Clintopic gel for nar. approx. (10mg+50mg)/g in tubes 15g per pack. #1

Name:
KLINTOPIK gel Composition 1 g of gel contains: Active substances: clindamycin (in the form of clindamycin phosphate) 10 mg, benzoyl peroxide anhydrous (in the form of benzoyl peroxide aqueous 77%) 50 mg. Excipients: carbomer (carbopol 980), dimethicone, sodium hydroxide, disodium lauryl sulfosuccinate, disodium edetate, glycerin, hydrated colloidal silicon dioxide, poloxamer 182, purified water.
Description:
An opaque gel that is white or white with a yellowish tint. Pharmacotherapeutic group and ATC code Acne topical preparations, D10AF51. Pharmacological propertiesPharmacodynamics Clindamycin is an antibiotic of the lincosamide group, which has a bacteriostatic effect against gram-positive aerobic microorganisms and a wide range of anaerobic bacteria. Lincosamides such as clindamycin bind to the 50S subunit of the bacterial ribosome. The action of clindamycin is mainly bacteriostatic, however, high concentrations may have a slow bactericidal effect against susceptible strains. Although clindamycin phosphate is inactive in vitro, rapid hydrolysis in vivo converts this compound to the antibacterial active clindamycin. The activity of clindamycin has been demonstrated in clinical studies in the treatment of comedones in patients with acne, sufficient for the activity of the drug against most strains of Propionibacteium acnes. Clindamycin in vivo inhibits all Propionibacteium acnes cultures tested (minimum inhibitory concentration (MIC) 0.4 μg/ml). After application of clindamycin, the percentage of free fatty acids on the surface of the skin is reduced from approximately 14 to 2%. Benzoyl peroxide has a mild keratolytic effect against comedones at all stages of their development. It is an oxidizing agent with bactericidal activity against Propionibacteium acnes, which is the cause of acne vulgaris. In addition, it is sebostatic, which counteracts the excessive production of sebum associated with acne. The combination of keratolytic and antibacterial action eliminates skin damage that occurs with mild to moderate acne vulgaris. The level of acquired resistance for particular organisms may vary by geographic location and time. Local resistance data should be taken into account, especially when treating serious infections. The inclusion of benzoyl peroxide reduces the potential for the emergence of clindamycin-resistant microorganisms. The presence of two active substances in the gel is more convenient to use and contributes to greater adherence to treatment by patients. Pharmacokinetics Absorption through the skin of clindamycin is negligible (0.043% of the applied dose). The presence of benzoyl peroxide in the composition of the drug does not affect the absorption of clindamycin. Radiolabeled studies have shown that absorption of benzoyl peroxide through the skin is possible only after it has been converted to benzoic acid. Benzoic acid is predominantly conjugated to form hippuric acid, which is excreted by the kidneys. Indications Acne of mild to moderate severity, especially with a predominance of inflammatory skin lesions. Dosage and administration For external use only. Adults and adolescents (age 12 years and older) Clintopic gel should be applied in a thin layer over the entire affected area once a day in the evening after the skin has been thoroughly cleansed with a mild cleanser and the skin has completely dried. The recommended period of use is from 2 to 5 weeks, but treatment with the drug should not exceed 12 weeks of continuous use. Children under 12 years of age The safety and efficacy of Clintopic Gel have not been studied in children under 12 years of age because acne vulgaris is very rare in this age group. Elderly patients There are no special recommendations for elderly patients. Side effects MedDRA convention for frequency Very common (≥1/10); frequent (≥1/100, <1/10); infrequent (≥1/1000, <1/100); rare (≥1/10000, <1/1000); very rare (<1/10000), with an unknown frequency (cannot be estimated from the available data). Immune system disorders: rare - allergic reactions, including hypersensitivity and anaphylactic reactions. Nervous system disorders: infrequent - paresthesia. From the gastrointestinal tract: with an unknown frequency - colitis (including pseudomembranous colitis), hemorrhagic diarrhea, diarrhea, abdominal pain. Skin and subcutaneous tissue disorders: very common - itching, burning sensation, dry skin in the area of application of the drug, erythema, peeling; frequent - dermatitis, photosensitivity in the area of application of the drug; infrequent - erythematous rash, aggravation of acne; with an unknown frequency - urticaria. General disorders and disorders at the injection site: frequent - pain in the area of application of the drug; with an unknown frequency - reactions in the application area, including discoloration of the skin. Contraindications - Hypersensitivity to clindamycin, lincomycin, benzoyl peroxide and / or to any of the components of the drug; - children's age up to 12 years; - lactation period; - Crohn's disease, ulcerative colitis, pseudomembranous colitis, including history. OverdoseSymptoms Excessive topical application of Clintopic gel can cause severe irritation. In such cases, stop using the drug until the signs of skin irritation disappear. When applied topically, benzoyl peroxide is mainly absorbed in an amount insufficient to cause systemic effects. With the local application of an excessive amount of clindamycin, its absorption may occur in an amount capable of causing systemic effects. In case of accidental ingestion of Clintopic gel, adverse reactions from the gastrointestinal tract may occur, similar to adverse reactions that occur with parenteral use of clindamycin. Treatment Apply appropriate symptomatic treatment to relieve irritation caused by the application of an excessive amount of the drug. In case of accidental ingestion, appropriate clinical attention is required. Precautions and application features Avoid getting the drug into the mouth, eyes, on the surface of the lips, other mucous membranes, as well as damaged and eczematous skin areas. It should be used with caution on sensitive areas of the skin. In case of accidental contact with the gel on these areas, they should be washed well with water. Clintopic gel should be used with caution in patients with atopic dermatitis who may experience increased skin dryness. During the first week of treatment, most patients experience increased flaking and redness of the skin. Depending on the severity of these side effects, patients may use moisturizers, temporarily reduce the frequency of use of Clintopic Gel, or temporarily discontinue use. The effectiveness of the drug when used with a frequency less than once a day has not been studied. The concomitant use of other topical acne treatments should be undertaken with caution due to the possible cumulative irritant effect, which can sometimes be severe, especially when exfoliating, desquamating, or abrasive ingredients are used concomitantly. If severe skin irritation occurs (for example, severe erythema, severe dryness of the skin and itching, severe stinging / burning), the drug should be discontinued. Since benzoyl peroxide can cause increased sensitivity to sunlight, you should avoid prolonged exposure to sunlight, and do not go to the solarium during the period of use of the drug. If exposure to the sun cannot be avoided, sunscreen cosmetics for the skin and clothing that protects from the sun's rays should be used. If the patient has sunburn, the use of the drug should be discontinued until the burns are cured. If prolonged or significant diarrhea occurs, or if the patient suffers from abdominal cramps, treatment with Clintopic should be stopped immediately, as these symptoms may indicate colitis associated with antibiotics. Appropriate diagnostic tests should be performed, such as determinations of Clostridium difficile and its toxin, as well as, if necessary, colonoscopy and consideration of treatment options for colitis. The drug can bleach hair, as well as colored or dyed material. Avoid contact with hair, fabrics, furniture or carpets. Clindamycin resistance Patients who have recently used parenteral or topical clindamycin or erythromycin are more likely to have propionobacteria and saprophytic flora with pre-existing antimicrobial resistance. Cross-resistance When using antibiotics alone, cross-resistance with other antibiotics such as lincomycin and erythromycin may occur. Use during pregnancy and breastfeeding The safety of using Clintopic gel in pregnant women has not been established. Therefore, it should be prescribed during pregnancy only if the expected benefit to the mother outweighs the potential risk to the fetus. It is not known whether clindamycin is excreted in breast milk when applied topically, but clindamycin has been reported in breast milk when administered orally and parenterally. Therefore, during breastfeeding, the drug is not used. Influence on the ability to drive vehicles or work with mechanisms The use of the drug does not affect the ability to drive vehicles and manage potentially dangerous mechanisms. Interactions with Other Drugs A cumulative irritant effect may occur when topical antibiotics, medical, plain or abrasive soaps and cosmetics that have a drying effect, as well as products with high concentrations of alcohol and/or astringents are used in combination. Clintopic gel should not be used in combination with preparations containing erythromycin due to possible antagonism with clindamycin. Clindamycin has been shown to have neuromuscular blocking properties that may potentiate the effects of other neuromuscular blockers. Therefore, it should be used with caution in patients treated with such drugs. The combined use of Clintopic gel with tretinoin, isotretinoin and tazarotene should be avoided, since benzoyl peroxide may reduce their effectiveness and increase irritation. If combined treatment is necessary, the drugs should be applied at different times of the day (for example, one in the morning, the other in the evening). Simultaneous use of preparations containing benzoyl peroxide and topical preparations containing sulfonamide may cause a temporary change in the color of the skin and hair on the head (yellow/orange). Release form, packingGel. 15 g of gel in an aluminum tube. One tube along with instructions for use in a cardboard box. Storage conditions Store between 2 oC and 8 oC. Keep out of the reach of children! Shelf life 18 months. Do not use the drug after the expiration date. Release conditions Released by doctor's prescription. Buy Clintopic gel d / nar. approx. (10mg+50mg)/g in tubes 15g per pack. No. 1 Price for Clintopic gel for nar. approx. (10mg+50mg)/g in tubes 15g per pack. No. 1 Instructions for use for Clintopic gel for nar. approx. (10mg+50mg)/g in tubes 15g per pack. #1