COMPOSITION :

Each capsule contains : Fluconazole 150 mg , 200 mg.

DESCRIPTION :

Flucan (Fluconazole) is an antimycotic compound belong to a new class of triazole agents. It is a powerful

specific inhibitor of the synthesis of fungal steroids. Flucan activity has been proved against opportunistic

mycotic infections such as those caused by Candida spp. , Cryptococcus neoformans , Microsporum spp. and

Tricophyton spp. After oral administration it is well absorbed, showing systemic bioavailability to 90% with

respect to its level reached after intravenous administration. Peak plasma concentration under fasted conditions

are reached after a period between 30 to 90 minutes . About 80% of the dose is excreted unchanged in urine.

INDICATIONS :

- Vaginal candidiasis, oropharyngitis, oesophagitis caused by candida.

- Fungal infections of the skin and nails due to candida or dermatophytes.

- Serious systemic candidal infections including genitourinary, gastrointestinal infections, peritonitis and

pneumonia.

- Cryptococcal meningitis.

- For the prophylaxis of fungal infections in immunocompromised patients.

DOSAGE AND ADMINISTRATION :

- Vaginal candidiasis : One capsule (150 mg) as a single oral dose is given.

- Cutaneous fungal infections : One capsule (150 mg) as a single oral dose is given. This dose is repeated

after one week. In rare cases , a dose can be given on the third and the fourth week .

- Oropharyngeal and oesophageal candidiasis: A daily dose of one capsule (150 mg) is given.

- Serious systemic candidiasis and Cryptococcal meningitis : Start with a loading dose of 2 - 3 capsules

(300 - 450 mg) then a daily dose of 1-2 capsules (150 - 300 mg) and treatment is continued according to case

response.

In patients with impaired renal functions :

- Full dosage , if plasma creatinine clearance exceeds 0.8 ml / sec. is recommended.

- Half dosage if plasma creatinine clearance is 0.35 - 0.8 ml / sec. is recommended.

- One quarter dosage , if plasma creatinine clearance is 0.18 - 0.35 ml / sec. is recommended.

RESTRICTIONS ON USE :

Contraindications

It is contraindicated in patient who have shown hypersensitivity to Fluconazole or triazole compounds or in case

of acute impaired liver function.

precautions

In patients who develop skin rash or liver function abnormalities ,treatment should be discontinued.

Use in pregnancy and lactation

Fluconazole is contraindicated during pregnancy and lactation.

DRUG INTERACTION :

- Fluconazole shows interaction with the following drugs : warfarin, tolbutamide, sulphonylureas, hydrochlorothiazide, phenytoine, rifampicin and theophyline. When the concomitant administration of one of the drugs

mentioned above and Fluconazole is necessary , It is sufficient to monitor the hematic levels of the respective

drug and adjust the doses to the therapeutic requirement level .

- In particular in the case of simultaneous administration of Fluconazole with tolbutamide, the dosage of the

hypoglycemic drug and the level of blood sugar are necessary to be monitored.

- In case of concomitant administration of Fluconazole with cyclosporin, monitoring of the plasma concentrations

of cyclosporin is advised.

SIDE EFFECTS :

- Fluconazole is very well tolerated. The commonest effects nausea, vomiting ,diarrhea , abdominal pain. Skin

rash, headache, dizziness may occur, also abnormalities of liver enzymes have been reported. In rare cases

as with other azoles group anaphylactic reaction may occur.

STORAGE INSTRUCTION :

Store below 30°C , in a dry place.

PRESENTATIONS :

Flucan150, 200 capsules : Pack of 2 capsules and hospital packs of different size.