Clotrimazole cream 1% 20g №1

Name:
Clotrimazole. Release form Cream. INNClotrimazole. FTH Antifungal agent. Composition 1 g of cream contains: active substance: clotrimazole 0.01 g. excipients: benzyl alcohol, cetostearyl alcohol, octyldodecanol, polysorbate 60, sorbitan stearate, synthetic cetaceum (ester cetyl wax), purified water.
Description:
Homogeneous mass of white color. Pharmacotherapeutic group Antifungal agents for external use. Derivatives of imidazole and triazole. ATX code: D01AC01. Pharmacological action Clotrimazole inhibits cell growth and division and, depending on the concentration, may have a fungistatic or fungicidal effect. Clotrimazole changes the permeability of the cell membrane by disrupting the synthesis of ergosterol and binding to the phospholipids of the fungal cell wall. Clinical studies have shown that topical treatment of infections with clotrimazole is as effective as other imidazole derivatives such as econazole and ketoconazole. Clotrimazole inhibits the synthesis of proteins, fats, DNA and polysaccharides, damages cellular nucleic acids and accelerates the excretion of potassium. It can also inhibit the activity of oxidases and peroxidases and the biosynthesis of triglycerides and phospholipids in fungi. At higher concentrations, clotrimazole causes damage to cell membranes through mechanisms independent of sterol synthesis. Clotrimazole prevents the transformation of Candida albicans blastospores into an invasive form of mycelium. A change in the activity of the cell membrane leads to cell death and depends on the degree of drug exposure to microbial organisms. The spectrum of activity Clotrimazole is characterized by a wide spectrum of activity. Clotrimazole inhibits the development and destroys dermatophytes (Epidermophyton floccosum, Microsporum canis, Trichophyton mentagrophytes, Trichophyton rubrum), yeasts (Candida spp., Cryptococcus neoformans) and dimorphic fungi (Coccidioides immitis, Histoplasma capsulatum, Paracoccidioides brasiliensis). Clotrimazole is also active against some gram-positive (Streptococcus, Staphylococcus, Gardnerella vaginalis) and gram-negative (Bacteroides) microorganisms. In vitro, clotrimazole inhibits the reproduction of Corynebacterium and Gram-positive cocci (with the exception of enterococci) at concentrations of 0.5-10 μg / ml. Clotrimazole has a wide spectrum of fungistatic and fungicidal activity in vitro. Its action on the mycelium of dermatophytes (Trichophyton, Microsporum, Epidermophyton) is similar to that of griseofulvin, and its action on budding fungi (Candida) is similar to the activity of polyenes (amphotericin B and nystatin). Clotrimazole at a concentration below 1 μg / ml inhibits the development of most strains of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum and Microsporum canis. Clotrimazole at a concentration of 3 μg / ml inhibits the development of most pathogens Pityrosporum orbiculare, Aspergillus fumigatus, Candida species, including Candida albicans, some strains of Staphylococcus aureus and Streptococcus pyogenes, as well as some strains of Proteus vulgaris and Salmonella. Clotrimazole is active against Sporothrix, Cryptococcus, Cefalosporium and Fusarium. Concentrations above 100 µg/ml are effective against Trichomonas vaginalis. Mushrooms resistant to clotrimazole are extremely rare; there are data only for individual strains of Candida guilliermondii. No resistance development has been reported in clotrimazole-sensitive fungi after passage of Candida albicans and Trichophyton mentagrophytes. Cases of development of resistance to clotrimazole in C. albicans strains resistant to polyene antibiotics due to chemical mutation have not been described. Pharmacokinetics When applied topically to the skin, clotrimazole is absorbed by the epidermis. Higher concentrations of clotrimazole are found in the horny and prickly layers of the epidermis, as well as in the papillary and reticular layers of the dermis, however, clotrimazole enters the systemic circulation in small quantities. Clotrimazole is metabolized in the liver to inactive substances excreted from the body through the kidneys and intestines. Indications for use Clotrimazole cream is used for the local treatment of fungal diseases of the skin: hands and feet, trunk, lower leg and foot, caused by dermatophytes Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum and Microsporum canis; pityriasis versicolor caused by Malassezia furfur (Pityrosporum orbiculare or Pityrosporum ovale); – fungal infections of the skin and mucous membranes of the external genital organs (labia, foreskin and glans penis) caused by Candida vulvitis or Candida balanitis. Contraindications Hypersensitivity to clotrimazole or excipients of the drug. Use during pregnancy and lactation Pregnancy There are limited data on the use of clotrimazole during pregnancy. Animal studies have not shown a direct or indirect effect on reproductive toxicity. As a precautionary measure, the use of clotrimazole in the first trimester of pregnancy should be avoided. Lactation Available pharmacodynamic/pharmacokinetic data in animals have shown excretion of clotrimazole/metabolites into milk. During treatment with clotrimazole, breastfeeding should be discontinued. Fertility Studies of the effect of clotrimazole on human fertility have not been conducted. Animal studies have not shown any effect on fertility Dosage and administrationFor external use. The cream should be applied in a thin layer 2-3 times a day on previously cleansed (using neutral pH soap) and dry affected areas for 2-4 weeks. The cream should be applied simultaneously to all affected areas. When applying the cream on the feet, they must be thoroughly washed, dried, and then applied to the areas between the toes. Patients should re-consult a doctor if symptoms do not improve after 7 days of treatment. Side effects The frequency of occurrence of adverse reactions is defined as follows: very often (≥ 1/10), often (from ≥ 1/100 to <1/10), infrequently (from ≥ 1/1,000 to < 1/100), rarely (from ≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), frequency unknown (frequency cannot be estimated from the available data). Immune system disorders: Frequency unknown: allergic reactions (such as urticaria, shortness of breath, arterial hypotension, syncope). Skin and subcutaneous tissue disorders: Not known: pruritus, rash, blisters, skin flaking, pain or discomfort, swelling, burning, irritation, erythema, tingling. If the listed adverse reactions occur, as well as reactions not mentioned in the instructions for medical use, you should contact your doctor. Overdose With external use of the drug, an overdose is unlikely. The use of clotrimazole in high doses does not cause any reactions and conditions that are life-threatening. The drug is not intended for oral administration. If by chance the cream is taken orally, anorexia, nausea, vomiting, abdominal pain, liver dysfunction are possible; rarely drowsiness, hallucinations, frequent urination, allergic skin reactions. In this case, it is necessary to carry out a gastric lavage and prescribe activated charcoal. In case of accidental contact of the cream with the eyes or mouth, immediately rinse them with water and consult a doctor as soon as possible. If the cream is swallowed, you should immediately consult a doctor. Interaction with other drugs Clotrimazole, applied topically to the mucous membranes of the external genital organs, can damage contraceptives made from latex (condoms and pessaries), and thereby weaken their effectiveness. Therefore, patients should use alternative methods of contraception during treatment with clotrimazole and for at least 5 days after its completion. Influence on the ability to drive a car and mechanisms Clotrimazole has no or very little effect on the ability to drive a car and mechanisms. Precautions Avoid applying the drug to the skin around the eyes. Do not swallow. All potentially infected areas of the skin must be treated at the same time. Propylene glycol, which is part of the cream, can cause skin irritation. Due to the presence of cetostearyl alcohol in the composition of the drug, the drug may cause local skin reactions (for example, contact dermatitis). PackingCream for external use 1%. 20 g of cream in an aluminum tube, varnished from the inside. 1 tube along with instructions for use in a cardboard box. Shelf life 3 years. Do not use after the expiration date. Storage conditions At temperatures below 25 ° C, out of the reach of children. Do not freeze. Release from pharmaciesWithout a prescription. 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