Clotrimazole spray for external use 1% 20g №1

Name:
Clotrimazole spray dnar.prim.1% in vial 20g in pack No. 1
Description:
Transparent solution. The main active ingredient Clotrimazole Form spray for external use Dosage 1% 20 ml Pharmacological action Antifungal drugs for the treatment of skin diseases. imidazole derivatives. ATX CODE: D01AC01. Pharmacological action Clotrimazole is an imidazole derivative, a broad-spectrum antifungal agent; depending on the concentration, it has fungistatic or fungicidal properties. Clotrimazole inhibits the synthesis of ergosterol, which leads to the destruction of the fungal membrane and a change in its permeability. Clotrimazole is active against Epidermophyton floccosum, Microsporum, Trichophyton Corynebacterium, Blastomyces dermatitidis, Coccidioides immitis, Histoplasma capsulatum, Aspergillus, Candida, Torulosis glabrata, inhibate (fungistatic effect) at 1 µg/ml in vitro and more than 6 µg/ml in vivo. At a concentration of more than 10 µg/kg, the effect becomes fungicidal for most microorganisms. For Candida 2 µg/ml may be fungicidal. Less sensitive are Cryptococcus, Malassezia furfur, Paracoccidioides, Sporothrix, some Gram-positive organisms such as Staphylococcus aureus, Streptococcus pyogenes, Gram-negative organisms such as (Bacteroides/Gardnerella-vaginalis), Corynebacterium minutissima (eritrasma). Indications for useThe spray for external use is indicated for topical use in the treatment of the following diseases: ringworm caused by dermatophytes (Trichophyton, Microsporum, Epidermophyton) fungi (Candida), molds and other fungi (Malassezia furfur). skin diseases caused by fungi and superinfections: interdigital infections of the hands or feet (Tinea pedis, Tinea mannum), skin mycoses (Tinea corporis, Pityriasis versicolor), erythrasma, mycoses of skin folds (Tinea inguinalis, Tinea cruris). mycoses in the area of beard and mustache growth (Tinea barbae, Tinea capitis). Dosage and administration When using the vial with the drug for the first time, press the sprayer 2-3 times. Spray distance 5-10 cm. It is recommended to clean and dry the sprayer after each use. The spray must be applied 2-3 times a day on a thoroughly washed and dried affected skin area for 4 weeks. After application, gently massage the affected area of the skin to absorb the solution into the skin. Therapy should be continued for 2 weeks after the disappearance of the clinical symptoms of the disease. Symptoms usually disappear within a few days of starting treatment, but premature discontinuation or irregular use increases the risk of relapse. If after 7 days from the start of use there are no signs of improvement or the condition worsens, the initial diagnosis should be reconsidered. Duration of treatment: for interdigital mycoses – 2-3 weeks; for the rest of dermatomycosis – 3-4 weeks; versicolor versicolor – 1-3 weeks. Taking appropriate hygiene measures is very important for the treatment of interdigital mycoses. After washing the feet, the interdigital area must be well dried. The spray is applied to clean, dried skin. With interdigital mycoses, it is very important to follow the rules of hygiene, it is recommended to dust the socks and the inner surface of the shoes in the morning to avoid high humidity, sweating and prevent re-infection. For the treatment of onychomycosis, additional systemic treatment is necessary. Dose adjustment is not required for elderly patients and children over 5 years of age. The efficacy and safety of the use of clotrimazole in children under 5 years of age has not been established. Use during pregnancy and lactation There are no data that would prove the negative effect of the drug on pregnancy. It is not recommended to use the drug in the first trimester of pregnancy. The question of the advisability of using the drug in the II and III trimesters of pregnancy should be decided individually. Caution should be exercised when using the drug during lactation. Spraying directly on the mammary gland during lactation is not recommended. Influence on the ability to drive vehicles and work with special equipment Does not affect the patient’s ability to perform work that requires increased attention and speed of psychomotor reactions. Interaction with other drugs Clotrimazole may inhibit the action of other topical antifungal agents, especially polyene antibiotics (nystatin, natamycin). Dexamethasone, used in high doses, inhibits the antifungal action of clotrimazole. If deodorant or other cosmetics are applied to the affected area of the skin, a decrease in the effectiveness of the drug cannot be ruled out. The combination of clotrimazole with hydrocortisone in the treatment of skin infections caused by Trichophyton mentagrophytes is more effective than clotrimazole alone. Contraindications Hypersensitivity to clotrimazole and other components of the drug, children under 5 years of age. CompositionSpray contains: active substance: clotrimazole 10 mg/ml; excipients: polyethylene glycol 300, propylene glycol, isopropyl alcohol. 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 the spray is accidentally taken orally, anorexia, nausea, vomiting, abdominal pain, liver dysfunction are possible; rarely drowsiness, hallucinations, frequent urination, allergic skin reactions. In this case, symptomatic and supportive treatment is necessary. Special instructions The spray is for external use only. Before use, the affected area must be washed well (preferably with alkaline soap) and dried. If, when applying the spray, irritation occurs at the site of application and allergic reactions, treatment should be discontinued and appropriate symptomatic treatment prescribed. Avoid applying the drug to the area around the eyes, nose, mouth. Do not spray on open wounds and mucous membranes. In case of contact with eyes, rinse them with plenty of running water. The excipient propylene glycol may cause skin irritation. It is necessary to cut the affected nail plates short in the treatment of onychomycosis. For better penetration of the drug into the tissues of the surface of the nails, they must be rough. In the treatment of interdigital mycoses, it is recommended to dust the socks and the inner surface of the shoe with talc or other absorbent powder. When treating dermatomycosis, it is not recommended to wear clothes and shoes that do not allow moisture and heat to pass through. After washing, the affected areas must be thoroughly dried. Clothing that covers painful areas and towels should be changed daily and washed at 90°C (disposable towels are recommended). Use in children There are no adequate data from clinical studies on the topical use of clotrimazole in children, so therapy with the drug in this group of patients should be carried out with caution. Features of use in patients with impaired liver function, kidney function, elderly patients For patients with impaired liver function, kidney function, as well as elderly patients, a change in the dosage of the drug is not required. Side effects Local allergic reactions, burning sensation and tingling, itching, slight irritation at the site of application of the drug, erythema, blistering, swelling, peeling of the skin. In case of side effects, it is necessary to wash the skin with soap and warm water and stop treatment. Storage conditionsStore in the manufacturer’s packaging at a temperature not exceeding 25 °C. Keep out of the reach of children. 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