
Packing/Price
10 × 1's
Form
Zocol cap 50 mg
Packing/Price
2 × 7's
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