COMPOSITION :
FLOW 150 TABLETS
(each tablet contains)
Fluconazole                        150mg

CLINICAL PHARMACOLOGY :
Fluconazole (FLOW) acts by inhibiting the synthesis of ergoterol, a major component of the cell membrane of fungi and yeast. The nitrogen in the azole ring of fluconazole binds to lanosterol-14-alpha-demethylase(a fungal cytochrome P-450 enzyme) and thus inhibits the conversion of lanosterol to ergosterol.
Fluconazole has high affinity for fungal cytochrome P-450 enzymes and weak affinity for human cytochrome P-450 systems. Hence unlike ketoconazole, fluconazole has no effect on steroid synthesis, including production of cholesterol, testosterone and oestrogen in dosages up to 400 mg daily.

INDICATIONS :
1. In Vulvo- vaginal candidiasis (moniliasis) :
2. In Severe, Extensive, recalcitrant dermatophyte and candida skin infections.

DOSAGE AND ADMINISTRATION :
1) Single oral dose of 150mg (for 1 day only) in Vulvo- vaginal candidiasis
2) a) Dermatophytoses (Severe, Extensive & Recalcitrant) - In Tinea pedis, Tinea cruris, Tinea corporis: Once-a-week for 4 weeks. - In onychomycoses (Tinea of nail): once a week for 9 to12 months.
b) Cutaneous candidiasis like Candidal Intertrigo & Candidal Paronychia: once -a- week for 4 weeks.
DOSE IN CHILDREN :
Although the use of fluconazole has not been extensively studied in children, dosage of 3 to 6 mg/kg once daily has been used safely in children (age group 3-13 years).

CONTRAINDICATIONS :
Hypersensitivity to fluconazole or any ingredient of the formulation. It should be used with caution in individuals hypersensitive to other azoles and imidazoles.

ADVERSE EFFECTS :
Therapy with fluconazole is well tolerated. A very low incidence of side effects has been reported with fluconazole therapy. The three most common side effects are nausea (3.7%), abdominal pain (1.7%) and headache (1.9%). Less common side effects are skin rash (1.8%), vomiting, diarrhea and abnormality of liver function tests (1.3%). Adverse effects are more commonly seen in patients with AIDS as compared to patients not having AIDS.

DRUG INTERACTIONS :
1) Absorption of fluconazole from GI tract is not affected by concomitant administration of drugs that decrease gastric acid secretion or increase gastric pH e.g.H2- antagonists, and antacids.
2) Fluconazole may increase the plasma concentrations and/ or activity of warfarin, phenytoin, cyclosporine and oral hypoglycaemic agents (tolbutamide, glipizide and glyburide).
3) Rifampicin enhances metabolism of fluconazole and thus may decrease its serum levels. Hence doses of fluconazole should be increased when given along with rifampicin.
4) Thiazide diuretics decrease the renal clearance and increase the serum concentrations of fluconazole.

WARNINGS AND PRECAUTIONS :
1. Fluconazole dosage should be adjusted in patients with renal impairment.
2. Patients who develop skin rash during fluconazole therapy should be monitored closely and it should be discontinued if the lesions progress.
3. Use during pregnancy -
There are no adequate and controlled studies on use of fluconazole in pregnant women. It should be used during pregnancy only when the potential benefits justify the possible risks of the foetus. Since it is not known whether fluconazole is distributed into human milk, it should be used with caution in nursing mothers.
4. Use In Infants And Children-
A limited number of studies in infants and children (given 3-6 mg/kg. daily of fluconazole), did not report unusual adverse effects.
5. If abnormal liver function tests results occur during fluconazole therapy, the patients should be monitored for the development of more severe hepatic injury.
Fluconazole should be discontinued if signs and symptoms consistent with liver disease develop.

STORAGE INSTRUCTIONS :
Store in a cool, dry place.