Flunol (fluconazole) capsules 150 mg. №1

Description

FLUNOL №1 COMPOSITION
active substance: fluconazole

1 capsule contains fluconazole 150 mg

Excipients: lactose, corn starch, colloidal silicon dioxide, magnesium stearate, sodium lauryl sulfate

hard gelatin capsule: gelatin, titanium dioxide (E 171), azorubin (E 122).

FLUNOL №1 DOSAGE FORM
Capsules.

FLUNOL №1 MAIN PHYSICAL AND CHEMICAL PROPERTIES:
hard gelatin capsules No. 1 with a pink lid and a white body, containing a homogeneous white powder.

PHARMACOLOGICAL GROUP
Antifungal agents for systemic use, derivatives of triazole. ATX code J02A C01.

PHARMACOLOGICAL PROPERTIES
Pharmacological.

Pharmacokinetics.

Fluconazole is well absorbed after oral administration; bioavailability exceeds 90%. Only 11-12% of fluconazole binds to blood plasma proteins. The volume of distribution is approximately the same as the volume of distribution of water in the body. Fluconazole penetrates well into all body fluids, including cerebrospinal fluid. The maximum plasma levels are reached after 0.5-1.5 hours, the biological half-life is about 30 hours (which is the basis for a single use of the drug in the treatment of vaginal candidiasis, for all other indications, fluconazole should be used once a day). Less than 5% of fluconazole is metabolized during the first passage through the liver. Approximately 80% of fluconazole is not metabolized and excreted by the kidneys, the remainder is excreted as metabolites.

INDICATIONS
Acute vaginal candidiasis when local therapy is not appropriate.

Candidal balanitis when topical therapy is not appropriate.

CONTRAINDICATIONS
Hypersensitivity to fluconazole, other azole compounds or to any of the excipients of the drug.
Concomitant use of fluconazole and terfenadine in patients who use fluconazole multiple times at doses of 400 mg / day and above (according to the results of a multiple-use interaction study).
Concomitant use of fluconazole and other drugs that prolong the QT interval and are metabolized by the CYPZA4 enzyme (for example, cisapride, astemizole, pimozide, quinidine and erythromycin).

INTERACTION WITH OTHER DRUGS AND OTHER INTERACTIONS
The simultaneous use of fluconazole and the following drugs is contraindicated.

Terfenadine. Due to the development of severe cardiac arrhythmias caused by prolongation of the QTc interval in patients who use azole antifungal drugs simultaneously with terfenadine, interaction studies of these drugs have been conducted. In one study, when using fluconazole at a dose of 200 mg per day, no prolongation of the QTc interval was detected. Another study using fluconazole at doses of 400 mg and 800 mg per day demonstrated that the use of fluconazole at doses of 400 mg per day or higher significantly increased plasma levels of terfenadine when these drugs were used concomitantly. Concomitant use of fluconazole 400 mg or higher with terfenadine is contraindicated. When using fluconazole at doses below 400 mg per day concomitantly with terfenadine, the patient’s condition should be carefully monitored.