Skinoren cream 20% 30 g

Description

Composition
Active substance:
1 g of cream contains: azelaic acid 0.2 g
Excipients:
Benzoic acid 0.002 g, 0.05 g of macrogol glyceryl stearate, glyceryl stearate mixture, cetostearyl alcohol, cetyl palmitate and glycerides of coconut oil fatty acids 0.07 g, tsetostearil etilkapronat 0.03 g propylene glycol 0.125 g, 85% glycerol 0.015 g, 0.508 Purified water city
Description:
White opaque homogeneous cream.
Product form:
Cream for external use of 20% to 30 g of an aluminum tube, sealed with a membrane-closed screw-on plastic cap. The tube together with instructions for use placed in a cardboard box.
Contraindications
Hypersensitivity to azelaic acid and other ingredients; Children up to age 12 years (acne), 18 years (hyperpigmentation such as melasma).
Carefully.
In bronchial asthma.
Dosage
200mg / g
Indications
Acne mild to moderate severity, including the presence of papules and pustules.
Hyperpigmentation type melasma, chloasma example.
Interaction with other drugs
Clinically significant interactions not revealed when using Skinoren® preparation.
Overdose
Until now, data on overdose are available.
pharmachologic effect
Pharmacological group:
Acne treatment for rashes.
Pharmacodynamics:
Azelaic acid in the treatment of acne normalize the disturbed keratinization processes in the follicles of the sebaceous glands, reducing the content of free fatty acids in the skin lipids. Shows antimicrobial activity against Propionobacterium acnes and Staphylococcus epidermidis. The antiinflammatory effect is also due to the decrease of neutrophil metabolism and decreased production of free radical forms of oxygen. Azelaic acid has a dose-dependent and time from the inhibitory effect on the growth and viability of abnormal melanocytes. Molecular mechanisms of this effect is not fully established. Existing data suggest that the main effect of azelaic acid in the treatment of melasma associated with inhibition of DNA synthesis and / or cellular respiration in abnormal melanocytes.
Pharmacokinetics:
After application to the skin azelaic acid penetrates into the epidermis and dermis, the penetration into the damaged skin is faster than in intact. After a single topical application 5 g of the cream 3.6% of the total dose of azelaic acid enters the systemic circulation. Part suck acid excreted by the kidneys in unchanged form part – in the form of dicarboxylic acids (C7, C5) formed as a result of beta-oxidation.
Pregnancy and breast-feeding
Use of the drug during pregnancy and lactation is possible only after consultation with your doctor.
Adequate and well-controlled studies with topical azelaic acid have not been conducted in pregnant women. The study on animals showed no adverse effects of azelaic acid with respect to pregnancy, fetal development, birth or postnatal development. The potential risk for humans is unknown. In pregnancy, the drug Skinoren® used only if the expected benefit to the mother outweighs the potential risk to the fetus. It is not known whether azelaic acid into breast milk. Given the low systemic absorption of azelaic acid when applied externally, during breastfeeding Skinoren® drug is used only if the expected benefit to the mother outweighs the potential risk to the child. Breastfeeding should avoid applying the product to the breast before feeding, should avoid contact with the skin of children, including those with breast skin after applying the product
Skinoren.
Conditions of supply of pharmacies
Without a prescription.
side effects
Observed in the clinical studies and post-marketing surveillance in the most common side effects were: burning, pruritus and erythema at the site of application.
Disorders of immune system: the frequency is unknown – the reaction of hypersensitivity (including angioneurotic edema, contact dermatitis, edema of the eyes, facial swelling), exacerbation of asthma.
Violations of the skin and subcutaneous tissue disorders: uncommon – seborrhea, acne (acne), depigmentation (bleaching) of the skin; rarely – cheilitis.
General disorders and application site: very often – the site of application: burning, itching, erythema (redness); often – the site of application: desquamation (detachment of the epidermis), pain, dryness, discoloration of the skin, irritation of the skin; infrequently – paresthesia, dermatitis, discomfort, swelling; rarely – the site of application: rash, eczema, sensation of heat, ulcers; the frequency is unknown – rash, hives.
If any of these instructions side effects are compounded, or if you notice any other side effects not mentioned in the instructions, tell your doctor.
special instructions
For external use only. Avoid cream falling into the eyes, mouth, and other mucous membranes. Accidental splashes of cream on the mucous membranes, including the eyes and mouth should be rinsed with plenty of water. If eye irritation persists, please consult your doctor. After each application Skinoren® cream wash hands. Melasma is located in the epidermis, or both in the epidermis and dermis, responds well to treatment with drugs Skinoren®. Melasma is located only in the dermis, is insensitive to treatment. For differential diagnosis use lamp
Wood. Preparation Skinoren® comprises benzoic acid, which can cause skin irritation, irritation of the eyes and mucous membranes, and propylene glycol, which can cause skin irritation. During post-marketing surveillance reported rarely in patients with exacerbation of bronchial asthma with topical azelaic acid.
Carefully read the manual before you start using the product. Keep these instructions, it may be needed again. If you have any questions, consult your doctor.
Medicines that you are being treated, meant to you personally, and should not be transferred to other persons as it may harm them even if you have the same symptoms that you have.
Effects on ability to drive vehicles, machinery.
Skinoren® drug does not affect the ability to drive and operate machinery.
Storage conditions
At a temperature of not higher than 30 C.
Keep out of the reach of children.
Dosing and Administration
Outwardly. Before applying the cream your skin with clean water should be rinsed thoroughly and then dry, or use a mild cleansing cosmetic.
Do not use occlusive dressings. After each application of the cream on the skin should be washed by hand. The cream is applied to a thin layer to the affected areas of the skin 2 times per day (morning and evening), gently rubbing the skin (2.5 cm of cream sufficient for the entire facial surface). Children from 12 to 18 years of drug Skinoren® applied in the treatment of acne, dose adjustment is not required.
Efficacy and safety of the drug in children younger than 12 years in the treatment of acne has not been established.
Efficacy and safety of the drug in children younger than 18 years in the treatment of melasma is not installed.
It is important that Skinoren® drug used regularly throughout the treatment period. The duration of treatment depends on the individual and the severity of the disease. Improvement occurs usually after 4 weeks of treatment.
If necessary, the treatment of acne Skinoren® possible to use the drug for several months.
In the treatment of melasma minimum period of application of the drug Skinoren® – 3 months. In treatment of melasma should necessarily apply sunscreens to protect against a wide spectrum of ultraviolet (UV) radiation: UVA and UVB range (UVA and UVB), in order to prevent aggravation of the disease and / or re-pigmentation of the skin bleached under the influence of the sun.
If within 1 month of the treatment of acne and 3 months for the treatment of melasma no improvement or worsening of the disease occurred, it is necessary to stop the use of Skinoren® drug and consult a doctor.
In the case of skin irritation should be reduced for every amount of cream applied cream or reduce the frequency of application of up to 1 time per day. Possible momentary removal of the drug, followed by resumption after the disappearance of symptoms of irritation at the recommended dose.
Use drug only according to the application and in those doses which are specified in the instruction. If necessary, please consult your physician before using the drug.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist