Composition
Active substance:
100 g of gel contains: benzoyl peroxide aqueous (in terms of benzoyl peroxide anhydrous)-2.5 g
Excipients:
Methacrylic acid copolymer - 2.0 g, poloxamer 182 - 0.2 g, carbomer 940 - 0.8 g, glycerol - 4.0 g, edetate dinatate - 0.1 g, sodium docusate - 0.05 g, propylene glycol - 4.0 g, colloidal silicon dioxide - 0.021 g, sodium hydroxide - to pH 5.1-5.5, purified water - up to 100 g.
Pharmacological action
Pharmacological action
Pharmacological group:
Acne rash remedy treatment
ATCH CODE: D10AE01.
Pharmacodynamics:
Benzoyl peroxide exhibits antimicrobial activity against Cutibacterium acnes (Propionibacterium acnes) and Staphylococcus epidermidis. Benzoyl peroxide has been shown to have potent broad-spectrum antimicrobial activity, particularly against Cutibacterium acnes (C. acnes), which are present in excessive amounts in hair follicles affected by acne. Benzoyl peroxide kills 94% of C. acnes bacteria after one week of use.
It has exfoliative (exfoliating), comedonal and keratolytic action, improves tissue oxygenation, suppresses sebum production in sebaceous glands.
Pharmacokinetics:
The penetration of benzoyl peroxide through the skin is low. The main part of benzoyl peroxide is converted into benzoic acid, which after absorption enters the systemic bloodstream and is rapidly excreted by the kidneys.
There is no cumulation in tissues. Topical application of Basiron® AS in therapeutic doses does not lead to side effects of systemic action.
Indications
Acne.
Use in pregnancy and lactation
Pregnancy
Clinical experience of external application of benzoyl peroxide in pregnancy is absent or limited. Data on its effect on reproductive function, fertility, or peri- and postnatal development, as well as properties of teratogenicity and embryotoxicity of the drug when used in animals are also absent. In large-scale clinical use for the treatment of acne in mass concentrations up to 10% for several decades, benzoyl peroxide has not caused effects on these parameters in humans. Benzoyl peroxide should be used in pregnant women only if clearly indicated after consultation with a physician.
Breastfeeding period
It is not known whether benzoyl peroxide or its metabolites are excreted with breast milk in humans. The risk to neonates/infants cannot be excluded. Application of Basiron® AC Gel to the breast area should be avoided during breastfeeding to avoid contact of the infant with the preparation.
Contraindications
Hypersensitivity to one of the ingredients of the drug. Children under 12 years of age.
Side effects
All undesirable reactions identified during clinical trials are associated with skin disorders. When reducing the frequency of use of the drug or withdrawal of treatment, they are reversible. The following categories are used to determine the frequency of adverse effects: very frequent (>1/10), frequent (>1/100 to < 1/10), infrequent (>1/1,000 to < 1/100), rare (>1/10,000 to < 1/1,000), very rare (< 1/10,000), unknown (frequency of occurrence cannot be estimated based on available data).
Skin and subcutaneous tissue disorders: very often: dry skin, erythema, skin peeling (desquamation), burning sensation of the skin; often: itching, skin soreness (pain, tingling), skin irritation (contact dermatitis); infrequently: allergic contact dermatitis
Facial swelling and allergic reactions, including hypersensitivity at the application site and anaphylaxis, have also been reported during the post-registration period with an unspecified incidence.
If any of the side effects mentioned in the instructions worsen or any other side effects not specified in the instructions are noted, a physician should be notified immediately.
Interaction
There is no information on the interaction of benzoyl peroxide with other medicinal products that can be used externally and simultaneously with benzoyl peroxide. However, the simultaneous use of products with exfoliating, drying or irritating effect (e.g. products containing alcohol) is not recommended.
How to take, course of treatment and dosage
For external use only.
With a light touch, apply the gel evenly to the affected area once or twice daily (morning and evening) on clean, dry skin. Patients with sensitive skin are recommended to apply the gel once a day in the evening. Therapeutic effect develops after 4 weeks of treatment, persistent improvement after 3 months of treatment.
A repeated course is possible after consultation with a doctor.
Overdose
Benzoyl peroxide gel is a preparation indicated for external application only. Excessive application of the drug will not lead to faster results or more pronounced effect, but severe irritation may occur. In such a case, treatment with the drug should be discontinued and appropriate symptomatic therapy should be administered.
Description
Often those who are faced with mild acne, try to cope with the disease on their own - they use cosmetics for sensitive facial skin, antiseptic solutions for acne and various masks from "black dots", etc. But sometimes even expensive cosmetics and other mass-market products do not have the expected effect - as a result, rashes do not disappear, but can progress and bring psychological discomfort.
The reason may be that acne is not so much a cosmetic problem, but a skin disease and one of the key factors in its development is the bacteria Cutibacterium acnes (C.acnes). That is why the fight against rashes requires not cosmetic products, but medicines with antimicrobial action, such as Basiron AC 2.5%.
Basiron® AC 2.5% - gel for the treatment of acne (pimples), which is suitable for sensitive skin prone to irritation. The drug is designed specifically for the treatment of acne and contains benzoyl peroxide - this substance has been successfully used in domestic and foreign medicine for more than a century.
Basiron® AC 2.5% acts comprehensively for mild acne:
- Destroys 94% of C.acnes bacteria after 1 week of application;
- Exfoliates;
- Reduces sebum production;
- Improves oxygen supply to tissues.
Basiron® AC 2.5% acne gel kills 94% of C.acnes bacteria after 1 week of use. It is not an antibiotic, remains effective with prolonged use and helps to achieve lasting improvement after 3 months of use. It is important to read the instructions and/or consult a physician before using the medication.
White or almost white homogeneous gel without foreign particles with a characteristic odor.
Special instructions
At the first application of the drug a slight burning sensation may occur, and within a few days - redness and peeling of the skin. Most patients experience noticeable flaking of the skin during the first weeks of treatment. This is not dangerous and usually resolves within one or two days with temporary discontinuation of treatment. If severe skin irritation occurs, the frequency of application should be reduced and the drug should be temporarily or completely discontinued.
When using benzoyl peroxide, such symptoms as swelling and blistering of the skin may occur. In this case it is necessary to stop treatment with the drug.
When applying the gel, avoid contact with mucous membranes of eyes, mouth and nose. In case of accidental contact of the drug with mucous membranes it is necessary to rinse them thoroughly with warm water. Caution should be exercised when applying the drug to the neck and other sensitive areas.
Excessive exposure to sunlight and UV radiation, which are additional causes of skin irritation, should be avoided.
Due to the risk of sensitization, benzoyl peroxide gel should not be applied to damaged skin.
Contact with dyed materials, including hair and dyed fabrics, may cause discoloration or discoloration.
EFFECT ON THE ABILITY TO DRIVE VEHICLES AND OPERATE MACHINERY
Basiron® AC Gel has no effect on the ability to drive vehicles and operate machinery.
Form of release
Gel for external use 2.5% by 40 g in a tube of low-density polyethylene with a tightly screw cap. One tube with instructions for use is placed in a cardboard pack.
Storage conditions
Store at a temperature not exceeding 25 ° C. Do not freeze. Keep out of reach of children.