RETIN-A Cream / Gel (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

Bausch Health US LLC

Λέξεις κλειδιά

0187-5160 0187-5162 0187-5164 0187-5172 0187-5170

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1. Description

RETIN-A Gel and Cream, containing tretinoin, are used for the topical treatment of acne vulgaris. RETIN-A Gel contains tretinoin (retinoic acid, vitamin A acid) in either of two strengths, 0.025% or 0.01% ...

2. Clinical Pharmacology

Although the exact mode of action of tretinoin is unknown, current evidence suggests that topical tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedo formation. Additionally, ...

3. Indications and Usage

RETIN-A is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established. ...

4. Contraindications

Use of the product should be discontinued if hypersensitivity to any of the ingredients is noted.

6.1. General

If a reaction suggesting sensitivity or chemical irritation occurs, use of the medication should be discontinued. Exposure to sunlight, including sunlamps, should be minimized during the use of RETIN-A, ...

6.4. Drug Interactions

Concomitant topical medication, 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 ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 91-week dermal study in which CD-1 mice were administered 0.017% and 0.035% formulations of tretinoin, cutaneous squamous cell carcinomas and papillomas in the treatment area were observed in some ...

6.7. Pregnancy

Teratogenic Effects Oral tretinoin has been shown to be teratogenic in rats, mice, hamsters, and subhuman primates. It was teratogenic and fetotoxic in Wistar rats when given orally or topically ...

6.9. Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when RETIN-A is administered to a nursing woman.

6.10. Pediatric Use

Safety and effectiveness in pediatric patients below the age of 12 have not been established.

6.11. Geriatric Use

Safety and effectiveness in a geriatric population have not been established. Clinical studies of RETIN-A did not include sufficient numbers of subjects aged 65 and over to determine whether they respond ...

7. Adverse Reactions

The skin of certain sensitive individuals may become excessively red, edematous, blistered, or crusted. If these effects occur, the medication should either be discontinued until the integrity of the skin ...

9. Overdosage

If medication is applied excessively, no more rapid or better results will be obtained and marked redness, peeling, or discomfort may occur. Oral ingestion of the drug may lead to the same side effects ...

10. Dosage and Administration

RETIN-A Gel or Cream should be applied once a day, before retiring, to the skin where acne lesions appear, using enough to cover the entire affected area lightly. Gel: Excessive application results in ...

11. How Supplied

RETIN-A (tretinoin) is supplied as:   RETIN-A Cream   RETIN-A Gel NDC Code RETIN-A Strength/ Form RETIN-A Qty. NDC Code RETIN-A Strength/ Form RETIN-A Qty. 0187-5160-20 ...

12. Storage and Handling

RETIN-A Gel, 0.025% and 0.01%: store below 86°F. RETIN-A Cream, 0.1%, 0.05%, and 0.025%: store below 80°F.