Indications
Flucam Capsule is used for:
Cryptococcal meningitis, Candidiasis, Tinea pedis, Tinea cruris, Tinea corporis, Vaginal candidiasis, Onychomycosis, Coccidioidomycosis, Cryptococcosis, Histoplasmosis, Mucosal candidiasis, Candidal balanitis, Dermatophytosis
Adult Dose
Oral
Oropharyngeal Candidiasis
200 mg PO on Day 1, THEN 100 mg qDay
Treatment should be continued for at least 2 weeks to decrease likelihood of relapse
Esophageal Candidiasis
200 mg PO on Day 1, THEN 100 mg qDay; doses up to 400 mg/day may be used based on patient’s response
Treat for a minimum of 3 weeks and for at least 2 weeks following resolution of symptoms
Vaginal candidiasis; Candidal balanitis
Uncomplicated: 150 mg PO as a single dose
Complicated: 150 mg PO q72hr for 3 doses
Recurrent: 150 mg PO qDay for 10-14 days followed by 150 mg once weekly for 6 months
Cutaneous candidiasis; Dermatophytosis; Pityriasis versicolor
Adult: 50 mg once daily for up to 6 wk.
Systemic candidiasis ; Cryptococcal infections
Adult: Initially, 400 mg, followed by 200-400 mg once daily. Treatment duration is based on clinical and mycological response, but is usually at least 6-8 wk in cryptococcal meningitis. To prevent relapse after a primary course of treatment for acute cryptococcal meningitis in AIDS patients: 100-200 mg daily.
Prophylaxis of fungal infections in immunocompromised patients
Adult: 50-400 mg daily.
Prophylaxis in patients undergoing bone marrow transplantation:
The recommended daily dosage is 400 mg, once daily. Patients who are anticipated to have severe granulocytopenia (less than 500 neutrophils per cu mm) should start Fluconazole Injection, USP prophylaxis several days before the anticipated onset of neutropenia, and continue for 7 days after the neutrophil count rises above 1000 cells per cu mm.
Vaginal
Vulvovaginal candidiasis
Adult: As Gel: Apply intravaginally at bedtime as a single dose for 10-14 days or bid for 7 days.
Child Dose
Child: PO 3–12 mg/kg/day, max 600 mg/day q24h
Max 800–1,000 mg/day may be used for some CNS fungal infections
Age Average Weight Dose/Day
1 year: 9 kg - ½ spoonful
1-2 years: 12 kg- 1 spoonful
2-3 years: 14 kg- 1½ spoonful
3-4 years: 16 kg- 2 spoonful
Renal Dose
Renal impairment: Haemodialysis patients: Usual dose given after each session.
CrCl (ml/min) Dosage Recommendation
<50 and not receiving dialysis 50% of the usual dose.
>50 Usual dose.
Administration
May be taken with or without food
Reconstitution: Powd for oral susp: Add 24 mL of distilled or purified water to the container labeled as containing 0.35 g or 1.4 g of fluconazole to provide a susp containing 50 mg or 200 mg per 5 mL, respectively. Shake vigorously to suspend the powd.
Contra Indications
Hypersensitivity.
Precautions
Renal or hepatic impairment. May prolong QT interval. Pregnancy, lactation. CDC guidelines recommend only using topical antifungal products to treat pregnant women with vulvovaginal yeast infections, including for longer periods than usual if these infections persist or recur.
Lactation
Enters breast milk; use caution
Pregnancy-Lactation
Interactions
May increase plasma concentrations of oral hypoglycaemics (e.g. tolbutamide, glyburide, glipizide), phenytoin, theophylline, tofacitinib, rifabutin. May increase prothrombin time w/ anticoagulants. May cause significant increase in ciclosporin levels in renal transplant patients w/ or w/o renal impairment. Rifampicin reduces fluconazole levels. May increase risk of nephrotoxicity w/ tacrolimus. May increase the effect of short-acting benzodiazepines (e.g. midazolam).
Potentially Fatal: Increased risk of cardiac arrhythmias or QT prolongation w/ terfenadine, cisapride, astemizole, pimozide, quinidine, halofantrine and erythromycin.
Adverse Effects
Side effects of Fluconazole :
>10%
Headache (2-13%)
1-10%
Nausea (2-7%),Abdominal pain (2-6%),Diarrhea (2-3%),Rash (2%),Vomiting (2-5%)
Frequency Not Defined
QT prolongation,Torsades de pointes,Alopecia,Anaphylactic reactions,Angioedema,Cholestasis,Dizziness,Dyspnea,Hepatic failure,Hepatitis,Hypertriglyceridemia,Hypokalemia,Increased alkaline phosphatase,Increased ALT/AST,Jaundice,Leukopenia,Pallor,Seizures,Stevens-Johnson syndrome,Taste perversion,Thrombocytopenia,Toxic epidermal necrolysis
Potentially Fatal: Hepatotoxicity; rarely anaphylaxis; Stevens-Johnson syndrome.
Mechanism of Action
Fluconazole decreases ergosterol synthesis by interfering w/ cytochrome P450 activity, thus inhibiting cell membrane formation of susceptible fungi including B. dermatitidis, Candida spp., C. immitis, C. neoformans, Epidermophyton spp., H. capsulatum, Micosporum spp., Trichophyton spp.
Note
Flucam 150mg Capsule manufactured by Amtech Pharma. Its generic name is Fluconazole. Flucam is availble in Nepal.
Farmaco Nepal drug index information on Flucam Capsule is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.