adapalene (Rx, OTC)

Brand and Other Names:Differin
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Dosing & Uses

AdultPediatric

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

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Adverse Effects

>10%

Dryness (1-45%)

Scaling (1-44%)

Burning/stinging (4-29%)

Erythema (0.5-26%)

1-10%

Skin discomfort (6%)

Pruritus (2%)

Desquamation (2%)

Sunburn (1%)

<1%

Acne flare

Conjunctivitis

Contact dermatitis

Eczema

Erythema

Eyelid edema

Rash

Skin discoloration

Postmarketing reports

Immune system disorders: Angioedema, face edema, lip swelling

Skin disorders: Application site pain

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Warnings

Contraindications

Hypersensitivity to adapalene or any of its components

Cautions

Avoid eyes, lips, and mucous membranes

For external use only

Minimize UV light exposure; use sunscreen and protective clothing

Extreme weather (eg, wind, cold) may cause skin irritation

Adverse reaction risk higher during first month of treatment; generally subsides with use

Do not apply product to abrasions or cuts or to eczematous or sunburned skin

Skin irritation: Apply moisturizer, reduce application frequency, or discontinue

Do not wax treated area or apply topical products that may further irritate skin (eg, astringents, abrasive soaps, and cleansers, exfoliants, sulfur, resorcinol, salicylic acid)

Anaphylaxis, angioedema, urticaria, face edema, eyelid edema, lip swelling, and pruritus sometimes requiring medical treatment have been reported during postmarketing use of adapalene; advise patients to stop using medication and seek medical attention if experiencing allergic or anaphylactoid/anaphylactic reactions during treatment

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Pregnancy & Lactation

Pregnancy

Available data from clinical trials with DIFFERIN Lotion use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes

Animal data

  • In animal reproduction studies, oral administration of adapalene to pregnant rats and rabbits during organogenesis at dose exposures 122 and 243 times, respectively, the human exposure at maximum recommended human dose (MRHD) of 2 g resulted in fetal skeletal and visceral malformations

Lactation

There are no data on presence of topical adapalene lotion or metabolite in human milk, effects on breastfed infant, or on milk production; in animal studies, adapalene is present in rat milk with oral administration of the drug; when a drug is present in animal milk, it is likely that the drug will be present in human milk

It is possible that topical administration of large amounts of adapalene could result in sufficient systemic absorption to produce detectable quantities in human milk; the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for therapy and any potential adverse effects on breastfed child from therapy or from underlying maternal condition

To minimize potential exposure to breastfed infant via breastmilk, use the smallest area of skin and for the shortest duration possible while breastfeeding; avoid application to areas with increased risk for potential ingestion by or ocular exposure to breastfeeding child

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Binds to specific retinoic-acid nuclear receptors and modulates cellular differentiation, keratinization, and inflammatory processes; exact mechanism of action for treatment of acne is unknown

Elimination

Excretion: Bile

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Administration

Topical Administration

Apply small (pea-sized) amount sparingly to entire face after cleansing with nonmedicated cleanser

For topical use only; not for ophthalmic, oral, or intravaginal use

Avoid mucous membranes, eyes, and lips

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
adapalene topical
-
0.1 % gel
adapalene topical
-
0.1 % cream
adapalene topical
-
0.3 % gel
adapalene topical
-
0.1 % gel
adapalene topical
-
0.3 % gel
adapalene topical
-
0.3 % gel
adapalene topical
-
0.3 % gel
adapalene topical
-
0.3 % gel
adapalene topical
-
0.1 % cream
Differin topical
-
0.1 % cream
Differin topical
-
0.1 % lotion
Differin topical
-
0.3 % gel

Copyright © 2010 First DataBank, Inc.

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Patient Handout

Patient Education
adapalene topical

ADAPALENE - TOPICAL

(a-DAP-a-leen)

COMMON BRAND NAME(S): Differin

USES: This medication is used to treat acne. It may decrease the number and severity of acne pimples and promote quick healing of pimples that do develop. Adapalene belongs to a class of medications called retinoids. It works by affecting the growth of cells and decreasing swelling and inflammation.

HOW TO USE: If you are using the over-the-counter product to self-treat, read and follow all directions on the product package before using this medication. If you have any questions, consult your pharmacist. If your doctor has prescribed this medication, use it as directed.Use this medication as directed by your doctor or the product package, usually once daily at bedtime. Before using, gently clean the affected skin with a mild or soapless cleanser and pat dry.If you are using the gel, cream, or lotion, wash your hands before and after applying this medication. Use your fingertips to apply a small amount of medication in a thin layer. If you are using the medicated swab, unwrap the swab and apply a thin layer to the affected area(s).Use this medication on the skin only. Avoid getting this medication in your eyes or on your lips. Do not apply to the inner lip area or inside the nose/mouth. If this medication gets into your eyes, flush with large amounts of water. Call your doctor if eye irritation develops. Do not apply to cut, scraped, or sunburned areas, or to skin affected by eczema (a skin condition).During the first few weeks of using adapalene, your acne might appear worse because the medication is working on pimples forming inside the skin. It may take 8 to 12 weeks to notice results from this medication.Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day. Do not use a larger amount or use it more often than directed. Your skin will not improve any faster, and your risk of developing side effects (such as redness, peeling, or pain) will increase.This medication is available in different strengths and forms (such as gel, cream, lotion). The best type of medication for you to use will depend on the condition of your skin and your response to treatment. Tell your doctor if your condition does not get better or if it gets worse.

SIDE EFFECTS: A brief sensation of warmth or stinging may occur right 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 lasts or gets worse, tell 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.If your doctor has directed you to use this medication, remember that your doctor 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 right away if you have any serious side effects, including: 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 rare. However, get medical help right away 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 or at www.fda.gov/medwatch.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 to vitamin A-related drugs (other retinoids such as isotretinoin); 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. Limit your time in the sun. Avoid tanning booths and sunlamps. Weather extremes such as wind or cold may also be irritating to the skin. Use sunscreen daily and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness. 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.During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Avoid using other skin products that are harsh, irritating, or drying on the treated area. These products include hair perming solutions, alcohol/lime/menthol-containing products (such as astringents, toners, shaving lotion), medicated or abrasive soaps or cleansers, soaps and cosmetics with a strong drying effect (such as alpha hydroxy acids, glycolic acid), and products containing sulfur, resorcinol, salicylic acid.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.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. This medication may be harmful if swallowed.

NOTES: Do not share this medication with others.Cosmetics may be used, but clean skin thoroughly before applying the medication.Some cosmetics and soaps may worsen your acne. Moisturizers may be safe to use. When buying cosmetics, moisturizers or other skin care products, check the label for "non-comedogenic" or "non-acnegenic." These products are unlikely to worsen your acne. Ask your doctor or pharmacist which products are safe to use. Remember, acne is not caused by dirt. Cleaning your skin too often or too vigorously can irritate your skin and worsen acne.

MISSED DOSE: If you forget to use this medication, use it as soon as you remember if you remember the same day. If you don't remember until morning, wait until your next dose is scheduled.

STORAGE: Store at room temperature. Avoid freezing. Different forms of this medication may have different storage requirements. Read the package labeling or ask your pharmacist for the storage requirements for the product you are using. Gel preparations are flammable. Do not expose to heat or fire sources. Do not smoke during use. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised August 2022. Copyright(c) 2022 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.