Aziderm 20% by Micro Labs (Skinoren) is used topically on the skin to treat mild or moderately severe acne and pimples. It is applied to relieve symptoms of various types of acne which may include redness, lesions, and bumps, etc. The medication is used for mild-to-moderate acne treatments.
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Qualitative and quantitative composition -
1g of Aziderm 20% by Micro Labs (Skinoren) contains 200 mg Azeliac Acid (20% w/w).
In skin prone to acne, it reduces swelling and redness through its anti-inflammatory actions. It is used for the treatment of moderate to mild acne and pimples. The medicine operates by reducing the number of bacteria triggering acne on your skin and aiding to maintain the skin pores healthy. So, the number of skin bumps due to acne gets reduced. Moreover, it limits the keratin production of the skin. Keratin is a protein that is often associated with blockage of the skin pores, resulting in acne formation. Aziderm functions by reducing the number of bacteria that cause acne on the body and helping to keep the pores free and unblocked thus decreasing the number of pimples. The main component of the cream is azelaic acid that belongs to a group of drug class termed dicarboxylic acids. This cream can be regarded as the first line of defense against Rosacea and Acne vulgaris. It is not indicated for severe acne infection and problems.
Aziderm (Skinoren / Azelaic acid cream) is indicated for the treatment of Rosacea and Acne vulgaris. It soothes the rosacea associated symptoms, which include pimples, flushing, and redness of the skin, etc.
The cream is used for the reduction of the symptoms linked to acne vulgaris as well. The common symptoms of acne vulgaris are skin bumps, tenderness, redness, blackheads, etc.
Mode of administration
Skinoren known as Aziderm is for external use only. Do not apply inside your mouth. Wash your hands before and after application. Make sure the skin is clean and dry. Apply the right amount of cream (a thin layer) to cover the affected area and rub lightly. It may take up to 4 weeks before you see the full effect of this medicine.
You should not use this medicine or ask your doctor before using it if you have the following conditions:
Herpes or fever blisters
You have the previous history of allergies to ingredients such as different preservatives, dyes, foods, medicines, azelaic acid, propylene glycol, and similar products.
In case you are planning a pregnancy or already pregnant
If you are breastfeeding
Special cautions and warnings - Contact your doctor or healthcare professional if your skin condition worsens or does not improve within the first 4 weeks. Tell your doctor if the medicine causes too much redness, dryness, or causes the skin to peel.
There is no official drug interactions are known or expected. However, do not use any other skin products in the affected area without first checking with your doctor or healthcare professional. Give your doctor a list of all medications, herbs, over-the-counter medicines, or dietary supplements that you are taking. Also, inform him whether you smoke, drink alcohol, or use other abusive drugs. Some of these may interact with Aziderm.
Side effects :
Aziderm common side effects of the medicine include:
Allergic reactions such as skin rashes, itching or hives, swelling of the face, lips, or tongue
Lighter skin color in treated areas (in patients with dark skin)
Severe burning, itching, scabs, or inflammation of the treated areas
In some people the following side effects can be seen:
Mild burning sensation, severe itching or tingling
Redness of the skin
Peeling of skin
In case of severe allergic reactions on rare occasions, symptoms like sudden and unexpected swelling of tongue, throat, face, and eyelids take place. People also suffer from difficulty in swallowing and breathing. These patients need immediate medical intervention and emergency care.
Keep the cream out of the eyes, mouth, and other sensitive areas of the skin. If the cream comes into contact with these parts of the skin by accident, wash the affected area with plenty of water and contact your doctor if the irritation persists.
Do not place bandages, bandages, or dressings on the skin on which the medication was applied.
There have been no indications of habit-forming phenomena of this cream.
If you are using other topical medications, apply them at different times of the day.
You can use small amounts of water-based cosmetics while using this medicine. Apply makeup after the cream has dried.
There is no medical assessment of the period needed to show the action of this cream.
No clinical assessment is made of the length of time this drug is active. after the initial use or stopping the use of the medicine.
For the use of Registered Medical Practitioner or a Hospital or a Laboratory only.
Aziderm 10% - Azelaic Acid 10% w/w
Benzoic Acid IP 0.2% w/w (as preservative) In a cream base.
Aziderm Azelaic Acid 20% w/w in a cream base.
Description: Azelaic Acid is a naturally occurring C9 dicarboxylic acid.
Structural Formula: HOOC-(CH2)7COOH
1,7- heptanedicarboxylic acid
Empirical Formula: C9H18O4
Molecular weight: 188.22
Azelaic Acid in Acne: Topical application of 20% Azelaic Acid cream (Skinoren) caused marked reduction in the densities of cutaneous micro-coccaceae and intrafollicular Propionibacterium Sp., and decreased the free fatty acid content of skin surface lipids. Topical 20% Azelaic acid cream also showed an antikeratinising effect on acne affected skin which was related to decreased synthesis of filaggrin (keratin filament aggregating protein); hence a reduction in follicular hyperkeratosis may partly underlie the drug's antiacne action 1. Since Azelaic acid affects the cornification process of the epidermal cells, it exerts a therapeutically positive effect on the formation of comedones. Azelaic acid also inhibits the release of oxygen radical from neutrophilic granulocytes, and thus may have a clinically relevant anti inflammatory action in acne.
Azelaic acid in hyperpigmentation: Azelaic acid appears to act selectively on hyperactive and abnormal melanocytes, by competitively inhibiting tyrosinase, the key enzyme for melanogenesis. The antiproliferative and cytotoxic actions of Azelaic acid may be due to reversible inhibition of variety of oxidoreductase enzymes like DNA polymerase and mitochondrial enzymes of the respiratory chain. Differences in cellular permeability and / or metabolic activity may account for the greater susceptibility of hyperactive and abnormal epidermal cells (keratinocytes and melanocytes) to the antiproliferative and depigmenting actions of Azelaic acid.
Pharmacokinetics: Following a single application of Aziderm to human skin in vitro, Azelaic acid penetrates into the stratum comeum (approximately 3 to 5% of the applied dose) and other viable skin layers (up to 10% of the dose is found in the epidermis and dermis). Negligible cutaneous metabolism occurs after topical application. Approximately 4% of the topically applied Azelaic acid is systemically absorbed. Azelaic add is mainly excreted unchanged in urine but undergoes some beta-oxidation to shorter chain dicarboxylic adds. After topical treatment of Aziderm in humans, plasma concentration and urinary excretion of Azelaic acid are not significantly different from baseline levels.
Indications: Aziderm / Skinoren is effective against hyperpigmentary disorders (such as melasma, post inflammatory melanoderma, Lentigo maligna) Aziderm is also effective in acne (comedonal and inflammatory acne)
Contra-indications: Hypersensitivity to Propylene glycol. Aziderm should not be used by pregnant, lactating women and in children below 12 years, as it has not been studied in these circumstances.
Warning: There have been isolated reports of hypopigmentation after use of Azelaic acid. Patients with dark complexion should be monitored for early signs of hypopigmentation.
Precautions: General: If sensitivity or severe irritation develops with use of Aziderm, treatment should be discontinued and appropriate therapy instituted.
Information to patients: Patients should be instructed to keep Aziderm away from mouth, eyes, and other mucous membranes. If Skinoren comes in contact with the eyes, then it should be thoroughly rinsed with copious amounts of water. Avoid the use of occlusive dressing or wrappings. Due to low pH of Azelaic acid, temporary skin irritation (pruritus, burning, or stinging) may occur when Aziderm is applied to broken or inflamed skin, usually at the start of treatment. However, this irritation commonly subsides if treatment is continued, if it continued, Aziderm should be applied only once-a-day, or the treatment should be stopped until these effects have subsided. If troublesome irritation persists, the patient should consult their physician.
Side effects: The most common adverse reactions occurring in approximately 1-5% of patients were pruritus, burning, stinging and tingling. Other adverse reactions such as erythema, dryness, rash, peeling, irritation, dermatitis, and contact dermatitis were reported in less than 1% of subjects. There is the potential for experiencing allergic reactions with use of Skinoren (Aziderm).
Dosage and administration: Before Aziderm is applied, the skin should be thoroughly cleaned with clear water or, if applicable a mild skin-cleansing agent. Astringent toiletries should generally be avoided. Aziderm cream should be gently rubbed into cleansed skin 2 to 3 minutes to ensure adequate penetration. The cream is to be applied on the affected areas of skin twice a day (morning and evening). As a guide a daily dose of 2g (1g Per application) will be sufficient. In the event of excessive irritation of the skin, the frequency of use of Aziderm should be reduced to once a day until the irritation ceases or the treatment should be temporarily interrupted. It is important to continue the use of Aziderm regularly over the entire period of treatment. The duration of use of Aziderm varies from person to person and depends on the severity of the acne/ hyperpigmentation. To obtain the best results, Aziderm / Skinoren should be used regularly over several months but not more than six months. Improvement in majority of patients with inflammatory lesions usually occurs within four weeks.
Storage: Store all drugs properly and keep them out of the reach of children. Store between 15°C-30°C (59°-86°F) Protect from freezing.
Usage and precautions:
This preparation should be used strictly under medical supervision only.
Aziderm-10% 15g tubes
Aziderm- 15g tubes
Andrew Fitton and Karen L Goa: Drugs: 1991; 780-798. Akamatsu H et al; Arch Dermatol Res; 1991; 283; 162-166 Nazzaro-Porro M et al; J Invest Dermatol: 1978a;71;205-208
Made In India by:
MICRO LABS LIMITED
92. SIPCOT Industnal Complex.
HOSUR-635 126 (T.N.)
® Rogd. Trade Mark