Fluzak 150mg 1 tablet — Made in India — Free Delivery

Product description

Fluzak is indicated for the treatment of the following diseases:

• Acute vaginal candidiasis when local therapy is not advisable.
• Candidal balanitis when local therapy is not advisable.

Compound

active substance: fluconazole;

1 tablet contains fluconazole 150 mg

Excipients: calcium hydrogen phosphate, corn starch, colloidal silicon dioxide, magnesium stearate, sodium starch (type A), sodium lauryl sulfate, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), talc, E 124 Ponso 4R dye (E 124).

Fluconazole is an antifungal agent of the triazole class. The primary mechanism of its action is the suppression of fungal 14-alpha-lanosterol demethylation, mediated by cytochrome P450, which is an integral step in the biosynthesis of fungal ergosterol.

Contraindications

Hypersensitivity to fluconazole, other azole compounds or to any of the excipients of the preparation.

Concomitant use of fluconazole and terfenadine in patients who use fluconazole multiple times at doses of 400 mg / day or more (according to the results of a multiple-use interaction study).

Concomitant use of fluconazole and other preparations that prolong the QT interval and are metabolized by the CYPZA4 enzyme (for example, cisapride, astemizole, pimozide, quinidine, amiodarone and erythromycin).

Method of administration and dosage

The tablets should be swallowed whole. Taking the preparation does not depend on food intake.

Adults.

The preparation is administered orally at a dose of 150 mg once.

Children

The efficacy and safety of the preparation for genital candidiasis in children have not been established, despite the comprehensive data on the use of fluconazole in children. If there is an urgent need for the use of the preparation in children (aged 12 to 17 years), the usual doses for adults should be used.

Application features

Application during pregnancy or lactation

Numerous congenital abnormalities have been reported in neonates (including brachycephaly, pinna dysplasia, excessive enlargement of the anterior fontanelle, curvature of the hip, brachiomenevic synostosis) whose mothers received high doses of fluconazole (400-800 mg / day) for at least three or more months for the treatment of coccidioidosis. The relationship between the use of fluconazole and these cases has not been determined.

Fluconazole passes into breast milk and reaches a lower concentration than in blood plasma. Breastfeeding can be continued after a single dose of fluconazole, which is 200 mg or less.

Breastfeeding is not recommended with repeated use of fluconazole or with high doses of fluconazole.

Fluconazole did not affect the fertility of males and females of the studied animals.

The ability to influence the reaction rate when driving or driving other mechanisms

Studies of the effect of the preparation Fluzac on the ability to drive vehicles or other mechanisms have not been carried out.

Patients should be informed about the possibility of developing dizziness or trial when using the preparation Fluzac. With the development of such symptoms, it is not recommended to drive vehicles or work with mechanisms.

Overdose

Fluconazole overdose has been reported; hallucinations and paranoid behavior were simultaneously reported.

In case of an overdose, it is necessary to carry out symptomatic supportive therapy and, if necessary, flush the stomach.

Fluconazole is largely excreted in the urine; forced diuresis can accelerate the elimination of the preparation. A hemodialysis session lasting 3:00 reduces the plasma level of fluconazole by 50%.

Adverse Reactions

The most common (> 1/10) adverse reactions were reported: headache, abdominal pain, diarrhea, nausea, vomiting, rash, increased levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and blood alkaline phosphatase.

Interaction with other medicinal products and other types of interactions

The simultaneous use of fluconazole and the following preparations is contraindicated.

Cisapride. It was reported about the development of adverse reactions from the heart, including paroxysmal ventricular tachycardia of the "pirouette" type in patients who simultaneously used fluconazole and cisapride. A controlled study demonstrated that the simultaneous use of 200 mg of fluconazole once a day and 20 mg of cisapride 4 times a day led to a significant increase in the level of cisapride in blood plasma and prolongation of the QT interval. The simultaneous use of fluconazole and cisapride is contraindicated (see "Contraindications").

Terfenadine. Due to the development of severe cardiac arrhythmias caused by prolongation of the QTc interval in patients who use azole antifungal preparations simultaneously with terfenadine, interaction studies of these preparations 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 the level of terfenadine in blood plasma when these preparations were used simultaneously. Concomitant use of fluconazole 400 mg or higher with terfenadine is contraindicated (see "Contraindications"). When using fluconazole at doses below 400 mg per day concomitantly with terfenadine, the patient's condition should be carefully monitored.

Astemizole. The combined use of fluconazole and astemizole may decrease the clearance of astemizole. The resulting increase in the concentration of astemizole in the blood plasma can lead to a prolongation of the QT interval and, in rare cases, to paroxysmal ventricular tachycardia of the "pirouette" type. Concomitant use of fluconazole and astemizole is contraindicated.

Pimozide and quinidine. The combined use of fluconazole and pimozide or quinidine can lead to inhibition of the metabolism of pimozide or quinidine, although no corresponding in vitro and in vivo studies have been performed. An increase in the concentration of pimozide or quinidine in blood plasma can cause prolongation of the QT interval and, in rare cases, lead to the development of paroxysmal ventricular tachycardia of the "pirouette" type. Concomitant use of fluconazole and pimozide or quinidine is contraindicated.

Erythromycin. The simultaneous use of erythromycin and fluconazole can lead to an increased risk of cardiotoxicity (prolongation of the QT interval, paroxysmal ventricular tachycardia of the "pirouette" type) and, as a consequence, to sudden cardiac death. The use of a combination of these preparations is contraindicated.

Amiodarone. The simultaneous use of fluconazole with amiodarone can lead to inhibition of the metabolism of amiodarone. There was an association between the use of amiodarone and prolongation of the QT interval. Concomitant use of fluconazole and amiodarone is contraindicated.

Storage conditions

Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.

Shelf life is 3 years.