Composition, form of production and packaging
? Tablets vaginal white, biconcave, oblong form, with engraving "CL".
1 tab.
clotrimazole 100 mg
Excipients: lactose monohydrate, corn starch, adipic acid (powder), sodium bicarbonate, copovidone, magnesium stearate, silicon dioxide colloid, polysorbate 80.
3 pcs. - Cellular outline packaging (2) complete with applicator - packs of cardboard.
? Tablets vaginal white, biconcave, oblong form.
1 tab.
clotrimazole 200 mg
Excipients: lactose monohydrate, corn starch, adipic acid (powder), sodium bicarbonate, copovidone, magnesium stearate, silicon dioxide colloid, polysorbate 80.
3 pcs. - Cellular outline packaging (1) complete with applicator - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the print edition of 2007.
PHARMACHOLOGIC EFFECT
[I] - Instruction on medical use approved by the Pharmacological Committee of the Ministry of Health of the Russian Federation on 14.03.2002.
Kandibene is a broad-spectrum antifungal agent for topical application. The antimycotic effect of clotrimazole (an imidazole derivative) is associated with impaired 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, and 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.
Effective against dermatophytes, yeast-like and mold fungi, as well as the causative agent of the multicolored lichen Pityriasis versicolor (Malazessia furfur) and the causative agent of erythrasma. It has an antimicrobial effect against gram-positive (staphylococcus, streptococcus) and gram-negative bacteria (Bacteroides, Gardnerella vaginalis), and also 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 Trichomonas vaginalis (candidiasis vulvovaginitis, trichomoniasis);
- genital superinfections caused by microorganisms sensitive to clotrimazole;
- sanation of the birth canal before delivery.
DOSING MODE
The drug is intended for intravaginal use only.
Vaginal tablets are administered in the evening in the vagina, as deep as possible, in the supine position on slightly bent legs, daily, for 6 days, 1 vaginal tablet. for 100 mg, or for 3 days for 1 vaginal tablet. on 200 mg. A second course of treatment is possible after consulting a doctor.
For the sanation of the birth canal, a single administration of 1 tablet is recommended.
SIDE EFFECT
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.
CONTRAINDICATIONS
- Hypersensitivity to clotrimazole or excipients;
- I trimester of pregnancy;
Use of tablets during menstruation should be avoided; with caution - during lactation.
PREGNANCY AND LACTATION
In clinical and experimental studies, it has not been established that the use of the drug during pregnancy or during lactation has a negative effect on the health of a woman or fetus (child). However, the question of the appropriateness of prescribing the drug should be decided individually after consulting a doctor. Application in the I trimester is contraindicated. During pregnancy, vaginal pills should be treated without an applicator.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Patients with hepatic insufficiency should periodically monitor the functional state of the liver.
SPECIAL INSTRUCTIONS
To prevent urogenital reinfection, simultaneous treatment of sexual partners is necessary.
For trichomoniasis, other drugs with systemic action (for example, metronidazole inside) should be used in conjunction with Kandibene for a more successful treatment.
With a simultaneous infection of the labia and adjacent areas (candidiasis vulvitis), an additional local treatment with Kandibene cream should be performed.
Patients with hepatic insufficiency should periodically monitor the functional state of the liver.
When signs of hypersensitivity or irritation appear, the treatment is stopped.
If there is no effect within 4 weeks, you should confirm the diagnosis.
OVERDOSE
The use of the drug in elevated doses does not cause any reaction and 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, pollakiuria, skin allergic reactions.
There is no specific antidote. It is necessary to prescribe activated charcoal. If necessary, treatment is symptomatic.
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 approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
Store at a temperature not higher than 25 В° C in a place inaccessible to children.
Shelf life - 3 g.
Do not use after the expiration date.
