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Active ingredients
Clotrimazole
Release form
Gel
Composition
1 g of gel contains: clotrimazole 20 mg. Excipients: cetyl alcohol, propylene glycol, glycerol, benzyl alcohol, emulsion wax (cetomacrogol), carbopol 940 (carbomer 940), sodium hydroxide, chlorocresol, purified water.
Pharmacological effect
The somatic effect of clotrimazole 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 the subsequent lysis of cells. It acts fungistatically in low concentrations, fungicidal in large concentrations, 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 the toxic level, which also contributes to the destruction of fungal cells. erythrasma. It has antimicrobial action against gram-positive (staphylococcus, streptococcus) and gram-negative bacteria (Bacteroides, Gardnerella vaginalis), as well as against Trichomonas vaginalis.
Pharmacokinetics
With intravaginal administration of clotrimazole absorption is 3-10% of the administered dose. High concentrations in the vaginal secretion and low in the blood persist for 48–72 hours. In the liver, it is rapidly metabolized to inactive metabolites.
Indications
Candida vulvovaginitis; trichomoniasis; genital superinfection caused by microorganisms sensitive to clotrimazole.
Contraindications
Period of menstruation; I trimester of pregnancy; Hypersensitivity to clotrimazole or other components of the drug.
Precautionary measures
Be wary appoint the drug during lactation.
Use during pregnancy and lactation
In clinical and experimental studies it has not been established that the use of the drug during pregnancy or during breastfeeding has a negative impact on the health of the woman or the fetus (child). However, the question of the advisability of prescribing the drug should be decided individually after consulting a doctor.
Dosage and administration
The drug is intended only for intravaginal use. A full gel applicator (about 5 g of the drug) is injected into the vagina, in the supine position and slightly bent legs, daily for 6 days in the evening. A repeated course of therapy is possible only on prescription.
Side effects
Itching, burning, hyperemia and swelling of the mucous membrane of the vagina, headache, gastralgia, frequent urination, intercurrent cystitis, burning sensation in the penis of the sexual partner, pain during sexual intercourse.
Overdose
The use of the drug in high doses does not cause any reactions and conditions, life-threatening.
Interaction with other drugs
With vaginal administration, clotrimazole reduces the activity of amphotericin B and other polyene antibiotics. When used simultaneously with natamycin and nystatin, clotrimazole activity may be reduced.
special instructions
To prevent urogenital reinfection, simultaneous treatment of sexual partners is necessary. For trichomoniasis, other drugs that have a systemic effect (for example, metronidazole - orally) should be used in conjunction with Candida for better treatment. should periodically monitor the functional state of the liver. If there is evidence of hypersensitivity or irritation, treatment is stopped. Do not use the drug on the mucous membrane of the eye. Do not use the drug during menstruation. If there is no effect for 4 weeks, the diagnosis should be confirmed.