Active substanceAdapalene + ClindamycinAdapalene + Clindamycin
Dosage form: & nbspgel for external use
Composition:

1 g of gel contains:

Active substances: adapalene (micronized) 1 mg, clindamycin phosphate, equivalent to clindamycin 10 mg.

Excipients: disodium edetate 0.5 mg, carbomer 940 (carbopol 940) 5.5 mg, propylene glycol 80 mg, methyl parahydroxybenzoate 1.0 mg, phenoxyethanol 2.5 mg, poloxamer 407 1.0 mg, sodium hydroxide 0.78 mg, purified water up to 1 g.

Description:

Homogeneous gel of white 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 ingredients of which are adapalen and clindamycin.

Adapalen - retinoid metabolite, which has an anti-inflammatory effect and pronounced comedonolytic activity (affects open and closed comedones), normalizes the processes of keratinization and epidermal differentiation. The mechanism of action of the drug is based on the binding of adapalene to specific nuclear receptors of retinoic acid. Adapalen normalizes the process of differentiation of epithelial cells of follicles, thereby reducing the formation of microcosmodes. Suppresses chemotaxis and chemokinetic reactions of polynucleated cells in humans, and also inhibits the metabolism of arachidonic acid and the formation of inflammatory mediators. Thus, it can be said that under the influence of adapalene, the cellular-mediated inflammatory component of acne is reduced.

Clindamycin - 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 phosphate 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 (the maximum inhibitory concentration is 0.4 μg / ml).

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 serum and urine, very low concentrations of clindamycin are detected.

Indications:

Acne.

Before use, consult a physician.

Contraindications:

Hypersensitivity to the components of the drug, pregnancy, lactation, age under 12 years (safety and efficacy data are not available).

With simultaneous systemic (oral, intravenous, intramuscular) application of clindamycin: Crohn's disease, ulcerative colitis, pseudomembranous colitis, incl. in the anamnesis.

Carefully:Dermatitis, eczema, allergic diseases, simultaneous reception of muscle relaxants.
Pregnancy and lactation:

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

Dosing and Administration:

Outwardly. Before applying the Clenzite-C gel, you must 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 into the eyes and lips. The therapeutic effect develops after 1-4 weeks, the course of therapy is 2-4 weeks. Persistent improvement after 3 months of treatment.Repeated courses of treatment after consultation with a doctor.

Use the drug only according to the method of administration and at the doses specified in the instructions for use. If the gel is applied excessively, the positive effect does not occur sooner.

Side effects:

From the skin and subcutaneous fat: dry skin, irritation, burning sensation, erythema, contact dermatitis, discomfort, sunburn at the site of application, skin peeling, tenderness of the skin, swelling of the skin, increased production of sebaceous glands, urticaria.

From the side of the organs of sight: irritation of the eyelids, itchy eyelids, swelling of the eyelids, erythema in the eyelids, burning sensation in the eyes.

From the digestive system: abdominal pain, gastrointestinal disorders (diarrhea, nausea, vomiting).

Other: allergic reactions, folliculitis caused by gram-negative flora, it is possible the development of pseudomembranous colitis.

In case of skin irritation development, treatment should be suspended until irritation disappears or frequency of application is reduced.

Consult your doctor if you experience any of these side effects or other side effects,not mentioned above.

Overdose:

Overdose with adapalene is unlikely.

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:

There have been no studies of interaction with other drugs. However, do not use other retinoids or antibiotics for external use, or drugs with a similar mechanism of action.

Care should be taken when applying cosmetic products simultaneously with exfoliating, irritating or drying effects due to the possible additional irritating effect.

Absorption of adapalene through the skin is low, so the development of interaction with drugs of systemic action is unlikely.

After external application of clindamycin in serum and urine, very low concentrations of clindamycin are detected. There is a cross-resistance of microorganisms to clindamycin and lincomycin.The antagonism between clindamycin and erythromycin was noted. Determined that clindamycin violates the neuromuscular transmission and, consequently, can enhance the effect of other muscle relaxants of peripheral action, so the drug should be used with caution in patients receiving drugs of this group.

It is not recommended simultaneous reception with medications containing erythromycin.

Special instructions:

At the initial stages of treatment, there may be an aggravation of acne, which disappears during the treatment. If the skin irritates, stop using the gel (temporarily or completely).

Avoid contact with the eyes, oral cavity, nasal cavity and other mucous membranes. If the product is accidentally ingested in the eyes, mouth or nose should be rinsed immediately with warm water.

Excessive exposure to sunlight or ultraviolet radiation should be avoided. 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.

It is not recommended simultaneous use of cosmetics with drying or irritating effect (for example, cologne, perfume and other ethanol-containing products).

With external application of clindamycin, the occurrence of diarrhea and colitis is extremely rare, nevertheless, 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 taken. Pseudomembranous colitis can appear both on the background of long-term use, and 2-3 weeks after cessation of treatment; manifested diarrhea, leukocytosis, fever, pain in the abdomen (sometimes accompanied by secretions with bloody masses of blood and mucus). If these phenomena occur in mild cases, it is sufficient to cancel the treatment and apply ion-exchange resins (colestramine, colestipol), in severe cases, compensation for loss of fluid, electrolytes and protein, the appointment of vancomycin inwards or metronidazole is indicated. Do not use drugs that inhibit intestinal motility.

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

Not studied.

Form release / dosage:

Gel for external use.

Packaging:

In tubes of laminated foil of 15 g and 30 g each. One tube together with the instruction for use is placed in a cardboard box.

Storage conditions:

In the dark place at a temperature of 2 ° C to 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years. Do not use after expiry date.

Terms of leave from pharmacies:Without recipe
Registration number:LSR-005531/07
Date of registration:28.12.2007 / 23.05.2014
Expiration Date:Unlimited
The owner of the registration certificate:Glenmark Pharmaceuticals Co., Ltd.Glenmark Pharmaceuticals Co., Ltd. India
Manufacturer: & nbsp
Representation: & nbspGLENMARK PHARMACEUTICALS LTD. GLENMARK PHARMACEUTICALS LTD. India
Information update date: & nbsp25.01.2018
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