Clenzite-C microspheres (Klenzit-C microspheres)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceAdapalene + ClindamycinAdapalene + Clindamycin
Dosage form: & nbspgel for external use
Composition:

1 g of gel contains:

Active substances:

Adapalene 10.0 mg microspheres comprising: adapalene micronized 1.0mg, methyl methacrylate, isobutyl methacrylate and ethylene glycol dimethacrylate crosspolymer ( "GANZPEARL GMP 0820") 9.0 mg.

Clindamycin phosphate 11.89 mg, equivalent to clindamycin 10.0 mg.

Excipients:

Disodium edetate 0.5 mg Carbomer 940 (Carbopol 940) 5.5 mg propyleneglycol 80.0 mg methyl parahydroxybenzoate 1.0 mg phenoxyethanol 2.5 mg Poloxamer 407 1.0 mg 1.0 mg sodium hydroxide, purified water up to 1 g.

Description:Homogeneous gel from white to white with a yellowish hue of color.
Pharmacotherapeutic group:Treatment for acne
ATX: & nbsp

D.10.A.X.30   Other drugs for topical treatment of acne in various combinations

Pharmacodynamics:

Combination drug for external use. The active substances of the drug "Clenzite-C microspheres" are adapalen and clindamycin.

Adapalen - retinoid metabolite, possessing a pronounced anti-inflammatory action and komedonoliticheskoy activity (effect on open and closed comedones), and normalizes the process of keratinisation of epidermal differentiation.

The mechanism of action of adapalene is based on interaction with specific receptors of skin epidermal cells. As a result of the action of adapalene, the binding of follicular epidermal cells to the mouth of the hair follicle and the acceleration of their exfoliation decrease, which reduces the likelihood of the formation of micro-medones. Adapalen has anti-inflammatory effect in vivo and in vitro, Influencing factors of inflammation by inhibiting migration of leukocytes in the focus of inflammation and the metabolism of arachidonic acid. Suppresses chemotaxis and chemokinetic reactions of polynucleated cells in humans. Adapalen in the preparation of Clenzite-C microsphere is concluded in microspheres. Microspheres are rounded microscopic particles made of synthetic polymers. The use of microsphere technology reduces the likelihood of side effects and increases stability, increases the bioavailability and effectiveness of the drug. The microspheres have the properties of micro-jaws that encapsulate the active substance and provide its time-controlled release after applying the micro-ice cream Clenzite-C to the skin in conjunction with the reduction of irritation,improvement of photostability and increased penetration of the drug into the skin.

Clindamycin phosphate - bacteriostatic antibiotic from the group of lincosamides, has a wide spectrum of action, binds to 50S subunit of the ribosomal membrane and suppresses protein synthesis in a microbial cell. Clindamycin inactive in vitro, but after application on the skin is rapidly hydrolyzed by phosphatases in the ducts of the sebaceous glands with the formation of clindamycin, which has antibacterial activity. The sensitivity of all strains studied Propionibacterium acnes to clindamycin in vitro (MIC of 0.4 μg / ml). After application of clindamycin on the skin, the amount of fatty acids on the skin surface decreases from 14% to 2%.

Pharmacokinetics:

Absorption of adapalene through the skin is very low (about 4% of the applied dose). Excretion from the body occurs mainly with bile. After external application of clindamycin phosphate in plasma and urine, very low concentrations of clindamycin are detected.

Indications:

Acne.

Contraindications:

- Hypersensitivity to the components of the drug;

- Simultaneous use with medicinal products containing erythromycin;

- Pregnancy;

- The period of breastfeeding;

- "Clenzite-C microspheres" is not recommended for use in children under the age of 18 (there is no data on efficacy and safety).

Carefully:

Dermatitis, eczema, allergic diseases, simultaneous reception of muscle relaxants, simultaneous use of drugs that have an irritant or drying effect on the skin. If you have any of the listed diseases, be sure to consult a doctor.

Pregnancy and lactation:

During pregnancy and breastfeeding, the use of the drug is contraindicated.

Dosing and Administration:

Outwardly. Before applying the "Clenzite-C microsphere" gel, it is necessary to clean and dry the skin. With a gentle touch, apply the gel evenly to the affected areas of the skin once a day before bedtime, avoiding getting the drug in the eyes, on the lips and other mucous membranes. The therapeutic effect develops after 1-4 weeks, the course of therapy is 4-8 weeks. Repeated treatment is possible after consultation with a doctor. When skin irritation occurs, treatment should be suspended until the signs of irritation disappear.

Side effects:

From the sense organs: a burning sensation in the eyes, irritation of the eyelids, itchy eyelids, swelling of the eyelids, erythema in the eyelid;

from the digestive system: abdominal pain, gastrointestinal disorders (diarrhea, nausea, vomiting);

from the skin: erythema, dryness and scaling of the skin, itching, burning, irritation of the skin, tingling, acne, contact dermatitis, increased production of sebaceous glands, urticaria, allergic reactions, sunburn (photosensitivity) at the site of the drug, discomfort, soreness of the skin, swelling skin;

Other: folliculitis caused by gram-negative flora;

In rare cases, it is possible to develop colitis.

Overdose:

With external application clindamycin can be absorbed in quantities that cause systemic effects. In case of an overdose, symptomatic and maintenance therapy is indicated. If you accidentally take the drug inside, you must rinse the stomach and immediately consult a doctor.

Interaction:

Investigation of interaction with other medicinal products was not carried out.However, do not use other retinoids or antibiotics for external use, or drugs with a similar mechanism of action.

Because the adapalen can cause local skin irritation in some patients, in order to avoid a cumulative effect, simultaneous use with other products that have a drying or irritating effect (therapeutic or abrasive soaps and detergents, soaps and cosmetic products with drying effect, perfumes, ethanol-containing agents, etc. is not recommended. .).

Caution should be exercised when combined with preparations that have an irritant or drying effect, including those containing sulfur, resorcinol or salicylic acid (possibly increasing side effects). It shows antagonism with erythromycin. Since systemic absorption of the drug with external application is negligible, any drug interactions with drugs used systemically are unlikely.

There is a cross-resistance of microorganisms to clindamycin and lincomycin. Determined that clindamycin violates the neuromuscular transmission and, consequently, can enhance the action of other peripheral muscle relaxants, so the drug should be used with caution in patients receiving drugs of this group.

Special instructions:

Excessive application of the gel does not lead to a faster or better result, at the same time, marked skin reactions - redness, peeling - can be noted. Avoid getting the drug on the mucous membrane of the eyes and the oral cavity. Wash hands thoroughly after application. If you accidentally contact Sensitive surfaces (eyes, mucous membranes, skin lesions) should be rinsed with plenty of water. In case of allergic reactions or severe irritation, the drug should be discontinued. The drug is not used in the presence of skin lesions, eczema, as well as in patients with severe acne and with the defeat of large areas of the body surface.

Avoid direct sunlight. may cause skin irritation. In case of prolonged exposure to the sun, do not apply the gel the day before, as well as on the day of the solar exposure and the subsequent day.

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.

Effect on the ability to drive transp. cf. and fur:

Not studied.

Form release / dosage:

Gel for external use.

Packaging:

For 15 grams or 30 grams per tube of laminated aluminum foil. Tuba with the instruction for use is placed in a cardboard box.

Storage conditions:

In the dark place at a temperature of 2 to 25 ° C. Keep out of the reach of children.

Shelf life:2 years. Do not use after the expiration date.
Terms of leave from pharmacies:On prescription
Registration number:LP-003034
Date of registration:15.06.2015 / 11.07.2017
Expiration Date:15.06.2020
The owner of the registration certificate:Glenmark Pharmaceuticals Co., Ltd.Glenmark Pharmaceuticals Co., Ltd. India
Manufacturer: & nbsp
Representation: & nbspGLENMARK IMPEX LLCGLENMARK IMPEX LLCRussia
Information update date: & nbsp25.01.2018
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