Adapalene topical cream 0.1%; gel 0.1% and 0.3%; lotion 0.1%

Adapalene topical

Active Ingredient

Administration Route

Alcohol Warning

Available Strength

Breastfeeding Warning

Excreted into human milk: Unknown

Excreted into animal milk: Unknown

Comments:

-This drug should be used in areas away from the chest to prevent accidental contact with the infant’s skin.

-Ointments should not be applied to the breast prior to breastfeeding; if necessary, water-miscible cream or gel products may be used, but the products should not be applied to the nipple area.

Risk to the nursing infant is considered low, as only a negligible amount is absorbed after topical application.

Clinical Pharmacology

Adapalene is a chemically stable retinoid-like compound. Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization, and inflammatory processes all of which represent important features in the pathology of acne vulgaris.

Pharmacokinetics 

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

Cost

0.1% (per gram): $6.03 – $6.55

Gel (Adapalene External):

0.1% (per gram): $4.37

0.3% (per gram): $6.60 – $6.88

Lotion (Differin External)

0.1% (per mL): $9.86

Dosage Form

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

Gel, External:

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

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

Lotion, External:

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

Dose Schedule

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

Dosing: Pediatric

Acne vulgaris, treatment: Children ≥7 years and Adolescents: Limited data available in ages <12 years 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.

Drug Class

Drug Unit

Food Warning

Included In
Health Insurance Plan

Interacting Drugs

Is Available Generically

Is Proprietary

Label Details

Legal Status

Manufacturer

Maximum Intake

Mechanism of Action

Non Proprietary Name

Overdosage

Pregnancy Category

Pregnancy Warning

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.

Prescribing Info

Prescription Status

Proprietary Name

Related Drugs

RxCUI

Warning

• Hypersensitivity reactions: Reactions such as pruritus, face edema, eyelid edema, and 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