Index of drugs

Topical acne treatment with existing comedones, papules and pustules in patients aged 12 years or older. The official guidelines on the proper use of antibacterial agents and acne treatment should be taken into account.

1 g of gel contains 10 mg (1%) of Clindamycin (in the form of phosphate) and 0.25 mg (0.025%) of tretinoin; the gel contains methyl and propyl p-hydroxybenzoates, butylhydroxytoluene.

Anti-acne treatment for external use. It is a combination of 2 active substances with different mechanisms of action. Clindamycin is a semi-synthetic derivative of Lincomycin with antibacterial activity. It was shown that under conditionsin vitro it works on bacteriaPropionibacterium acnes, which are one of the pathophysiological factors affecting the development of acne vulgaris. Clindamycin also has anti-inflammatory effects on acne vulgaris. Topical tintin has a comedolytic and anti-inflammatory effect. It reduces the integrity of epithelial cells of the hair follicles, as a result of which it inhibits the formation of micro-blackheads. In addition, it stimulates mitotic activity and accelerates the exchange of epithelial cells of the hair follicles, facilitating the excretion of blackheads. Comedolytic activity is associated with the normalization of the processes of exfoliation of the hair follicle epithelium. The anti-inflammatory activity of tretinoin is due to the inhibition of toll-like receptor (TLR) activity. Simultaneous treatment with both substances is therefore directed at many pathogenic factors: abnormal keratinisation of hair follicles, proliferationP. acnes, inflammation and increased production of sebum. The skin absorption of tretinoin contained in approximately 4 g of gel administered for 14 consecutive days was minimal; the plasma levels of tretinoin remained below the lower limit of quantification at any chosen time point after application of the gel or were close to the lower limit of quantification, with the values ​​found ranging from 1.0 to 1.6 ng / ml. The plasma clindamycin concentration was generally not more than 3.5 ng / ml. Neither a single dose nor long-term treatment with topical tretinoin changes the systemic retinoid concentration, which is maintained in the range of endogenous concentrations occurring in the body in natural conditions. Clindamycin is converted into the skin by phosphatases, resulting in the form of clindamycin with a stronger effect. The process of converting clindamycin is therefore the main determinant of the antimicrobial action of the drug in the skin layers after topical application of clindamycin phosphate.

Hypersensitivity to Clindamycin, Lincomycin, tretinoin or any of the excipients. Sectional enteritis, ulcerative colitis or history of post-antibiotic colitis. Skin cancer in a medical or family history. Occurring in the past: acute eczema, rosacea and peridural dermatitis. Severe form of nodular-cystic acne (acne acne and fulminant acne).

It is not recommended to use the drug to treat mild forms of acne vulgaris. Avoid contact of the gel with the mouth, eyes and mucous membranes as well as skin damaged or with eczema. Caution should be exercised when applying to the skin in sensitive areas. Use cautiously in patients prone to atopy. During the treatment, it is not recommended to use drugs or cosmetics that strongly dry the skin or are highly irritating (see interactions). During treatment, reduce exposure to sunlight and use appropriate products containing sunscreen, which SPF is at least 30, along with the proper protective clothing (eg hat). Do not use lamps or sunbeds during treatment. Patients with sunburn should not use this medicine until the burns heal.Patients who, due to their profession, may be forced to significantly expose to sunlight and patients naturally sensitive to the sun should take special care. If sunburn occurs, treatment should be discontinued until strong erythema and exfoliation have resolved. Using the drug in greater amounts or more often than is recommended may cause redness of the skin, burning sensation and discomfort. In case of severe irritation, especially at the beginning of treatment, the medication should be discontinued for some time or the frequency of application should be reduced. There have been sporadic cases of development of folliculitis induced by Gram-negative bacteria during treatment with topical preparations containing clindamycin at a concentration of 1% - if such changes occur, the gel should be discontinued and other medicines should be used. Prolonged use of clindamycin may cause the development of resistance and / or excessive growth of non-sensitive bacteria or fungi on the skin, although this is rare. Cross-resistance to other antibiotics such as lincomycin or Erythromycin may occur. In the event of long-term or severe diarrhea or systolic abdominal pain, treatment should be stopped immediately because these symptoms may indicate antibiotic colitis; appropriate diagnostic tests should be performed and then possible methods of treatment of colitis should be considered. Safety and efficacy have not been established in children <12 years of age - use is not recommended. Safety and efficacy have not been established in patients> 65 years of age. Excipients: methyl and propyl p-hydroxybenzoate can cause allergic reactions (probably of delayed type); butylhydroxytoluene may cause local skin reactions (eg contact dermatitis) or irritation of eyes and mucous membranes.

The drug is not recommended for use during pregnancy, especially during the first trimester. It can only be used in women of childbearing age when effective contraception is used during and for 1 month after treatment. Do not use during breast-feeding.

Uncommon: acne, dry skin, erythema, seborrhea, hypersensitivity to light, pruritus, rash, exfoliative rash, skin exfoliation, sunburn, reactions at the site of application (burning, dermatitis, dry skin, erythema). Rare: hypersensitivity reactions, hypothyroidism, headache, eye irritation, gastrointestinal inflammation, nausea, dermatitis, virus infectionherpes, skin rash, skin bleeding, skin burning sensation, loss of skin pigment, reactions at the application site (irritation, swelling, erosion, skin discoloration, itching, exfoliation), feeling hot, pain. In children and adolescents (12-17 years) skin dryness was observed slightly more often.

Outwardly. Adults and adolescents (aged ≥12 years): once a day before bedtime, wash the whole face with a mild soap and dry; on the fingertip, squeeze a portion of the pea-sized gel, apply it spot-on to the chin, cheeks, nose and forehead, and then gently spread over the whole face. The drug should not be used continuously for more than 12 weeks without careful assessment of the changes. It should be noted that improvement can only be seen after several weeks from the start of treatment. If you miss a dose, do not take a double dose to make up for a forgotten dose.Special groups of patients. Considering the low systemic exposure to clindamycin and tretinoin after topical application of the gel, no clinically significant systemic exposures are expected in the case of moderate renal or hepatic impairment; in the case of severe disorders, it is recommended to make decisions individually.