Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied RETIN-A MICRO (tretinoin) gel is opaque and white to very pale yellow in color and is supplied as follows: Strength Amount of Tretinoin in One Gram of Gel Quantity/Package Type NDC 0.04% 0.4 mg 20 gram tube 0187-5144-20 45 gram tube 0187-5144-45 50 gram pump 0187-5144-50 0.06% 0.6 mg 50 gram pump 0187-5146-50 0.08% 0.8 mg 50 gram pump 0187-5148-50 0.1% 1 mg 20 gram tube 0187-5140-20 45 gram tube 0187-5140-45 50 gram pump 0187-5140-50 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store pump upright.; PRINCIPAL DISPLAY PANEL - 0.08% 50 g Carton NDC 0187-5148-50 RETIN-A MICRO ® (tretinoin) Gel microsphere 0.08% PUMP For Topical Use Only Rx Only Ortho Dermatologics NET WT. 50 g 9440608 20000365J 0.08pct carton; PRINCIPAL DISPLAY PANEL - 0.06% 50 g Carton NDC 0187-5146-50 RETIN-A MICRO ® tretinoin Gel (microsphere) 0.06% PUMP For Topical Use Only Rx only Ortho Dermatologics NET WT. 50 g 9581504 20001795E 0.06pct carton; PRINCIPAL DISPLAY PANEL - 0.04% 50 g Carton NDC 0187-5144-50 RETIN-A MICRO ® tretinoin gel (microsphere) 0.04% PUMP For Topical Use Only Rx Only Ortho Dermatologics Net Wt . 50g 9450907 0.04pct carton; PRINCIPAL DISPLAY PANEL - 0.1% 50 g Carton NDC 0187-5140-50 RETIN-A MICRO ® tretinoin gel (microsphere) 0.1% PUMP For Topical Use Only Rx Only Ortho Dermatologics Net Wt . 50g 9450707 0.1pct carton
- 16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied RETIN-A MICRO (tretinoin) gel is opaque and white to very pale yellow in color and is supplied as follows: Strength Amount of Tretinoin in One Gram of Gel Quantity/Package Type NDC 0.04% 0.4 mg 20 gram tube 0187-5144-20 45 gram tube 0187-5144-45 50 gram pump 0187-5144-50 0.06% 0.6 mg 50 gram pump 0187-5146-50 0.08% 0.8 mg 50 gram pump 0187-5148-50 0.1% 1 mg 20 gram tube 0187-5140-20 45 gram tube 0187-5140-45 50 gram pump 0187-5140-50 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store pump upright.
- PRINCIPAL DISPLAY PANEL - 0.08% 50 g Carton NDC 0187-5148-50 RETIN-A MICRO ® (tretinoin) Gel microsphere 0.08% PUMP For Topical Use Only Rx Only Ortho Dermatologics NET WT. 50 g 9440608 20000365J 0.08pct carton
- PRINCIPAL DISPLAY PANEL - 0.06% 50 g Carton NDC 0187-5146-50 RETIN-A MICRO ® tretinoin Gel (microsphere) 0.06% PUMP For Topical Use Only Rx only Ortho Dermatologics NET WT. 50 g 9581504 20001795E 0.06pct carton
- PRINCIPAL DISPLAY PANEL - 0.04% 50 g Carton NDC 0187-5144-50 RETIN-A MICRO ® tretinoin gel (microsphere) 0.04% PUMP For Topical Use Only Rx Only Ortho Dermatologics Net Wt . 50g 9450907 0.04pct carton
- PRINCIPAL DISPLAY PANEL - 0.1% 50 g Carton NDC 0187-5140-50 RETIN-A MICRO ® tretinoin gel (microsphere) 0.1% PUMP For Topical Use Only Rx Only Ortho Dermatologics Net Wt . 50g 9450707 0.1pct carton
Overview
Chemically, tretinoin is all-trans-retinoic acid, also known as (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. Tretinoin is a retinoid and a metabolite of naturally occurring Vitamin A. Tretinoin has a molecular weight of 300.44, a molecular formula of C 20 H 28 O 2 and the following chemical structure: RETIN-A MICRO (tretinoin) gel is for topical use. Each gram of RETIN-A MICRO gel: • 0.04%, contains 0.4 mg of tretinoin • 0.06%, contains 0.6 mg of tretinoin • 0.08%, contains 0.8 mg of tretinoin • 0.1%, contains 1 mg of tretinoin The formulation contains methyl methacrylate/glycol dimethacrylate crosspolymer (MICROSPONGE ® System), propylene glycol dicaprylate/dicaprate and butylated hydroxytoluene. Other components consist of benzyl alcohol, butylated hydroxytoluene, carbomer 974P, cyclomethicone and dimethicone copolyol, disodium EDTA, glycerin, PPG-20 methyl glucose ether distearate, propylene glycol, purified water, sorbic acid, and trolamine. Tretinoin Chemical Structure
Indications & Usage
RETIN-A MICRO ® is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. RETIN-A MICRO is a retinoid indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. ( 1)
Dosage & Administration
For topical use only. Not for oral, ophthalmic, or intravaginal use. • Prior to RETIN-A MICRO use, thoroughly cleanse area(s) with a mild, non-medicated cleanser then pat the skin dry. • When applying RETIN-A MICRO, keep away from the eyes, the mouth, paranasal creases of the nose, and mucous membranes. • Apply a thin layer of RETIN-A MICRO (0.04%, 0.06%, 0.08%, or 0.1%) to skin where acne lesions appear (cover the entire affected area), once daily in the evening. Do not apply more than a thin layer [see Warning and Precautions (5.1) ] . Improvements in acne lesions may be noticed after two weeks of RETIN-A MICRO therapy, but more than seven weeks of therapy may be needed for sustained benefit. If RETIN-A MICRO was temporarily discontinued due to local adverse reactions, RETIN-A MICRO therapy may be resumed upon resolution of local adverse reactions. • For topical use only. Not for oral, ophthalmic, or intravaginal use. ( 2 ) • Keep away from eyes, mouth, paranasal creases of the nose, and mucous membranes. ( 2 ) • Apply a thin layer of RETIN-A MICRO to skin where acne lesions appear (cover the entire affected area) (0.04%, 0.06%, 0.08%, or 0.1%) once daily in the evening ( 2 ).
Warnings & Precautions
• Local Skin Irritation : RETIN-A MICRO can cause local skin irritation, including excessive dryness, redness, swelling, peeling, itching, blistering, burning, or stinging ( 5.1 ) • Avoid use on eczematous skin or during weather extremes, such as severe wind or cold. • To reduce the risk of local skin irritation, wash the treated skin gently, using a mild, non-medicated soap, avoid washing the treated skin too often or scrubbing it hard when washing, and apply a topical moisturizer. • If severe local skin irritation occurs, discontinue use temporarily or permanently. • Initial Worsening of Inflammatory Acne Vulgaris : During the early weeks of RETIN-A MICRO treatment, an apparent exacerbation of inflammatory lesions may occur. If RETIN-A MICRO is tolerated, this should not be considered a reason to discontinue therapy. ( 5.2 ) • Photosensitivity : RETIN-A MICRO can cause photosensitivity. Advise patients to avoid or minimize unnecessary exposure to UV light, including sunlight and sunlamps. Advise patients to use sunscreen (SPF ≥15) and sun-protective clothing if UV light exposure cannot be avoided. Avoid use on sunburn skin. ( 5.3 ) 5.1 Local Skin Irritation RETIN-A MICRO can cause local skin irritation, including excessive dryness, redness, swelling, peeling, itching, blistering, burning, or stinging [see Adverse Reactions (6.1) ] . Use of RETIN-A MICRO in greater than the recommended dosage (more frequent than once daily application or excessive application) will not result in more rapid or improved acne results and may result in marked redness, peeling, or discomfort. Tretinoin has been reported to cause severe local skin irritation on eczematous skin. Weather extremes, such as severe wind or cold, may increase the risk of skin irritation in patients using RETIN-A MICRO. To reduce the risk of local skin irritation, instruct RETIN-A MICRO-treated patients to: • Avoid use of RETIN-A MICRO in areas affected by eczema. • Minimize or avoid use of RETIN-A MICRO with weather extremes. • Wash the treated skin gently, using a mild, non-medicated soap, pat it dry, and avoid washing the treated skin too often or scrubbing it hard when washing. RETIN-A MICRO is not recommended with concomitant use of medicated or abrasive soaps and cleansers, products that have a strong drying effect, products with high concentrations of alcohol, astringents, spices, or lime peels. • Apply a topical moisturizer. Advise patients that concomitant use of topical over the counter (OTC) acne products containing benzoyl peroxide, sulfur, resorcinol, or salicylic acid with RETIN-A MICRO may increase the risk for local skin irritation including dryness, erythema, and peeling. Consider withholding the use of topical OTC acne products if signs of skin irritation develop. Advise patients to allow the skin irritation effects of the topical OTC acne products to subside before initiation of RETIN-A MICRO treatment. If severe local skin irritation occurs, discontinue RETIN-A MICRO use temporarily or permanently. Efficacy of RETIN-A MICRO at reduced frequencies of application has not been established. 5.2 Initial Worsening of Inflammatory Acne Vulgaris During the early weeks of RETIN-A MICRO treatment, an apparent exacerbation of inflammatory acne vulgaris lesions may occur. If RETIN-A MICRO is tolerated, initial worsening of inflammatory acne vulgaris lesions should not be considered a reason to discontinue therapy. 5.3 Photosensitivity RETIN-A MICRO can cause photosensitivity. Advise patients to avoid or minimize unnecessary exposure to ultraviolet (UV) light, including sunlight and sunlamps, while using RETIN-A MICRO. Advise patients with sunburn to not use RETIN-A MICRO until the sunburn fully recovers. Advise patients, especially those who may be required to have extended periods of UV light exposure (e.g., due to occupation or sports), those with inherent sensitivity to the sun, or those using drugs that cause photosensitivity, to use sun protection daily in the form of sunscreen (sun protection factor [SPF] ≥ 15) and sun-protective clothing, when UV exposure cannot be avoided, even on days when it is not sunny or inside activities are expected.
Contraindications
None. None. ( 4 )
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 Bausch Health US, LLC at 1-800-321-4576 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. RETIN-A MICRO, 0.1% The safety of RETIN-A MICRO, 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 RETIN-A MICRO, 0.1% and 175 subjects received vehicle, applied topically once daily in the evening, for 12 weeks. Mean age was 19 years (range 11-40) and 55% were female [see Clinical Studies (14.1) ] . RETIN-A MICRO 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 RETIN-A MICRO, 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 RETIN-A MICRO, 0.1%-treated subjects had cutaneous irritation scores indicative of severe cutaneous irritation and 6% (14/224) of RETIN-A MICRO 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. RETIN-A MICRO, 0.04% The safety of RETIN-A MICRO, 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 RETIN-A MICRO, 0.04% and 226 subjects received vehicle, applied once daily in the evening, for 12 weeks. Mean age was 19 years (range 11-49) and 57% were female [see Clinical Studies (14.2) ] . RETIN-A MICRO 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 RETIN-A MICRO, 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 RETIN-A MICRO, 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 RETIN-A MICRO, 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 RETIN-A MICRO, 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. RETIN-A MICRO, 0.04% and 0.1% In a double-blind trial, 156 subjects with acne vulgaris were treated for 12-weeks with RETIN-A MICRO 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 RETIN-A MICRO 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.
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