Zerkalin external solution. 10mg / ml, 30ml vial cap.

Description

Composition
Active substance:
1 ml contains: Clindamycin hydrochloride based on the anhydrous clindamycin hydrochloride – 11.5 mg (corresponding to 10 mg of clindamycin).
Excipients:
Ethanol (ethyl alcohol 96%), propylene glycol, purified water.
Description:
Colorless transparent liquid with a characteristic odor.
Product form:
Topical solution, 10 mg / ml.
30 ml vial of dark glass with a dropper and a screw cap. Each vial-IV together with instructions for medical application is placed in a cardboard box.
Contraindications
Hypersensitivity to clindamycin or lincomycin history; in patients with antibiotic-associated colitis in history; age 12 years.
Carefully:
It should be used in patients with a predisposition to allergic reactions.
Indications
The drug used for the treatment of acne (acne vulgaris).
Interaction with other drugs
Not recommended simultaneous application of clindamycin with other drugs for the treatment of acne, containing exfoliating, softening and abrasives (e.g., benzoyl peroxide, tretinoin, resorcinol, salicylic acid, sulfur) because of possible irritant to the skin.
There is cross-resistance of microorganisms to clindamycin and lincomycin. antagonism was observed between clindamycin and erythromycin. It is found that clindamycin in systemic administration gives neuromuscular transmission and thus may enhance the action of other peripherally acting muscle relaxant, however, despite the fact that after topical application of the drug Zerkalin® its level in blood is significantly lower than after ingestion of clindamycin inwardly, the drug should be used with caution in patients receiving drugs in this group.
Overdose
When applied topically clindamycin can be absorbed in amounts that cause systemic effects. The possible systemic side effects include diarrhea, hemorrhagic diarrhea, including pseudomembranous colitis. In case of overdose shown holding symptomatic and supportive therapy.
pharmachologic effect
Pharmacological group:
Lincosamide antibiotic.
Pharmacodynamics:
Clindamycin – group lincosamides antibiotic, active against all strains of Propionibacterium acnes, the minimum inhibitory concentration (MIC) – 0.4 g / ml. It inhibits the synthesis of proteins in microbial cell through interaction with the 50S-ribosomal subunits. After application to the skin the amount of free fatty acids on the skin surface is reduced from about 14 to 2%.
Pharmacokinetics:
Clindamycin is rapidly accumulates in the comedones, which exhibits antibacterial activity. The average concentration of the antibiotic in the contents comedones after application of the solution significantly exceeds the index of the minimum inhibitory concentration for all strains of Propionibacterium acnes – causative agent of acne. After solution application to the skin of clindamycin hydrochloride in plasma and urine was determined by very low concentrations of clindamycin.
Pregnancy and breast-feeding
Clinical data on the use of the drug in pregnant and lactating women is limited. In experimental animal studies it has not been established clindamycin teratogenic and embryotoxic and foetotoxic effects were observed only after oral administration of clindamycin in high doses. As reproductive toxicity studies in animals do not always predictive of response in humans during pregnancy drug can be used if the potential benefit to the mother outweighs the potential risk to the fetus.
Despite the fact that after topical application of the drug Zerkalin® breastfeeding women its level in the blood is significantly lower than after administration of clindamycin in, the decision to terminate breast-feeding or terminate the use of the drug should be made based on an assessment of the importance of the drug to the mother and the risk for a child.
Conditions of supply of pharmacies
Without recipe.
side effects
Classification of adverse reactions to organs and organ systems indicating the frequency of occurrence: very often (> 1/10), often (> 1/100
special instructions
Avoid exposure of the drug to the mucous membrane of the eyes and mouth. After applying the product, wash hands. Accidental contact with sensitive surfaces (eyes, skin abrasions, mucous membranes) should be given area, rinse with cool water.
The use of clindamycin (and other antibiotics) orally or parenterally, in some cases associated with the development of severe diarrhea and pseudomembranous colitis. With topical clindamycin cases of diarrhea and colitis are rare, however, caution should be exercised, and to conduct appropriate diagnostic and therapeutic measures drug severe or prolonged diarrhea should be abolished in the development and, if necessary.
If necessary, please consult your physician before using the drug.
The effect on the ability to operate vehicles, machinery
Zerkalin® drug does not affect the ability to drive vehicles or to engage in other potentially hazardous activities that require high concentration and psychomotor speed reactions.
Storage conditions
Store at a temperature not higher than 25 C in the reach of children.
Dosing and Administration
Outwardly. The solution was applied to the affected area pretreated and dried skin 2 times a day, morning and evening.
The course of treatment to obtain satisfactory results, treatment should be continued for 6-8 weeks and can be extended to 6 months if necessary.
If after treatment there is no improvement or there are new symptoms, you should consult with your doctor.
Use drug only according to the application and in those doses which are specified in the instruction. If necessary, please consult your physician before using the drug.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist