Differin Gel .3%

DRUG DESCRIPTION

DIFFERIN (adapalene) Gel, 0.3% contains adapalene 0.3% (3 mg/g) in a topical aqueous gel for use in the treatment of acne vulgaris, consisting of carbomer 940, edetate disodium, methylparaben, poloxamer 124, propylene glycol, purified water, and sodium hydroxide. May contain hydrochloric acid for pH adjustment.

The chemical name of adapalene is 6-[3-(l-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. It is a white to off-white powder, which is soluble in tetrahydrofuran, very slightly soluble in ethanol, and practically insoluble in water. The molecular formula is C28H28O3 and molecular weight is 412.53. Adapalene is represented by the following structural formula.

DIFFERIN®
  (adapalene) Structural Formula Illustration

What are the possible side effects of adapalene topical (Differin)?

Stop using this medication and 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 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 are more likely to occur, such as mild burning, warmth, stinging, tingling, itching, redness, or irritation.

This is not a...

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What are the precautions when taking adapalene (Differin Gel .3%)?

Before using adapalene, tell your doctor or pharmacist if you are allergic to it; 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: eczema.

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

Avoid electrolysis, waxing and chemical depilatories for hair...

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Differin Gel .3% Consumer (continued)

SIDE EFFECTS: A brief sensation of warmth or stinging may occur immediately after applying the medication. Skin redness, dryness, itching, scaling, mild burning, or worsening of acne may occur during the first 2-4 weeks of using the medication. 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 decrease how often you use adapalene, change the strength, 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.

Tell your doctor immediately if any of these unlikely but serious side effects occur: very red/irritated skin, an intense burning sensation, eye redness and watering (conjunctivitis), eyelid swelling, skin discoloration.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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 adapalene, tell your doctor or pharmacist if you are allergic to it; 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: eczema.

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

Avoid electrolysis, waxing and chemical depilatories for hair removal on the treated areas while using this product.

If you have recently used products containing sulfur, resorcinol or salicylic acid, use adapalene with caution. Wait until the effects of such products on the skin have decreased before using adapalene.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Differin Gel .3% Patient Information Including Side Effects

Brand Names: Differin

Generic Name: adapalene topical (Pronunciation: a DAP a leen)

  • What is adapalene topical (Differin Gel .3%)?
  • What are the possible side effects of adapalene topical (Differin Gel .3%)?
  • What is the most important information I should know about adapalene topical (Differin Gel .3%)?
  • What should I discuss with my healthcare provider before using adapalene topical (Differin Gel .3%)?
  • How should I use adapalene topical (Differin Gel .3%)?
  • What happens if I miss a dose (Differin Gel .3%)?
  • What happens if I overdose (Differin Gel .3%)?
  • What should I avoid while using adapalene topical (Differin Gel .3%)?
  • What other drugs will affect adapalene topical (Differin Gel .3%)?
  • Where can I get more information?

What is adapalene topical (Differin Gel .3%)?

Adapalene is a topical (applied to the skin) medication similar to vitamin A. It helps the skin renew itself.

Adapalene topical is used to treat severe acne in people who are at least 12 years old.

Adapalene topical may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of adapalene topical (Differin Gel .3%)?

Stop using this medication and 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 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 are more likely to occur, such as mild burning, warmth, stinging, tingling, itching, redness, or irritation.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about adapalene topical (Differin Gel .3%)?

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

Do not use skin products that contain alpha hydroxy or glycolic acid while you are also using adapalene topical.

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medication skin products unless your doctor has told you to.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Adapalene topical can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

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