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Adapalene: Drug information

Adapalene: Drug information
(For additional information see "Adapalene: Patient drug information" and see "Adapalene: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Differin;
  • Differin [OTC]
Brand Names: Canada
  • Differin;
  • Differin XP
Pharmacologic Category
  • Acne Products;
  • Retinoic Acid Derivative;
  • Topical Skin Product, Acne
Dosing: Adult
Acne vulgaris

Acne vulgaris: Topical: Cream 0.1%; Gel 0.1%, 0.3%; Lotion 0.1%: Apply once daily. Consider starting with the lowest possible concentration to minimize skin irritation and increase potency as tolerated. For moderate to severe acne, may be used as part of an appropriate combination regimen (Ref). If irritation occurs, may reduce the frequency of application.

Rosacea

Rosacea (off-label use): Topical: 0.1% Gel: Apply to affected area once daily in the evening for up to 12 weeks (Ref).

Dosing: Kidney Impairment: Adult

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

Dosing: Hepatic Impairment: Adult

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

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Adapalene: Pediatric drug information")

Acne vulgaris, treatment

Acne vulgaris, treatment: Children ≥7 years and Adolescents: Limited data available in ages <12 years (Ref): Topical: Apply once daily; cream, gel, or solution should be applied in the evening (at bedtime). Note: During the initial 2 weeks of therapy, it may appear that acne worsens; full effect may take up to 8 to 12 weeks of therapy.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely necessary due to low systemic absorption.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely necessary due to low systemic absorption.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adolescents and adults.

>10%: Dermatologic: Burning sensation of skin (≤29%), erythema of skin (≤38%), exfoliation of skin (≤44%), pruritus (≤21%), stinging of the skin (≤29%), xeroderma (≤45%)

1% to 10%: Dermatologic: Skin irritation (≤2%), skin pain (discomfort; ≤2%), sunburn (≤2%)

<1%:

Dermatologic: Acne flare, dermatitis (including contact dermatitis), eczema, skin discoloration, skin rash

Ophthalmic: Conjunctivitis, eyelid edema

Postmarketing:

Hypersensitivity: Anaphylaxis, angioedema, facial edema, swelling of lips

Local: Application-site pain

Contraindications

Hypersensitivity to adapalene or any component of the formulation.

OTC labeling: When used for self-medication, do not use on damaged skin (cuts, abrasions, eczema, sunburn).

Canadian labeling: Additional contraindications (not in US labeling): Patients with eczema or seborrheic dermatitis; women who are pregnant or planning to become pregnant.

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Reactions such as anaphylaxis, angioedema, urticaria, pruritus, face edema, eyelid edema, and lip swelling have been reported. Discontinue use immediately if allergic or anaphylactoid/anaphylactic reactions occur.

• Photosensitivity: Use is associated with increased susceptibility/sensitivity to UV light; avoid sunlamps or excessive sunlight exposure. Daily sunscreen use and other protective measures are recommended. Patients with sunburn should discontinue use until sunburn has healed.

• Skin irritation: Certain cutaneous signs and symptoms such as erythema, dryness, scaling, stinging/burning, or pruritus may occur during treatment; these are most likely to occur during the first 2 to 4 weeks and will usually lessen with continued use. Treatment can increase skin sensitivity to weather extremes of wind or cold. Concomitant topical medications (eg, medicated or abrasive soaps and cleansers, or cosmetics with a strong drying effect, products with high concentrations of alcohol, astringents, spices or limes) should be avoided due to increased skin irritation. Depending on the severity of irritation, use moisturizer, reduce the frequency of application, or discontinue use.

Other warnings/precautions:

• Appropriate use: For external use only; avoid contact with abraded, broken, eczematous, or sunburned skin, mucous membranes, eyes, lips, and angles of the nose. Wax depilation is not recommended.

Warnings: Additional Pediatric Considerations

May cause mild hyperglycemia; more common in pediatric patients. Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures and respiratory depression; use caution (AAP 1997; Shehab 2009).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Cream, External:

Differin: 0.1% (45 g)

Generic: 0.1% (45 g)

Gel, External:

Differin: 0.1% (15 g, 45 g); 0.3% (45 g) [contains edetate (edta) disodium, methylparaben, propylene glycol]

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

Generic: 0.1% (15 g [DSC], 45 g); 0.3% (45 g)

Lotion, External:

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

Pad, External:

Generic: 0.1% (14 ea)

Solution, External:

Generic: 0.1% (60 mL [DSC], 120 mL)

Generic Equivalent Available: US

May be product dependent

Pricing: US

Cream (Adapalene External)

0.1% (per gram): $6.03 - $6.55

Cream (Differin External)

0.1% (per gram): $14.11

Gel (Adapalene External)

0.1% (per gram): $4.37

0.3% (per gram): $1.77 - $6.88

Gel (Differin External)

0.1% (per gram): $0.55

0.3% (per gram): $14.64

Lotion (Differin External)

0.1% (per mL): $10.36

Pads (Adapalene External)

0.1% (per each): $105.00

Solution (Adapalene External)

0.1% (per mL): $8.80

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

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

Cream, External:

Differin: 0.1% (2 g, 15 g, 45 g, 60 g) [contains edetate (edta) disodium, methylparaben, propylparaben, trolamine (triethanolamine)]

Gel, External:

Differin: 0.1% (2 g, 15 g, 45 g, 60 g) [contains edetate (edta) disodium, methylparaben, propylene glycol]

Differin XP: 0.3% (2 g, 60 g) [contains edetate (edta) disodium, methylparaben, propylene glycol]

Administration: Adult

Topical: For topical use only; not for oral, ophthalmic, or intravaginal use. Avoid contact with abraded, broken, eczematous, or sunburned skin, mucous membranes, eyes, lips, and angles of the nose. Moisturizers may be used if necessary; avoid alpha hydroxy or glycolic acid-containing products. A mild transitory sensation of warmth or slight stinging may occur shortly after application.

Cream/gel: Apply a thin film to face and other affected areas of the skin after washing with a mild, soapless, or nonmedicated cleanser in the evening before bedtime; apply enough to cover entire affected area.

External pad: Remove pad from foil just prior to use. Before bedtime, wash and dry area to be treated, then apply pad containing topical solution to affected areas. Discard pad after single use.

Lotion: Apply a thin film after washing gently with a mild or soapless cleanser and then pat dry; dispense a nickel size amount (3 to 4 pump actuations) to cover entire face and other affected areas of the skin.

Administration: Pediatric

Topical: For topical external use only. Avoid contact with eyes, angles of the nose, lips, and mucous membranes. Do not apply to cuts, abrasions, eczematous, or sunburned skin. Shortly after application, a mild transitory sensation of warmth or slight stinging may occur. Moisturizers may be used if necessary; avoid moisturizers containing alpha hydroxy or glycolic acid-containing products. Wash hands after application.

Cream/gel: Cleanse affected area with a mild or soapless cleanser and pat dry; apply a thin film to skin in the evening before bedtime; apply enough to cover entire affected area.

External pad: Remove pad from foil just prior to use. Before bedtime, wash and dry area to be treated, then apply pad containing topical solution to affected areas. Discard pad after single use.

Lotion: Apply after washing gently with a mild or soapless cleanser and then pat dry; dispense a nickel size amount (3 to 4 pump actuations) to cover entire face.

Solution: External Pad (Plixda): Remove pad from foil just prior to use. Before bedtime, wash and dry area to be treated, then apply pad containing topical solution to affected areas. Discard pad after single use.

Use: Labeled Indications

Acne vulgaris: Treatment of acne vulgaris.

Use: Off-Label: Adult

Rosacea

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

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

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

Methoxsalen (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Methoxsalen (Systemic). Risk C: Monitor therapy

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

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

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

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

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

Pregnancy Considerations

Outcome data following maternal use of adapalene during pregnancy are available (Autret 1997; Panchaud 2012; Weiss 2021).

In general, topical products are recommended for the treatment of acne in pregnancy due to lower systemic exposure. However, because adapalene may share the characteristic of teratogenicity with other retinoids, agents other than adapalene are preferred. Avoid applying large amounts over prolonged periods of time to decrease the potential for systemic absorption (Akhavan 2003; Kong 2013; Leechman 2006).

Breastfeeding Considerations

It is not known if adapalene is present in breast milk.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. The use of topical agents is generally preferred over systemic agents for the treatment of acne in patients who are breastfeeding. Topical adapalene may be compatible with breastfeeding; however, specific studies are not available. Avoid applying large amounts over prolonged periods of time to decrease the potential for systemic absorption (Kong 2013; Leechman 2006). Mothers should wash hands following application. Because topical agents can be transferred to a breastfeeding infant, avoid direct skin-to-skin contact with treated areas (Anderson 2018). Use of alternative agents or postponement of therapy may also be considered (Zip 2002).

Mechanism of Action

Retinoid-like compound which is a modulator of cellular differentiation, keratinization, and inflammatory processes, all of which represent important features in the pathology of acne vulgaris

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: 8 to 12 weeks

Absorption: Topical: Minimal; only trace amounts have been measured in serum after chronic application

Half-life elimination, terminal: 7 to 51 hours (gel)

Excretion: Bile

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Deriva | Differin | Surecure;
  • (AR) Argentina: Acnidazil | Axne | Dermotopic | Differin | Doniq | Exogel | Panalene | Sinac;
  • (AT) Austria: Differin;
  • (AU) Australia: Differin;
  • (BD) Bangladesh: Aclene | Adapel | Adgar | Apalene | Fona;
  • (BE) Belgium: Differin;
  • (BR) Brazil: Adacne | Adapaleno | Adapel | Belpele | Dalap | Deriva micro | Differin;
  • (CH) Switzerland: Differin;
  • (CI) Côte d'Ivoire: Fona;
  • (CL) Chile: Adapac | Adapaleno | Adiamil | Daplen | Differin | Flamir | Nyskin | Zudenina;
  • (CN) China: Chu ya | Differin;
  • (CO) Colombia: Adamac | Adapgel | Differin | Glenpalene | Zudenina | Zudenina f;
  • (CZ) Czech Republic: Belakne | Differine;
  • (DE) Germany: Differin | Differine | Dipalen;
  • (DK) Denmark: Redap;
  • (DO) Dominican Republic: Adaferin | Adiamil | Deriva | Dicron | Panalene | Zudenina;
  • (EC) Ecuador: Adiamil | Deriva | Deriva gel aqueous | Dermotopic | Differin;
  • (EE) Estonia: Differin;
  • (EG) Egypt: Acne Jed | Acnescave | Adagel | Adanoid | Aknapalen | Marpalene | Pal mash | Randapalene;
  • (ES) Spain: Differine;
  • (ET) Ethiopia: T3 ada;
  • (FI) Finland: Differin;
  • (FR) France: Adapalene Dci | Adapalene Teva | Adapalene winthrop | Differine;
  • (GB) United Kingdom: Differin;
  • (GR) Greece: Adaferin;
  • (HK) Hong Kong: Aclear | Acure | Differin | Ellia | Fona | Opalen;
  • (HR) Croatia: Sona;
  • (HU) Hungary: Differin;
  • (ID) Indonesia: Evalen | Palenox;
  • (IE) Ireland: Differin;
  • (IL) Israel: Adaferin;
  • (IN) India: Aclene | Acneril | Adaclene | Adaferin | Adapen | Adaple | Adapnil | Adaret | Adiff | Aditop | Adlene | Adlene ad | Admark | Alangel | Alene | Ap | Apalene | Apgel | Deriva aqueous | Medapine | Opalen | Rozac;
  • (IT) Italy: Differin;
  • (JO) Jordan: Acne mafee | Differin | Surecure;
  • (JP) Japan: Adapalene iwaki | Adapalene jg | Adapalene nipro | Adapalene nissin | Adapalene tck | Adapalene teikoku | Adapalene toko | Adapalene yd | Differin;
  • (KE) Kenya: Adapco | Fona | Klenzit;
  • (KR) Korea, Republic of: Acferin | Aclea | Aclen | Adipolin | D2o | Differin | Dongkoo adapalene | Ellibel | Newcne;
  • (KW) Kuwait: Differine | Surecure;
  • (LB) Lebanon: Differin | Differine;
  • (LT) Lithuania: Differin | Differine;
  • (LU) Luxembourg: Differin;
  • (LV) Latvia: Differin | Differine;
  • (MA) Morocco: Differine;
  • (MX) Mexico: Adaferin | Bracitor | Leneda | Trabalene | Yunneco;
  • (MY) Malaysia: Deriva | Deriva ms | Differin | T3 ada;
  • (NL) Netherlands: Differin;
  • (NO) Norway: Differin;
  • (NZ) New Zealand: Differin;
  • (PE) Peru: Alviera | Andropalene | Deriva | Deriva ms | Differin | Ganaxin | Panalene;
  • (PH) Philippines: Differin | Klenzit;
  • (PK) Pakistan: Aclene | Acne Lene | Acneris | Acnolin | Acpalene | Acpro | Adaferin | Adapal | Adapco | Adapco forte | Adapen | Adaplex | Adaptin | Adiff | Adlob | Aroleen | Arsodap | Clear | Clear cream | Clenac | Differin | Elucider | Gallet | Inapel | Pimpal | Semycin | Vee laar;
  • (PL) Poland: Acnelec | Differin;
  • (PR) Puerto Rico: Differin | Plixda;
  • (PT) Portugal: Differin;
  • (PY) Paraguay: Adapne | Adiamil | Differin | Sinac | Zudenina | Zudenina f;
  • (QA) Qatar: Deriva | SureCure;
  • (RU) Russian Federation: Adaclean | Adaklin | Adolen | Clenzit | Differin;
  • (SA) Saudi Arabia: Adolin | Deriva | Differin | Surecure | Watene;
  • (SE) Sweden: Differin;
  • (SG) Singapore: Differin;
  • (SI) Slovenia: Belakne | Differin;
  • (SK) Slovakia: Belakne | Differine;
  • (TH) Thailand: Differin;
  • (TN) Tunisia: Differine;
  • (TR) Turkey: Acnefferin | Differin;
  • (TW) Taiwan: Acnely | Acure | Adagene T | Adalene | Adamei | Adarin | Adayung | Andopin | Anefree | Apalene | Beautyface | Differin | Easy acne | Feeling | Kwaie | Madyo | Maydo gel | Niffulene | Olena | Palene | Shinny | Tifforly;
  • (UA) Ukraine: Deriva gel aqueous;
  • (UY) Uruguay: Differin | Zudenina;
  • (VE) Venezuela, Bolivarian Republic of: Adapne | Adiamil | Bioskin | Deriva aqueous | Differin | Zudenina;
  • (VN) Viet Nam: Akneyash | Edithz;
  • (ZA) South Africa: Dapta | Deriva | Differin;
  • (ZM) Zambia: Acfree | Deriva;
  • (ZW) Zimbabwe: Deriva
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