Retinoid

Differin

Approved 19 Jun 2007TopicalGel

The FDA lists this product in 5 strengths and forms.

Indications

Adapalene Gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. Adapalene Gel, 0.3%, is a retinoid, indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. ( 1 )

Contraindications

Adapalene Gel is contraindicated in patients who have known hypersensitivity to adapalene or any excipient of Adapalene Gel [see WARNINGS AND PRECAUTIONS (5.1)]. Contraindicated in patients who have known hypersensitivity to adapalene or any excipient of Adapalene Gel. ( 4 )

Warnings and precautions

Allergic/Hypersensitivity Reactions: Allergy/hypersensitivity reactions include anaphylaxis angioedema, face edema, eyelid edema, lip swelling, and pruritis. Discontinue Adapalene Gel in the event of an allergic/hypersensitivity reaction. (5.1) Ultraviolet Light and Environmental Exposure: Avoid exposure to sunlight and sunlamps. Wear sunscreen when sun exposure cannot be avoided (5.2). Local Cutaneous Reactions : Erythema, scaling, dryness, and stinging/burning were reported with use of Adapalene Gel.

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. (5.3).

5.1Allergic/ Hypersensitivity Reactions

Adverse reactions including anaphylaxis angioedema, face edema, eyelid edema, lip swelling, and pruritus that sometimes required medical treatment have been reported during postmarketing use of adapalene. Advise a patient to stop using Adapalene Gel and seek medical attention if experiencing allergic or anaphylactoid/anaphylactic reactions during treatment..

5.2Ultraviolet Light and Environmental Exposure Exposure

Warnings and precautions

5.1Allergic/ Hypersensitivity Reactions

5.2Ultraviolet Light and Environmental Exposure Exposure

Adverse reactions

The most frequently reported ( > 1%) adverse reactions were erythema, scaling, dryness, and/or burning/stinging. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials 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 subjects who used Adapalene Gel once daily for 12 weeks.

Of the subjects 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 Adapalene Gel from the controlled clinical trial is provided in the following table: Table 1: Physician assessed local cutaneous irritation with Adapalene Gel * Total number of subjects with local cutaneous data for at least one post-Baseline evaluation.

Incidence of Local Cutaneous Irritation with Adapalene Gel (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 (14.2%) 9 (3.6%) Table 2: Patient reported local cutaneous adverse reactions with Adapalene Gel * Selected adverse reactions defined by investigator as Possibly, Probably or Definitely Related Adapalene Gel Vehicle Gel N = 258 N = 134 Related* Adverse Reactions Dry Skin Skin Discomfort Desquamation 57 (22.1%) 36 (14%) 15 (5.8%) 4 (1.6%) 6 (4.5%) 2 (1.5%) 0 (0%) 0 (0%) The following adverse reactions occurred in less than 1 % of subjects: acne flare, contact dermatitis, eyelid edema, conjunctivitis, erythema, pruritus, skin discoloration, rash, and eczema.

In a one-year, open-label safety trial of 551 subjects with acne who received Adapalene Gel, the pattern of adverse reactions was similar to the 12-week controlled study.

6.2Postmarketing Experience

The following adverse reactions have been identified during post approval use of adapalene: Immune system disorders: angioedema, face edema, lip swelling Skin disorders: application site pain 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 drug exposure.

Differin

Indications

Contraindications

Warnings and precautions

5.1Allergic/ Hypersensitivity Reactions

5.2Ultraviolet Light and Environmental Exposure Exposure

Two medicines in one question?

Differin

Indications

Contraindications

Warnings and precautions

5.1Allergic/ Hypersensitivity Reactions

5.2Ultraviolet Light and Environmental Exposure Exposure

Two medicines in one question?

5.3Local Cutaneous Reactions

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience

Composition

Strengths and forms

Official product information

At a glance