Adapalene

Name: Adapalene

Brand names

  • Differin®

Is adapalene available as a generic drug?

GENERIC AVAILABLE: Yes

Introduction

Retinoid; synthetic naphthoic acid-derivative.7 8 10 11 12 13 14 15 16 17 18 19 20 22

Adapalene Pharmacokinetics

Absorption

Bioavailability

Minimally absorbed following topical application.1 31 32

Elimination

Elimination Route

Eliminated principally by biliary excretion.1 31 32

What do I need to tell my doctor BEFORE I take Adapalene?

  • If you have an allergy to adapalene or any other part of adapalene.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Contraindications

Adapalene gel should not be administered to individuals who are hypersensitive to Adapalene or any of the components in the vehicle gel.

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Cream, External:

Differin: 0.1% (45 g)

Generic: 0.1% (45 g)

Gel, External:

Differin: 0.3% (45 g) [contains edetate disodium, methylparaben, propylene glycol]

Differin: 0.1% (15 g, 45 g) [fragrance free, oil free; contains edetate disodium, methylparaben, propylene glycol]

Generic: 0.1% (45 g); 0.3% (45 g)

Lotion, External:

Differin: 0.1% (59 mL) [contains methylparaben, propylene glycol, propylparaben]

Generic: 0.1% (59 mL)

Dosing Geriatric

Refer to adult dosing.

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F); do not freeze. Protect from light.

Lotion: Protect from light and heat; do not refrigerate.

Dosing & Uses

Dosage Forms & Strengths

topical cream

  • 0.1% (Rx)

topical gel

  • 0.1% (OTC)
  • 0.3% (Rx)

topical lotion

  • 0.1% (Rx)

Acne Vulgaris

Apply thin film to entire face and other affected areas of the skin qPM after washing gently with nonmedicated soap

Dosage Forms & Strengths

topical cream

  • 0.1% (Rx)

topical gel

  • 0.1% (OTC)
  • 0.3% (Rx)

topical lotion

  • 0.1% (Rx)

Acne Vulgaris

<12 years: Safety and efficacy not established

≥12 years: Apply thin film to entire face and other affected areas of the skin qPM after washing gently with nonmedicated soap

What should i avoid while using adapalene topical (differin)?

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.

Where can i get more information?

Your pharmacist can provide more information about adapalene topical.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 1.08. Revision date: 12/15/2010.

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For Healthcare Professionals

Applies to adapalene topical: topical cream, topical gel, topical lotion, topical solution, topical swab

Dermatologic

Pruritus, erythema, scaling, dryness, irritation, sunburn, and acne flares usually occurred during the first month of therapy and decreased thereafter. These side effects were reversible when treatment was discontinued.

Skin exfoliation was associated with skin exposed to mechanical abrasion (e.g., waxing).[Ref]

Very common (10% or more): Persistent pruritus (up to 74%), persistent burning/stinging (up to 71%), erythema (up to 60%), scaling (up to 60%), pruritus (up to 60%), dryness (up to 48%), pruritus immediately after administration (up to 30%), skin stinging or burning (up to 22%)
Common (1% to 10%): Skin irritation, sunburn
Uncommon (0.1% to 1%): Contact dermatitis/eczema, dermatitis, skin discomfort/pain, skin exfoliation, acne/acne flares, skin swelling
Postmarketing reports: Allergic dermatitis/allergic contact dermatitis, rash, eczema, skin discoloration[Ref]

Local

Very common (10% or more): Burning (up to 60%); burning immediately after application (up to 30%)
Frequency not reported: Burning/stinging[Ref]

Burning and stinging usually occurred during the first month of therapy and decreased thereafter. These side effects were reversible when treatment was discontinued.[Ref]

Respiratory

Common (1% to 10%): Pharyngitis, rhinitis, sinusitis[Ref]

Genitourinary

Common (1% to 10%): Dysmenorrhea[Ref]

Ocular

Uncommon (0.1% to 1%): Eyelid irritation, eyelid erythema, eyelid pruritus, eyelid swelling/edema
Postmarketing reports: Conjunctivitis[Ref]

Gastrointestinal

Uncommon (0.1% to 1%): Tooth anomaly, tooth disorder[Ref]

Hypersensitivity

Rare (0.01% to 0.1%): Allergic reaction
Postmarketing reports: Allergic contact dermatitis/allergic dermatitis[Ref]

Other

Rare (0.01% to 0.1%): Lack of drug effect
Frequency not reported: Flu syndrome[Ref]

Nervous system

Frequency not reported: Headache[Ref]

Some side effects of adapalene topical may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Liver Dose Adjustments

Data not available

Adapalene topical Pregnancy Warnings

This drug should be used during pregnancy only if the benefit clearly outweighs the risk to the fetus. AU TGA pregnancy category: D US FDA pregnancy category: C Comment: -Some experts recommend treatment discontinuation during pregnancy, while other experts recommend avoiding use during the first trimester.

Animal data have revealed evidence of fetal skeletal malformations, including supernumerary ribs, at high topical doses. Teratogenic effects were observed in animal models given large oral doses. There are no controlled data in human pregnancy. AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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