ADAPALINE GEL 0.3% 45G
Generic: ADAPALENE
ADAPALINE GEL 0.3% 45G
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Identification
ADAPALENE
ADAPALENE
Alembic Pharmaceuticals Inc.
HUMAN PRESCRIPTION DRUG
Administration
GEL
TOPICAL
ANDA213508
Active Ingredients
| Ingredient | Strength |
|---|---|
| ADAPALENE | 3 mg/g |
Pharmacological Class
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
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Clinical Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Adapalene gel, 0.3% 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 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Wash affected areas gently with a non-medicated soap. Apply a thin film of adapalene gel to the entire face and any other affected areas of the skin once daily in the evening. 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 adapalene gel. Instruct patients to minimize sun exposure and 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. Wash affected areas gently with a non-medicated soap. ( 2 ) Apply a thin film of adapalene gel, to the entire face and other affected areas of the skin once daily in the evening. ( 2 ) For topical use only. Not for ophthalmic, oral or intravaginal use. ( 2 )
Adverse Reactions
6 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 Alembic Pharmaceuticals, Inc. at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical 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 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 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%) 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. 6.2 Post-Marketing 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.
Information for Patients
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information) Information for Patients Patients using adapalene gel should receive the following information and instructions: Apply a thin film of adapalene gel to the entire face and any other affected areas of the skin once daily in the evening. Apply a thin film of adapalene gel 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 contact with the eyes, lips, angles of the nose, and mucous membranes Moisturizers may be used if necessary; however, products containing alpha hydroxy or glycolic acids should be avoided. This medication should not be applied to cuts, abrasions, eczematous, or sunburned skin. Wax depilation should not be performed on treated skin due to the potential for skin erosions. Minimize exposure to sunlight including sunlamps. Recommend the use of sunscreen products and protective apparel (e.g., hat) when exposure cannot be avoided. Contact the doctor if skin rash, pruritus, hives, chest pain, edema, and shortness of breath occurs, as these may be signs of allergy or hypersensitivity. This product is for external use only. Lactation: Use adapalene gel on the smallest area of skin and for the shortest duration possible while breastfeeding. Avoid application of adapalene gel to areas with increased risk for potential ingestion by or ocular exposure to the breastfeeding child. [ See Use in Specific Populations, Lactation (8.2)] Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Manufactured by: Alembic Pharmaceuticals Limited (Derma Division), Karakhadi, Vadodara 391450, India. Mfg. License No.: G/25/2216 Revised: 06/2024
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.