Clotrimazole Cream 1% 15g

Form

kremi

Dosage mg

0.01

Pack

1

Clotrimazole 1% Cream 1. Trade name of the medicinal product: Clotrimazole 2. Qualitative and quantitative composition: Each tube contains 1% w/w Clotrimazole. Each 1 g of cream contains 10 mg of Clotrimazole. Excipient: Cetostearyl alcohol. For a full list of excipients, see section 6.1 3. Pharmaceutical form: Cream A smooth white cream. 4. Clinical data: 4.1 Indications for use: Intended for the treatment of the following: - All types of dermatomycoses caused by molds and other fungi (e.g., Trichophyton species), including dermatophytosis (ringworm); - All types of dermatomycoses caused by yeasts (Candida species), as well as athlete's foot (tinea pedis), pityriasis versicolor, erythrasma; - Secondary infections of skin diseases caused by these fungi; - Diaper dermatitis complicated by candidiasis, vulvitis, and balanitis. 4.2 Method of administration and dosage: Dosage: - There is no separate dosage regimen for adolescents and the elderly. Method of administration: The cream should be applied in a thin layer to the affected area 2-3 times a day and rubbed in well. A 0.5 mm strip of cream is sufficient to treat an area the size of the palm of the hand. In case of foot infection, the feet should be washed and dried, especially between the toes, before applying the cream. Treatment should continue for at least one month for dermatophytic infections and at least two weeks for candidal infections. 4.3 Contraindications: Hypersensitivity to the active substance or any of the excipients listed in section 6.1. Not to be used for nail or scalp infections. 4.4 Special warnings and precautions for use: This product contains cetostearyl alcohol, which may cause local skin reactions (e.g., contact dermatitis). 4.5 Interaction with other medicinal products: Contraceptives: Laboratory studies show that concomitant use may damage latex-containing contraceptives, thus reducing their effectiveness. In such cases, it is recommended to use alternative methods of contraception for at least 5 days after using this preparation. 4.6 Pregnancy, lactation and fertility: Pregnancy: Data on the use of Clotrimazole during pregnancy are limited. Animal studies have shown reproductive toxicity at high oral doses (see section 5.3). Due to minimal systemic absorption after topical application of Clotrimazole, adverse effects regarding reproductive toxicity are not predicted. The use of Clotrimazole during pregnancy is possible only under medical supervision. Lactation: Clinical data on the use of the drug in breastfeeding women are limited. Animal studies have shown that Clotrimazole is excreted in breast milk. The risk to the infant is not entirely excluded. The advisability of using the drug during breastfeeding should be decided individually after consulting a doctor. Fertility: Clinical studies on the effect of Clotrimazole on fertility in women have not been conducted. Data from animal studies have not revealed any effect of the drug on fertility. 4.7 Effects on ability to drive and use machines: The product does not affect the ability to drive or operate machinery. 4.8 Undesirable effects: Since the listed undesirable effects are based on spontaneous reports, it is not possible to determine the exact frequency for each of them. Immune system disorders: Anaphylactic reaction, angioneurotic edema, hypersensitivity. Vascular disorders: Syncope, hypotension. Respiratory, thoracic and mediastinal disorders: Dyspnea. Skin and subcutaneous tissue disorders: Blisters, contact dermatitis, erythema, paresthesia, skin exfoliation, itching, rash, urticaria, burning sensation of the skin. General disorders and administration site conditions: Irritation, application site reaction, edema, pain. Reporting of suspected adverse events: Reporting of suspected adverse reactions is important after the authorization of the medicinal product. It allows for continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions. 4.9 Overdose: There is no risk of acute intoxication, as overdose is not expected after topical application (when applying the drug to large areas of skin under conditions that increase absorption), nor after accidental oral intake. There is no specific antidote. In case of accidental oral intake, gastric lavage may rarely be necessary if a life-threatening dose has been ingested within the last hour, or if symptoms of overdose are present (e.g., dizziness, nausea, vomiting). Gastric lavage may be performed if adequate protection of the airways is ensured. 5. Pharmacological properties: 5.1 Pharmacodynamic properties: Pharmacotherapeutic group: Antifungal preparations for topical use, imidazole and triazole derivatives. Mechanism of action: Clotrimazole acts against fungi by inhibiting ergosterol synthesis. Inhibition of ergosterol synthesis leads to structural and functional impairment of the cytoplasmic membrane. Pharmacodynamic effects: Clotrimazole has a broad spectrum of antimycotic activity in vitro and in vivo, including dermatophytes, yeasts, molds, etc. Under appropriate test conditions, the minimum inhibitory concentration (MIC) values for these fungal species are less than 0.062-8.0 mg/mL substrate. The mechanism of action of Clotrimazole is predominantly fungistatic, fungicidal. depending on the concentration of Clotrimazole at the site of infection. In vitro activity is limited to the proliferation of fungal elements; fungal spores are only slightly sensitive. In addition to antimycotic activity, Clotrimazole also has activity against Trichomonas vaginalis, Gram-positive microorganisms (Streptococci/Staphylococci), and Gram-negative microorganisms (Bacteroides/Gardnerella vaginalis). In vitro, Clotrimazole inhibits the proliferation of Corynebacteria and Gram-positive cocci, except for enterococci, at substrate concentrations of 0.5-10 mg/mL. Resistant variants of sensitive fungal species are very rare; the development of secondary resistance by sensitive fungi has so far only been observed in isolated cases under therapeutic conditions. 5.2 Pharmacokinetic properties: Pharmacokinetic studies conducted after dermatological use showed that Clotrimazole is minimally absorbed into the human bloodstream from intact or inflamed skin. The peak serum concentration of Clotrimazole obtained in the study was below the limit of detection, 0.001 µg/mL. This means that topically applied Clotrimazole is unlikely to cause systemic effects or side effects. 5.3 Preclinical safety data: Based on preclinical study data, no hazards have been identified for humans with repeated use regarding toxicity, genotoxicity, and carcinogenicity. Clotrimazole was not teratogenic in reproductive toxicity studies in mice, rats, and rabbits. High-dose use in rats was associated with toxic effects on the maternal organism, fetal organism, reduced fetal weight, and decreased offspring viability. Rats showed excretion of Clotrimazole and/or its metabolites in milk at concentrations 10-20 times higher than plasma concentrations 4 hours after administration, with subsequent decrease to 0.4 of the indicated value after 24 hours. 6. Pharmaceutical details: 6.1 List of excipients: Cetostearyl alcohol, Cremophor A6, Cremophor A25, Methylparaben, Propylparaben, White soft paraffin, Propylene glycol, Liquid paraffin, and Purified water. 6.2 Incompatibilities: None 6.3 Shelf life: 24 months 6.4 Storage conditions: Store below 30°C. Protect from light and moisture. Keep the medicine out of reach of children. 6.5 Packaging, form and contents: Cream in a sealed laminated tube. One tube in a cardboard box. Pack sizes: 15 g. 6.6 Special precautions for disposal and handling: None Dispensing category: Pharmaceutical product group III, available without prescription.