Differin Information
Differin (Adapalene) Indications And Usage
Differin (Adapalene) Lotion is indicated for the topical treatment of acne vulgaris in patients 12 years and older.
Differin (Adapalene) Dosage And Administration
Apply a thin film of Differin (Adapalene) Lotion to the entire face and other affected areas of the skin once daily, after washing gently with a mild soapless cleanser. Dispense a nickel size amount of Differin (Adapalene) Lotion (3-4 actuations of the pump) to cover the entire face. Avoid application to the areas of skin around eyes, lips and mucous membranes.
Differin (Adapalene) Lotion is for topical use only and not for oral, ophthalmic, or intravaginal use.
Differin (Adapalene) Dosage Forms And Strengths
Each gram of the lotion contains 1 mg (0.1%) adapalene in an oil-in-water emulsion.
Differin (Adapalene) Contraindications
Differin (Adapalene) Warnings And Precautions
Signs and symptoms of local skin irritation (such as erythema, scaling, dryness, stinging/burning) may be experienced with use of Differin (Adapalene) Lotion. These are most likely to occur during the first 2 weeks of treatment, are mostly mild to moderate in severity, and usually lessen with continued use of Differin (Adapalene) Lotion. Depending upon the severity of these side effects, patients should be instructed to use a moisturizer, reduce the frequency of the application of Differin (Adapalene) Lotion 0.1%, or discontinue use.
Differin (Adapalene) Lotion should not be applied to cuts, abrasions, eczematous or sunburned skin. As with other retinoids, use of “waxing” as a depilatory method should be avoided on skin treated with Differin (Adapalene) Lotion.
Avoid concomitant use of other potentially irritating topical products (abrasive soaps and cleansers, soaps and cosmetics that have strong skin-drying effect and products with high concentrations of alcohol, astringents, spices, or limes).
Differin (Adapalene) Use In Specific Populations
Pregnancy Category C. There are no well-controlled trials in pregnant women treated with Differin (Adapalene) Lotion. Therefore, Differin (Adapalene) Lotion should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal reproduction studies have not been conducted with Differin (Adapalene) Lotion. Furthermore, such studies are not always predictive of human response.
Human Data
In clinical trials involving Differin (Adapalene) Lotion, 0.1% in the treatment of acne vulgaris, women of childbearing potential initiated treatment only after a negative pregnancy test. Two women became pregnant while using Differin (Adapalene) Lotion, 0.1%. One patient delivered a healthy full term baby and the other patient electively terminated her pregnancy.
Animal Data
No teratogenic effects were observed in rats treated with oral doses of 0.15 to 5.0 mg adapalene/kg/day, up to 25 times (mg/m2/day) the maximum recommended human dose (MRHD) of 2 grams of Differin (Adapalene) Lotion. However, teratogenic changes were observed in rats and rabbits when treated with oral doses of ≥ 25 mg adapalene/kg/day representing 123 and 246 times MRHD, respectively. Findings included cleft palate, microphthalmia, encephalocele and skeletal abnormalities in rats; and umbilical hernia, exophthalmos and kidney and skeletal abnormalities in rabbits.
Dermal teratology studies conducted in rats and rabbits at doses of 0.6-6.0 mg adapalene/kg/day [25-59 times (mg/m) the MRHD] exhibited no fetotoxicity and only minimal increases in supernumerary ribs in both species and delayed ossification in rabbits.
Systemic exposure (AUC 0-24h) to adapalene at topical doses (6.0 mg/kg/day) in rats represented 101 times the exposure to adapalene in patients with acne treated with Differin (Adapalene) Lotion applied to the face, chest and back (2 grams applied to 1000 cm² of acne-involved skin).
Differin (Adapalene) Description
Differin (Adapalene) Lotion, 0.1% for topical use, is an adapalene-based product.
Adapalene is a naphthoic acid derivative with retinoid-like properties. The chemical name for adapalene is (6-[3-(1-adamantyl)-4-meghoxyphenyl]-2-naphthoic acid). Adapalene has the following structural formula:
Adapalene:
Differin (Adapalene) Lotion contains the following inactive ingredients: carbomer 941, disodium edetate, medium chain triglycerides, methylparaben, phenoxyethanol, poloxamer 124, polyoxyl-6-polyoxyl-32 palmitostearate, PPG-12/SMDI copolymer, propylene glycol, propylparaben, sodium hydroxide, stearyl alcohol, and purified water.
Differin (Adapalene) Clinical Studies
The safety and efficacy of Differin (Adapalene) Lotion applied once daily for the treatment of acne vulgaris were assessed in two 12-week, multicenter, controlled clinical studies of similar design, comparing Differin (Adapalene) Lotion to the Lotion vehicle in acne subjects.
In Study 1, 1075 subjects were randomized to Differin (Adapalene) Lotion or vehicle. The median age of these subjects was 16.7 years old and 53.1% were females. At baseline subjects had between 20 to 50 inflammatory lesions and 30 to 100 non-inflammatory lesions. The majority of subjects (91.0%) had a baseline IGA score of ‘Moderate’.
In Study 2, 1066 subjects were randomized to Differin (Adapalene) Lotion or vehicle. The median age of subjects was 16.7 years old and 53.7% were females. At baseline subjects had the same inclusion criteria as in Study 1 and 95.7% of subjects had a baseline IGA score of ‘Moderate’.
The outcome of the two studies is presented in .
Differin (Adapalene) How Supplied/storage And Handling
Differin (Adapalene) Lotion, 0.1%, is packaged in a 2 oz (59 mL) bottle which is equipped with a Lotion dispensing pump.
The Differin (Adapalene) Lotion is supplied as follows:
2 oz bottle pump
Storage and handling
Differin (Adapalene) Patient Counseling Information
Marketed by:GALDERMA LABORATORIES, L.P., Fort Worth, Texas 76177 USAManufactured by:Galderma Production Canada Inc., Baie d’Urfé, QC, H9X 3S4 CanadaMade in Canada.GALDERMA is a registered trademark.P51503-0
Differin (Adapalene) Package Label
2 FL OZ(59 mL)
GALDERMA
Storage: Store at controlled room temperature 68° - 77°F (20° - 25°C) with excursions permitted between 59° - 86°F (15° - 30°C). Do not freeze or refrigerate.
Marketed by:GALDERMA LABORATORIES, L.P.14501 North FreewayFort Worth, Texas 76177 USAManufactured by:Galderma Production Canada Inc.Baie d’Urfé, QC, H9X 3S4 CanadaMade in Canada.GALDERMA is a registered trademark.P51638-1
