Atralin

Name: Atralin

Is tretinoin available as a generic drug?

GENERIC AVAILABLE: Yes

What is the dosage for tretinoin?

Before applying topical tretinoin, the affected area of the skin should be cleansed with soap and dried. Patients should then wait 20 to 30 minutes before applying tretinoin, gently rubbing it into the affected area. The hands should be washed immediately after application. Tretinoin usually is applied once daily, in the evening.

Indications

Atralin Gel is indicated for topical treatment of acne vulgaris.

What other drugs will affect tretinoin topical?

Do not use skin products that contain benzoyl peroxide, sulfur, resorcinol, or salicylic acid unless otherwise directed by your doctor. These products can cause severe skin irritation if used with tretinoin topical.

It is not likely that other drugs you take orally or inject will have an effect on topically applied tretinoin. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

What should i discuss with my healthcare provider before using tretinoin topical?

FDA pregnancy category C. It is not known whether tretinoin topical is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.

Tretinoin topical can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

What should i avoid while using tretinoin topical?

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Tretinoin topical can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water. Do not use tretinoin topical on skin that is sunburned, windburned, dry, chapped, or irritated. Also avoid using this medication in wounds or on areas of eczema. Wait until these conditions have healed before using tretinoin topical.

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medication skin products unless your doctor has told you to.

Your skin may be more sensitive to weather extremes such as cold and wind while using this medicine.

Side effects

Clinical Trials Experience

Because clinical trials are conducted under prescribing 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.

In two randomized, controlled trials, 674 subjects received treatment for up to 12 weeks with Atralin Gel [see Clinical Trials]. In these studies, 50% of the subjects who were treated with Atralin Gel reported one or more adverse reactions; 30% of the subjects reported treatment-related adverse reactions. In the vehicle group, 29% of the 487 randomized subjects reported at least one adverse reaction; 5% of the subjects reported events that were treatment-related. There were no serious, treatment-related adverse reactions reported by subjects in any of the treatment groups.

Selected adverse reactions that occurred in at least 1% of subjects in the two trials combined are shown in Table 1 (below). Most skin-related adverse reactions first appear during the first two weeks of treatment with Atralin Gel, and the incidence rate for skin-related reactions peaks around the second and third week of treatment. In some subjects the skin-related adverse reactions persists throughout the treatment period.

Table 1: Number of Subjects with Selected Adverse Reactions (Occurring in At Least 1% of Subjects)

Event Atralin Gel
(n = 674)
Vehicle Gel
(n = 487)
Dry Skin 109 (16%) 8 (2%)
Peeling/Scaling/ Flaking Skin 78 (12%) 7 (1%)
Skin Burning Sensation 53 (8%) 8 (2%)
Erythema 47 (7%) 1 ( < 1%)
Pruritus 11 (2%) 3 (1%)
Pain of Skin 7 (1%) 0 (0%)
Sunburn 7 (1%) 3 (1%)

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Atralin Gel. 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.

Temporary hyper-or hypopigmentation has been reported with repeated application of tretinoin.

Read the entire FDA prescribing information for Atralin (Tretinoin)

Read More »

In Summary

More frequent side effects include: exfoliation of skin, stinging of the skin, localized warm feeling, and mild erythema. See below for a comprehensive list of adverse effects.

Tretinoin Identification

Substance Name

Tretinoin

CAS Registry Number

302-79-4

Drug Class

Antineoplastic Agents

Dermatologic Agents

Keratolytic Agents

Retinoids

Administrative Information

LactMed Record Number

539

Last Revision Date

20161110

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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