DIFLU

Fluconazole

Description:

Diflu (Fluconazole), the first of a new subclass of synthetic triazole antifungal agent which acts by inhibition of the ergosterol component of the fungal cell membrane. It is active against a broad spectrum of fungal pathogens and is available for oral use.

Composition:

Diflu-50 Capsule: Each capsule contains Fluconazole INN 50 mg.

Diflu-150 Capsule: Each capsule contains Fluconazole INN 150 mg.

Diflu Powder for Suspension: When prepared each 5 ml contains Fluconazole INN 50 mg.

Indications:

It is indicated in the treatment of acute or recurrent vaginal candidiasis, mucosal candidiasis (as oropharyngeal candidiasis, oesophagitis, candiduria), systemic candidiasis and cryptococcal infections (including meningitis).

Dosage & administration:

The daily dose of Diflu should be based on the nature and severity of the fungal infection. Most cases of the fungal infections require multiple dose therapy. Treatment should be continued until clinical parameters or laboratory tests indicate that active fungal infection has subsided. An  inadequate period of treatment may lead to recurrence of active infection. Immuno-compromised patients usually require maintenance therapy to prevent relapse.

Infections                                           Recommended dosage

Adults:

Vaginal candidiasis                              150 mg as a single dose

Oropharyngeal candidiasis                    200 mg on the 1st day followed by 100 mg daily for 14 days

oesophageal candidiasis                     200 mg on the 1st day followed by 100 mg daily for 14-30 days

Systemic candidiasis &                     400 mg on the 1st day followed by cryptococcal infection          200 mg  daily for 28                                              days or longer based on clinical response

Tinea corporis/tinea cruris/tinea           150 mg weekly for 4-6 weeks

pedis/other tinea Kerion                      50 mg daily for 20 days

Pityriasis versicolor                             400 mg as a single dose

Onychomycosis                                  150 mg weekly for 12 months

Children above 1 year:

Superficial candidiasis         1-2 mg/Kg body weight daily

Systemic candidiasis &        3-6 mg/Kg body weight daily

cryptococcal infection

In serious life threatening infections Diflu in doses, up to 12 mg/Kg body weight daily can be given to children aged 5-13 years (maximum 400 mg daily). For children with age between 1 to 6 years, the dose of Diflu syrup is as follows:

Age               Average body weight                     Dose/Day

1 year                        9 Kg                     0.5 measuring Spoonful

1-2 years                  12 Kg                        1 measuring Spoonful

2-3 years                  14 Kg                     1.5 measuring Spoonful

3-4 years                  16 Kg                        2 measuring Spoonful

4-6 years                  20 Kg                     2.5 measuring Spoonful

Contraindications:

It is contraindicated to patients hypersensitive to this drug and in advanced liver disease, children below the age of 1 year, nursing mother.

Side-effects:

Therapy with Fluconazole is well tolerated. In 4000 patients receiving Fluconazole for various indications and for duration of 7 days or more, the incidence of side effects were 16%. Only 1.5% of subjects required discontinuation of medication. The most common adverse events were related to the gastro-intestinal system: nausea (3.7%), abdominal pain (1.17%), vomiting (1.7%) and diarrhoea (1.5%). Headache (1.9%) and skin rash (1.8%) were also seen. It should be noted that approximately one third of this group were patients with AIDS and severe systemic disorders. Therefore the data may not be applicable to patients receiving Fluconazole for the treatment of superficial mycoses.

Cautions:

Caution should be taken in renal impairment, pregnancy and breast-feeding and raised liver enzymes. The use of Fluconazole in children below the age of 1 year is not recommended.

Use in Pregnancy & Lactation:

Fluconazole should used in pregnancy only if the potential benefit justifies the possible risk to the foetus. Fluconazole is secreted in human milk at concentrations similar to plasma. Therefore the use of Fluconazole in nursing mother is not recommended.

Drug Interactions:

Rifampicin reduces plasma concentration of Fluconazole. Effect of nicoumalone and warfarin is enhanced. Plasma concentrations of sulphonylureas & theophylline is possibly increased. Effect of phenytoin is enhanced.

Packing:

Diflu-50 Capsule: Box containing 8x6's capsules in blister pack.

Diflu-150 Capsule: Box containing 2x6's capsules in blister pack.

Diflu Powder for Suspension: Bottle containing dry powder for preparation of 35 ml Suspension.