Composition, form of production and packaging
? The vaginal tablets are white, oval, truncated on one side, biconvex, without a shell, with a monogram "G" on one side and a "V6" sign on the other side.
1 tab.
clotrimazole 100 mg
Auxiliary substances: adipic acid - 70 mg, corn starch - 260 mg, silicon dioxide colloid - 2.67 mg, lactose monohydrate - 483.33 mg, magnesium stearate - 4 mg, methyl parahydroxybenzoate - 0.8 mg, sodium hydrogen carbonate - 54.67 mg, sodium carboxymethyl starch - 42 mg , povidone K-30 - 12.67 mg, propyl parahydroxybenzoate 0.2 mg, talc 10 mg.
6 pcs. - Strips of aluminum foil (1) complete with applicator - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2016.
PHARMACHOLOGIC EFFECT
Antifungal preparation of a broad spectrum of action for topical use, an imidazole derivative. It also has antibacterial, antiprotozoal and trichomonasidic effects.
The antimycotic effect of clotrimazole 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 small concentrations, it acts fungistatically, in large concentrations it acts fungicidal, and not only on proliferating cells. 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 is Corynebacterium minutissimum, as well as Staphylococcus spp., Streptococcus spp .;Gram-negative bacteria: Bacteroides, Gardnerella vaginalis. In high concentrations, it is active against 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. The liver is rapidly metabolized 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 clotrimazole;
- sanation of the birth canal before delivery.
DOSING MODE
The drug is used intravaginally. Tablets should be injected as deep as possible into the vagina, lying on their backs with slightly bent legs.
Assign 100 mg (1 tab.) 1 time / day (evening) for 6 days. A second course of treatment is possible after consulting a doctor.
For the sanation of the birth canal before delivery , a single injection of 1 tablet is recommended.
Instructions for using the applicator
1. Pull out the applicator piston until it stops. 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. Insert the tablet into the vagina, slowly pressing the applicator piston until it stops.
4. Remove the applicator.
5. After use and before reuse, remove the piston completely from the applicator, rinse the piston and applicator with warm (not hot) soapy water and wipe dry.
SIDE EFFECT
Possible: itching, burning and edema of the vaginal mucosa, vaginal discharge, headache, gastralgia, frequent urination, intercurrent cystitis, burning sensation in the penis at the sexual partner, pain during intercourse.
CONTRAINDICATIONS
- Hypersensitivity to clotrimazole;
- I trimester of pregnancy.
With caution: the period of lactation.
PREGNANCY AND LACTATION
The drug is contraindicated in the first trimester of pregnancy. The question of the expediency of prescribing the drug in the second or third trimester should be decided individually after consultation with the doctor. When prescribing the drug in 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.
Caution should be given during breastfeeding (it is not known whether clotrimazole penetrates breast milk).
APPLICATION FOR CHILDREN
Do not use the drug in children under 12 years of age.
SPECIAL INSTRUCTIONS
To prevent urogenital infection, simultaneous treatment of sexual partners is necessary.
For trichomoniasis, other drugs with systemic action (for example, metronidazole inside) should be used in combination with Candide-B6 for a more successful treatment.
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.
Use of tablets during menstruation should be avoided.
Use in Pediatrics
Do not use the drug in children under 12 years of age.
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 followingsymptoms are possible : anorexia, nausea, vomiting, gastralgia, impaired liver function; rarely - drowsiness, hallucinations, pollakiuria, skin allergic reactions.
Treatment: There is no specific antidote. It is necessary to take activated charcoal; if necessary, symptomatic therapy.
DRUG INTERACTION
With vaginal administration, clotrimazole reduces the activity of amphotericin B and other polyene antibiotics.
With simultaneous application with nystatin, the activity of clotrimazole may decrease.
TERMS OF RELEASE FROM PHARMACY
The drug is dispensed without a prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a dry, protected from light, out of reach of children at a temperature of no higher than 25 В° C. Shelf life - 4 years.
