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Composition:


active ingredients: adapalene, clindamycin;


1 g of gel contains adapalene 1 mg, clindamycin (in the form of clindamycin phosphate) 10 mg;


excipients: disodium edetate, carbomer 940, propylene glycol, methyl parahydroxybenzoate (E 218), poloxamer 407, phenoxyethanol, sodium hydroxide, purified water.


Dosage form. Gel.


Basic physical and chemical properties: homogeneous gel of white or pale yellow color.


Pharmacotherapeutic group.


Topical acne medications.


ATX code D10A D53.


Pharmacological properties.


Pharmacodynamics. Adapalene is a derivative of naphthoic acid, a retinoid-like substance that modulates the processes of cellular differentiation and keratinization, as well as inflammatory processes of the skin, which make up the main pathogenetic links in the development of acne. Adapalene binds to the retinoid receptors of the cell nucleus and, thus, promotes normal differentiation of epithelial cells of follicles, which leads to a decrease in the formation of microcomedones and prevents the development of acne, helps to maintain intact skin.


The therapeutic effect of the drug usually manifests itself within 8-12 weeks from the start of treatment. When adapalene is used as a gel, the absorption of the drug through the skin into the blood is extremely low.


Clindamycin phosphate is a semi-synthetic antibiotic that acts as an inhibitor of bacterial protein synthesis by binding to the 50S subunit of ribosomes and inhibiting the process of initiating peptide chain formation. Clindamycin inhibits all Propionibacterium aspes cultures to be tested with a minimum inhibitory concentration of 0.4 mcg/ml. Cross-resistance between clindamycin and erythromycin was detected.


Pharmacokinetics. Not investigated.


Clinical characteristics.


Indications.


Topical treatment of common acne (acne vulgaris).


Contraindications.


Hypersensitivity to adapalene, clindamycin or other components of the drug, as well as to lincomycin. Enteritis, ulcerative colitis, antibiotic-associated colitis (in the Anamnesis), Crohn's disease.


Interactions with other drugs and other types of interactions.


Since the drug may have a local irritating effect in some patients, the simultaneous use of other potentially irritating topical medications increases the risk of undesirable effects on the skin.


Use the gel with caution with preparations containing sulfur, resorcinol or salicylic acid.


If it is necessary to use the drug together with other medications, apply the gel 1 time a day at night, and in the morning use other drugs.


Clindamycin has the property of blocking neuromuscular transmission, which can lead to an increase in the effect of other drugs with similar properties. Therefore, it should be used with caution in patients receiving such drugs. There is cross-resistance between clindamycin and lincomycin. Antagonism between erythromycin and clindamycin was also noted.


Application features.


The drug is intended for topical use only.


Avoid contact of the gel with the eyes, lips, areas of the wings of the nose and the skin around the eyes, as well as with the mucous membranes. If the gel accidentally gets on these areas, rinse them thoroughly with warm water.


Do not apply the gel to eczematous skin lesions, sunburn, cuts, or other skin lesions.


During treatment, excessive exposure to sunlight and ultraviolet light, including lamps, should be avoided, as the skin becomes more vulnerable and the risk of erythema from the sun increases.


Use during treatment of the drug together with cosmetics that dry the skin (abrasive or therapeutic soaps, skin cleansers, products containing excessive amounts of alcohol, astringents, creams or lotions for or after shaving, detergents) can lead to an irritating effect.


In case of an allergic reaction to any of the components of the drug, therapy should be discontinued and appropriate measures should be taken.


When clindamycin is applied topically, the antibiotic is absorbed from the skin surface. Diarrhea, blood-mixed diarrhea, and colitis (in particular pseudomembranous colitis) have been reported with external and systemic administration of clindamycin.


Studies show that the main cause of colitis associated with the use of antibiotics is a toxin produced by Clostridium. Colitis is usually characterized by severe persistent diarrhea and severe abdominal colic and can be accompanied by the release of blood and mucus. Pseudomembranous colitis can be detected by endoscopic examination. Fecal culture for Clostridium difficile and fecal analysis for the presence of Clostridium difficile toxin can help in the diagnosis of this disease.


If significant diarrhea develops, the drug should be discontinued. In cases of severe diarrhea, an endoscopic examination of the large intestine should be considered to establish an accurate diagnosis.


The use of peristalsis-suppressing agents, such as opiates and Diphenoxylate with atropine, may prolong and/or worsen this condition. Vancomycin has been found to be effective in the treatment of pseudomembranous colitis associated with the use of antibiotics caused by Clostridium difficile. The usual dose for adult patients is 500 mg to 2 g of vancomycin per day orally, divided into 3-4 doses, for 7-10 days. Cholestyramine or colestipol resins bind vancomycin in vitro. If concomitant use of resin and vancomycin is necessary, it is advisable to use each of these drugs at different times.


Given the potential for diarrhea, blood-mixed diarrhea, and pseudomembranous colitis, the doctor should decide whether it is appropriate to use other medications (see the sections "contraindications" and "adverse reactions").


It is necessary to avoid contact with the drug on the mucous membrane of the eyes and in the oral cavity. When applying the gel, wash your hands thoroughly. In case of accidental contact with sensitive surfaces (eyes, abrasions on the skin, mucous membranes), it is necessary to thoroughly rinse this area with cool water.


Oral and parenteral administration of clindamycin has been associated with the development of severe colitis, which can lead to death. Caution should be exercised when prescribing dosage forms of clindamycin phosphate for external use to patients with atopy.


Use during pregnancy or lactation.


Since adequate clinical trials regarding the safety of the drug in pregnant women have not been conducted, the gel should not be used during this period.


The use of the drug during breast-feeding is contraindicated.


Ability to influence the reaction rate when driving vehicles or other mechanisms.


It doesn't affect you.


Dosage and administration.


The drug should be used in adults and children over 12 years of age.


Apply the gel in a thin layer on clean, dry skin in places of rashes 1 time a day, at night.


During the first weeks of treatment, the acne process may worsen due to the effect of the active substance on the lesions that were previously invisible. In this case, treatment should not be discontinued, the therapeutic effect is observed 8-12 weeks after the start of treatment.


Children.


The safety and efficacy of the drug in children under 12 years of age have not been established, so the drug should not be used in children of this age category.


Overdose.


When applying the gel in excessive amounts, redness and peeling of the skin may occur.


Therapy is symptomatic.


Adverse reactions.


Redness, flaking, dryness, itching and burning of the skin at the site of applying the gel immediately after its application, which passes in the future. Allergic reactions, photosensitivity reactions, acne, tingling sensation, gram-negative folliculitis, gastrointestinal disorders, abdominal pain, urticaria, increased oiliness of the skin, contact dermatitis, burning eyes, occasionally there are adverse reactions in the form of diarrhea, diarrhea mixed with blood and colitis (including pseudomembranous colitis).

Tags: Deriva S® [Adapalene, Clindamycin]