Drug: Differin Gel .3%

DIFFERIN (adapalene) Gel, 0.3% contains adapalene 0.3% (3 mg/g) in a topical aqueous gel for use in the treatment of acne vulgaris, consisting of carbomer 940, edetate disodium, methylparaben, poloxamer 124, propylene glycol, purified water, and sodium hydroxide. May contain hydrochloric acid for pH adjustment. The chemical name of adapalene is 6-[3-(l-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. It is a white to off-white powder, which is soluble in tetrahydrofuran, very slightly soluble in ethanol, and practically insoluble in water. The molecular formula is C28H28O3 and molecular weight is 412.53. Adapalene is represented by the following structural formula.

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Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reactions rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. In the multi-center, controlled clinical trial, signs and symptoms of local cutaneous irritation were monitored in 258 acne patients who used DIFFERIN Gel, 0.3% once daily for 12 weeks. Of the patients who experienced cutaneous irritation (erythema, scaling, dryness, and/or burning/stinging), the majority of cases were mild to moderate in severity, occurred early in treatment and decreased thereafter. The incidence of local cutaneous irritation with DIFFERIN Gel, 0.3% from the controlled clinical study is provided in the following table: Table 1: Physician assessed local cutaneous irritation with DIPPERIN Gel
Incidence of Local Cutaneous Irritation with DIFFERIN Gel, 0.3% from Controlled Clinical Study (N = 253*)
Maximum Severity Scores Higher Than Baseline   Mild Moderate Severe Erythema 66 (26.1%) 33 (13.0%) 1 (0.4%) Scaling 110 (43.5%) 47 (18.6%) 3 (1.2%) Dryness 113 (44.7%) 43 (17.0%) 2 (0.8%) Burning/Stinging 72 (28.5%) 36 (142%) 9 (3.6%) * Total number of subjects with local cutaneous data for at least one post-Baseline evaluation. Table 2: Patient reported local cutaneous adverse reactions with DIFFERIN Gel
  DIFFERIN (adapalene) Gel, 0.3% Vehicle Gel N=258 N=134 Related* Adverse Reactions 57(22.1%) 6 (4.5%)   Dry Skin 36(14%) 2(1.5%)   Skin Discomfort 15(5.8%) 0 (0.0%)   Desquamation 4(1.6%) 0 (0.0%) * Selected adverse reactions defined by investigator as Possibly, Probably or Definitely Related Related adverse reactions from the controlled clinical trial that occurred in greater than 1% of patients who used DIFFERIN Gel, 0.3% once daily included: dry skin (14.0%), skin discomfort (5.8%), pruritus (1.9%), desquamation (1.6%), and sunburn (1.2%). The following selected adverse reactions occurred in less than 1% of patients: acne flare, contact dermatitis, eyelid edema, conjunctivitis, erythema, pruritus, skin discoloration, rash, and eczema. In a one-year, open-label safety study of 551 patients with acne who received DIFFERIN Gel, 0.3%, the pattern of adverse reactions was similar to the 12-week controlled study. Postmarketing Experience The following adverse reactions have been identified during post approval use of adapalene: skin irritation, application site pain, face edema, eyelid edema, lip swelling, and angioedema. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drag exposure. Read the Differin Gel .3% (adapalene) Side Effects Center for a complete guide to possible side effectsLearn More »

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Apply a thin film of DIFFERIN Gel, 0.3% to the entire face and any other affected areas of the skin once daily in the evening, after washing gently with a non-medicated soap. Avoid application to the areas of skin around eyes, lips, and mucous membranes. A mild transitory sensation of warmth or slight stinging may occur shortly after the application of DIFFERIN Gel, 0.3%. Patients should be instructed to minimize sun exposure. Patients may be instructed to use moisturizers for relief of dry skin or irritation. If therapeutic results are not noticed after 12 weeks of treatment, therapy should be re-evaluated. For topical use only. Not for ophthalmic, oral or intravaginal use.

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Concomitant Topical Medications As DIFFERIN Gel, 0.3% has the potential to induce local irritation in some patients, concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices, or lime) should be approached with caution. Particular caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid in combination with DIFFERIN Gel, 0.3%. If these preparations have been used, it is advisable not to start therapy with DIFFERIN Gel, 0.3%, until the effects of such preparations have subsided. No formal drug-drug interaction studies were conducted with DIFFERIN Gel, 0.3%.Last reviewed on RxList: 9/24/2010
This monograph has been modified to include the generic and brand name in many instances.

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DIFFERIN Gel, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

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DIFFERIN Gel, 0.3% should not be administered to individuals who are hypersensitive to adapalene or any of the components in the gel vehicle. Last reviewed on RxList: 9/24/2010
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

DIFFERIN Gel, 0.3% is intended for topical use only. If the medication is applied excessively, no more rapid or better results will be obtained and marked redness, scaling, or skin discomfort may occur. Chronic ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of vitamin A.

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Dosage Forms And Strengths Each gram of DIFFERIN Gel, 0.3% contains 3 mg adapalene in an off-white aqueous gel. DIFFERIN Gel, 0.3% is supplied in the following size. 45 g tube - NDC 0299-5918-45 Storage: Store at controlled room temperature 68° to 77°F (20° to 25°C) with excursions permitted between 59° to 86°F (15° to 30°C). Protect from freezing. Keep out of reach of children. Marketed by: Galderma Laboratories, L.P. Fort Worth, Texas 76177 USA. Manufactured by: DPT Laboratories, Ltd. San Antonio, Texas 78215 USA. Revised: 08/2010. Last reviewed on RxList: 9/24/2010
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Ultraviolet Light and Environmental Exposure Exposure to sunlight, including sunlamps, should be minimized during use of DIFFERIN Gel, 0.3%. Patients who normally experience high levels of sun exposure, and those with inherent sensitivity to sun, should be warned to exercise caution. Use of sunscreen products and protective clothing over treated areas is recommended when exposure cannot be avoided. Weather extremes, such as wind or cold, also may be irritating to patients under treatment with DIFFERIN Gel, 0.3%. Local Cutaneous Reactions Certain cutaneous signs and symptoms of treatment such as erythema, scaling, dryness, and stinging/burning were reported with use of DIFFERIN Gel, 0.3%. These were most likely to occur during the first four weeks of treatment, were mostly mild to moderate in intensity, and usually lessened with continued use of the medication. Depending upon the severity of these side effects, patients should be instructed to either use a moisturizer, reduce the frequency of application of DIFFERIN Gel, 0.3% or discontinue use. Avoid contact with the eyes, lips, angles of the nose, and mucous membranes. The product 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 adapalene. As DIFFERIN Gel has the potential to induce local irritation in some patients, concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect and products with high concentrations of alcohol, astringents, spices, or lime) should be approached with caution. Allergic/ Hypersensitivity Reactions: Reactions characterized by symptoms such as pruritus, face edema, eyelid edema, and lip swelling, requiring medical treatment have been reported during postmarketing use of adapalene. A patient should stop using DIFFERIN Gel, 0.3% and consult a doctor if experiencing allergic or anaphylactoid/anaphylactic reactions (e.g., skin rash, pruritus, hives, chest pain, edema, and shortness of breath) during treatment. Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies with adapalene have been conducted in mice at topical doses of 0.4,1.3, and 4.0 mg/kg/day, and in rats at oral doses of 0.15, 0.5, and 1.5 mg/kg/day. These doses are up to 3 times (mice) and 2 times (rats) in terms of mg/irf/day the potential exposure at the maximum recommended human dose (MRHD), assumed to be 2.5 grams DIFFERIN Gel, 0.3%. In the oral study, increased incidence of benign and malignant pheochromocytomas in the adrenal medullas of male rats was observed. No photocarcinogenicity studies were conducted. Animal studies have shown an increased risk of skin neoplasms with the use of pharmacologically similar drugs (e.g., retinoids) when exposed to UV irradiation in the laboratory or to sunlight. Although the significance of these studies to human use is not clear, patients should be advised to avoid or minimize exposure to either sunlight or artificial UV irradiation sources. Adapalene did not exhibit mutagenic or genotoxic effects in vitro (Ames test, Chinese hamster ovary cell assay, mouse lymphoma TK assay) and in vivo (mouse micronucleus test). Reproductive function and fertility studies were conducted in rats administered oral doses of adapalene in amounts up to 20 mg/kg/day (up to 26 times the MRHD based on mg/m2 comparisons). No effects of adapalene were found on the reproductive performance or fertility of the F0 males or females. There were also no detectable effects on the growth, development and subsequent reproductive function of the FI offspring. Use In Specific Populations Pregnancy Teratogenic effects. Pregnancy Category C. Retinoids may cause fetal harm, when administered to pregnant women. Adapalene has been shown to be teratogenic in rats and rabbits when administered orally (see Animal Data below). There are no adequate and well-controlled studies in pregnant women. DIFFERIN Gel, 0.3% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The safety and efficacy of DIFFERIN Gel, 0.3% in pregnancy has not been established. Human Data In clinical trials involving DIFFERIN Gel, 0.3% in the treatment of acne vulgaris, women of child-bearing potential initiated treatment only after having had a negative pregnancy test and used effective birth control measures during therapy. However, 6 women treated with DIFFERIN Gel, 0.3% became pregnant. One patient elected to terminate the pregnancy, two patients delivered healthy babies by normal delivery, two patients delivered prematurely and the babies remained in intensive care until reaching a healthy state and one patient was lost to follow-up. Animal Data
  • No teratogenic effects were seen in rats at oral doses of 0.15 to 5.0 mg/kg/day adapalene representing up to 6 times the maximum recommended human dose (MRHD) based on mg/m2 comparisons. Adapalene has been shown to be teratogenic in rats and rabbits when administered orally at doses ≥ 25 mg/kg representing 32 and 65 times, respectively, the MRHD based on mg/m2 comparisons. Findings included cleft palate, microphthalmia, encephalocele and skeletal abnormalities in the rat and umbilical hernia, exophthalmos and kidney and skeletal abnormalities in the rabbit.
  • Cutaneous teratology studies in rats and rabbits at doses of 0.6,2.0, and 6.0 mg/kg/day exhibited no fetotoxicity and only minimal increases in supernumerary ribs in both species and delayed ossification in rabbits. Systemic exposure (AUC0-24h) to adapalene 0.3% gel at topical doses of 6.0 mg/kg/day in rats and rabbits represented 5.7 and 28.7 times, respectively, the exposure in acne patients treated with adapalene 0.3% gel applied to the face, chest and back (2 grams applied to 1000 cm2 of acne involved skin).
Nursing Mothers It is not known whether adapalene is excreted in human milk. Because many drags are excreted in human milk, caution should be exercised when DIFFERIN Gel, 0.3% is administered to a nursing woman. Pediatric Use Safety and effectiveness have not been established in pediatric patients below the age of 12. Geriatric Use Clinical studies of DIFFERIN Gel, 0.3% did not include subjects 65 years of age and older to determine whether they respond differently than younger subjects. Safety and effectiveness in geriatric patients age 65 and above have not been established.Last reviewed on RxList: 9/24/2010
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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