Tretinoin
Generic Name: tretinoin
Brand Names:
Tretinoin
11 DESCRIPTION Tretinoin gel (microsphere), 0.08% is a white to very pale yellow opaque gel for topical treatment of acne vulgaris. 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. It is a member of the retinoid class of compounds and a metabolite of naturally occurring Vitamin A.
Overview
11 DESCRIPTION Tretinoin gel (microsphere), 0.08% is a white to very pale yellow opaque gel for topical treatment of acne vulgaris. 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. It is a member of the retinoid class of compounds and a metabolite of naturally occurring Vitamin A.
Uses
1 INDICATIONS AND USAGE Tretinoin gel (microsphere) is a retinoid indicated for topical application in the treatment of acne vulgaris. Tretinoin gel (microsphere) is a retinoid, indicated for topical treatment of acne vulgaris. (1)
Dosage
2 DOSAGE AND ADMINISTRATION For topical use only. Not for ophthalmic, oral, or intravaginal use. Tretinoin gel (microsphere) should be applied once a day, in the evening, to the skin where acne lesions appear, using enough to cover the entire affected area in a thin layer. Areas to be treated should be cleansed thoroughly before the medication is applied. If medication is applied excessively, no more rapid or better results will be obtained and marked redness, peeling, or discomfort may occur. A transitory feeling of warmth or slight stinging may be noted on application.
Side Effects
6 ADVERSE REACTIONS Most common adverse reactions are skin pain, pruritus, skin irritation/subcutaneous irritation, pharyngitis, and erythema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151 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.
Warnings
5 WARNINGS AND PRECAUTIONS Tretinoin gel (microsphere) should not be used on eczematous or sunburned skin due to potential for severe irritation. ( 5.1 , 5.2 ) Avoid unprotected exposure to sunlight including sunlamps (UV light), when using tretinoin gel (microsphere) due to potential for increased photosensitization. Use sunscreen of at least SPF 15 and protective clothing during exposure. ( 5.2 ) Avoid use of tretinoin gel (microsphere) with weather extremes, such as wind or cold due to potential for increased irritation. ( 5.2 ) 5.1 Local Irritation The skin of certain individuals may become excessively dry, red, swollen, or blistered. Tretinoin has been reported to cause severe irritation on eczematous skin and should be used with utmost caution in patients with this condition. 4 CONTRAINDICATIONS None. None. (4)
Pregnancy
8.1 Pregnancy Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Tretinoin gel (microsphere) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Thirty human cases of temporally associated congenital malformations have been reported during two decades of clinical use of tretinoin products.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Tretinoin gel (microsphere) is opaque and white to very pale yellow in color. Tretinoin gel (microsphere), 0.08%, is supplied in 50 gram pump. NDC 72162-2303-2 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. Keep out of reach of children.
Frequently Asked Questions
What is Tretinoin used for?▼
1 INDICATIONS AND USAGE Tretinoin gel (microsphere) is a retinoid indicated for topical application in the treatment of acne vulgaris. Tretinoin gel (microsphere) is a retinoid, indicated for topical treatment of acne vulgaris. (1)
What are the side effects of Tretinoin?▼
6 ADVERSE REACTIONS Most common adverse reactions are skin pain, pruritus, skin irritation/subcutaneous irritation, pharyngitis, and erythema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151 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.
Can I take Tretinoin during pregnancy?▼
8.1 Pregnancy Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Tretinoin gel (microsphere) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Thirty human cases of temporally associated congenital malformations have been reported during two decades of clinical use of tretinoin products.
What are the important warnings for Tretinoin?▼
5 WARNINGS AND PRECAUTIONS Tretinoin gel (microsphere) should not be used on eczematous or sunburned skin due to potential for severe irritation. ( 5.1 , 5.2 ) Avoid unprotected exposure to sunlight including sunlamps (UV light), when using tretinoin gel (microsphere) due to potential for increased photosensitization. Use sunscreen of at least SPF 15 and protective clothing during exposure. ( 5.2 ) Avoid use of tretinoin gel (microsphere) with weather extremes, such as wind or cold due to potential for increased irritation. ( 5.2 ) 5.1 Local Irritation The skin of certain individuals may become excessively dry, red, swollen, or blistered. Tretinoin has been reported to cause severe irritation on eczematous skin and should be used with utmost caution in patients with this condition. 4 CONTRAINDICATIONS None. None. (4)
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.