Effezel, gel for external use 1mg/g + 25mg/g 30

Composition

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of 1 g of gel contains:

Active ingredients:  

Adapalene – 0.001 g, Benzoyl peroxide-0.025 g. Excipients:

Simulgel 600 RNA (copolymer of acrylamide and acryloyl dimethyl taurate 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;Disodium edetate-0.001 g; Glycerol-0.04 g; Poloxamer 124-0.002 g; Propylene Glycol-0.04 g; Purified water-up to 1 g

Pharmacological action

Pharmaceutical group:

A drug for the treatment of acne. Retinoid.

Pharmaceutical action:  

Effezel gel contains two active substances with different, but complementary, mechanisms of action. Adapalene is a chemically stable derivative of naphthoic acid with a retinoid-like effect. Adapalene acts pathogenetically in acne vulgaris: it is a strong modulator of cellular differentiation and keratinization processes, and also has an anti-inflammatory effect.

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

Current data suggest that when applied topically, adapalene normalizes the process of differentiation of follicle epithelial cells, thus reducing the formation of microcomedones. In vitro, adapalene inhibits the chemotactic (directed) and chemokinetic (voluntary) responses of human polymorphonuclear leukocytes, as well as inhibits the metabolism of arachidonic acid and the formation of inflammatory mediators.

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

– Benzoyl peroxide has an antimicrobial effect, in particular, against Propionibacterium acnes, which is present in the sebaceous-hair follicle in acne. It has an exfoliating and keratolytic effect. It has a sebostatic effect, preventing excessive sebum production accompanying acne

Pharmacokinetics:  

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

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

Indications

It is effective in the topical treatment of acne with comedones, papules and pustules.

Use during pregnancy and lactation

The safety and efficacy of the drug have not been studied in children under 12 years of age.

Pregnancy Data on topical use of the combination of adapalene and benzoyl peroxide in pregnant women are not sufficient. However, several available data collected from patients treated with the drug in early pregnancy do not indicate any negative effects of the drug.

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

Due to the limited available data, as well as due to the possible weak penetration of adapalene through the skin. Effezel should not be used during pregnancy. In case of pregnancy, treatment should be discontinued.

Lactation Studies on the penetration of the drug into animal or human milk after skin application of Effezel gel have not been conducted. Since systemic exposure to Effezel in lactating women is negligible, no effect on breastfed children is expected.

Effezel can be used during breast-feeding. Avoid contact of the newborn with the drug, applying the drug to the breast when used during breastfeeding.

Contraindications

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

Side effects

The frequency of side effects is distributed in the following order: often (in 1% – 10% of cases); infrequently (in 0.1% – 1% of cases).

Skin and subcutaneous fat disorders: Common: dry skin, irritable contact dermatitis, burning and skin irritation. Infrequently: itching. sunburn. Frequency unknown (post-marketing data): allergic contact dermatitis.

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

Interaction

Interaction studies with other drugs have not been conducted. Based on the available experience with the use of adapalene and oenzoyl peroxide, interactions with other drugs were not detected.

However, other retinoids or benzoyl peroxide should not be used simultaneously. or drugs with a similar mechanism of action. Care should be taken when applying cosmetics with exfoliating, irritating or drying effects at the same time, because of the possible additional irritating effect.

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

Penetration of benzoyl peroxide through the skin is low, it is completely metabolized to benzoic acid, which is quickly eliminated from the body. In this regard, the development of interaction of benzoic acid with systemic drugs is unlikely.

How to take, course of use and dosage

Externally. Apply a thin film using your fingertips to the entire affected area once a day in the evening on clean and dry skin, avoiding contact with the eyes and lips.

The therapeutic effect develops after 1-4 weeks of treatment. The duration of treatment should be determined by the doctor based on the patient’s clinical condition.

In case of signs of skin irritation, the use of non-comedogenic products with a moisturizing effect is recommended. The number of applications can be reduced (for example, every other day), treatment can be temporarily suspended until the signs of irritation disappear or completely stopped.

Overdose

Effezel should only be applied once a day.

In case of accidental ingestion, appropriate symptomatic therapy should be performed.

Special instructions

-Do not apply Effezel gel to damaged or eczematous skin as a result of injuries (cuts or abrasions).

– Avoid contact with eyes, mouth, nostrils and other mucous membranes. If the drug gets into your eyes, immediately flush them with warm water. The product contains propylene glycol (E 1520), which can cause skin irritation. If hypersensitivity to any of the ingredients of the drug is suspected, the use of Effezel should be discontinued.

– Avoid excessive exposure to sunlight or UV radiation. Avoid contact with any colored materials (including hair and colored fabrics), as this may cause discoloration or discoloration.

Form of production

Gel for external use

Storage conditions

In a dark place, at a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Adapalene, Benzoyl Peroxide

Conditions of release from pharmacies

By prescription

Dosage form

gel for external use

Description

Children over 9 years old, For adults

Indications

Acne