Zerkalin, 10 mg / ml, 30 ml

Jadran-Galensky Laboratories a.o., Croatia

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Product Overview

Structure

1 ml of the drug contains: 

Active substance :

clindamycin hydrochloride in terms of clindamycin anhydrous hydrochloride - 11.5 mg (corresponding to 10 mg of clindamycin). 

Excipients :

ethanol (ethyl alcohol 96%),

propylene glycol

purified water.

pharmachologic effect

Pharmacotherapeutic group

Antibiotic Lincosamide.

ATX Code: D10AF01 

Pharmacological properties

Pharmacodynamics

Clindamycin is an antibiotic of the lincosamide group, active against all strains of Propionibacteriumacacnes, the minimum inhibitory concentration (MIC) is 0.4 μg / ml. Inhibits protein synthesis in a microbial cell due to interaction with the 50S subunits of ribosomes. After application to the skin, the amount of free fatty acids on the surface of the skin decreases from about 14 to 2%. 

Pharmacokinetics

Clindamycin accumulates rapidly in comedones, where it exhibits antibacterial activity. The average concentration of antibiotic in the comedone content after application of the solution is significantly higher than the minimum inhibitory concentration for all strains of Propionibacteriumacnes, the causative agent of acne. After applying a solution of clindamycin hydrochloride in the blood plasma and urine to the skin, very low concentrations of clindamycin are determined.

 

Indications

The drug is used to treat acne (acnevulgaris).

Pregnancy and lactation

Perhaps the skin application of Zerkalin solution during pregnancy if the intended benefit to the mother outweighs the potential risk to the fetus. 
If necessary, use during lactation recommended the termination of breastfeeding.

Contraindications

  • ulcerative colitis (including history);
  • pseudomembranous colitis (including history);
  • Crohn's disease;
  • hypersensitivity to clindamycin or lincomycin, as well as other components of the drug Zerkalin history;

With caution: age up to 12 years, lactation, in patients with allergies, as well as while taking muscle relaxants.

Side effects

Classification of adverse reactions by organs and organ systems with an indication of the frequency of their occurrence: very often (≥1 / 10), often (≥1 / 100, <1/10), infrequently (≥ 1/1000, <1/100), rarely (≥1 / 10000, <1/1000), very rarely (<1/10000), including individual messages, the frequency is unknown (the frequency cannot be estimated based on the available data).

Disorders of the skin and subcutaneous tissue

Very common: dry skin, skin irritation, urticaria

Often: seborrhea

Frequency unknown: contact dermatitis.

Gastrointestinal Disorders

Infrequently: indigestion

Frequency unknown: pseudomembranous colitis, abdominal pain

Infectious and parasitic diseases

Frequency unknown: folliculitis.

Violations of the organ of vision

Frequency unknown: eye pain.

If any of the side effects specified in the instructions are aggravated or other side effects are noted that are not listed in the instructions, you should immediately inform your doctor.

Interaction

The simultaneous use of clindamycin with other preparations for the treatment of acne containing exfoliating, emollient and abrasive substances (e.g. benzoyl peroxide, tretinoin, resorcinol, salicylic acid, sulfur) is not recommended because of the possible irritating effect on the skin.

There is cross-resistance of microorganisms to clindamycin and lincomycin. Antagonism between clindamycin and erythromycin has been observed. It has been established that clindamycin during systemic use disrupts neuromuscular transmission and, therefore, can enhance the effect of other peripheral muscle relaxants, therefore, despite the external use of Zerkalin®, its blood level is significantly lower than after taking clindamycin by mouth, the drug should use with caution in patients receiving drugs of this group.

How to take, course of administration and dosage

Outwardly. The solution is applied to the affected area of ​​previously cleaned and dried skin 2 times a day, in the morning and in the evening.
 
The course of treatment: to obtain satisfactory results, treatment should be continued for 6-8 weeks, and if necessary, you can continue up to 6 months.
 
If, after treatment, improvement does not occur or new symptoms appear, it is necessary to consult a doctor.
 
Use the drug only according to the method of application and at the doses indicated in the instructions. If necessary, please consult your doctor before using the medicine.

Overdose

When applied topically, clindamycin can be absorbed in amounts that cause systemic effects.
 
Possible systemic side effects include diarrhea, hemorrhagic diarrhea, including pseudomembranous colitis.
 
In case of an overdose, symptomatic and supportive therapy is indicated.

Special instructions

Avoid getting the drug on the mucous membrane of the eyes and in the oral cavity. After applying the drug, wash your hands thoroughly. In case of accidental contact with sensitive surfaces (eyes, abrasions on the skin, mucous membranes), rinse this area with plenty of cool water.

The use of clindamycin (as well as other antibiotics) orally or parenterally in some cases is associated with the development of severe diarrhea and pseudomembranous colitis. With topical 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 discontinued and, if necessary, appropriate diagnostic and therapeutic measures should be taken.

If necessary, please consult your doctor before using the medicine.

Influence on the ability to drive vehicles, mechanisms

The drug Zerkalin® does not affect the ability to drive vehicles or engage in other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Release form

Solution for external use alcohol

Storage conditions

In a dry, dark place at a temperature of no higher than 25 ° C

Shelf life

2 years

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