Klenzit 0.1% 15g gel

The instruction for medical use of Klenzit Torgovoye medicine a name of Klenzit the International unlicensed name Adapalen Lekarstvennaya a form Gel, 0.1%, 15 g Structure of 1 g of drug contains active agent - adapalen 1.0 mg, excipients: dinatrium edetat, carbomer 940, propylene glycol, methylparaben, phenoxyethanol, half-oxameasures 407, sodium hydroxide, water purified. Description Opaque gel of white color. Pharmacotherapeutic Dermatology group. Anti-acne drugs. An anti-acne drugs for topical administration. Retinoids for topical treatment of acne rash. Adapalen. The ATX D10AD03 code the Pharmacological Pharmacokinetics Absorption properties of an adapalen through skin low, in clinical trials the level of an adapalen in plasma at prolonged use on big sites of skin made 0.15 ng/ml. Metabolites are removed with bile. The pharmacodynamics Adapalen is the synthetic retinoid derivative of naphthoic acid, possesses komedonolitichesky and anti-inflammatory action. Drug affects a follicular hyperkeratosis, regulating process of keratinization and desquamation, affects the opened and closed comedones, preventing formation of microcomedones. The main mechanism of action – selection linking with nuclear RAq-receptors of cells of epidermis as a result of which there is a decrease in stseplennost of epithelial cells to the mouth of a grease and hair follicle and reduction, prerequisites for formation of microcomedones. This mechanism regulates a final differentiation of keratinotsit that provides normalization of process of keratinization and reduction of prerequisites for forming of microcomedones. Has anti-inflammatory effect by inhibition of metabolism of arachidonic acid and migration of leukocytes in the inflammation center. Indications - acne rash easy and moderate severity, including in the presence of comedones, papules and pustules the Route of administration and doses Outwardly, apply once a day before going to bed to clean dry skin in places of rashes, evenly, light touch, avoiding hit in eyes and on lips. The clinical result comes in 4-8 weeks of treatment. Duration of treatment is determined by the dermatologist. Drug should not be used at patients with heavy acne rash. Side effects Often - burning sensation, reddening, peeling, irritation, xeroderma Seldom - contact dermatitis, discomfort of skin, sunblisters, an acne - allergic reactions, a photosensitization With an unknown frequency * - skin pain, a cutaneous dropsy, irritation a century, an erythema, an itching, swelling a century * post-marketing these Disturbances of the immune system Frequency is unknown - anaphylactic reaction, a Quincke's disease of Disturbance from skin and hypodermic fabrics Frequency is unknown - a burn on the place of applique (the majority of cases of a burn on the place of use were superficial burns, but cases with the second degree of a burn were described), hypoxanthopathy, the Contraindication skin hyperpegmentation - hypersensitivity to an adapalen or other components of drug - a liver and renal failure - the expressed lipidemia - pregnancy - the lactation period - children's age up to 12 years With care: dermatitis, seborrhea, eczema. Medicinal interactions Absorption of an adapalen through skin is low therefore its interaction with system medicines is improbable. It is not established interactions with other medicines which can be applied outwardly and along with the drug Klenzit gel. At Klenzit gel use in the evening, it is possible to use such drugs for external treatment of acne rash in the morning as erythromycin solutions (to 4%) or phosphate clindamycin (1%) or gels of benzoyl of water-based peroxide (up to 10%) as these drugs do not cause mutual degradation or cumulative irritation. Nevertheless, along with adapaleny it is not necessary to use other retinoids or drugs with the similar mechanism of action. Simultaneous use of the drug Klenzit, gel and means, for a peeling, the abrasive cleaning means and also means with drying, knitting or irritant action (aromatic or products that contain alcohol) is not recommended. Special instructions Within the first weeks of treatment the aggravation of acne process owing to impact of active agent on the defeat centers invisible is possible earlier. In the presence of irritation of skin drug should be used less often, or to temporarily stop use, or to stop drug use in general. It is necessary to avoid contact of Klenzit of gel with eyes, lips, sites of wings of a nose and with skin around eyes and also mucous membranes. If gel got on these sites, they should be washed with warm water carefully. It is not necessary to apply gel in dermatitis, on the eczematic, burned in the sun or damaged sites of skin, it is also not necessary to use it together with other keratolytic drugs of topical administration. It is necessary to avoid influence of UF and sunshine. Use during treatment of cosmetics which dry skin (as abrasive or medical soap, cleaners of skin, means containing excess amount of alcohol, astringents, creams or lotions for and after shaving, detergents) can cause the irritating effect. In case of developing of an allergy at drug treatment, therapy it is necessary to stop and see a doctor. After use it is necessary to close a tube cover densely. As a part of drug there is methylparahydroxybenzoate (methylparaben) which can cause allergic reactions of the slowed-down type. Filler propylene glycol can cause irritation of skin. Use in pediatrics the efficiency and safety of the drug Klenzit is not established, gel for children is younger than 12 years. Pregnancy and the period of a lactation of Primeneniye Klenzit, gel during pregnancy and the period of a lactation is not recommended. Throughout all course of treatment drug and 1 month later after treatment, it is necessary to use reliable means of contraception. It is not recommended to use drug in case of pregnancy planning. The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms does not influence driving or work with difficult technical devices. Overdose of Cases of overdose of Klenzit, gel it was not observed. Symptoms: strengthening of side effects – a dermahemia, peeling, feeling of discomfort. Treatment: to wash out the struck area, symptomatic therapy. A form of release and packing On 15 g in an aluminum tuba with the screw-on plastic cover. On 1 tuba together with the instruction for medical use in the state and Russian languages place in a pack from cardboard Storage conditions to Store at a temperature not above 25 °C. To store out of children's reach! 3 years not to apply a period of storage after an expiration date. Prescription status According to the prescription of Producer/Upakovshchik Glenmark Pharmasyyutikalz Ltd, the RAFT No. E 37.39, MIDS of Area, Saptur, Nasik – 422007, Maharashtra, India. The holder of the registration certificate of Glenmark Pharmasyyutikalz Ltd, India the Name, the address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan, the accepting claim (offer) on quality of medicines from consumers and responsible for post-registration observation of safety of medicine Representative office 'GLENMARK PHARMACEUTICALS LIMI-TED (GLENMARK PHARMATSEVTIKALS LIMITED)' in RK, 050005, Almaty, Al-Farabi Avenue, 7, business center of Nurla Tau, block 4 A, office 12. ph. + 7 (727) 311 04 41. Al. address: Safety.KZ&UZ@glenmarkpharma.com