WHAT IS EPIDUO?

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Epiduo gel contains a combination of adapalene and benzoyl peroxide. Adapalene is similar to vitamin A. It helps the skin renew itself. Benzoyl peroxide has an antibacterial effect. It also has a mild drying effect, which allows excess oils and dirt to be easily washed away from the skin. Epiduo gel is used to treat acne vulgaris (severe acne) in people who are at least 9 years old.

EPIDUO (adapalene and benzoyle peroxide) gel, 0.1%/2.5% is a white to very pale yellow, opaque gel for topical use containing adapalene 0.1% and benzoyl peroxide 2.5%. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-methoxyphenyl]-2- naphthoic acid). It has the following structural formula:

Adapalene:

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MOLECULAR FORMULA: C28H28O3      MOLECULAR WEIGHT: 412.5
Benzoyl Peroxide is a highly lipophilic oxidizing agent that localizes in both bacterial and keratinocyte cell membranes. The chemical name for benzoyl peroxide is dibenzoyl peroxide. It has the following structural formula:

Benzoyl Peroxide:

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MOLECULAR FORMULA: C14H10O4      MOLECULAR WEIGHT: 242.23

EPIDUO gel contains the following inactive ingredients: acrylamide/sodium acryloyldimethyltaurate copolymer, docusate sodium, edetate disodium, glycerin, isohexadecane, poloxamer 124, polysorbate 80, propylene glycol, purified water, and sorbitan oleate

Uses

This medication is used on the skin to treat acne. This medication is a combination ofadapalene (a retinoid) and benzoyl peroxide (an antibiotic and skin-peeling agent). This product may decrease the number and severity of acne pimples and promote quick healing of pimples that do appear. Adapalene works by affecting the growth of cells and decreasing swelling and inflammation. Benzoyl peroxide works by reducing the amount of acne-causing bacteria and by causing the skin to dry and peel off

IMPORTANT: For use on the skin only (topical). Do not use EPIDUO gel in or on your mouth, eyes, or vagina.
Read this Patient Information leaflet about EPIDUO gel before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your treatment or your medical condition. If you have any questions about EPIDUO gel, talk with your doctor or pharmacist.

What should i tell my doctor before using epiduo gel?

Before you use EPIDUO gel, tell your doctor if you:

  • have other skin problems, including cuts or sunburn
  • have any other medical conditions
  • Are you pregnant or planning to become pregnant? It is not known if EPIDUO gel can harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • Are breastfeeding or planning to breast feed? It is not known if EPIDUO gel passes into your breast milk and if it can harm your baby. Talk to your doctor about the best way to feed your baby if you use EPIDUO gel.

 

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements.

Especially tell your doctor if you use any other medicine for acne. Using EPIDUO gel with topical medicines that contain sulfur, resorcinol or salicylic acid may cause skin irritation.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I use EPIDUO gel?

  • Use EPIDUO gel exactly as your doctor tells you to use it. EPIDUO gel is for skin use only. Do not use EPIDUO gel in or on your mouth, eyes, or vagina.
  • Apply EPIDUO gel 1 time a day.
  • Do not use more EPIDUO gel than you need to cover the treatment area. Using too much EPIDUO gel or using it more than 1 time a day may increase your chance of skin irritation.

Applying EPIDUO gel:

  • Wash the area where the gel will be applied with a mild cleanser and pat dry.
  • EPIDUO gel comes in a tube and a pump. If you have been prescribed the:
    • Tube: Squeeze a small amount (about the size of a pea) of EPIDUO gel onto your fingertips and spread a thin layer over the affected area.
    • Pump: Depress the pump to dispense a small amount (about the size of a pea) of EPIDUO gel and spread a thin layer over the affected area.

What should I avoid while using EPIDUO gel?

  • You should avoid spending time in sunlight or artificial sunlight, such as tanning beds or sunlamps. EPIDUO gel can make your skin sensitive to sun and the light from tanning beds and sunlamps. You should wear sunscreenand wear a hat and clothes that cover the areas treated with EPIDUO gel if you have to be in sunlight.
  • You should avoid weather extremes such as wind and cold as this may cause irritation to your skin.
  • You should avoid applying EPIDUO gel to cuts, abrasions and sunburned skin.
  • You should avoid skin products that may dry or irritate your skin such as harsh soaps, astringents, cosmetics that have strong skin drying effects and products containing high levels of alcohol.
  • You should avoid the use of “waxing” as a hair removal method on skin treated with EPIDUO gel.
  • EPIDUO gel may bleach your clothes or hair. Allow EPIDUO gel to dry completely before dressing to prevent bleaching of your clothes.

Call your doctor for medical advice about side effects.

How should I store EPIDUO gel?

  • Store EPIDUO gel at room temperature, 68° – 77° F (20° – 25° C)
  • Keep EPIDUO gel inside container and out of light and away from heat.

 

Keep EPIDUO gel and all medicines out of the reach of children.

General information about EPIDUO gel

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use EPIDUO gel for a condition for which it was not prescribed. Do not give EPIDUO gel to other people, even if they have the same symptoms you have. It may harm them.

SIDE EFFECTS

Skin redness, dryness, peeling, mild burning, swelling, or worsening of acne may occur during the first 4 weeks of using this product. These effects usually decrease with continued use. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Your doctor may want you to use a moisturizer, decrease how often you use the product, or have you stop using it.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

PRECAUTIONS

Before using this product, tell your doctor or pharmacist if you are allergic to

adapalene or benzoyl peroxide; or to vitamin A-related drugs (other retinoids such as isotretinoin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other skin conditions (such as eczema).This drug may bleach hair or colored fabric (such as clothing, bedding, and towels). Use caution when applying near the hairline, while dressing, and while choosing towel and bed sheet colors (if leaving on the skin overnight).

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear a hat or other protective clothing when outdoors. Wait until your skin has completely recovered from a sunburn before using this product. Weather extremes such as wind or cold may also be irritating to the skin.

Avoid electrolysis, waxing and chemical depilatories for hair removal on the treated areas while using this product. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk when used on the skin. Consult your doctor before breast-feeding. What should I know regarding pregnancy, nursing and administering Epiduo topical to children or the elderly?

INTERACTIONS

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Some products that may interact with this drug include: other drugs that may increase your sensitivity to sunlight (such as tetracyclines, thiazide water pills such ashydrochlorothiazide, sulfa drugs such as sulfamethoxazole, quinolone antibiotics such as ciprofloxacin), other acne skin treatments (such as tretinoin, dapsone).

Avoid using other skin products that are harsh, irritating, or drying on the treated area. These products include hair perming solutions, alcohol/lime/menthol-containing products (such as astringents, toners, shaving lotion), medicated or abrasive soaps or cleansers, soaps and cosmetics with a strong drying effect (such as alpha hydroxy acids, glycolic acid), and products containing sulfur, resorcinol, salicylic acid. If you have recently used products containing sulfur, resorcinol or salicylic acid, use this product with caution. Wait until the effects of such products on the skin have decreased before using this product.

OVERDOSE

This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact a poison control center or emergency room right away.

Notes: Do not share this medication with others. Cosmetics may be used, but clean skin thoroughly before applying the medication. Some cosmetics and soaps may worsen your acne. Moisturizers may be safe to use. When buying cosmetics, moisturizers, or other skin care products, check the label for “non-comedogenic” or “non-acnegenic.” These products are unlikely to worsen your acne. Ask your doctor or pharmacist which products are safe to use. Remember, acne is not caused by dirt. Cleaning your skin too often or too vigorously can irritate your skin and worsen acne.

MISSED DOSE

If you miss a dose, apply it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE

Store tightly closed at room temperature. Do not freeze. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

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Epiduo

Results

Epiduo Results

Expect more from your treatment.  The dual action of Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% will give you results. It’s been proven safe and effective for short- and long-term acne treatment. Clinical trials with thousands of patients showed that many people’s breakouts visibly improved and continued to get better with consistent treatment.

Even when your breakouts are under control, Epiduo Gel is safe to use, as recommended by a doctor, to keep your skin on the right track. As with most acne treatments, Epiduo Gel may come with mild side effects. If your skin is irritated at first, you should see improvements after the first couple of weeks. Typical side effects associated with short-term and long-term use of Epiduo Gel are redness, scaling, dryness, stinging and burning where applied. A non-comedogenic moisturizer such as Cetaphil® DERMACONTROL™ Oil Control Moisturizer SPF 30 can help if your skin becomes dry. Unless major discomfort occurs, it’s best to keep using Epiduo Gel to make sure you’re on the right path. But don’t hesitate to talk to your doctor.

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