Candide-B6 - instructions for use, dose, side effects, contraindications

Excipients: adipic acid 70.0 mg, corn starch 260.0 mg, silicon dioxide colloid 2.67 mg, lactose monohydrate 483.33 mg, magnesium stearate 4.0 mg, methyl parahydroxybenzoate 0.8 mg, sodium hydrogen carbonate 54.67 mg, carboxymethyl sodium starch 42.0 mg, povidone K-30 12.67 mg, propyl parahydroxybenzoate 0.2 mg, talc 10.0 mg.

Description:White, biconvex tablets without shell, oval, truncated on the one hand, with the monogram "G" on one side and the "V6" sign on the other side.

Pharmacotherapeutic group:Antifungal agent

ATX: & nbsp

G.01.A.F.02 Clotrimazole

Pharmacodynamics:

Pharmacological action - an antifungal agent of a wide spectrum of action for topical application, antibacterial, antiprotozoal, trihomonatsidnoe.The antimycotic effect of the active active agent clotrimazole (imidazole derivative) is associated with a disruption in the synthesis of ergosterol, which is part of the cell membrane of fungi, which changes the permeability of the membrane and causes subsequent cell lysis. In fungicidal concentrations, it interacts with mitochondrial and peroxidase enzymes, resulting in an increase in the concentration of hydrogen peroxide to a toxic level, which also contributes to the destruction of fungal cells.

Clotrimazole is active against the following pathogens:

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

Effective against Gram-positive bacteria - the causative agent of erythrasma Corynebacterium minutissimum, and Staphylococcus spp., Streptococcus spp., gram-negative bacteria - Bacteroides, Gardnerella vaginalis. In high concentrations, it is active in relation to Trichomonas vaginalis.

Pharmacokinetics:

When clotrimazole is administered intravaginally, the absorption is 3-10% of the dose administered. High concentrations in the vaginal secretion and low blood concentrations persist for 48-72 hours. Rapidly metabolized in the liver to inactive metabolites.

Indications:

Genital infections caused by yeast-like fungi of the genus Candida and / or Ttrichomonas vaginalis (candidiasis vulvovaginitis, trichomoniasis);
genital superinfections caused by microorganisms sensitive to kpotrimazole;
sanation of the birth canal before delivery.

Contraindications:

Hypersensitivity to clotrimazole and other components of the drug;
I trimester of pregnancy.

Carefully:Lactation period.

Pregnancy and lactation:Contraindicated in I trimester of pregnancy. The question of the expediency of prescribing II or III trimester should be addressed individually after consultation with a physician. When prescribing the drug during the II or III trimesters of pregnancy, it is necessary to take into account the ratio of the prospective benefit from the appointment of the drug to the mother and the possible risk to the fetus. It is undesirable to use a vaginal applicator. With caution - during breastfeeding (it is not known whether clotrimazole in breast milk).

Dosing and Administration:

Locally. For intravaginal use only. Vaginal tablets are administered in the evening in the vagina, as deep as possible lying on the back with slightly bent legs, daily for 6 days for 1 vaginal tablet of 100 mg.A second course of treatment is possible after consulting a doctor.

For the sanation of the birth canal before childbirth, a single injection of one tablet is recommended.

Instructions no using the applicator:

1. Pull the applicator piston to the stop. Place one vaginal tablet in the applicator;

2. Carefully insert the applicator with the tablet as deep as possible into the vagina (best in the supine position on the back with slightly bent legs);

3. Enter the tablet into the vagina, slowly pressing the applicator piston until it stops;

4. Remove the applicator;

5. After use and before re-use, remove the piston completely from the applicator, rinse the piston and applicator with warm (not hot) soapy water and wipe dry.

Side effects:Itching, burning and swelling of the vaginal mucosa, vaginal discharge, headache, gastralgia, frequent urination, intercurrent cystitis, burning sensation in the penis at the sexual partner, pain during intercourse.

Overdose:The use of the drug in elevated doses does not cause any reactions or conditions that are life-threatening. In case of unintended use of the drug (inside), the following symptoms are possible: anorexia,nausea, vomiting, gastralgia, impaired liver function; rarely - drowsiness, hallucinations, lallakuria, skin allergic reactions.

There is no specific antidote. Must be taken internally Activated carbon. If necessary, treatment is symptomatic.

Interaction:With vaginal administration Clotrimazole reduces the effectiveness of amphotericin B and other polyene antibiotics. With simultaneous application with nystatin, the activity of clotrimazole may decrease.

Special instructions:

To prevent urogenital infection, simultaneous treatment of sexual partners is necessary.
For trichomoniasis, for more successful treatment with Candida-Bb, other drugs with systemic action should be used (for example, metronidazole inside).
With a simultaneous infection of the labia and adjacent areas (candidiasis vulvitis), you should additionally undergo local treatment with Candida cream.
During pregnancy, vaginal pills should be treated without an applicator.
Patients with hepatic insufficiency should periodically monitor the functional state of the liver.
If signs of hypersensitivity or irritation develop, the treatment is stopped.
If there is no effect within 6 days, you should confirm the diagnosis.
With care - the period of lactation.
Use of tablets during menstruation should be avoided.
Do not use in children under 12 years.

Form release / dosage:Vaginal tablets are 100 mg.

Packaging:6 tablets per strip of aluminum foil. 1 strip along with the applicator and instructions for use in a cardboard pack.

Storage conditions:

In a dry, dark place at a temperature of 2 to 25 ° C. Keep out of the reach of children.

Shelf life:4 years. Do not use the drug after the expiration date

Terms of leave from pharmacies:Without recipe

Registration number:П N012759 / 01

Date of registration:09.12.2011 / 19.12.2012

Expiration Date:Unlimited

The owner of the registration certificate:Glenmark Pharmaceuticals Co., Ltd.Glenmark Pharmaceuticals Co., Ltd. India

Manufacturer: & nbsp

GLENMARK PHARMACEUTICALS, Ltd. India

Representation: & nbspGLENMARK PHARMACEUTICALS LTD. GLENMARK PHARMACEUTICALS LTD. India

Information update date: & nbsp21.11.2017

Illustrated instructions

Instructions

Candide-B6 (Candid-V6)