Instructions Clotrimazole solution for external use 1% bottle 25 ml
Composition
active ingredient: clotrimazole;
1 ml of the drug contains clotrimazole (calculated as 100% dry matter) - 10 mg;
excipients: propylene glycol, polyethylene glycol 400, ethanol 96%.
Dosage form
Solution for external use.
Main physicochemical properties: transparent, colorless or almost colorless with a slightly yellowish color liquid.
Pharmacotherapeutic group
Antifungal drugs for topical use.
Imidazole and triazole derivatives. ATX code D01A C01.
Pharmacological properties
Pharmacodynamics
Clotrimazole is an imidazole derivative, a broad-spectrum antifungal agent. Its mechanism of action is to inhibit the synthesis of ergosterol, which is necessary for the construction of the fungal cell membrane, which leads to a violation of its permeability and subsequent destruction of the cell. In addition, clotrimazole inhibits the activity of peroxidases, which further facilitates the accumulation of hydrogen peroxide in the fungal cell. The concentration of hydrogen peroxide increases to a toxic level, which leads to further destruction of the cell.
Clotrimazole has a broad spectrum of action: effective against dermatophytes, yeast fungi; has an antibacterial effect against erythrasma pathogens, staphylococci (Staphylococcus spp.) and streptococci (Streptococcus spp.).
Pharmacokinetics
When applied to the skin, it penetrates the stratum corneum and accumulates there. When applied externally, a small amount of the drug is absorbed through the skin. It is practically not absorbed into the systemic bloodstream.
Indication
Fungal infections of the skin and mucous membranes caused by dermatophytes, yeasts, molds and other pathogens sensitive to clotrimazole; oral candidiasis (candidiasis stomatitis).
Lichen variegated, erythrasma.
Contraindication
Hypersensitivity to clotrimazole and/or other components of the drug.
Interaction with other medicinal products and other types of interactions
Clotrimazole inhibits the action of other antifungal drugs for external use, in particular amphotericin, nystatin and natamycin.
The antimicrobial effect of clotrimazole is enhanced by high concentrations of hydroxybenzoic acid propyl ester.
Dexamethasone in high doses inhibits the antifungal effect of clotrimazole.
Application features
Clotrimazole should be used with caution if allergic reactions to any other antifungal agents have been observed in the past. If irritation or other signs of hypersensitivity occur, the drug should be discontinued.
The drug should not be used in ophthalmological practice. Contact of the drug with the eyes should be avoided. If this happens, the eyes should be rinsed with plenty of water.
Do not swallow the drug!
During the treatment period, it is not recommended to wear clothing and shoes that do not allow air and moisture to pass through. After applying the drug, the treated surface should not be covered or an occlusive (airtight) bandage should be applied.
If there is no effect, a microbiological study should be performed to confirm the diagnosis and exclude another cause of the disease.
It is necessary to use the drug for the entire period of treatment, even if the symptoms of the disease have disappeared earlier. Following these recommendations will help prevent the development of reinfection (recurrence of the disease).
The product contains propylene glycol, which may cause skin irritation (contact dermatitis).
Ability to influence reaction speed when driving vehicles or other mechanisms
No effect.
Use during pregnancy or breastfeeding
Clinical studies on the effect of clotrimazole on fertility in women have not been conducted, but animal studies have not shown an effect of clotrimazole on fertility.
There are limited studies on the use of clotrimazole during pregnancy. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of clotrimazole during the first trimester of pregnancy.
Breastfeeding should be discontinued during treatment with clotrimazole.
Method of administration and doses
Before applying the drug, wash the skin with warm soapy water, especially the areas between the fingers, and dry thoroughly. Apply Clotrimazole to the affected areas 2-3 times a day and rub in lightly. The amount of Clotrimazole should be sufficient for uniform application to the entire affected surface. For ringworm of the feet, it is recommended to use the drug after each wash.
For the treatment of fungal lesions of the oral cavity, 10-20 drops (0.5-1 ml) of the solution should be applied to the affected areas of the mucous membrane using a cotton swab or stick 3-4 times a day. After applying the drug, it is recommended not to eat or drink for 1 hour.
The duration of treatment is:
dermatomycoses – 3-4 weeks; erythrasma – 2-4 weeks; lichen planus – 1-3 weeks.
Children
Since there is no experience with the use of the drug in children, the drug is not recommended for the treatment of this category of patients.
When using the drug according to the instructions, overdose is unlikely.
Symptoms: There is no risk of acute intoxication, as overdose is unlikely to occur after a single application to the skin (application to large areas of skin under conditions conducive to increased absorption), as well as after accidental oral administration.
In case of ingestion of a large amount of the drug, gastric lavage may rarely be necessary if a life-threatening dose has been administered within the previous hour or if there are visible symptoms of overdose: nausea, vomiting, abdominal pain, impaired liver function.
Treatment: There is no specific antidote. Discontinue use of the drug, gastric lavage should be performed only in cases where there is adequate respiratory protection. Symptomatic therapy.
Adverse reactions
Immune system.
Allergic reactions, including anaphylactic/anaphylactoid reactions (anaphylactic shock, angioedema, hypotension, syncope, dyspnoea, urticaria).
Skin and subcutaneous tissue.
Redness, blistering, peeling, burning/heating sensation, tingling, local swelling, itching, rash, general irritation, pain/discomfort, dryness; allergic, contact dermatitis.
The appearance of these symptoms requires discontinuation of treatment with the drug.
Expiration date
3 years.
Storage conditions
In a place protected from light at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
25 ml in a bottle.
Vacation category
Without a prescription.
Producer
Public Joint Stock Company "Research and Production Center "Borshchagov Chemical and Pharmaceutical Plant".
Location of the manufacturer and its business address
Ukraine, 03134, Kyiv, Myru St., 17.
