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Retin-A MICRO is a brand name for Tretinoin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND 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)
Verbatim from this product's FDA label. Tap a section to expand.
2 DOSAGE AND 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.
1%) to skin where acne lesions appear (cover the entire affected area), once daily in the evening. 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.
1%) once daily in the evening ( 2 ).
6 ADVERSE REACTIONS Most common adverse reactions were skin irritation, skin burning, erythema, peeling, dryness, itching, and dermatitis. gov/medwatch. 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.
1% for the treatment of acne vulgaris was evaluated in two multicenter, double-blind, randomized, vehicle-controlled clinical trials (Studies 1 and 2). 1% and 175 subjects received vehicle, applied topically once daily in the evening, for 12 weeks.
1) ] . RETIN-A MICRO is not approved for use in pediatric patients younger than 12 years of age [see Indications and Usage (1) ] . 1) ] . 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.
04% for the treatment of acne vulgaris was evaluated in two multicenter, double-blind, randomized, vehicle-controlled clinical trials (Studies 3 and 4). 04% and 226 subjects received vehicle, applied once daily in the evening, for 12 weeks.
2) ] . RETIN-A MICRO is not approved for use in pediatric patients younger than 12 years of age [see Indications and Usage (1) ] . 1) ] . 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).
04%-treated subjects experienced moderate cutaneous irritation, and none had severe cutaneous irritation at Week 2. 3% (3/225) of subjects discontinued treatment due to cutaneous irritation, which included dryness in one subject and peeling and urticaria in another.
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. 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. 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.
4 CONTRAINDICATIONS None. None. ( 4 )
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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1% (n=78) topically once daily. 1% group). 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. 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.
• 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. 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. 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. , 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.