Basiron AS, gel 2.5% 40 g

Baziron AC has high antimicrobial activity against Propionibacterium acnes and Staphylococcus epidermidis, has a comedolytic and anti-inflammatory effect, improves tissue oxygenation, suppresses sebum production in sebaceous glands, absorbs excess sebum and moisturizes the skin.

In in vivo studies on culture results, it has been shown to suppress Propionibacterium acnes culture growth by 94% by day 7 and 97-99% by day 15.

The anti-inflammatory effect of benzoyl peroxide is based on the inactivation of free radicals in the focus of inflammation and inhibition of free fatty acids.

The base of the product is an acrylate copolymer/glycerol complex to ensure controlled adsorption of excess sebum and the gradual release of glycerol to soften and moisturize the skin.

Pharmacokinetics

The penetration of benzoyl peroxide through the skin is low. Most of the benzoyl peroxide is converted to benzoic acid, which after absorption enters the systemic bloodstream and is rapidly excreted by the kidneys.

There is no cumulation in the tissues. Topical application of Basiron AS in therapeutic doses does not lead to adverse systemic effects.

Indications

Acne.

Pharmacological effect

Pharmacological action

Pharmacological group:
Acne rash treatment

ATX CODE: D10АЭ01.

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 is present in excessive amounts in acne-affected hair follicles. Benzoyl peroxide kills 94% of C. acnes bacteria after one week of use.

It has an exfoliative (exfoliating), comedolytic and keratolytic effect, improves tissue oxygenation, suppresses sebum production in the sebaceous glands.

Pharmacokinetics:
Skin penetration of benzoyl peroxide is low. The main part of benzoyl peroxide is converted into benzoic acid, which, after absorption, enters the systemic circulation and is quickly excreted by the kidneys.

There is no cumulation in tissues. Cutaneous use of Baziron® AS in therapeutic doses does not lead to systemic side effects.

Special instructions

When you first use the drug, you may experience a slight burning sensation, and within a few days you may experience redness and peeling of the skin. Most patients experience noticeable peeling of the skin in the first weeks of treatment. This is not dangerous and usually goes away within one or two days if treatment is stopped temporarily. If severe skin irritation occurs, reduce the frequency of application of the drug, temporarily or completely stop using the drug.

Symptoms such as swelling and blistering of the skin may occur when using benzoyl peroxide. In this case, it is necessary to stop treatment with the drug.

When applying the gel, avoid contact with the mucous membranes of the eyes, mouth and nose. If the drug accidentally gets on the mucous membranes, rinse them thoroughly with warm water. Care should be taken when applying the drug to the neck and other sensitive areas.

Avoid excessive exposure to sunlight and UV radiation, which are additional causes of skin irritation.

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.

INFLUENCE ON THE ABILITY TO DRIVE VEHICLES AND WORK WITH MECHANISMS
Gel Baziron® AC does not affect the ability to drive vehicles and operate machinery.

Active ingredient

Benzoyl peroxide

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, disodium edetate – 0.1 g, sodium docusate – 0.05 g, propylene glycol – 4.0 g, colloidal silicon dioxide – 0.021 g, sodium hydroxide – up to pH 5.1-5.5, purified water – up to 100 g.

Pregnancy

Pregnancy
Clinical experience with the topical use of benzoyl peroxide during pregnancy is absent or limited. There are also no data on its effects on reproductive function, fertility, or peri- and postnatal development, as well as the teratogenicity and embryotoxicity properties of the drug when used in animals. When used extensively clinically for the treatment of acne in mass concentrations up to 10% for several decades, benzoyl peroxide did not cause any effects on these parameters in humans. Benzoyl peroxide should only be used in pregnant women if clearly indicated after consultation with a doctor.

Breastfeeding period
It is not known whether benzoyl peroxide or its metabolites are excreted in human breast milk. A risk to newborns/infants cannot be excluded. To avoid contact of an infant with the drug during breastfeeding, avoid applying Baziron® AS gel to the chest area.

Contraindications

Hypersensitivity to one of the ingredients of the drug. Children under 12 years old.

Side Effects

All adverse reactions identified during clinical studies are associated with skin disorders. If the frequency of use of the drug is reduced or treatment is discontinued, they are reversible. The following categories are used to determine the incidence of adverse effects: very common (>1/10), common (>1/100 to 1/1,000 to 1/10,000 to <1/1,000), very rare (<1/10,000), unknown (frequency cannot be estimated based on available data).Disorders of the skin and subcutaneous tissues: very often: dry skin, erythema, peeling of the skin (desquamation), burning sensation of the skin; often: itching, skin soreness (pain, tingling), skin irritation (contact dermatitis); uncommon: allergic contact dermatitis
Cases of facial swelling and allergic reactions, including hypersensitivity at the application site and anaphylaxis with an unknown incidence, have also been reported during the post-marketing period.

If any of the side effects indicated in the instructions are aggravated or any other side effects not listed in the instructions are noted, you should immediately inform your doctor.

Interaction

There is no information on the interaction of benzoyl peroxide with other drugs that can be used externally and simultaneously with benzoyl peroxide. However, the simultaneous use of products with exfoliating, drying or irritating effects (for example, products containing alcohol) is not recommended.

Overdose

Benzoyl peroxide gel is a drug indicated for external use only. Excessive application of the drug will not lead to faster results or a more pronounced effect, but it may cause severe irritation. In this case, treatment with the drug should be stopped and appropriate symptomatic therapy should be prescribed.

Storage conditions

Store at a temperature not exceeding 25° C. Do not freeze. Keep out of the reach of children.

Shelf life

3 years

Manufacturer

Galderma Laboratories, France