Adapalene

Name: Adapalene

What is adapalene, and how does it work (mechanism of action)?

Adapalene is a gel used for the treatment of acne vulgaris (pimples). The exact mechanism of action is not known. Scientists believe that when adapalene is applied to the skin, it affects the growth of skin cells and thereby reduces the formation of pimples.

What is the dosage for adapalene?

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.

How supplied

Dosage Forms And Strengths

Each gram of DIFFERIN Gel, 0.3% contains 3 mg adapalene in an off-white aqueous gel.

DIFFERIN Gel, 0.3% is supplied in the following size.

45 g tube - NDC 0299-5918-45

Storage: Store at controlled room temperature 68° to 77°F (20° to 25°C) with excursions permitted between 59° to 86°F (15° to 30°C). Protect from freezing. Keep out of reach of children.

Marketed by: Galderma Laboratories, L.P. Fort Worth, Texas 76177 USA. Manufactured by: DPT Laboratories, Ltd. San Antonio, Texas 78215 USA. Revised: 08/2010.

Uses for Adapalene

Acne Vulgaris

Treatment of acne vulgaris.1 4 5 6 7 11 12 13 14 16 17 18 19 20 21 22 31 32

Interactions for Adapalene

Specific Drugs

Drug

Interaction

Comments

Keratolytic agents (e.g., resorcinol, salicylic acid, sulfur)

Possible additive effects1 31 32

Allow sufficient time for the effects of the keratolytic agent to subside before initiating adapalene1 31 32

Photosensitizing agents (e.g., fluoroquinolone anti-infectives, phenothiazines, sulfonamides, thiazide diuretics)

Possible increased phototoxicity33

Avoid concomitant use33

Other Topical Preparations

Potential pharmacodynamic interaction (increased skin irritation).1 31 32 Avoid concurrent use of topical preparations with high concentrations of alcohol, menthol, spices, or lime (e.g., lotions, astringents, perfume); irritating cosmetics (e.g., toners, peeling [desquamating] agents); permanent wave solutions; or hair depilatories or waxes.1 31 32 33

Stability

Storage

Topical

Cream, Gel, Solution

20–25°C.1 31 32

Protect cream from freezing.32

Store solution upright in tight container.31

What are some things I need to know or do while I take Adapalene?

  • Tell all of your health care providers that you take adapalene. This includes your doctors, nurses, pharmacists, and dentists.
  • Skin may look worse before it looks better.
  • You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
  • Some weather conditions may irritate the skin. Talk with the doctor.
  • Do not wax the affected skin. This may irritate the skin.
  • Use of other skin products while using this medicine may cause more irritation.
  • Talk with your doctor before you use other drugs or products on your skin.
  • It may take a few months to see the full effect.
  • This medicine may cause harm if swallowed. If adapalene is swallowed, call a doctor or poison control center right away.
  • Do not give this medicine to a child younger than 12 years old without first checking with the doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using adapalene while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

What are some other side effects of Adapalene?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Irritation where this medicine is used.
  • Redness.
  • Dry skin.
  • Burning.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Warnings

Use of Adapalene gel should be discontinued if hypersensitivity to any of the ingredients is noted. Patients with sunburn should be advised not to use the product until fully recovered.

How is Adapalene Supplied

Adapalene Gel, 0.1% is supplied in the following size:

45 g

laminate tube

NDC 0093-6301-95

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Protect from Freezing.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured in Croatia By:
PLIVA Hrvatska d.o.o.
Zagreb, Croatia
Manufactured For:
TEVA PHARMACEUTICALS USA, INC.
North Wales, PA 19454

Rev. A 12/2015

Package/Label Display Panel

Adapalene Gel 0.1%, 45 Grams, Carton Text

NDC 0093-6301-95

Adapalene GEL

0.1%

For External Use Only. NOT FOR OPHTHALMIC USE.
Rx only

45 GRAMS

TEVA

Adapalene 
Adapalene gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0093-6301
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Adapalene (Adapalene) Adapalene 1 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)  
EDETATE DISODIUM  
METHYLPARABEN  
POLOXAMER 182  
PROPYLENE GLYCOL  
WATER  
SODIUM HYDROXIDE  
HYDROCHLORIC ACID  
Packaging
# Item Code Package Description
1 NDC:0093-6301-95 45 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090962 06/02/2010
Labeler - Teva Pharmaceuticals USA, Inc. (001627975)
Revised: 04/2017   Teva Pharmaceuticals USA, Inc.

Dosing Renal Impairment

There are no dosage adjustments provided in manufacturer’s labeling; however, systemic absorption is not extensive, making the need for a dose adjustment unlikely.

Drug Interactions

Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Avoid combination

Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Monitor therapy

Multivitamins/Fluoride (with ADE): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Avoid combination

Multivitamins/Minerals (with ADEK, Folate, Iron): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Avoid combination

Multivitamins/Minerals (with AE, No Iron): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Avoid combination

Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Monitor therapy

Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Monitor therapy

What is adapalene topical (differin)?

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.

Other Comments

Administration advice:
-This drug is for topical use only, and should be used with caution around mucous membranes and disrupted skin (e.g., abrasions, cuts, eczema, sunburns).
-Containers should be kept tightly closed when not in use.
-Non-comedogenic and non-astringent cosmetics may be used during treatment.
-Moisturizers may be used during treatment, but patients should avoid those containing alpha hydroxy or glycolic acids.
-Lotion formulations: A small amount (approximately 3 to 4 actuations of the pump) should be applied to the affected area.
-Swab formulations: The swab should be removed from its foil pouch just prior to application. Once used, the swab should be properly discarded.

Storage requirements:
-The manufacturer product information should be consulted.

General:
-Excessive application may increase the risk of skin irritation without improving efficacy.
-Safety and efficacy of use in the treatment of severe pustular, deep cystic, or acne conglobulata have not been established. This drug should not be used to treat severe acne.

Monitoring:
-Excessive skin irritation
-Sunburns/increased photosensitivity

Patient advice:
-Patients should be counseled on using appropriate sun protection while on therapy.
-Patients should be instructed to wash the affected area with a mild, non-medicated soap and pat the area dry before application. Patients should be told to avoid washing the area too frequently or scrubbing the skin too hard.
-Patients should be warned that benefits may not be seen for up to 12 weeks; initially, acne may look worse, but patients should not discontinue use during this time.
-Patients should be told to avoid contact with extremes in weather, other topical drugs, agents with strong drying effects, preparations with high alcohol concentrations, abrasive soaps, astringents, spices, and/or lime or lime peels to decrease the risk of skin irritation.
-Patients should be advised to speak to their healthcare provider if they are pregnant, intend to become pregnant, or are breastfeeding.

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