ACTION AND MECHANISM

- [ANTI-ACNE]. [TOPICAL ANTIBACTERIAL] active against Propionibacterium acnes, a microorganism involved in acne vulgaris. It is also [KERATOLYTIC] and [ANTISEBORRHEIC], counteracting hyperkeratinization and excess sebum secretion associated with acne.

SPECIAL WARNINGS

- If a reaction occurs that suggests sensitivity to any of the components, discontinue application.

SENIORS

No specifically geriatric information is available.

PATIENT ADVICE

- Avoid applying to damaged skin, eyes, and mouth. - Avoid contact with hair or dyed fabrics, as it may bleach them. - Avoid excessive exposure to sunlight or UV radiation. - Notify your doctor and/or pharmacist if you experience any symptoms of an allergic reaction. - Use caution when using exfoliating, irritating, or drying cosmetics, as they may enhance the irritating effect of benzoyl peroxide.

CONTRAINDICATIONS

- Hypersensitivity to benzoyl peroxide.

PREGNANCY

FDA Pregnancy Category C. It is not known whether it causes fetal harm when administered to pregnant women or if it affects reproductive capacity. However, topical administration is generally considered safe for use during pregnancy. Use in pregnant women only if clearly needed.

PHARMACOKINETICS

The percutaneous penetration of benzoyl peroxide is low; when applied to the skin, it is completely converted to benzoic acid which is rapidly eliminated in urine.

INDICATIONS

- [ACNE VULGAR] of moderate degree.

INTERACTIONS

No interactions have been described, and due to its low absorption, none are expected. However, it would be advisable to avoid co-administration with azelaic acid and exfoliating, irritating, or drying cosmetics.

LACTATION

It is unknown whether this drug is excreted in breast milk and what the possible effects may be on the infant. Use with caution.

CHILDREN

The safety and efficacy of this drug in children under 12 years of age have not been established. Use is not recommended in children under 12 years of age.

GUIDELINES FOR PROPER ADMINISTRATION

Apply a thin film of gel to freshly washed, dry skin using your fingertips, avoiding the eyes, mouth, nostrils, or mucous membranes. If it gets into the eyes, rinse immediately with lukewarm water. Do not apply to damaged or eczematous skin, or to cuts or abrasions. May cause discoloration, so avoid contact with any dyed materials (hair, fabrics).

POSOLOGY

Adults, topical use: Initial treatment: 1-2 applications daily to the freshly washed and dried affected area. In patients with very sensitive skin, it is advisable to start treatment with one application daily. It is recommended to begin with the lowest concentration and gradually increase it. Improvement may be observed within 4-6 weeks, although longer periods may be necessary.

PRECAUTIONS

- [WOUNDS]. Do not apply to damaged or eczematous skin, or to cuts or abrasions due to the possible risk of absorption. Avoid contact with the eyes, mouth, nostrils, or mucous membranes. If contact occurs, rinse immediately with lukewarm water. - [HYPERSENSITIVITY REACTIONS]. If a reaction occurs that suggests sensitivity to any of the components, discontinue use. - Use of cosmetics. Exercise caution when using cosmetics with exfoliating, irritating, or drying effects, as these may potentiate the irritating effects of benzoyl peroxide. - [PHOTOSENSITIVITY REACTIONS]. Benzoyl peroxide may cause photosensitivity. Avoid excessive exposure to sunlight or UV radiation. It is advisable to use sunscreen or protective clothing. - Avoid contact with the eyes, mucous membranes, inflamed or eroded skin, and hair. - May bleach hair and dyed or colored fabrics.

ADVERSE REACTIONS

The following may appear at the application site: - [WOUNDS]. [DRY SKIN], [SKIN PEELING], [ERYTHEMA] and occasionally [EDEMA]. - [HYPERSENSITIVITY REACTIONS]: [CONTACT DERMATITIS] (burning, stinging and redness). In case of excessive [SKIN IRRITATION], remove the product with soap and water, and do not reapply until the following day.

COMPOSITION

BENZOYL PEROXIDE: 50 MILLIGRAMS