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Active ingredients
Clindamycin
Release form
Gel
Composition
on 1 g: Active substances: clindamycin (in the form of phosphate) - 10 mg. Auxiliary substances: allantoin - 2 mg, methylparaben - 3 mg, propylene glycol - 50 mg, polyethylene glycol - 100 mg, carbomer 934P - 7.5 mg, sodium hydroxide solution 40 % - qs, purified water - qs up to 1 year
Pharmacological effect
An antibiotic of the group of lincosamides for local use. Clindamycin phosphate is not active in vitro, but after being applied to the skin, it is rapidly hydrolyzed by phosphatases in the ducts of the sebaceous glands to form clindamycin, which has antibacterial activity. The sensitivity of all studied strains of Propionibacterium acnes to clindamycin in vitro (MIC 0.4 μg / ml) was shown. After applying clindamycin on the skin, the amount of free fatty acids on the skin surface decreases from approximately 14% to 2%.
Pharmacokinetics
After topical administration of 1% clindamycin phosphate gel in the serum and urine, very low concentrations of clindamycin are determined. Clindamycin activity in comedoons in patients with acne vulgaris is shown. The average concentration of the antibiotic in comedone contents after applying a solution of clindamycin in isopropyl alcohol and water (10 mg / ml) for 4 weeks averaged 597 mcc / g of comedo content (0-1490 mcc / g). Pharmacokinetics in special groups of patients Studies have not included a sufficient number of patients over the age of 65 years to be able to assess whether there are differences in pharmacokinetics in elderly patients compared with younger patients.
Indications
- acne vulgaris.
Contraindications
- history of antibiotic-associated colitis; - age up to 12 years (safety and efficacy data are not available); - sensitivity to clindamycin or lincomycin in history.
Use during pregnancy and lactation
In animal studies with the introduction of clindamycin s / c or inside the deterioration of fertility, as well as any negative effects on the fetus is not detected, except in cases of use of the drug in doses toxic to the mother. The results of animal studies can not always be extrapolated to humans. In clinical studies with systemic administration of the drug to women in the second and third trimesters of pregnancy, there was no increase in the incidence of congenital fetal abnormalities. Research on the use of the drug in women in the first trimester of pregnancy has not been conducted.The drug 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 after external use. Clindamycin is found in breast milk after oral or parenteral administration, so during lactation you should either discontinue the drug or stop breastfeeding, given the degree of importance of the drug for the mother.
Dosage and administration
Outwardly. A thin layer of gel is applied to the affected area of clean, dry skin 2 times / day. To obtain satisfactory results, treatment should be continued for 6-8 weeks, and if necessary, can be continued for up to 6 months. If, after using the drug for several months, the effectiveness of therapy decreases, should take a break in treatment for 4 weeks.
Side effects
Classification of the frequency of adverse reactions: very often (≥1 / 10), often (≥1 / 100 and <1/10), infrequently (≥1 / 1000 and <1/100), rarely (≥1 / 10 000 and <1 / 1000), very rarely (<1/10 000), frequency unknown (impossible to determine based on available data). Infectious and parasitic diseases: frequency unknown - folliculitis. On the part of the organ of vision: frequency unknown - pain in the eyes. On the digestive side Systems: often - a violation of digestion; frequency is unknown - abdominal pain, pseudomembranous colitis. On the skin side: very often - dry skin, skin irritation, urticaria; often - seborrhea; frequency is unknown - contact dermatitis. If any of the side effects indicated in the instructions are aggravated or any other side effects that are not mentioned in the instructions are noted, the patient should immediately inform the doctor.
Overdose
Symptoms: when applied topically, clindamycin can be absorbed in quantities that cause systemic effects; possible systemic side effects include diarrhea, hemorrhagic diarrhea, including pseudomembranous colitis. Treatment: symptomatic and supportive therapy.
Interaction with other drugs
There is cross-resistance of microorganisms to clindamycin and lincomycin. Antagonism between clindamycin and erythromycin has been noted. It has been established that clindamycin disrupts neuromuscular transmission and, therefore, may enhance the effect of other muscle relaxants of peripheral action, therefore the drug should be used with caution in patients receiving drugs in this group.
special instructions
Avoid contact with the mucous membrane of the eyes and mouth. After applying the gel should wash hands thoroughly. In case of accidental contact with sensitive surfaces (eyes, skin abrasions, mucous membranes), this area should be thoroughly rinsed with cool water. The use of clindamycin (like other antibiotics) inside or parenterally is sometimes associated with the development of severe diarrhea and pseudomembranous colitis. With external use of clindamycin cases of diarrhea and colitis are rare, however, caution should be exercised, and with the development of severe or prolonged diarrhea, the drug should be canceled and, if necessary, appropriate diagnostic and therapeutic measures. Usually the onset of diarrhea, colitis, and pseudomembranous colitis occurs within a few weeks after oral and parenteral therapy with clindamycin is completed. In the case of severe diarrhea, the question of whether to have a colonoscopy should be addressed. Administration of drugs that reduce GI motility, such as opioid analgesics and diphenoxylate with atropine, can prolong and / or worsen the course of this complication. Vancomycin has been found to be effective against antibiotic-associated pseudomembranous colitis caused by Clostridium difficile. The usual dose, divided into 3-4 injections for adults, ranges from 500 mg to 2 g of vancomycin / day orally for 7–10 days. Effect on the ability to drive a car and control mechanisms There is no reason to believe that the use of the drug Dalacin; may affect the ability to drive and control machinery.