Adapalene apollo Adapalene apollo Adapalene

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1 Adapalene apollo Adapalene apollo Adapalene CAS Number : Molecular Weight : g/mol Molecular Formula : C28H28O3 Systematic (IUPAC) : 6-[3-(adamantan-1-yl)-4- methoxyphenyl] naphthalene-2-carboxylic acid Type : small molecule Description : Adapalene is a topical retinoid primarily used in the treatment of acne and is also used (off-label) to treat keratosis pilaris as well as other skin conditions. It is currently marketed by Galderma under the trade names Differin in some countries, and Adaferin in India. Categories : Dermatologic Agents Taxonomy

2 Kingdom : Organic Classes : Retinoids Substructures Hydroxy Compounds Benzyl Alcohols and Derivatives Naphthalenes Acetates Benzoates Phenols and Derivatives Ethers Benzene and Derivatives Biphenyl and Derivatives Carboxylic Acids and Derivatives Adamantanes Aromatic compounds Anisoles Benzoyl Derivatives Retinoids Cyclooctane and Derivatives Phenyl Esters Pharmacology Indication : For the topical treatment of comedo, papular and pustular acne (acne vulgaris) of the face, chest or back. Pharmacodynamics : Adapalene is a chemically stable retinoid-like compound. Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization, and inflammatory processes all of which represent important features in the pathology of acne vulgaris.

3 Mechanism of action : Mechanistically, adapalene binds to specific retinoic acid nuclear receptors (gamma and beta) and retinoid X receptors but does not bind to the cytosolic receptor protein. Although the exact mode of action of adapalene is unknown, it is suggested that topical adapalene may normalize the differentiation of follicular epithelial cells resulting in decreased microcomedone formation. Absorption : Absorption of adapalene through human skin is low. Only trace amounts (<0.25 ng/ml) of parent substance have been found in the plasma of acne patients following chronic topical application of adapalene in controlled clinical trials Metabolism : Metabolized mainly by O-demethylation, hydroxylation and conjugation, and excretion is primarily by the biliary route. Route of elimination : Excretion appears to be primarily by the biliary route. Toxicity : The acute oral toxicity of adapalene in mice and rats is greater than 10 ml/kg. Chronic ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of Vitamin A. Affected organisms : Humans and other mammals Dosing Wash and dry the affected areas. Apply a thin layer of gel to the affected areas once daily at bedtime. Avoid the eyes, lips and nose. There may be a worsening of acne during the first few weeks of therapy because adapalene promotes the growth of pimples that have begun to form but are not yet visible. Therefore, treatment should not be stopped if acne appears to be worsening. Beneficial effects should be seen by 8 to 12 weeks.

4 Uses This medication is used to treat acne. It may decrease the number and severity of acne pimples and promote quick healing of pimples that do develop. Adapalene belongs to a class of medications called retinoids. It works by affecting the growth of cells and decreasing swelling and inflammation. How To Use? Wash your hands before applying this medication. Gently clean the affected skin with a mild or soapless cleanser and pat dry. Use your fingertips to apply a small amount of medication in a thin layer, usually once daily at bedtime, or as directed by your doctor. A gauze pad or cotton swab can be used to apply the solution.use this medication on the skin only. Do not apply to the inner lip area or inside the nose/mouth. Do not apply to cut, scraped, sunburned, or eczema-affected skin.avoid getting this medication in your eyes. If this medication gets into your eyes, flush with large amounts of water. Call your doctor if eye irritation develops. Wash your hands after using the medication to avoid accidentally getting it in your eyes.during the first few weeks of using adapalene, your acne might appear worse because the medication is working on pimples forming inside the skin. It may take up to 8-12 weeks to notice results from this medication.use it regularly in order to get the most benefit from it. To help you remember, use it at the same time each day. Do not use a larger amount or use it more frequently than recommended. Your skin will not improve any faster, and it will increase the risk of developing redness, peeling and pain.this medication is available in different strengths and forms (e.g., gel, cream, solution). The best type of medication for you to

5 use will depend on the condition of your skin and your response to therapy. Inform your doctor if your condition persists or worsens. Why is this medication prescribed? Adapalene is used to treat acne. Adapalene is in a class of medications called retinoid-like compounds. It works by stopping pimples from forming under the surface of the skin. How should this medicine be used? Adapalene comes as a gel, a solution (liquid), and a cream to apply to the skin. The solution comes in a glass bottle with an applicator and as individual pledgets (medicated wipes for one time use). It is usually applied once a day at bedtime. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Apply adapalene exactly as directed. Do not apply more or less of it or apply it more often than prescribed by your doctor. Applying more adapalene or applying adaplene more often than recommended will not speed up or improve results, but it may irritate your skin. Adapalene controls acne but does not cure it. Your acne may get worse during the first few weeks of treatment, and it may take 8-12 weeks or longer before you feel the full benefit of adapalene. Pimples can take 6-8 weeks to form under the skin, and during the first weeks of your treatment, adapalene may bring these pimples to the skin surface. Continue to use adapalene even if your acne worsens or you do not see much improvement at first. Do not stop using adapalene without talking to your doctor. Do not apply adapalene to skin that is sunburned, broken, or covered with eczema (a skin disease). If you

6 have any of these conditions, do not apply adapalene until your skin has healed. Be careful not to get adapalene in your eyes, nose, or mouth. If you do get adapalene in your eyes, wash them with plenty of water and call your doctor. Your eyes may become irritated, swollen, or infected. To use the cream, gel, or solution, follow these steps: Gently wash the affected skin with a mild soap or soapless cleanser and pat dry with a soft towel. Do not use harsh or abrasive cleansers, and do not scrub your skin vigorously. Ask your doctor or pharmacist to recommend a gentle cleanser. If you are using the gel or cream, use your fingers to spread a thin film of medication over the affected area. If you are using a pledget, remove it from the foil pouch and gently wipe the entire affected area. If you are using the glass bottle of solution, apply a thin layer to the affected area using the applicator provided. You may feel a slight warmth or stinging in the place where you applied adapalene. This feeling is normal and should go away by itself in a short time. If you used a pledget, throw it away after use. Do not save it to use again. Other uses for this medicine This medication may be prescribed for other uses; ask your doctor or pharmacist for more information. What special precautions should I follow? Before taking adapalene, tell your doctor and pharmacist if you are allergic to adapalene or any other medications. tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or

7 using. Be sure to mention all skin care products including soaps, cleansers, moisturizers, and cosmetics. Many skin care products can irritate your skin if you use them with adapalene. This is especially likely if you use products that are harsh, dry out the skin, or contain alcohol, spices, lime rind, sulfur, resorcinol, salicylic acid, or alpha hydroxy acid. If you have been using these products, your doctor may want you to wait for your skin to return to normal before you begin using adapalene. tell your doctor if you have or have ever had eczema or cancer. tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using adapalene, call your doctor. plan to avoid unnecessary or prolonged exposure to real and artificial sunlight and to wear protective clothing, sunglasses, and sunscreen with an SPF of 15 or higher, especially if you sunburn easily. Also avoid prolonged exposure to cold or wind. Adapalene may make your skin sensitive to sunlight or extreme weather. do not use hot wax to remove unwanted hair during your treatment with adapalene. What special dietary instructions should I follow? Unless your doctor tells you otherwise, continue your normal diet. What should I do if I forget a dose? Apply the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not apply a double dose to make up for a missed one. What side effects can this medication cause?

8 Adapalene may cause side effects. The following symptoms are likely to affect your skin during the first 2-4 weeks of treatment. Tell your doctor if any of these symptoms are severe or do not go away: redness scaling dryness burning or stinging itching Medications that are similar to adapalene have caused tumors in laboratory animals who were given the medications and exposed to real or artificial sunlight. It is not known whether adapalene increases the risk of tumors in humans. Protect yourself from sunlight and sunlamps while taking adapalene, and talk to your doctor about the risks of taking this medication. Adapalene may cause other side effects. Call your doctor if you have any unusual problems while taking this medication. What storage conditions are needed for this medicine? Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). If you are using a bottle of adapalene solution, be sure to store it upright. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication. What other information should I know? Keep all appointments with your doctor.

9 Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies. apollo asia Division APOLLO Pharmaceuticals API Manufacturer INDIA [P] Ltd. asia Division Mr.Vipin Saxena CEO Cellular: Cellular: Direct : FAX : Wireline Purchase HELPDESK: Wireline Sales HELPDESK:

10 Wireless 24x7 HELPDESK: Blackberry Pin : 32E6500D 32E C58 apollo@hotmail.co.in Sales@apollopharma.in Export@apollopharma.in purchase@apollopharma.in Chat: MSN Hotmail:VipinrSaxena Skype NAME:VipinrSaxena Rocketmail:VipinrSaxena Google mail:vipinrsaxena BlackBerry:28415C58 Regd. Office :- 1104, Maker Chamber V, Nariman Point Mumbai, INDIA

11 Pin: Industrial Office D-62, OIC India Oshiwara Industrial Centre, New Link Road, Goregoan West, Mumbai, INDIA Pin: Manufacturing Unit Address: Plot No. 117A, Village: Chamble Near MonaTona Limited.Wada, Maharashtra, PIN : INDIA apollo@hotmail.co.in Sales@apollopharma.in Export@apollopharma.in purchase@apollopharma.in

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