CANDİDİN

1 Capsule of 150 mg

COMPOSITION: Each capsule contains 150 mg Fluconazole.

Excipients: Titanium dioxide

PHARMACOLOGICAL PROPERTIES

Fluconazole, a synthetic triazole derivative, is an antifungal agent and it is structurally related to imidazole-derivative antifungal

agents. Fluconazole is fungistatic in action and exerts its activity by altering cellular membrane permeability and resulting in leakage

of essential elements such as amino acids, potassium outside the cell and impaired uptake of precursor molecules like purine.

Spectrum of pharmacological activity: in vitro susceptibility tests have shown that fluconazole is active against some strains of

Candida (such as C. albicans, C. kefyr, C. capsulatum), in-vivo studies on mice and rabbits have shown that it is also active for the

treatment of pulmonary infections caused by C. neoformans. In in vivo animal studies, fluconazole has been effective against tinea

versicolor caused by Malassezia furfur and infections caused by Trichophyton or Microsporum canis.

PHARMACOKINETICS:

The pharmacokinetic properties of fluconazole are similar following administration by the intravenous or oral routes. After oral

administration, fluconazole is rapidly and nearly completely absorbed. Peak plasma concentrations occur between 1 and 2 hours and

the absorption is not dependent on the presence of food.

Steady-state concentrations are reached within 5-10 days following doses of 50-400 mg given once daily. However, administration of

a loading dose of twice the usual daily dose followed by normal daily doses results in plasma concentrations close to steady-state by

the second day.

Fluconazole is distributed widely into the whole body after oral and i.v. administration and concentrations in the tissues such as nails,

saliva, and vaginal secretion are approximately equal to plasma concentrations. It is 11-12% bound to plasma proteins.

Plasma elimination half-life in adults with normal renal function is approximately 30 hours (range: 20-50 hours).

Elimination is delayed in patients with impaired renal function.

INDICATIONS:

Actinazole (Fluconazole) is indicated for the treatment of acute or recurrent vaginal candidiasis.

CONTRAINDICATIONS:

Candidin is contraindicated in patients who have shown hypersensitivity to fluconazole or to similar compounds.

WARNINGS / PRECAUTIONS:

Although serious adverse hepatic effects have been reported only rarely with fluconazole, the possibility that these effects may occur

during fluconazole therapy should be considered and fluconazole therapy should be discontinued if signs and symptoms consistent

with liver disease develop. Potentially fatal exfoliative skin disorders have been reported rarely in patients with a serious underlying

disease receiving fluconazole. Immunocompromised patients who develop rash during fluconazole therapy should be monitored

closely and the drug should be discontinued.

Warning for pediatric patients:

Safety and efficacy of fluconazole in pediatric patients under 16 years of age have not been demonstrated. There are on-going studies.

No abnormal adverse effects have been recorded in studies on limited number of pediatric cases between 3 -19 years of age.

Pregnancy and Lactation:

Pregnancy Category: C

There are no adequate and well controlled studies in pregnant women with fluconazole. Therefore, fluconazole should be used during

pregnancy only after a careful benefit/risk evaluation. Fluconazole is excreted in the human milk and therefore should be used

cautiously in lactating women.

Renal Impairment:

As fluconazole is primarily cleared as unchanged drug, no dosage adjustment is necessary.

ADVERSE EFFECTS:

Fluconazole is generally well tolerated. 5 to 30% patients treated with fluconazole for 7 days or more experienced adverse effects.

Gastrointestinal:

Mild or moderate nausea, vomiting, abdominal pain, diarrhea, in rare cases flatulence, dry mouth and hiccup.

Dermatological:

Rash, including diffuse rash accompanied by eosinophilia, and pruritus have been reported in up to about 5% of patients receiving

fluconazole.

Hepatic:

Mild and transient increases in SGOT, SGPT, alkaline phosphatase and bilirubin levels. These increases may return to normal levels

during or after discontinuation of the therapy.

Central Nervous System:

In very rare cases dizziness and headache may occur.

IF YOU NOTICE ANY SIDE EFFECTS NOT MENTIONED IN THE LEAFLET, PLEASE INFORM YOUR DOCTOR OR

PHARMACIST.

DRUG INTERACTIONS:

Fluconazole alters the pharmacokinetic parameters of the drugs metabolized by the liver. Concurrent use of fluconazole with

coumarin-type anticoagulants results in an increase in prothrombin time.

In addition, concomitant use of fluconazole with sulfonylurea agents such as chlorpropamide, glybenclamide has increased the half-

lives of these agents. Concurrent use with cyclosporine has increased the plasma cyclosporine concentrations. Phenytoin

concentrations also increase with fluconazole. However this may result in phenytoin toxicity. On the other hand, concurrent use with

thiazide diuretics may result in increased fluconazole peak plasma concentrations.

DOSAGE AND ADMINISTRATION

Vulvovaginal candidiasis: The recommended dosage of Candidin is 150 mg as a single oral dose.

OVERDOSAGE:

There limited data on overdosage with fluconazole. In case of an acute overdosage, supportive and symptomatic treatment should be

initiated immediately.

DO NOT USE WITHOUT CONSULTING TO A PHYSICIAN.

KEEP OUT OF REACH AND SIGHT OF CHILDREN.

STORAGE CONDITIONS:

Store below 30ºC (room temperature) and protect from light.

HOW SUPPLIED:

1 Capsule of 150 mg

OTHER PHARMACEUTICAL DOSAGE FORMS:

3 and 7 capsules of 50 mg and 2 capsules of 150 mg

License No: 08/03/1996 -177/44

License Holder: Toprak İlaç ve Kimyevi Mad. San. ve Tic. A.Ş.

Toprak Center, Ihlamur Yıldız Cad., No: 10 34353 Beşiktaş, İstanbul, Turkey

Manufactured by: Toprak İlaç ve Kimyevi Mad. San. ve Tic. A.Ş.

Tem Otoyolu Adapazarı Çıkışı, Kandaklar Mevkii Adapazarı, Sakarya, Turkey

PRESCRIPTION ONLY MEDICINE.