Trilitas

Trilitas is an FDA-registered drug product whose active ingredient is TAZAROTENE. It is labelled by Perfero Pharma, Inc. taken by topical and marketed as a human prescription drug product. Identifiers on file: NDC 87143-200, application ANDA214136, label effective 20260518. It is one of 4 FDA drug label records sharing the active ingredient TAZAROTENE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing TAZAROTENE are most often described in connection with: trilitas gel, topical treatment, body surface, plaque psoriasis, acne vulgaris, area involvement, mild moderate, retinoid indicated. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE Trilitas™ gel, 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis of up to 20% body surface area involvement. ( 1.1 ) Trilitas™ gel, 0.1% is indicated for the topical treatment of mild to moderate facial acne vulgaris. ( 1.2 ) Limitations of Use The safety of Trilitas™ gel use on more than 20% body surface area has not been established. ( 1.3 ) 1.1 Plaque Psoriasis Trilitas™ (tazarotene) gel, 0.1% is indicated for the topical treatment of patients with plaque psoriasis of up to 20% body surface area involvement. 1.2 Acne Vulgaris Trilitas™ (tazarotene) gel, 0.1% is also indicated for the topical treatment of patients with facial acne vulgaris of mild to moderate severity. The efficacy of Trilitas™ gel in the treatment of acne previously treated with other retinoids or resistant to oral antibiotics has not been established. 1.3 Limitations of Use The safety of Trilitas™ gel use on more than 20% body surface area has not been established in psoriasis or acne [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ].

2 DOSAGE AND ADMINISTRATION Trilitas™ gel is for topical use only. Trilitas™ gel is not for ophthalmic, oral, or intravaginal use. Avoid accidental transfer of Trilitas™ gel into eyes, mouth, or other mucous membranes. If contact with mucous membranes occurs, rinse thoroughly with water [see Warnings and Precautions (5.2) ]. Wash hands thoroughly after application. Apply a thin layer of Trilitas™ gel only to the affected area once daily in the evening. ( 2.1 , 2.2 ) Not for ophthalmic, oral, or intravaginal use. ( 2.2 ) If contact with eyes occurs, rinse thoroughly with water. ( 2.2 ) 2.1 Psoriasis It is recommended that treatment starts with tazarotene gel, 0.05%, with strength increased to 0.1% if tolerated and medically indicated. Apply a thin film (2 mg/cm 2 ) of Trilitas™ gel once per day, in the evening, to cover only the psoriatic lesions on no more than 20% of body surface area. If a bath or shower is taken prior to application, the skin should be dry before applying the gel. If emollients are used, they should be applied at least an hour before application of Trilitas™ gel. Because unaffected skin may be more susceptible to irritation, application of tazarotene to these areas should be carefully avoided. Tazarotene gel was investigated for up to 12 months during clinical trials for psoriasis. 2.2 Acne Cleanse the face gently. After the skin is dry, apply a thin layer (2 mg/cm 2 ) of Trilitas™ gel, 0.1% once per day, in the evening, to the skin where acne lesions appear. Use enough to cover the entire affected area. Trilitas™ gel was investigated for up to 12 weeks during clinical trials for acne. Use effective sunscreens and wear protective clothing while using Trilitas™ gel [see Warnings and Precautions (5.3) ].

4 CONTRAINDICATIONS Trilitas™ gel is contraindicated in: Pregnancy. Retinoids may cause fetal harm when administered to a pregnant female [see Warnings and Precautions (5.1) , Use in Specific Populations (8.1 , 8.3) ]. Individuals who have known hypersensitivity to any of its components [see Warnings and Precautions (5.2) ]. Pregnancy ( 4 , 8.1 ) Hypersensitivity ( 4 )

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in more detail in other sections of the labeling: Embryofetal toxicity [see Warnings and Precautions (5.1) ] Photosensitivity and Risk of Sunburn [see Warnings and Precautions (5.3) ] Plaque Psoriasis: Most common adverse reactions occurring in 10 to 30% of patients are pruritus, burning/stinging, erythema, worsening of psoriasis, irritation, and skin pain. ( 6.1 ) Acne Vulgaris: Most common adverse reactions occurring in 10 to 30% of patients are desquamation, burning/stinging, dry skin, erythema and pruritus. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Perfero Pharma, Inc. at 1-973-629-0109 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 clinical practice. Psoriasis A total of 439 subjects 14 to 87 years of age were treated with tazarotene gel, 0.05% and 0.1% in two controlled clinical trials. The most frequent adverse events reported with tazarotene gel, 0.05% and 0.1% occurring in 10 to 30% of subjects, in descending order, included pruritus, burning/stinging, erythema, worsening of psoriasis, irritation, and skin pain. Reactions occurring in 1 to 10% of subjects included rash, desquamation, irritant contact dermatitis, skin inflammation, fissuring, bleeding, and dry skin. Increases in "psoriasis worsening" and "sun-induced erythema" were noted in some subjects over the 4th to 12th months of treatment as compared to the first three months of a 1 year study. In general, the incidence of adverse events with tazarotene gel 0.05% was 2 to 5% lower than that seen with tazarotene gel 0.1%. Acne A total of 596 subjects 12 to 44 years of age were treated with tazarotene gel, 0.05% and 0.1% in two controlled clinical trials. The most frequent adverse events reported during clinical trials with tazarotene gel, 0.1% in the treatment of acne occurring in 10 to 30% of subjects, in descending order, included desquamation, burning/stinging, dry skin, erythema and pruritus. Reactions occurring in 1 to 10% of subjects included irritation, skin pain, fissuring, localized edema and skin discoloration. 6.2 Postmarketing Experience 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. The following adverse reactions have been identified during postapproval use of tazarotene. Skin and subcutaneous tissue disorders: blister, dermatitis, urticaria, skin exfoliation, skin discoloration (including skin hyperpigmentation or skin hypopigmentation), swelling at or near application sites, and pain.

FDA lists 4 drug label records with TAZAROTENE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Trilitas used for?
1 INDICATIONS AND USAGE Trilitas™ gel, 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis of up to 20% body surface area involvement. ( 1.1 ) Trilitas™ gel, 0.1% is indicated for the topical treatment of mild to moderate facial acne vulgaris. ( 1.2 ) Limitations of Use The safety of Trilitas™ gel use on more than 20% body surface area has not been established. ( 1.3 ) 1.1 …

Who makes Trilitas?
Perfero Pharma, Inc. is the labeler of record for Trilitas. 4 FDA label records share the active ingredient TAZAROTENE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Trilitas come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Trilitas prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing TAZAROTENE?
Yes. 4 FDA drug label records list TAZAROTENE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Trilitas been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.