Composition, form of production and packaging
? The solution for external use is transparent, colorless, with the smell of ethanol.
100 ml
clindamycin hydrochloride 1.14 g,
which corresponds to the content of clindamycin 1 g
Excipients: ethanol (ethyl alcohol 96%) - 60.8 g, propylene glycol - 8.69 g, purified water - 17.37 g.
30 ml - bottles of dark glass with a dropper (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
Clindamycin is an antibiotic of the group of lincosamides, is active against all strains of Propionibacterium acnes, the minimum inhibitory concentration (MIC) is 0.4 Ојg / ml. Inhibits the synthesis of proteins in the microbial cell due to interaction with the 50S-subunits of the ribosomes. After application to the skin, the amount of free fatty acids on the skin surface decreases from about 14% to 2%.
PHARMACOKINETICS
Clindamycin rapidly accumulates in comedones, where it exhibits antibacterial activity.
The average concentration of antibiotic in the content of comedones after application of the solution is significantly higher than the minimum inhibitory concentration for all strains of Propionibacterium acnes, the causative agent of acne. After applying clindamycin hydrochloride solution to the skin in blood and urine, very low concentrations of clindamycin are determined.
INDICATIONS
- treatment of acne vulgaris (acne vulgaris).
DOSING MODE
Outwardly. The solution is applied to the affected area of ​​the previously cleaned and dried skin 2 times / day, morning and evening. The course of treatment: to obtain satisfactory results, treatment should be continued for 6-8 weeks, and if necessary, continue for up to 6 months.
SIDE EFFECT
The drug is usually well tolerated, however, local application of the solution may cause irritation (at the site of application), burning, itching, dry skin, erythema, scaling, increased sebum secretion, contact dermatitis. With resorption, there is a possibility of developing pseudomembranous enterocolitis.
CONTRAINDICATIONS
- Crohn's disease;
- ulcerative colitis (including in the anamnesis);
- pseudomembranous colitis (including in the anamnesis);
- Hypersensitivity to clindamycin or lincomycin, as well as other components of the drug in the anamnesis;
With caution : age to 12 years, lactation period, in patients with allergies, as well as with the simultaneous intake of muscle relaxants.
PREGNANCY AND LACTATION
Perhaps the dermal application of the solution during pregnancy, if the intended use for the mother exceeds the potential risk to the fetus. If it is necessary to use during lactation, it is recommended to stop breastfeeding.
APPLICATION FOR CHILDREN
With caution : age to 12 years.
SPECIAL INSTRUCTIONS
When using the drug should avoid contact with the eyes and the oral cavity, and after use it is necessary to wash your hands.
DRUG INTERACTION
It is not recommended that clindamycin chloride be used concomitantly with other acne treatment products containing exfoliating, softening and abrasive substances (eg benzoyl peroxide, tretinoin, resorcinol, salicylic acid, sulfur) because of the possible cumulative irritant effect on the skin.
Clindamycin and erythromycin are antagonists, as a result of which simultaneous use of these antibiotics is not recommended.
There is cross-resistance between clindamycin and lincomycin.
May enhance the effect of muscle relaxants, disrupting neuromuscular transmission.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
Store in a dry place, protected from light, out of reach of children, at a temperature of no higher than 25 В° C. Shelf life - 2 years.
