Clotrimazole Akrikhin ointment 1% 20g
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Active ingredients
Clotrimazole
Release form
Ointment
Composition
; ketoconazole 20 mg; Excipients: propylene glycol, carmellose sodium, castor oil, distilled monoglycerides, emulsifying wax, nipagin (methyl parahydroxybenzoate), dibunol (butyl hydroxytoluene), purified water. ;
Pharmacological effect
; Ketoconazole-Acre - antifungal agent. It has fungicidal and fungistatic effect. The mechanism of action is to inhibit the synthesis of ergosterol and changes in the lipid composition of the membrane. It is active against the pathogen of multi-colored depriving Malassezia furfur, the causative agents of several ringworms (Trichophyton, Epidermophyton floccosum, Microsporum), the causative agents of candidiasis (Candida), and the causative agents of systemic mycoses (Cryptococcus). ; Active also against gram-positive cocci: Staphylococcus spp., Streptococcus spp.
Pharmacokinetics
; Ketoconazole is a weak dibasic compound that dissolves and is absorbed in an acidic environment. Cmax of ketoconazole in plasma is about 3.5 mcg / ml and is achieved within 1-2 hours after a single oral dose of 200 mg during a meal. The bioavailability of ketoconazole is maximized when taken with food. Absorption of ketoconazole is reduced in patients with low acidity of gastric juice, for example, taking antacid drugs, such as aluminum hydroxide, and antisecretory drugs, such as histamine H2 receptor blockers and proton pump inhibitors, as well as in patients with achlorhydria, caused by a certain disease. ; Plasma protein binding, mainly with the albumin fraction, is 99%. Ketoconazole is widely distributed in the tissues, but only a small part of the drug penetrates into the cerebrospinal fluid. ; After absorption from the gastrointestinal tract, ketoconazole is metabolized in the liver to form a large number of inactive metabolites. In vitro studies have shown that CYP3A4 isoenzyme is involved in the metabolism of ketoconazole. The main metabolic pathways are the oxidation and cleavage of the imidazole and piperazine rings, oxidative O-dealkylation and aromatic hydroxylation. Ketoconazole is not an inducer of its own metabolism. Removal from plasma is biphasic: during the first 10 hours, T1 / 2 is 2 hours, subsequently - 8 hours.; About 13% is excreted in the urine, of which 2-4% - unchanged. Excreted mainly with bile in the digestive tract and about 57% excreted in the feces.
Indications
; Fungal diseases of the skin, mikozy skin folds, feet; ; pityriasis versicolor, erythrasma, superficial candidiasis caused by dermatophytes, yeast (including the genus Candida), mold and other fungi, and pathogens sensitive to clotrimazole; ; mycoses complicated by secondary pyoderma.
Contraindications
Hypersensitivity to clotrimazole, I trimester of pregnancy.
Use during pregnancy and lactation
; Contraindicated in the first trimester of pregnancy. ; In experimental studies, it was found that when used in high doses, clotrimazole has an embryotoxic effect. ; It is not known whether clotrimazole is excreted in breast milk. Although clotrimazole is not contraindicated for use during pregnancy and lactation, the potential risk should be considered when choosing antifungal therapy.
Dosage and administration
; When applied topically applied to the affected skin 2-3 times a day for 2-4 weeks. ; When processing the oral cavity is used 1-2 times a day for no more than 7 days. ; Intravaginal - 100-500 mg for 1-6 days.
Side effects
; Local reactions: contact allergic dermatitis, redness, burning sensation.
Interaction with other drugs
; Reduces the effect of polyene antibiotics (amphotericin, nystatin, natamycin, etc.). Para-hydroxybenzoic acid propyl ester in high concentrations enhances the antifungal effect of clotrimazole, and dexamethasone reduces it. ; With simultaneous use with nystatin, clotrimazole activity may be reduced.
special instructions
; To prevent the spread of urogenital infections requires simultaneous treatment of sexual partners. When trichomoniasis for a more successful treatment in conjunction with clotrimazole should be prescribed other drugs that have a systemic effect (for example, metronidazole inside). ; Vaginal pills are not recommended during menstruation. ; In the case of an unintended method of using the drug (orally), the following symptoms are possible - anorexia, nausea, vomiting, gastralgia, abnormal liver function, rarely drowsiness, hallucinations, pollakiuria, skin allergic reactions. In these situations, you must take activated charcoal and consult a doctor. ; If allergic reactions or irritation develops, treatment should be stopped and another therapy should be selected.; In case of ringworm, it is recommended to apply the solution after each washing of the feet. ; It is not recommended to apply the drug on the skin in the eye area. ; If no clinical improvement is noted after 4 weeks from the start of treatment, it is necessary to confirm the diagnosis microbiologically and exclude another cause of the disease.