Epiduo Gel

DRUG DESCRIPTION

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:

Adapalene Structural Formula Illustration

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:


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.

What are the possible side effects of adapalene and benzoyl peroxide topical (Epiduo)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

During your first 4 weeks of using adapalene and benzoyl peroxide topical, your skin may be dry, red, or scaly. You may also feel some burning or stinging. Call your doctor if these side effects are severe.

Less serious side effects may include mild itching.

This is not a complete list of side effects and others may occur. Call your doctor for...

Read All Potential Side Effects and See Pictures of Epiduo Gel

What are the precautions when taking adapalene and benzoyl peroxide gel (Epiduo Gel)?

Before using this product, tell your doctor or pharmacist if you are allergic to adapalene or benzoyl peroxide; 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...

Read All Potential Precautions of Epiduo Gel


Epiduo Gel Consumer (continued)

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.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this product, tell your doctor or pharmacist if you are allergic to adapalene or benzoyl peroxide; 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.


Epiduo Gel Patient Information Including Side Effects

Brand Names: Epiduo

Generic Name: adapalene and benzoyl peroxide (topical) (Pronunciation: a DAP a leen and BEN zoyl per OX ide)

  • What is adapalene and benzoyl peroxide topical (Epiduo Gel)?
  • What are the possible side effects of adapalene and benzoyl peroxide topical (Epiduo Gel)?
  • What is the most important information I should know about adapalene and benzoyl peroxide topical (Epiduo Gel)?
  • What should I discuss with my healthcare provider before using adapalene and benzoyl peroxide topical (Epiduo Gel)?
  • How should I use adapalene and benzoyl peroxide topical (Epiduo Gel)?
  • What happens if I miss a dose (Epiduo Gel)?
  • What happens if I overdose (Epiduo Gel)?
  • What should I avoid while using adapalene and benzoyl peroxide topical (Epiduo Gel)?
  • What other drugs will affect adapalene and benzoyl peroxide topical (Epiduo Gel)?
  • Where can I get more information?

What is adapalene and benzoyl peroxide topical (Epiduo Gel)?

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.

Adapalene is a medication similar to vitamin A. It helps the skin renew itself.

The combination of adapalene and benzoyl peroxide topical (for the skin) is used to treat acne in people who are at least 12 years old.

Adapalene and benzoyl peroxide topical may also be used for other purposes not listed in this medication guide.

What are the possible side effects of adapalene and benzoyl peroxide topical (Epiduo Gel)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

During your first 4 weeks of using adapalene and benzoyl peroxide topical, your skin may be dry, red, or scaly. You may also feel some burning or stinging. Call your doctor if these side effects are severe.

Less serious side effects may include mild itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about adapalene and benzoyl peroxide topical (Epiduo Gel)?

Before using this medication, tell your doctor about all other medicated skin products you are using. Using more than one acne medication at a time could cause severe skin irritation.

Avoid getting this medication in your mouth, nose, or eyes, or on your lips. If it does get into any of these areas, rinse with water. Do not use adapalene and benzoyl peroxide topical on sunburned, windburned, dry, chapped, irritated, or broken skin. Also avoid using adapalene and benzoyl peroxide topical on wounds or on areas of eczema. Wait until these conditions have healed before using this medication.

Avoid using skin products that can cause dryness or irritation, such as harsh soaps, shampoos, or skin cleansers, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime.

Do not use other medicated skin products unless your doctor has told you to.

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