Tretinoin
Generic: TRETINOIN
Basic Information
Manufacturer
Amneal Pharmaceuticals NY LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
4b6006e3-f7a4-4823-8217-3e5b0f7e58d9
Indications & Usage
1 INDICATIONS AND USAGE Tretinoin gel (microsphere) is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.
Tretinoin gel (microsphere)is a retinoid indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.
(1)
Tretinoin gel (microsphere)is a retinoid indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.
(1)
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions were skin irritation, skin burning, erythema, peeling, dryness, itching, and dermatitis.
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 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 reaction 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.
Tretinoin gel, 0.1% The safety of tretinoin gel, 0.1% for the treatment of acne vulgaris was evaluated in two multicenter, double-blind, randomized, vehicle-controlled clinical trials (Studies 1 and 2).
A total of 347 subjects with acne vulgaris were treated in Studies 1 and 2 in which 172 subjects received tretinoin gel, 0.1% and 175 subjects received vehicle, applied topically once daily in the evening, for 12 weeks.
Mean age was 19 years (range 11 to 40) and 55% were female [see Clinical Studies (14.1) ] .
Tretinoin gel is not approved for use in pediatric patients younger than 12 years of age [see Indications and Usage (1) ] .
In Studies 1 and 2, subjects treated with tretinoin gel, 0.1% had increased cutaneous irritation scores for erythema, peeling, dryness, burning/stinging, or itching that peaked during the initial two weeks of therapy and decreased thereafter, compared to those treated with vehicle [see Warnings and Precautions (5.1)] .
During the 12-week treatment period, no more than 3% of tretinoin gel, 0.1%-treated subjects had cutaneous irritation scores indicative of severe cutaneous irritation and 6% (14/224) of tretinoin gel, 0.1%-treated subjects discontinued treatment due to cutaneous irritation.
Of these 14 subjects, four had severe cutaneous irritation after 3 to 5 days of treatment, with blistering in one subject.
Tretinoin gel, 0.04% The safety of tretinoin gel, 0.04% for the treatment of acne vulgaris was evaluated in two multicenter, double-blind, randomized, vehicle-controlled clinical trials (Studies 3 and 4).
A total of 451 subjects with acne vulgaris were treated in Studies 3 and 4 in which 225 subjects received tretinoin gel, 0.04% and 226 subjects received vehicle, applied once daily in the evening, for 12 weeks.
Mean age was 19 years (range 11 to 49) and 57% were female [see Clinical Studies (14.2) ] .
Tretinoin gel is not approved for use in pediatric patients younger than 12 years of age [see Indications and Usage (1) ] .
In Studies 3 and 4, subjects treated with tretinoin gel, 0.04% had increased cutaneous irritation scores for erythema, peeling, dryness, burning/stinging, or itching that peaked during the initial two weeks of therapy and decreased thereafter, compared to those treated with vehicle [see Warnings and Precautions (5.1) ] .
Approximately half of the 225 subjects in the tretinoin gel, 0.04%-treated group had cutaneous irritation at Week 2.
Of the subjects who experienced cutaneous irritation, most had signs or symptoms that were mild in severity (severity was ranked on a 4-point ordinal scale: 0=none, 1=mild, 2=moderate, and 3=severe).
Less than 10% of tretinoin gel, 0.04%-treated subjects experienced moderate cutaneous irritation, and none had severe cutaneous irritation at Week 2.
In Studies 3 and 4, during the 12-week treatment period, the majority of tretinoin gel, 0.04%-treated subjects experienced cutaneous irritation (mild, moderate, or severe), of which, 1% (2/225) of subjects had cutaneous irritation scores indicative of a severe irritation and 1.3% (3/225) of subjects discontinued treatment due to cutaneous irritation, which included dryness in one subject and peeling and urticaria in another.
Tretinoin gel, 0.04% and 0.1% In a double-blind trial, 156 subjects with acne vulgaris were treated for 12-weeks with tretinoin gel, 0.04% (n=78) or 0.1% (n=78) topically once daily.
In this trial, the most frequently reported adverse events affected the skin and subcutaneous tissue (15% in the 0.04% group, and 21% in the 0.1% group).
The most prevalent events in the 0.04% group were skin irritation (6%); and in the 0.1% group, skin burning (8%), erythema (5%), skin irritation (4%), and dermatitis (4%).
In this trial, 63% of the adverse events were of mild intensity, and 34% were of moderate intensity.
6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of tretinoin gel and other topical tretinoin products.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Hyper- or hypopigmentation has been reported with repeated application of tretinoin.
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 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 reaction 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.
Tretinoin gel, 0.1% The safety of tretinoin gel, 0.1% for the treatment of acne vulgaris was evaluated in two multicenter, double-blind, randomized, vehicle-controlled clinical trials (Studies 1 and 2).
A total of 347 subjects with acne vulgaris were treated in Studies 1 and 2 in which 172 subjects received tretinoin gel, 0.1% and 175 subjects received vehicle, applied topically once daily in the evening, for 12 weeks.
Mean age was 19 years (range 11 to 40) and 55% were female [see Clinical Studies (14.1) ] .
Tretinoin gel is not approved for use in pediatric patients younger than 12 years of age [see Indications and Usage (1) ] .
In Studies 1 and 2, subjects treated with tretinoin gel, 0.1% had increased cutaneous irritation scores for erythema, peeling, dryness, burning/stinging, or itching that peaked during the initial two weeks of therapy and decreased thereafter, compared to those treated with vehicle [see Warnings and Precautions (5.1)] .
During the 12-week treatment period, no more than 3% of tretinoin gel, 0.1%-treated subjects had cutaneous irritation scores indicative of severe cutaneous irritation and 6% (14/224) of tretinoin gel, 0.1%-treated subjects discontinued treatment due to cutaneous irritation.
Of these 14 subjects, four had severe cutaneous irritation after 3 to 5 days of treatment, with blistering in one subject.
Tretinoin gel, 0.04% The safety of tretinoin gel, 0.04% for the treatment of acne vulgaris was evaluated in two multicenter, double-blind, randomized, vehicle-controlled clinical trials (Studies 3 and 4).
A total of 451 subjects with acne vulgaris were treated in Studies 3 and 4 in which 225 subjects received tretinoin gel, 0.04% and 226 subjects received vehicle, applied once daily in the evening, for 12 weeks.
Mean age was 19 years (range 11 to 49) and 57% were female [see Clinical Studies (14.2) ] .
Tretinoin gel is not approved for use in pediatric patients younger than 12 years of age [see Indications and Usage (1) ] .
In Studies 3 and 4, subjects treated with tretinoin gel, 0.04% had increased cutaneous irritation scores for erythema, peeling, dryness, burning/stinging, or itching that peaked during the initial two weeks of therapy and decreased thereafter, compared to those treated with vehicle [see Warnings and Precautions (5.1) ] .
Approximately half of the 225 subjects in the tretinoin gel, 0.04%-treated group had cutaneous irritation at Week 2.
Of the subjects who experienced cutaneous irritation, most had signs or symptoms that were mild in severity (severity was ranked on a 4-point ordinal scale: 0=none, 1=mild, 2=moderate, and 3=severe).
Less than 10% of tretinoin gel, 0.04%-treated subjects experienced moderate cutaneous irritation, and none had severe cutaneous irritation at Week 2.
In Studies 3 and 4, during the 12-week treatment period, the majority of tretinoin gel, 0.04%-treated subjects experienced cutaneous irritation (mild, moderate, or severe), of which, 1% (2/225) of subjects had cutaneous irritation scores indicative of a severe irritation and 1.3% (3/225) of subjects discontinued treatment due to cutaneous irritation, which included dryness in one subject and peeling and urticaria in another.
Tretinoin gel, 0.04% and 0.1% In a double-blind trial, 156 subjects with acne vulgaris were treated for 12-weeks with tretinoin gel, 0.04% (n=78) or 0.1% (n=78) topically once daily.
In this trial, the most frequently reported adverse events affected the skin and subcutaneous tissue (15% in the 0.04% group, and 21% in the 0.1% group).
The most prevalent events in the 0.04% group were skin irritation (6%); and in the 0.1% group, skin burning (8%), erythema (5%), skin irritation (4%), and dermatitis (4%).
In this trial, 63% of the adverse events were of mild intensity, and 34% were of moderate intensity.
6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of tretinoin gel and other topical tretinoin products.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Hyper- or hypopigmentation has been reported with repeated application of tretinoin.