Adapalene (Page 3 of 4)

14 CLINICAL STUDIES

The safety and efficacy of once daily use of adapalene gel, 0.3% for treatment of acne vulgaris were assessed in one 12 week, multi-center, controlled, clinical study, conducted in a total of 653 patients 12 years to 52 years of age with acne vulgaris of mild to moderate severity. All female patients of child-bearing potential enrolled in the study were required to have a negative urine pregnancy test at the beginning of the study and were required to practice a highly effective method of contraception during the study. Female patients who were pregnant, nursing or planning to become pregnant were excluded from the study.

Patients enrolled in the study were Caucasian (72%), Hispanic (12%), African-American (10%), Asian (3%), and other (2%). An equal number of males (49.5%) and females (50.5%) enrolled. Success was defined as “Clear” or “Almost Clear” in the Investigator’s Global Assessment (IGA). The success rate, mean reduction, and percent reduction in acne lesion counts from Baseline after 12 weeks of treatment are presented in the following table:

Table 3: Clinical study primary efficacy results at Week 12
Adapalene Gel, 0.3% Adapalene Gel, 0.1% Vehicle Gel
N=258 N=261 N=134
IGA Success Rate 53 (21%) 41 (16%) 12 (9%)
Inflammatory Lesions
Mean Baseline Count 27.7 28.1 27.2
Mean Absolute (%) Reduction 14.4 (51.6%) 13.9 (49.7%) 11.2 (40.7%)
Non-inflammatory Lesions
Mean Baseline Count 39.4 41.0 40.0
Mean Absolute (%) Reduction 16.3 (39.7%) 15.2 (35.2%) 10.3 (27.2%)
Total Lesions
Mean Baseline Count 67.1 69.1 67.2
Mean Absolute (%) Reduction 30.6 (45.3%) 29.0 (41.8%) 21.4 (33.7%)

16 HOW SUPPLIED/STORAGE AND HANDLING

Adapalene gel, 0.3% is supplied in the following size. 45g tube – NDC 0472-0126-45

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.

17 PATIENT COUNSELING INFORMATION

“See FDA-approved patient labeling (Patient Information)”

Information for Patients

Patients using adapalene gel, 0.3%, should receive the following information and instructions:

  1. This medication is to be used only as directed by the physician.
  2. Do not use more than the recommended amount and do not apply more than once daily as this will not produce faster results, but may increase irritation.
  3. Apply a thin film of adapalene gel, 0.3% to the entire face and any other affected areas of the skin once daily in the evening, after washing gently with a non-medicated soap.
  4. Avoid contact with the eyes, lips, angles of the nose, and mucous membranes.
  5. Moisturizers may be used if necessary; however, products containing alpha hydroxy or glycolic acids should be avoided.
  6. Exposure of the eye to this medication may result in reactions such as swelling, conjunctivitis, and eye irritation.
  7. This medication should not be applied to cuts, abrasions, eczematous, or sunburned skin.
  8. Wax depilation should not be performed on treated skin due to the potential for skin erosions.
  9. Minimize exposure to sunlight including sunlamps. Recommend the use of sunscreen products and protective apparel (e.g., hat) when exposure cannot be avoided.
  10. During the early weeks of therapy, an apparent exacerbation of acne may occur. This may be due to the action of the medication on previously unseen lesions and should not be considered a reason to discontinue therapy.
  11. Contact the doctor if skin rash, pruritus, hives, chest pain, edema, and shortness of breath occurs, as these may be signs of allergy or hypersensitivity.
  12. It is for external use only.

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Rev. A 1/2020

PATIENT INFORMATION

Adapalene (a dap’ a leen) Gel, 0.3%

Important: For use on the skin only (topical). Do not use adapalene gel, 0.3% in or on your mouth, eyes, or vagina.

Read this Patient Information that comes with adapalene gel, 0.3% 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 adapalene gel, 0.3%, talk with your doctor or pharmacist.

What is adapalene gel, 0.3%?

Adapalene gel, 0.3% is a prescription medicine for skin use only (topical) used to treat acne vulgaris in people 12 years of age and older.

Acne vulgaris is a condition in which the skin has blackheads, whiteheads and pimples.

It is not known if adapalene gel, 0.3% is safe and effective in children younger than 12 years of age or in people 65 years of age and older.

Who should not use adapalene gel, 0.3%?

Do not use adapalene gel, 0.3% if you:

  • are allergic to adapalene or any of the ingredients in adapalene gel, 0.3%. See the end of this Patient Information for a complete list of ingredients in adapalene gel, 0.3%.

What should I tell my doctor before using adapalene gel, 0.3%?

Before you use adapalene gel, 0.3%, tell your doctor if you:

  • have other skin problems, including cuts or sunburn
  • have any other medical conditions
  • are pregnant or planning to become pregnant. It is not known if adapalene gel, 0.3% can harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if adapalene 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 adapalene gel, 0.3%.

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

Especially tell your doctor if you use any other medicine for acne. Using adapalene gel, 0.3% 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 adapalene gel, 0.3%?

  • Use adapalene gel, 0.3% exactly as your doctor tells you to use it. Adapalene gel, 0.3% is for skin use only. Do not use adapalene gel, 0.3% in or on your mouth, eyes, or vagina.
  • Apply adapalene gel, 0.3% 1 time a day. Do not use more adapalene gel, 0.3% than you need to cover the treatment area. Using too much adapalene gel, 0.3% or using it more than 1 time a day may increase your chance of skin irritation.

Applying adapalene gel, 0.3%:

  • Wash the area where adapalene gel, 0.3% will be applied with a soap that does not contain a medicine and pat dry.
  • Adapalene gel, 0.3% comes in a tube. Squeeze a small amount onto your fingertips and spread a thin layer over the entire face and any other affected areas.

What should I avoid while using adapalene gel, 0.3%?

  • You should avoid spending time in sunlight or artificial sunlight, such as tanning beds or sunlamps. Adapalene gel, 0.3% can make your skin sensitive to sun and the light from tanning beds and sunlamps. You should wear sunscreen and wear a hat and clothes that cover the areas treated with adapalene gel, 0.3% 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 adapalene gel, 0.3% 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 adapalene gel, 0.3%.

What are the possible side effects of adapalene gel, 0.3%?

Adapalene gel, 0.3% may cause serious side effects including:

  • Local skin reactions. Local skin reactions are most likely to happen during the first 4 weeks of treatment and usually lessen with continued use of adapalene gel, 0.3%. Signs and symptoms of local skin reaction include:
    • Redness
    • Dryness
    • Scaling
    • Stinging or burning
  • Allergic reactions. Adapalene gel, 0.3% may cause an allergic reaction that may require medical treatment. Stop using adapalene gel, 0.3% and tell your doctor right away if you have any of these symptoms of an allergic reaction:
    • skin rash, itching or hives
    • trouble breathing or chest pain
    • swelling of your face, eyes, lips, tongue or throat

You may use a moisturizer for relief of dry skin or irritation, however you should avoid products that contain alpha hydroxy or glycolic acid.

The most common side effects of adapalene gel, 0.3% are:

  • skin pain
  • skin peeling
  • sunburn

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of adapalene gel, 0.3%. For more information, ask your doctor or pharmacist.

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

You may also report side effects to Actavis at 1-800-432-8534.

How should I store adapalene gel, 0.3%?

  • Store adapalene gel, 0.3% at room temperature between 68°F to 77°F (20°C to 25°C).
  • Do not freeze adapalene gel, 0.3%.

Keep adapalene gel, 0.3% and all medicines out of the reach of children.

General information about adapalene gel, 0.3%

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use adapalene gel, 0.3% for a condition for which it was not prescribed. Do not give adapalene gel, 0.3% to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about adapalene gel, 0.3%. If you would like more information, talk with your doctor. You can also ask your doctor or pharmacist for information about adapalene gel, 0.3% that is written for health professionals.

What are the ingredients in adapalene gel, 0.3%?

Active ingredient: adapalene

Inactive ingredients: carbomer 940, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water and sodium hydroxide. May contain hydrochloric acid for pH adjustment.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Rev. A 1/2020

3701600-6200 GW7332

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