Local treatment of maculopapular pustular pustular acne.
Composition:
1 g of gel contains 150 mg of azelaic acid. The drug contains benzoic acid and propylene glycol.
Action:
Anti-acne treatment for topical use. The mechanism of action of azelaic acid is unknown. researchin vitro andex vivo indicate that it can anti-inflammatory by limiting the formation of pro-inflammatory, free oxygen radicals. After topical application, azelaic acid penetrates all skin layers. Penetration is faster with damaged skin. Azelaic acid absorbed through the skin is excreted unchanged and metabolites in the urine.
Contraindications:
Hypersensitivity to azelaic acid or to any of the excipients.
Precautions:
Care should be taken to avoid contact with the eyes, mouth and other mucous membranes. Wash hands after each application. Do not use occlusive dressings and protective dressings. Due to the high sensitivity of facial skin with rosacea, during treatment with the gel should refrain from treatment with other topical preparations, as well as the use of skin care products that could cause local irritation, such as soaps, facials containing alcohol, medicated tinctures, astringents and abrasives for cleaning the skin. The gel is not recommended for use in children and adolescents under 18 years of age, due to the lack of data on the safety and efficacy of rosacea treatment. The drug contains benzoic acid (1 mg / g gel), which gently irritates the skin, eyes and mucous membranes and propylene glycol (120 mg / g gel), which can cause skin irritation.
Pregnancy and lactation:
Caution should be exercised when prescribing azelaic acid to pregnant women and breastfeeding mothers. There are no adequate and well-controlled studies with topically applied azelaic acid in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal / fetal development, parturition or postnatal development. Infants must not come into contact with the treated skin / breast.
Side effects:
Very common: pruritus, burning / pain at the place of use. Common: paraesthesia, dry skin, rash, swelling at the application site. Uncommon: acne, contact dermatitis; feeling of discomfort, erythema, urticaria at the place of use. In clinical trials, patients treated with azelaic acid in the form of an acne gel observed a change of color at the site of application, but were not observed in patients treated for rosacea, although this can not be excluded (frequency not known).
Dosage:
Externally on the skin. Apply to affected areas on the skin twice a day (morning and evening) and gently massage into thoroughly cleansed water and dried skin. About 0.5 g (= 2.5 cm) of gel is sufficient for the entire face area. The period of application may vary individually and depends on the severity of skin lesions. Usually, a marked improvement is visible after 4 weeks of treatment. For optimal results, the gel can be used for several months according to the clinical result. If skin irritation occurs, reduce the frequency or use of the gel once per day until the irritation subsides. If necessary, discontinue treatment for a few days. In the absence of improvement after 2 months of use or in the case of exacerbation of rosacea symptoms, discontinue use and consider other treatment options.
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