Candide B6

General characteristics. Structure:

Active agent: Clotrimazolum – 100,0 mg

Excipients: adipic acid 70,0mg, starch corn 260,0mg, silicon dioxide colloid 2,67mg, lactoses monohydrate of 483,33 mg, magnesium stearate 4,0mg, methylparahydroxybenzoate (0,8mg), sodium гидрокорбанат 54,67mg, sodium 42,0mg carboxymethylstarch, povidone K – 30 12,67mg, пропилпарагидроксибензоат 0,2 mg, talc 10,0mg.

Pharmacological properties:

Pharmacological action - antifungal broad-spectrum agent for topical administration, antibacterial, antiprotozoan, trikhomonatsidny. The anti-mycotic effect of active active ingredient of Clotrimazolum (derivative an imidazole) is connected with disturbance of synthesis of the ergosterol which is a part of a cellular membrane of mushrooms that changes permeability of a membrane and causes the subsequent lysis of a cell. In fungicidal concentration interacts with mitochondrial and peroksidazny enzymes therefore there is an increase in concentration of peroxide of hydrogen up to toxic level that also promotes destruction of fungal cells.

Clotrimazolum is active concerning the following activators:

Blastomyces dermatitidis
Candida spp (has identical activity with nystatin)
Coccidioides immitis
Cryptococcus neoformans (Torula histolytica)
Dermatoophytes (Trichophyton, Microsporum, Epidermophyton)
Histoplasma capsulatum
Malassezia furfur
Naegleria fowleri
Nocardia spp
Paracoccidioides brasiliensis
Sporotrichum schenckii

It is effective concerning gram-positive bacteria – Corynebacterium minutissimum erythrasma activator, and also Staphylococcus spp., Streptococcus spp., gram-negative bacteria - Bacteroides, Gardnerella vaginalis. In high concentration it is active concerning Trichomonas vaginalis.

Pharmacokinetics. At use of Clotrimazolum intravaginalno absorption makes 3-10% of the entered dose. High concentration in a vaginal secret and low concentration in blood remain within 48-72 hours. It is quickly metabolized in a liver to inactive metabolites.

Indications to use:

- the genital infections caused by drozhzhepodobny mushrooms of the sort Candida and/or Trichomonas vaginalis (a candidosis vulvovaginitis, trichomoniasis);
- the genital superinfections caused by the microorganisms sensitive to Clotrimazolum; - sanitation of patrimonial ways before childbirth.

Route of administration and doses:

Locally. Only for intravaginalny use. Vaginal tablets enter in the evening into a vagina as it is possible more deeply lying on spin at slightly bent legs, daily within 6 days on 1 vaginal tablet on 100 mg. The repeated course of treatment is possible after consultation of the doctor. For sanitation of patrimonial ways before childbirth single introduction of one tablet is recommended.
Instruction for use of the applicator:
1. To put forward the applicator piston against the stop. To place one vaginal tablet in the applicator;
2. To carefully insert the applicator with a tablet most deeply into a vagina (it is the best of all in a dorsal decubitus at slightly bent legs);
3. To enter a tablet into a vagina, slowly pressing the applicator piston against the stop; 4. To take the applicator;
5. After use and before reuse completely to take поршенб from the applicator, to wash out the piston and the applicator soap water warm (not more hotly) and to wipe dry.

Precautionary measures at use and special instructions:

- Prevention of an urogenital infection requires simultaneous treatment of sexual partners.
- At trichomoniasis together with Kandid V-6 should apply other medicines possessing systemic action to more successful treatment (for example, metronidazole inside).
- At a simultaneous infection of vulvar lips and adjacent sites (a candidosis vulvitis)
it is necessary to carry out in addition topical treatment by Candide's drug cream.
- During pregnancy treatment by vaginal tablets should be carried out without applicator.
At patients with a liver failure it is necessary to control a functional condition of a liver periodically.
- At manifestation of signs of hypersensitivity or irritation treatment is stopped.
- In the absence of effect within 6 days it is necessary to confirm the diagnosis.
- With care – the lactation period.
- It is necessary to avoid use of tablets in the period of periods.
- It is not necessary to apply at children up to 12 years.

Features of use:

Medicine use by pregnant women, women during breastfeeding:
Contraindications to use in the I trimester of pregnancy. The question of expediency of purpose of drug in II or the III trimester has to be solved individually after consultation with the doctor. At purpose of drug during II or III trimesters of pregnancy it is necessary to consider a ratio of estimated advantage of purpose of drug for mother and possible risk for a fruit. Use of the vaginal applicator is undesirable. With care – during breastfeeding (it is unknown whether Clotrimazolum gets into breast milk).

Side effects:

Itch, burning and hypostasis of a mucous membrane of a vagina, allocation from a vagina, a headache, a gastralgia, the speeded-up urination, intercurrent cystitis, a burning sensation in a penis at the sexual partner, pain during sexual intercourse.

Interaction with other medicines:

At vaginal introduction Clotrimazolum reduces efficiency of Amphotericinum In and other half-yen antibiotics. At simultaneous use with nystatin activity of Clotrimazolum can decrease.

Contraindications:

- Hypersensitivity to Clotrimazolum and other components of drug;
- I trimester of pregnancy.

Overdose:

Use of drug in the raised doses does not cause any reactions or states, life-threatening. In case of unforeseen use of drug the following symptoms are (inside) possible: anorexia, nausea, vomiting, gastralgias, abnormal liver function; seldom - drowsiness, hallucinations, a pollakiuria, skin allergic reactions. There is no specific antidote. It is necessary to accept inside absorbent carbon. If necessary symptomatic treatment.

Storage conditions:

In the dry, protected from light place at a temperature from 2 to 25 °C.
To store in the place, unavailable to children.

Issue conditions:

Without recipe

Packaging:

Tablets vaginal 100 mg. On 6 tablets in a strip from aluminum foil. On 1 strip together with the applicator and the application instruction in a cardboard pack.