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Active ingredients
Clotrimazole
Release form
Cream
Composition
Active ingredient: Clotrimazole (Clotrimazolum). Concentration of active ingredient (mg): 1 g
Pharmacological effect
Clotrimazole is a broad-spectrum antifungal agent for topical use. The antimycotic effect of the active substance (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 the subsequent lysis of the cell. It acts fungistatically in low concentrations, and fungistically 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 a toxic level, which also contributes to the destruction of fungal cells. Effective against dermatophytes, yeast-like and mold fungi, as well as the pathogen of multi-colored depriving Pityriasis versicolor (Malazessia furfur) and the causative agent of erythrasma. It has antimicrobial action against gram-positive (staphylococcus, streptococcus) and gram-negative bacteria (Bacteroides, Gardiierella vaginalis), as well as against Trichomonas vaginalis.
Pharmacokinetics
When using clotrimazole and intravaginal absorption is 3-10% of the injected dose. High concentrations in the vaginal secretion and low blood concentrations are maintained for 48-72 hours. In the liver, it is rapidly metabolized to inactive metabolites.
Indications
For external treatment of fungal skin diseases caused by dermatophytes, yeast-like fungi, mold fungi, as well as causative agents sensitive to clotrimazole: mycoses of the feet, hands, body, skin folds, candidal vulvitis, candidal balanitis, varicolor versicolor, erythrasma, fungal infections of the outer ear.
Contraindications
Hypersensitivity to clotrimazole or other components of the drug.
Precautionary measures
The drug should be used with caution if allergic reactions to any other antifungal agents have been previously observed. In case of irritation or other manifestations of hypersensitivity, the use of the drug should be stopped.The drug is not used in ophthalmic practice. Contact with the drug should be avoided. If this happens, wash your eyes with plenty of water. Do not swallow the drug. During treatment, it is not recommended to wear clothes and shoes that do not allow air and moisture. After applying the drug should not cover the treated surface or impose an occlusive (airtight) dressing on it. It is necessary to use the drug throughout the prescribed period of treatment, even if the acute symptoms of the disease disappeared earlier. Compliance with these recommendations will help prevent the development of reinfection. The drug contains cetostearyl alcohol, which can cause local skin reactions (for example, contact dermatitis). If the drug is used as noted in the section "Route of administration and dose", only a very small amount of the active substance (clotrimazole) will be absorbed by the body. Thus, there is no likelihood that systemic effects may occur (action on other organs). If you missed the next application, you should apply the drug as soon as you think about it, but it is better to skip the application if it is almost time for the next use of the drug.
Use during pregnancy and lactation
If you are pregnant or nursing, if you assume that you are pregnant or do not exclude the possibility of becoming pregnant, inform your doctor. During pregnancy or lactation, the drug should be prescribed only when absolutely necessary, provided that the intended benefit to the mother outweighs the potential risk to the fetus or child. Do not put the drug on the mammary glands during lactation
Dosage and administration
For external use. The cream should be applied to the affected skin 2-3 times a day. To prevent recurrence, treatment should continue for at least two weeks after all symptoms of the infection have disappeared. The cream should be applied to clean, dry areas of the affected skin (washed with soap with a neutral pH), the cream should be applied on the feet between the fingers. The duration of treatment depends on the severity of the disease, its localization, the effectiveness of treatment. Duration of treatment: ringworm - 3-4 weeks.Erythrasma - 2-4 weeks. versicolor versicolor - 1-3 weeks. Candida vulvitis and balanitis - 1-2 weeks. The duration of treatment may vary according to individual characteristics, but a treatment duration of less than 3 weeks is not recommended. To prevent recurrence of infection, the drug should be continued for 1-2 weeks after the disappearance of all symptoms of the disease. If after 7 days of treatment symptoms do not improve, you should consult with your doctor.
Side effects
The adverse events listed below are listed in accordance with the damage to organs and organ systems and the frequency of occurrence. The frequency of occurrence is determined as follows: very often (≥110), often (≥1100 and less than 110), infrequently (≥11000 and less than 1100), rarely (≥110 000 and less than 11 000), very rare (less than 110 000, including individual cases), unknown (frequency cannot be estimated from currently available data). Frequency categories were formed on the basis of post-registration observation. On the part of the immune system: unknown - allergic reaction (manifested by urticaria, fainting, hypotension, shortness of breath). On the part of the skin and subcutaneous tissues: unknown - rash, itching, vesicular rash, peeling, pain or discomfort, swelling, burning, irritation.
Overdose
When using the drug according to the instructions overdose is unlikely. If a large amount of the drug is accidentally swallowed, dizziness, nausea, vomiting, abdominal pain, and abnormal liver function may occur. Treatment: stop the use of the drug, flush the stomach, if necessary, conduct symptomatic therapy.
Interaction with other drugs
If you are currently taking other drugs in the recent past, tell your doctor. The drug can reduce the effects of other local antifungal drugs, including amphotericin B, nystatin and natamycin. Dexamethasone in high doses inhibits the antifungal effect of the drug. Local application of high concentrations of hydroxybenzoic acid propyl ester enhances the antifungal effect of the drug.
special instructions
Use during pregnancy or lactation.If you are pregnant or nursing, if you assume that you are pregnant or do not exclude the possibility of becoming pregnant, inform your doctor. During pregnancy or lactation, the drug should be prescribed only when absolutely necessary, provided that the intended benefit to the mother outweighs the potential risk to the fetus or child. Do not put the drug on the mammary glands during lactation.