Mirror - instructions for use, dose, side effects, contraindications

Pharmacodynamics:Clindamycin is an antibiotic of the lincosamides group, is active against all strains Propionibacterium acnes, the minimum inhibitory concentration (MIC) is 0.4 μg / ml. Inhibits the synthesis of proteins in the microbial cell due to interaction with the 508 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 Propionibacterium acnes - causative agent of acne. After applying clindamycin hydrochloride solution to the skin in blood and urine, very low concentrations of clindamycin are determined.

Indications:The drug is used to treat acne (acne vulgaris).

Contraindications:

- Hypersensitivity to clindamycin or lincomycin in the anamnesis;

- in patients with an antibiotic-associated colitis in the anamnesis;

- age up to 12 years.

Carefully:

With caution should be used in patients with a predisposition to allergic reactions.

Pregnancy and lactation:

Clinical data on the use of the drug in pregnant and lactating women are limited. In experimental studies on animals, teratogenic action of clindamycin was not established, and embryotoxic and fetotoxic effects were noted 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, during pregnancy the drug can be used if the potential benefit to the mother exceeds the possible risk to the fetus.

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

Dosing and Administration:

Outwardly. The solution is applied to the affected area of the previously cleaned and dried skin 2 times a day, in the morning and in the evening.

Course of treatment: to obtain satisfactory results, treatment should be continue for 6-8 weeks, and if necessary, you can continue up to 6 months. If there is no improvement after treatment or new symptoms appear, it is necessary to consult a doctor.

Use the drug only according to the method of administration and the doses specified in the instructions. If necessary, please consult with your doctor before using the medication.

Side effects:

Classification of adverse reactions in organs and organ systems, indicating 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 can not be estimated from the available data).

Disturbances from the skin and subcutaneous tissues

Very often: dry skin, skin irritation, urticaria.

Often: seborrhea.

Frequency unknown: contact dermatitis.

Disorders from the gastrointestinal tract

Infrequent digestion.

The frequency is unknown: pseudomembranous colitis, abdominal pain.

Infectious and parasitic diseases

Frequency unknown: folliculitis.

Disturbances on the part of the organ of sight

The frequency is unknown: pain in the eyes.

If any of the side effects indicated in the manual are aggravated or other side effects not indicated in the instructions are noted, they should immediately inform the doctor.

Overdose:With external application clindamycin can be absorbed in quantities that cause systemic effects. Possible systemic side effects include diarrhea, hemorrhagic diarrhea, including pseudomembranous colitis. In case of an overdose, symptomatic and maintenance therapy is indicated.

Interaction:

It is not recommended to use clindamycin concomitantly with other acne treatment products containing exfoliating, softening and abrasive substances (for example, benzoyl peroxide, tretinoin, resorcinol, salicylic acid, sulfur) due to possible irritant effects on the skin.

There is a cross-resistance of microorganisms to clindamycin and lincomycin. The antagonism between clindamycin and erythromycin was noted. Determined that clindamycin at systemic application violates neuromuscular transmission and, therefore,can enhance the action of other peripheral muscle relaxants, therefore, despite the fact that after external use of the drug Zerkaline®, its level in the blood is much lower than after taking clindamycin inwards, the drug should be used with caution in patients receiving drugs of this group.

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

The use of clindamycin (as well as other antibiotics) orally or parenterally in a number of cases is associated with the development of severe diarrhea and pseudomembranous colitis. With external application of clindamycin, the occurrence of diarrhea and colitis is rare, nevertheless, caution should be exercised, and with the development of severe or prolonged diarrhea, the drug should be discontinued and, if necessary, carried out the appropriate diagnostic and therapeutic measures.

If necessary, please consult with your doctor before using the medication.

Effect on the ability to drive transp. cf. and fur:Zerkaline® does not affect the ability to drive or engage in other potentially hazardous activities that require increased attention and speed of psychomotor reactions.

Form release / dosage:Solution for external use, 10 mg / ml

Packaging:

To 30 ml in a bottle of dark glass with a dropper and a screw cap. Each vial-dropper along with the instruction for medical use is placed in a cardboard box.

Storage conditions:Keep at a temperature not exceeding 25 ° C at inaccessible to children.

Shelf life:3 years. Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:PL-000534

Date of registration:12.05.2011 / 14.08.2017

Expiration Date:Unlimited

The owner of the registration certificate:Yadran Galensky Laboratories a.o.Yadran Galensky Laboratories a.o. Croatia

Manufacturer: & nbsp

JADRAN Galenski Laboratorij, d.d. Croatia

Representation: & nbspYadran Galen Laboratory as.Yadran Galen Laboratory as.Croatia

Information update date: & nbsp12.10.2017

Illustrated instructions

Instructions

Mirrorin® (Zerkalin®)