Skip to Content

Tretinoin (Topical)

Pronunciation

Pronunciation

(TRET i noyn)

Index Terms

  • Retinoic Acid
  • trans-Retinoic Acid
  • Vitamin A Acid

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Cream, External:

Avita: 0.025% (20 g, 45 g)

Refissa: 0.05% (20 g, 40 g) [contains edetate disodium, methylparaben, propylparaben]

Renova: 0.02% (40 g, 60 g) [contains benzyl alcohol, cetyl alcohol, edetate disodium, methylparaben, propylparaben]

Renova Pump: 0.02% (44 g) [contains benzyl alcohol, cetyl alcohol, edetate disodium, methylparaben, propylparaben]

Retin-A: 0.025% (20 g, 45 g); 0.05% (20 g, 45 g); 0.1% (20 g, 45 g)

Tretin-X: 0.0375% (35 g); 0.075% (35 g)

Generic: 0.025% (20 g, 45 g); 0.05% (20 g, 40 g, 45 g, 60 g); 0.1% (20 g, 45 g)

Gel, External:

Atralin: 0.05% (45 g) [contains benzyl alcohol, butylparaben, ethylparaben, fish collagen hydrolyzates, isobutylparaben, methylparaben, propylparaben, trolamine (triethanolamine)]

Avita: 0.025% (20 g, 45 g)

Retin-A: 0.01% (15 g, 45 g); 0.025% (15 g, 45 g)

Retin-A Micro: 0.04% (20 g, 45 g); 0.1% (20 g, 45 g) [contains benzyl alcohol, disodium edta, propylene glycol, trolamine (triethanolamine)]

Retin-A Micro Pump: 0.04% (50 g); 0.08% (50 g); 0.1% (50 g) [contains benzyl alcohol, disodium edta, propylene glycol, trolamine (triethanolamine)]

Generic: 0.01% (15 g, 45 g); 0.025% (15 g, 45 g); 0.04% (20 g, 45 g, 50 g); 0.05% (45 g); 0.1% (20 g, 45 g, 50 g)

Kit, External:

Tretin-X: 0.025% [DSC], 0.05%, 0.1% [DSC] [contains benzyl alcohol, cetearyl alcohol, disodium edta, fd&c red #40, methylparaben, propylparaben, tartrazine (fd&c yellow #5), trolamine (triethanolamine)]

Brand Names: U.S.

  • Atralin
  • Avita
  • Refissa
  • Renova
  • Renova Pump
  • Retin-A
  • Retin-A Micro
  • Retin-A Micro Pump
  • Tretin-X

Pharmacologic Category

  • Acne Products
  • Retinoic Acid Derivative
  • Topical Skin Product, Acne

Pharmacology

Tretinoin is a derivative of vitamin A. When used topically, it modifies epithelial growth and differentiation. In patients with acne, it decreases the cohesiveness of follicular epithelial cells and decreases micromedo formation. Additionally, tretinoin stimulates mitotic activity and increased turnover of follicular epithelial cells causing extrusion of the comedones.

Absorption

Minimal

Metabolism

Hepatic; forms metabolites

Excretion

Urine and feces

Onset of Action

Acne: ≥2 weeks, may take ≥7 weeks; Facial wrinkles: Up to 6 months

Use: Labeled Indications

Acne vulgaris: Atralin, Avita, Retin-A, Retin-A Micro, Stieva-A [Canadian product], Tretin-X, Vitamin-A Acid [Canadian product]: Treatment of acne vulgaris.

Limitations of use (Stieva-A [Canadian product]): In most cases, use is not effective for the treatment of severe pustular and deep cystic nodular acne.

Palliation of fine wrinkles: Renova: Adjunctive treatment for mitigation (palliation) of fine wrinkles in patients who use comprehensive skin care and sun avoidance programs.

Palliation of fine wrinkles, mottled hyperpigmentation, and facial skin roughness: Refissa: Adjunctive treatment for mitigation (palliation) of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin in patients who do not achieve such palliation using comprehensive skin care and sun avoidance programs alone.

Contraindications

Hypersensitivity to tretinoin or any component of the formulation. Note: There are no contraindications listed in Atralin or Retin-A Micro US labeling.

Documentation of allergenic cross-reactivity for retinoids is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Dosing: Adult

Acne vulgaris: Topical:

US labeling: Apply once daily to acne lesions before bedtime or in the evening.

Canadian labeling: Initial: Apply once daily to affected area before bedtime (in clinical trials therapy lasted up to 12 weeks). May consider less frequent application or using a reduced strength during the first few weeks of treatment if needed (eg, patients with sensitive and/or fair complexion, exacerbation of acne or skin irritation). Interrupt therapy if necessary for skin irritation; may resume therapy after subsides. Discontinue therapy for persistent irritation. Maintenance: Upon satisfactory response may consider less frequent application.

Palliation of fine wrinkles (Refissa/Renova), mottled hyperpigmentation, and tactile roughness of facial skin (Refissa): Topical: Apply a pea-sized amount of cream to entire face once daily in the evening or before bedtime.

Dosing: Geriatric

Refer to adult dosing; safety/efficacy of Refissa has not been established in patients >50 years of age; safety/efficacy of Renova has not been established in patients >71 years of age.

Dosing: Pediatric

Acne vulgaris: Children ≥10 years (Atralin) or ≥12 years (Retin-A Micro, Tretin-X) and Adolescents: Topical: Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling. Stieva-A [Canadian product] labeling indicates that there are no dosage adjustments necessary.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling. Stieva-A [Canadian product] labeling indicates that there are no dosage adjustments necessary.

Administration

Prior to application, wash hands; gently wash face with a mild soap; pat dry and wait 20 to 30 minutes. Apply thin layer to affected area in the evening or before bedtime, avoiding eyes, ears, nostrils, and mouth. If stinging or irritation develop, temporarily discontinue or decrease frequency of application. Wash hands immediately after applying. Avoid use of products to the affected area that contain high concentrations of alcohol, astringents, or spices. Do not apply to sunburned skin. If combination topical therapy is required, consider separating applications (eg, one drug in the morning and the other in the evening or before bedtime).

Retin-A Micro: Avoid contact with lime peel and application area.

Hazardous agent; use appropriate precautions for handling and disposal (NIOSH 2014 [group 3]).

Storage

Atralin gel, Avita gel: Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Protect from freezing.

Avita cream: Store below 30°C (86°F). Avoid freezing.

Refissa: Store at 20˚C to 25˚C (68˚F to 77˚F). Do not freeze.

Renova: Store at 25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F).

Retin-A cream, Tretin-X cream: Store below 27°C (80°F).

Retin-A gel: Store below 30°C (86°F).

Retin-A Micro gel: Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Store pump upright.

Stieva-A [Canadian product]: Store at 15°C and 30°C (59°F and 86°F). Do not freeze.

Vitamin A Acid [Canadian product]: Store at 15°C and 30°C (59°F and 86°F).

Drug Interactions

Aminolevulinic Acid: Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid. Monitor therapy

Multivitamins/Fluoride (with ADE): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Avoid combination

Multivitamins/Minerals (with ADEK, Folate, Iron): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Avoid combination

Multivitamins/Minerals (with AE, No Iron): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Avoid combination

Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Monitor therapy

Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Monitor therapy

Adverse Reactions

1% to 10%:

Dermatologic: Burning sensation of the skin (gel: 8%), skin irritation (gel: 4% to 6%; severe: 1% to ≤3%), erythema (5%), dermatitis (gel: 4%)

Local: Skin edema

Warnings/Precautions

Concerns related to adverse effects:

• Fish allergies: Atralin gel contains soluble fish proteins; use caution in patients with sensitivities or allergies to fish.

• Hypersensitivity reactions: Discontinue tretinoin if drug sensitivity, chemical irritation, or a systemic adverse reaction occurs.

• Photosensitivity: Use is associated with increased susceptibility/sensitivity to UV light; avoid or minimize excessive exposure to sunlamps or sunlight. Daily sunscreen (SPF 15 or higher) use and other protective measures (eg, clothing over treated areas) are recommended. Use with caution in patients with personal or family history of skin cancer.

• Skin irritation: Treatment can increase skin sensitivity to weather extremes of wind or cold. Excessive dryness, redness, and swollen or blistered skin may occur. Also, concomitant topical medications (eg, medicated or abrasive soaps, cleansers, or cosmetics with a strong drying effect) should be used with caution due to increased skin irritation. Reduce the amount, frequency, or discontinue use until irritation disappears.

Disease-related concerns:

• Eczema: Use with caution in patients with eczema; may cause severe irritation.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Dosage form specific issues:

• Cream 0.02%: Do not use the 0.02% cream for longer than 52 weeks when using for palliation of fine wrinkles.

• Cream 0.05%: Do not use the 0.05% cream for longer than 48 weeks when using for palliation of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin.

• Gel: Flammable; do not expose to high temperatures or flame.

Special handling:

• Hazardous agent: Use appropriate precautions for handling and disposal (NIOSH 2014 [group 3]).

Other warnings/precautions:

• Appropriate use: For external use only; avoid contact with abraded skin, sunburned skin, mucous membranes, eyes, mouth, angles of the nose. When used for palliation of fine wrinkles, mottled hyperpigmentation, or facial skin roughness, should be used as part of a comprehensive skincare and sun avoidance program.

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events were observed in animal reproduction studies following topical application of tretinoin. Teratogenic effects were also observed in pregnant women following topical use; however, a causal association has not been established. When treatment for acne is needed during pregnancy, other agents are preferred (Kong, 2013). These products should not be used for palliation of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin in women who are pregnant, attempting to conceive, or at high risk for pregnancy.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience dry skin, itching, redness, warmth sensation, stinging, peeling, or skin discoloration. Have patient report immediately to prescriber severe skin irritation or edema of skin (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Hide