Products information : FLUKAS 150

FLUKAS 150 150 mg Fluconazole
 
Products technical sheet

Pharmaceutical form and presentation

 Pharmaceutical form
Capsules
Presentation
Box of 1 capsule
M.A number:923 337 3

Pharmacological class

 This drug is a triazolic antifungal agent for systemic use intended to the treatment of infections caused by yeasts and fungi.

Composition

 Fluconazole base …………..................……150mg
Excipients: lactose monohydrated, sodium lauryl sulphate, pre gelatinized corn starch, talc, anhydrous colloidal silica and magnesium stearate…………..................s.q.f  one size 1 capsule

Therapeutic indications

 - Acute or recurrent vaginal candidiasis. These forms of candidiasis being likely to respond to a local treatment.
- Dermatomycosis including plantar epidermophytosis (tinea pedis), ringworm of the body (tinea corporis), eczema marginatum (tinea cruris), onychomycosis (tinea unguium) and cutaneous candidiasis.
- Treatment of Pityriasis versicolor

Contraindications

 Absolute:
-Hypersensitivity to fluconazole and/or to other azoles’ derivatives.
-Pregnant or breastfeeding women.
Relative:
Halofantrine

Warnings and precautions of use

 Warnings
In case of overdosage, you have to contact your doctor.
Precautions of use
- Children: the available data are too much limited to recommend the use of fluconazole.
- In patients with known hepatic and/or renal impairment and when a severe pathology is associated, the monitoring of the hepatic function is recommended; the discontinuation of fluconazole is to be considered in case of worsening of hepatic tests.
The patients should be informed that in case of occurrence of symptoms evoking severe hepatic impairment (important asthenia, anorexia, persisting nausea, vomiting and icterus), they should immediately stop fluconazole and rapidly consult their doctor.
- A special clinical monitoring is to be imposed in patients with already presented a cutaneous reaction following fluconazole or another azoles derivative use. The patients should be informed that in case of occurrence of bullous lesions, they should immediately stop fluconazole and rapidly consult their doctor.
- Because of the presence of lactose, this drug is contra-indicated in patients with congenital galctosemia, galactose and glucose malabsorption syndromes or lactase deficiency.

Pregnancy and breastfeeding

 The use of fluconazole in pregnant and breastfeeding women is not recommended. However, the use of fluconazole in pregnant women can be considered in very severe infections and only when there are no other treatments available.

Drugs interactions

 Fluconazole exerts a very specific activity on cytochrome P450 enzymes (issued from fungi)
Contraindicated combinations:
Astemizole, terfenadine and cisparide.
Combinations to be used with precautions:
Coumarinic anticoagulants (warfarine), hypoglycemiant sulfamids, hydrochlorothiazide, phenytoine, oral contraceptive agents, rifampicin, cyclosporine, theophyllin, rifabutin, tacromilus and zidovudin.

Undesirable effects

-Gastro-intestinal effects: nausea, flatulence, abdominal pains and diarrhea
-Cutaneous and allergic: rashes, severe cutaneous reactions such as bullous toxidermia (Stevens - Johnson syndrome, Lyell syndrome, particularly in case of AIDS), anaphylactic reactions.
-Some cases of alopecia, generally reversible, were reported.
-General effects: headaches which could be related to the product.
-Hepatic effects: increase in hepatic transaminases, usually reversible after treatment discontinuation; some cases of severe hepatic impairment were exceptionally reported.
-Hematological effects: leukopenia (neutropenia, agranulocytosis) and thrombocytopenia.

Dosage and mode of administration

 Dosage
Adults:
-Vaginal infections caused by candida: one single dose of flukas 150mg.
-Dermatomycosis and infections caused by Candida: the usual dosage is one capsule of flukas 150mg/week during 2 – 4 weeks
-Plantar epidermophytosis: one capsule of flukas 150mg/week during up to 6 weeks
Elderly:
No dosage adjustment according to the creatinin clearance is required in the single dose treatment.
Mode of administration
Oral route

Storage

 To be stored in a temperature less than 30°C.

Delivery conditions

 List I. table A. under medical prescription.