Effezel gel for external use 1 mg + 25 mg g 30g
Condition: New product
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Active ingredients
Adapalen + Benzoyl Peroxide
Release form
Gel
Composition
Cream for external use 1 g active substance: terbinafine hydrochloride 10 mg (equivalent to 8.8 mg of terbinafine base) excipients: sodium hydroxide - 1.2 mg; benzyl alcohol - 10 mg; sorbitan stearate - 19 mg; cetyl palmitate - 20 mg; cetyl alcohol - 40 mg; cetostearyl alcohol (cetyl alcohol - 60%, stearyl alcohol - 40%) - 40 mg; polysorbate 60 - 61 mg; isopropyl myristate - 80 mg; purified water - 718.8 mg
Pharmacological effect
Effezel contains in its composition two active substances with different, however complementary, mechanisms of action. Adapalen. Adapalen 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 cell differentiation and keratinization, 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. Modern data suggest that when applied locally, adapalen regulates the process of differentiation of epithelial cells of the follicles, thus reducing the formation of microcomedo. In vitro adapalen inhibits chemotactic (directed) and chemokinetic (arbitrary) responses of human polymorphonuclear leukocytes, as well as inhibits arachidonic acid metabolism and the formation of inflammatory mediators. According to in vitro studies, adapalen inhibits AP-1 factors, as well as the expression of toll-like receptors-2. Thus, it can be said that the cell-mediated inflammatory component of acne is reduced under the influence of adapalene. Benzoyl peroxide. Benzoyl peroxide has an antimicrobial effect, in particular, against Propionibacterium acnes, present in the oil-hair follicle with acne. Provides exfoliating and keratolytic action. It has a sebiostatic effect, preventing excessive sebum production that accompanies acne.
Pharmacokinetics
The absorption of adapalene through the skin is very low (about 4% of the applied dose). Excretion from the body occurs mainly through bile.Benzoyl peroxide penetration through the skin is low. It is completely converted into benzoic acid, which is rapidly excreted from the body.
Indications
Acne treatment with comedones, papules and pustules.
Contraindications
Hypersensitivity to the active substances or any of the components of the drug; Children's age up to 9 years (safety and efficacy of the drug has not been established).
Use during pregnancy and lactation
Pregnancy Studies on animals in which adapalen was taken orally in high doses showed toxic effects on the reproductive system. Clinical experience with the external use of a combination of adapalene and benzoyl peroxide during pregnancy is limited, but the poorly available data collected from patients who received the drug in early pregnancy do not indicate any of its negative effects. Due to the limited nature of the data available, and also due to the possibility of insignificant penetration of adapalene through the skin, Effezel should not be used during pregnancy. If pregnancy occurs, treatment should be discontinued. The period of breastfeeding Studies of the penetration of the drug into the milk of animals or humans after dermal application of the gel Effesel was not conducted. Since the systemic exposure of the combination of adapalene and benzoyl peroxide in breastfeeding women is insignificant, no effect on breastfed infants is expected. Effezel can be applied during breastfeeding. Contact of the infant with the drug, application of the drug on the chest when used during breastfeeding should be avoided.
Dosage and administration
Outwardly. Apply a thin layer using fingertips to the entire affected surface once a day in the evening on clean and dry skin, avoiding contact of the gel in the eyes, on the lips, mucous membranes and corners of the nose. The therapeutic effect develops after 1-4 weeks of treatment. The duration of treatment should be determined by the doctor based on the clinical condition of the patient. In case of signs of skin irritation, the use of non-comedogenic cosmetics with a moisturizing effect is recommended, depending on the degree of skin irritation, the number of applications can be reduced (for example,every other day), treatment may be temporarily suspended until the signs of irritation disappear or are completely stopped. The resumption of treatment is possible after consulting a doctor.
Side effects
When using the drug Effezel, the following undesirable reactions may occur in the place of its application, presented in the table in accordance with the classification by organ systems and frequency of occurrence: very often (≥ 1/10), often (≥ 1 / 100- <1/10) , infrequently (≥ 1 / 1000- <1/100), rarely (≥ 1 / 10000- <1/1000), very rarely (<1/10000), the frequency is unknown (cannot be estimated based on the available data): Violations on the part of the organ of vision Unknown Hypostasis of the eyelids Disturbances on the part of the respiratory system, organs of the chest and mediastinum Unknown Sensation of constriction in throat Disorders of the skin and subcutaneous tissues often (≥ 1 / 100- <1/10) Dry skin, contact dermatitis, skin irritation, burning sensation of the skin, erythema, peeling of the skin, rash infrequently (≥ 1 / 1000- <1/100 ) Itching, sunburn Unknown Allergic contact dermatitis, swelling of the face, skin soreness (tingling sensation), blisters (vesicles) When using the drug Effezel, as a rule, during the first week of treatment, symptoms such as skin irritation, redness, dryness, peeling, burning and soreness of the skin (tingling sensation Ia), mild or moderate severity, which pass spontaneously and require drug discontinuation. If any of the side effects indicated in the instructions are aggravated, or any other side effects that are not indicated in the instructions are noted, you should immediately inform your doctor.
Overdose
Effesel should be applied only once a day. If accidentally swallowed, appropriate symptomatic therapy should be carried out.
Interaction with other drugs
Research interaction with other drugs was not conducted. Based on the experience of using adapalene and benzoyl peroxide, no interactions with other drugs have been identified. However, it is not necessary to use other retinoids or benzoyl peroxide, or drugs with a similar mechanism of action, along with the drug Effezel. Care should be taken when applying cosmetics with a peeling, irritating or drying effect at the same time due to the possible additional irritating effect. The absorption of adapalene through the skin is low, so its interaction with systemic drugs is unlikely.Benzoyl peroxide penetration through the skin is low, it is fully metabolized to benzoic acid, which is rapidly excreted from the body. In this regard, the interaction of benzoic acid with systemic drugs is unlikely.
special instructions
Do not apply Effesel gel on injured skin (cuts or abrasions) or eczematous altered skin. Avoid contact with eyes, oral cavity, nostrils and other mucous membranes. In case of contact with eyes, rinse immediately with warm water. The drug contains propylene glycol (E1520), which can cause skin irritation. If you suspect a hypersensitivity to any of the ingredients of the drug use of the drug Effezel should be discontinued. Excessive exposure to sunlight or artificial UV light should be avoided. Contact with any dyed materials (including hair and dyed fabrics) should be avoided, as this may cause discoloration or discoloration.