Zerkalin, vial 10 mg/ml, 30 ml

Composition

>

1 ml of the drug contains: 

Active ingredient:

clindamycin hydrochloride in terms of clindamycin hydrochloride anhydrous – 11.5 mg (corresponds to 10 mg of clindamycin).

Auxiliary substances:

ethanol (96% ethyl alcohol),

propylene glycol,

purified water..

Pharmacological action

Pharmacotherapy group

The antibiotic is lincosamide.

ATX code: D10AF01

Pharmacological properties

Pharmacodynamics

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

Pharmacokinetics

Clindamycin quickly accumulates in comedones, where it exhibits antibacterial activity. The average antibiotic concentration in the comedone content after applying the solution significantly exceeds the minimum suppressive concentration for all Propionibacteriumacnes strains-the causative agent of acne. After applying a solution of clindamycin hydrochloride to the skin, very low concentrations of clindamycin are detected in the blood plasma and urine.

Clinical pharmacology

Clinical data on the use of the drug in pregnant and lactating women are limited. In experimental animal studies, no teratogenic effects of clindamycin were established, and embryotoxic and fetotoxic effects were observed only after oral administration of clindamycin in high doses. Since studies of reproductive toxicity in animals do not always allow predicting a response in humans, the drug can be used during pregnancy if the potential benefit to the mother outweighs the possible risk to the fetus.

Despite the fact that after external use of the drug Zerkalin® in breast-feeding women, its blood level is significantly lower than after oral administration of clindamycin, the decision to stop breastfeeding or discontinue the drug should be made taking into account the assessment of the importance of the drug for the mother and the risk to the child.

Indications

The drug is used to treat acne (acnevulgaris).

Contraindications

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

With caution: under 12 years of age, lactation, in patients with allergies, as well as when taking muscle relaxants at the same time.

Side effects

Classification of adverse reactions by organ and organ system, indicating the frequency of their occurrence: very common (≥1/10), common (≥1/100, <1/10), infrequent (≥ 1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (

Skin and subcutaneous tissue disorders

Very common: dry skin, skin irritation, hives

Often: Seborrhea

Frequency unknown: contact dermatitis.

Disorders of the gastrointestinal tract

Infrequently: digestive disorders

Frequency unknown: pseudomembranous colitis, abdominal pain

Infectious and parasitic diseases

Frequency unknown: folliculitis.

Visual disturbances

Frequency unknown: eye pain.

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

Interaction

Concomitant use of clindamycin with other acne medications containing exfoliating, emollient, and abrasive substances (such as benzoyl peroxide, tretinoin, resorcinol, salicylic acid, and sulfur) is not recommended due to the possible irritant effect on the skin.

There is a cross-resistance of microorganisms to clindamycin and lincomycin. Antagonism between clindamycin and erythromycin was noted. Clindamycin has been shown to interfere with neuromuscular transmission during systemic administration and, therefore, may enhance the effect of other peripheral muscle relaxants. Therefore, despite the fact that after external administration of Zerkalin®, its blood level is significantly lower than after oral administration of clindamycin, the drug should be used with caution in patients receiving drugs of this group.

How to take, course of administration and dosage

Externally. The solution is applied to the affected area of pre-cleaned and dried skin 2 times a day, morning and evening. Course of treatment: for satisfactory results, treatment should be continued for 6-8 weeks, and if necessary, it can be continued for up to 6 months. If there is no improvement after treatment or new symptoms appear, you should consult your doctor. Use the drug only according to the method of use and in the doses indicated in the instructions. If necessary, please consult your doctor before using the medicine.

Overdose

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

Special instructions

Avoid contact with 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, skin abrasions, mucous membranes), the area should be thoroughly rinsed with 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. When clindamycin is used externally, cases of diarrhea and colitis are rare, however, caution should be exercised, and if severe or prolonged diarrhea develops, 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 and mechanisms

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

Form of production

Solution for external use of alcohol 10 mg / ml.30 ml in a dark glass bottle with a dropper and a screw-on lid. Each dropper bottle together with the instructions for medical use is placed in a cardboard box.

Storage conditions

Store at a temperature not exceeding 25 °C out of the reach of children.

Shelf

life is 3 years. Do not use after the expiration date.

Active ingredient

Clindamycin

Weight

Weight: 79 g.