Effexel, gel 1 mg/g+25 mg/g 30 g

Pharmgroup:

The drug for the treatment of acne. Retinoid.

Pharmic action:

Effesel gel contains in its composition two active substances with different, but complementary, mechanisms of action.

Adapalen is a chemically stable naphthic acid derivative with retinoid-like action. Adapalene acts pathogenetically in acne vulgaris: it is a strong modulator of cell differentiation and keratinization processes and also has an anti-inflammatory effect.

The mechanism of action of the drug is based on adapalene’s binding to specific retinoic acid nuclear receptors.

The current data suggests that when applied topically, adapalene normalizes differentiation of follicle epithelial cells, thus reducing formation of microcomedones. In vitro adapalene inhibits chemotactic (directional) and chemokinetic (arbitrary) responses of human polymorphonuclear leukocytes and inhibits arachidonic acid metabolism and formation of inflammatory mediators.

According to in vitro studies adapalene inhibits AP-1 factors as well as the expression of toll-like receptor-2. Thus, we can say that adapalene reduces the cell-mediated inflammatory component of acne.

Benzoyl peroxide has antimicrobial effects, particularly against Propionibacterium acnes present in the salivary follicle of acne. It has an exfoliating and keratolytic effect. It has sebostatic action, preventing excessive production of sebum accompanying acne

Pharmacokinetics:

The pharmacokinetic properties of Effesel Gel are similar to the pharmacokinetics of Differin (adapalene) 0.1% gel for external use.

The penetration of benzoyl peroxide through the skin is low. It is completely converted to benzoic acid, which is rapidly eliminated from the body.

Indications

Common acne (vulgar), Acne

Effective in the local treatment of acne with comedones, papules and pustules.

Active ingredient

Adapalene, Benzoyl peroxide

Composition

1 g gel contains:

Active substances:

Adapalene – 0.001 g,
Benzoyl peroxide – 0.025 g.

Excipients:

Simulgel 600 RNA (acrylamide and acryloyldimethyl taurate copolymer 35-40%;
Isohexadecane 20-25%;
Polysorbate 80 5-10%;
Soroitan oleate 2.5%;
Water up to 100%) – 0.04 g;
Sodium docusate – 0.0005 g;
Dinatrium edetate – 0.001 g;
Glycerol – 0.
Polyoxamer 124 – 0.002 g;
Propylene glycol – 0.04 g;
Purified water – up to 1 g.

How to take, the dosage

Externally.
Apply a thin film with fingertips all over the affected area once a day in the evening on clean and dry skin, avoiding contact with eyes and mucosa of the lips.

Therapeutic effect develops after 1-4 weeks of treatment. The duration of treatment should be determined by the physician based on the clinical condition of the patient.

In case of signs of skin irritation, non-comedogenic products with a moisturizing effect are recommended, the number of applications could be reduced (e.g. every other day), the treatment could be temporarily suspended until the signs of irritation disappear or stopped completely.

Interaction

There have been no studies of interactions with other medicinal products. Based on the available experience with adapalene and oenzoyl peroxide, no interactions with other medications have been identified.

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

The penetration of benzoyl peroxide through the skin is low, and it is fully metabolized to benzoic acid, which is rapidly eliminated from the body. Because of this, the development of interactions between benzoic acid and systemic medications is unlikely.

Special Instructions

Effezel Gel should not be applied to skin that has been damaged by trauma (cuts or abrasions) or eczematous lesions.

Avoid contact with the eyes, mouth, nostrils and other mucous membranes. If the product gets into the eyes, rinse immediately with warm water. The drug contains propylene glycol (E1520), which may cause skin irritation. If hypersensitivity to any of the ingredients of the drug is suspected, the use of Effazel should be discontinued.

Excessive exposure to sunlight or UV radiation should be avoided. Contact with any dyed materials (including hair and dyed fabrics) should be avoided, as this can cause discoloration or discoloration.

Contraindications

Hypersensitivity or allergic reactions to the active ingredients or any of the ingredients of the drug.

Side effects

Frequency of side effects is distributed in the following order: frequently (1% to 10% of cases); infrequently (0.1% to 1% of cases).

Skin and subcutaneous fatty tissue:

Frequently: dry skin, irritable contact dermatitis, burning and skin irritation.
Infrequent: itching. sunburn.
Frequency unknown (postmarketing data):allergic contact dermatitis.

If skin irritation develops, its intensity is usually mild to moderate, with local tolerability symptoms (redness, dryness, peeling and burning). which peak during the first week of treatment and then go away spontaneously.

Overdose

Effexel should be applied only once a day.

In case of accidental ingestion, appropriate symptomatic treatment should be given.

Pregnancy use

Safety and efficacy have not been studied in children younger than 12 years of age.

Pregnancy

There are not enough data on the topical use of the combination of adapalene and benzoyl peroxide in pregnant women. However, the few available data collected from patients who received the drug in early pregnancy do not indicate any adverse effects.

The studies on the combination of adapalene and benzoyl peroxide in animals in which the drug was fed orally to animals showed toxic effects on the reproductive system at high systemic exposure.

In view of the limited data available and the possible poor skin penetration of adapalene. Effexel should not be used during pregnancy. Treatment should be discontinued if pregnancy occurs.

Lactation

There have been no studies of penetration of the drug into animal or human milk after topical application of Effesel Gel. Because systemic exposure of Effesel in breastfeeding women is negligible, no effect on breastfed infants is expected.

Effezel can be used during breastfeeding. Contact of the newborn with the drug, and application to the breast during breastfeeding should be avoided.