Onicon 50 mg (Tablet)

Unit Price: ৳ 6.00 (3 x 10: ৳ 180.00)

Strip Price: ৳ 60.00

Medicine Details

Category	Details
Generic	Fluconazole
Company	Zenith pharmaceuticals ltd
Also available as	Onicon 50 mg suspension

Indications

Vaginal Candidiasis
Oropharyngeal Candidiasis
Oesophageal Candidiasis
Tinea corporis/Tinea cruris/Tinea pedis/Other Tinea
Kerion
Pityriasis versicolor
Onychomycosis
Invasive candidal infections and cryptococcal infections (including meningitis)
Prevention of cryptococcal meningitis
Prevention of fungal infections in immunocompromised patients
Systemic Candidiasis and Cryptococcal infection
Superficial Candidiasis
Fungal urinary tract infections
Disseminated candidiasis
Prophylaxis for fungal infection in neutropenic cancer patients
Acute treatment of other systemic fungal infections such as coccidioidomycosis and histoplasmosis

Pharmacology

Fluconazole is a triazole antifungal agent. It is a potent inhibitor of fungal cytochrome P-450 dependent enzymes. Cytochrome P-450 enzyme system is essential component of fungal cell membrane which is responsible for the synthesis of ergosterol.

Dosage & Administration

Adults:
- 150 mg as a single dose (for Vaginal Candidiasis)
- 200 mg in 1st day followed by 100 mg daily for 14 days (for Oropharyngeal Candidiasis)
- 200 mg in 1st day followed by 100 mg daily for 14-30 days (for Oesophageal Candidiasis)
- 150 mg weekly for 4-6 weeks (for Tinea corporis/Tinea cruris/Tinea pedis/Other Tinea)
- 50 mg daily for 20 days (for Kerion)
- 400 mg as a single dose (for Pityriasis versicolor)
- 150 mg weekly for 12 months (for Onychomycosis)
- Orally or by IV infusion, 400 mg on first day then 200-400 mg daily (for Invasive candidal infections and cryptococcal infections (including meningitis))
- Orally or by IV infusion 200 mg daily (for Prevention of cryptococcal meningitis)
- Orally or by IV infusion, 50-400 mg daily (for Prevention of fungal infections in immunocompromised patients)
Use in Specific Population:
- Elderly patient: The normal dose should be used if there is no evidence of renal impairment
- Renal Impairment: No adjustment in single dose therapy is required. In multiple dose therapy of patients with renal impairment, normal doses should be given on days 1 and 2 of treatment and thereafter the dosage intervals should be modified based on creatinine clearance
Pediatric Dosing:
- In Superficial Candidiasis: 1-2 mg/kg daily
- In Systemic Candidiasis & Cryptococcal infection: 3-6 mg/kg daily

Interaction

Fuconazole increased the prothombin time after warfarin administration
Onicon has been shown to prolong the serum half-life of concomitantly administed oral sulphonyl ureas
Co-administration of multiple-dose hydrochlorothiazide to healthy volunteers receiving fuconazole increased plasma concentrations of fuconazole by 40%
Concomitant administration of fuconazole and phenytoin may increase the level of phenytoin to a clinically signifcant degree
Fuconazole and rifampicin may decrease the AUC and shorten half-life of fuconazole
No clinically signifcant impairment of fuconazole absorption occurs when co-administered with food, cemetidine, antacids or following total body irradiation for bone marrow transplantation

Contraindications

Fluconazole should not be used in patients with known hypersensitivity to Fluconazole or to related triazole compounds

Side Effects

Nausea
Abdominal discomfort
Diarrhoea
Fatulence
Rash (Incidence less than 1%)
Anaphylaxis (rarely reported)

Pregnancy & Lactation

Fluconazole adverse fetal effects have been seen in animals only at dose levels associated with maternal toxicity

Precautions & Warnings

Abnormalities of hepatic, renal, haematological and other biochemical function tests observed especially in patients with serious underlying diseases such as AIDS and cancer
Post-mortem findings of hepatic necrosis reported in patients receiving multiple concomitant medications
Rare cases of severe cutaneous reactions reported
Use during lactation not recommended
Unlikely to impair a patient's ability to drive or use machinery

Use in Special Populations

Use in the elderly: The normal dose should be used if there is no evidence of renal impairment
Use in renal impairment: No adjustments in single dose therapy are required. In multiple dose therapy, dosage intervals or daily dosage should be modifed in accordance with creatinine clearance

Overdose Effects

In the event of overdosage, supportive measures and symptomatic treatment with gastric lavage if necessary may be adequate. As fuconazole is excreted largely in the urine, forced volume diuresis would probably increase the elimination rate. A three hour session of haemodialysis decreases plasma levels by approximately 50%