Adapalene + Clindamycin Ideya farm (Gel) Instructions for Use

Marketing Authorization Holder

Idea Pharm LLC (Russia)

Manufactured By

Oxford Laboratories, Pvt. Ltd. (India)

ATC Code

D10AX30 (Other combined drugs for the topical treatment of acne)

Active Substances

Clindamycin (Rec.INN registered by WHO)

Adapalene (Rec.INN registered by WHO)

Dosage Form

Adapalene + Clindamycin Ideya farm

Gel for external use 1 mg/g + 10 mg/g

Dosage Form, Packaging, and Composition

Gel for external use

15 g – tubes – cardboard packs – Over-the-Counter
30 g – tubes – cardboard packs – Over-the-Counter
50 g – tubes – cardboard packs – Over-the-Counter

Pharmacotherapeutic Group

Acne vulgaris treatment agent

Pharmacological Action

Combined drug for external use, the active substances of which are Adapalene and Clindamycin.

Adapalene is a retinoid metabolite with anti-inflammatory action and pronounced comedolytic activity (affects open and closed comedones), normalizes the processes of keratinization and epidermal differentiation. The mechanism of action of adapalene is based on interaction with specific γ-receptors of skin epidermal cells. As a result of the action of adapalene, the binding of follicular epidermal cells in the orifice of the sebaceous hair follicle decreases and their exfoliation accelerates, which reduces the likelihood of microcomedones formation. Adapalene has an anti-inflammatory effect in vivo and in vitro, affecting inflammatory factors by inhibiting leukocyte migration in the inflammation focus and arachidonic acid metabolism. It suppresses chemotaxis and chemokinetic reactions of human polymorphonuclear cells.

In the preparation containing microspherical Adapalene, the latter is enclosed in microspheres. Microspheres are round microscopic particles made of synthetic polymers. The use of microsphere technology reduces the likelihood of side effects and increases stability, increases bioavailability and efficacy of the drug. Microspheres have the properties of microsponges that encapsulate the active substance and provide its controlled release over time after applying the gel to the skin, combined with reduced irritation, improved photostability and increased penetration of the drug into the skin.

Clindamycin is a bacteriostatic antibiotic from the lincosamide group, has a broad spectrum of action, binds to the 50S subunit of the ribosomal membrane and suppresses protein synthesis in the microbial cell. Clindamycin is inactive in vitro, but after application to the skin it is rapidly hydrolyzed by phosphatases in the sebaceous gland ducts to form clindamycin, which has antibacterial activity. Sensitivity of all studied strains of Propionibacterium acnes to clindamycin in vitro has been shown (MIC 0.4 µg/ml). After application of clindamycin to 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). Elimination from the body occurs mainly with bile.

After external application of clindamycin phosphate, very low concentrations of clindamycin are determined in blood serum and urine.

Indications

Acne.

ICD codes

Dosage Regimen

The drug is applied externally. Before applying the gel, it is necessary to clean and dry the skin. Apply the gel evenly with a light touch to the affected areas of the skin once a day before bedtime, avoiding contact of the drug with the eyes, lips and other mucous membranes.

The therapeutic effect develops after 1-4 weeks. The course of therapy is 2-8 weeks. A repeated course of treatment is possible after consultation with a doctor.

Adverse Reactions

Skin and subcutaneous tissue disorders: dry skin, skin irritation, tingling, burning sensation, itching, erythema, contact dermatitis, discomfort sensation, photosensitivity at the site of drug application, skin peeling, skin soreness, skin swelling, increased sebum production, exacerbation of acne, urticaria.

Eye disorders: eyelid irritation, eyelid itching, eyelid swelling, eyelid erythema, burning sensation in the eyes.

Gastrointestinal disorders: abdominal pain, gastrointestinal disorders (diarrhea, nausea, vomiting).

Other: allergic reactions, folliculitis caused by gram-negative flora; rarely – possible development of pseudomembranous colitis.

Contraindications

Simultaneous use with medicinal products containing erythromycin; pregnancy; lactation period; age under 12 years (data on safety and efficacy are lacking); age under 18 years – for gel containing microspherical Adapalene (data on safety and efficacy are lacking); hypersensitivity to the components of the drug.

With caution: dermatitis, eczema, allergic diseases, simultaneous use of muscle relaxants, simultaneous use of drugs that have an irritating or drying effect on the skin.

Use in Pregnancy and Lactation

The use of the drug is contraindicated during pregnancy and lactation.

Pediatric Use

The use of the drug is contraindicated under the age of 12 years (data on safety and efficacy are lacking).

The gel containing microspherical Adapalene is contraindicated for use under the age of 18 years (data on safety and efficacy are lacking).

Special Precautions

In the initial stages of treatment, an exacerbation of acne may be observed, which disappears during the treatment. If skin irritation occurs, it is necessary to stop using the gel (temporarily or completely).

Excessive application of the gel does not lead to a faster or better result, while pronounced skin reactions may be noted – redness, peeling.

Avoid contact of the drug with the mucous membrane of the eyes and oral cavity. After applying the drug, wash hands thoroughly. In case of accidental contact with sensitive surfaces (eyes, mucous membranes, skin lesions), rinse this area abundantly with water.

The drug should not be used in the presence of skin lesions, eczema, as well as in patients with severe acne and with lesions of large areas of the body surface.

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

During therapy with the drug, direct sunlight should be avoided, as skin irritation may appear. If prolonged sun exposure is planned, the gel should not be applied the day before, as well as on the day of sun exposure and the following day.

Cases of diarrhea and colitis with external use of clindamycin are rare, nevertheless, 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 carried out.

Drug Interactions

Interaction studies with other medicinal products have not been conducted. Nevertheless, other retinoids or antibiotics for external use, or drugs with a similar mechanism of action should not be used simultaneously.

Since Adapalene may cause local skin irritation in some patients, to avoid a cumulative effect, simultaneous use with cosmetic products that have exfoliating, irritating or drying effects (medicated or abrasive soaps and cleansers; soaps and cosmetic products with a drying effect; perfumes, ethanol-containing products and others) is not recommended.

Caution should be exercised when used simultaneously with drugs that have an irritating or drying effect, including drugs containing sulfur, resorcinol or salicylic acid (possible enhancement of side effects).

The drug exhibits antagonism towards erythromycin.

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

There is cross-resistance of microorganisms to clindamycin and lincomycin.

It has been established that Clindamycin impairs neuromuscular transmission and, therefore, may enhance the effect of other peripheral muscle relaxants, so the drug should be used with caution in patients receiving drugs of this group.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.