Version May 2024
Melasma: Topical: Apply a thin film once daily to affected areas until control is achieved; not indicated for use beyond 8 weeks.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Dermatologic: Erythema (41%), desquamation (38%), burning sensation of skin (18%), xeroderma (14%), pruritus (11%)
1% to 10%:
Central nervous system: Paresthesia (3%), hyperesthesia (2%)
Dermatologic: Acne vulgaris (5%), telangiectasia (3%), dyschromia (2%), skin irritation (2%), acne rosacea (1%), papule (1%), skin rash (1%), skin vesicle (1%)
Gastrointestinal: Xerostomia (1%)
<1%, postmarketing, and/or case reports (reported with one or more components): Acneiform eruption, allergic contact dermatitis, atrophic striae, Cushing's syndrome, exogenous ochronosis, folliculitis, HPA-axis suppression, hypopigmentation, miliaria, perioral dermatitis, secondary infection, skin atrophy
Hypersensitivity to fluocinolone, hydroquinone, tretinoin, or any component of the formulation
Concerns related to adverse effects:
• Adrenal suppression: Systemic absorption of topical corticosteroids may cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis.
• Dermatitis: Cutaneous hypersensitivity/contact dermatitis to individual ingredients has been reported; instruct patients to seek medical attention.
• Exogenous ochronosis: Hydroquinone may produce exogenous ochronosis (gradual blue/black darkening of skin); discontinuation is recommended.
• Kaposi's sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi's sarcoma (case reports); if noted, discontinuation of therapy should be considered.
• Systemic effects: Topical corticosteroids may be absorbed percutaneously. Absorption of topical corticosteroids may cause manifestations of Cushing's syndrome, hyperglycemia, or glycosuria. Absorption is increased by the use of occlusive dressings, application to denuded skin, or application to large surface areas.
Concurrent drug therapy issues:
• Hormonal contraceptives: Consider changing to nonhormonal contraceptive measures in patients who may be receiving hormonal contraceptives.
Special populations:
• Pediatric: Children may absorb proportionally larger amounts of corticosteroids after topical application and may be more prone to systemic effects. HPA axis suppression, intracranial hypertension, and Cushing's syndrome have been reported in children receiving topical corticosteroids. Prolonged use may affect growth velocity; growth should be routinely monitored in pediatric patients.
Dosage form specific issues:
• Sodium metabisulfate: Contains sodium metabisulfite; may cause hypersensitivity reactions, including anaphylaxis, in individuals with sulfite allergy.
Other warnings/precautions:
• Darker skin types: Has not been evaluated in skin types V and VI; excessive bleaching may occur in individuals with darker skin.
• Patient information: Instruct patients to avoid UV exposure, including sunlight (protective clothing and sunscreen recommended). Local irritation, dryness, and pruritus may be expected following application. Avoid contact with abraded skin, mucous membranes, eyes, nose, angles of the mouth.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External:
Tri-Luma: Fluocinolone acetonide 0.01%, hydroquinone 4%, and tretinoin 0.05% (30 g) [contains cetyl alcohol, methylparaben, propylparaben, sodium metabisulfite]
No
Cream (Tri-Luma External)
0.01-4-0.05% (per gram): $9.81
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Topical use only; not for oral, ophthalmic, or intravaginal use. Apply 30 minutes before bedtime. Wash face with mild cleanser; rinse and pat dry. Apply to lesion and 1/2 inch of normal-appearing skin surrounding each lesion. Rub lightly and uniformly into the skin. Do not use occlusive dressings. Avoid sun exposure; use a sunscreen with SPF 30 and wear protective clothing during the day. Moisturizers and /or cosmetics may be used during the day.
Hazardous agent (NIOSH 2016 [group 3]).
Tretinoin is a hazardous agent. Use appropriate precautions for receiving, handling, administration, and disposal (NIOSH 2016). Gloves (single) should be worn during receiving, unpacking, and placing in storage.
NIOSH recommends double gloving, a protective gown, and (if liquid that could splash) eye/face protection for administration of a topical product; if there is potential for inhalation, respiratory protection is recommended (NIOSH 2016). Facilities may perform assessment of some (non-antineoplastic) hazardous drugs to determine if appropriate for alternative containment strategies and handling requirements; assess risk to determine appropriate containment strategy (USP-NF 2017).
Melasma: Short-term treatment of moderate to severe melasma of the face
KIDs List: Medium, high, and very high potency topical corticosteroids, when used in neonates and infants <1 year of age for diaper dermatitis, are identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list; use should be avoided due to risk of adrenal suppression; systemic absorption is higher in pediatric patients than adults (strong recommendation; low quality of evidence) (PPA [Meyers 2020]).
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Risk X: Avoid combination
Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Risk C: Monitor therapy
Methoxsalen (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Methoxsalen (Systemic). Risk C: Monitor therapy
Multivitamins/Fluoride (with ADE): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Risk X: Avoid combination
Multivitamins/Minerals (with ADEK, Folate, Iron): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Risk X: Avoid combination
Multivitamins/Minerals (with AE, No Iron): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Risk X: Avoid combination
Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Risk C: Monitor therapy
Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Risk C: Monitor therapy
Concurrent use with vitamin A may enhance adverse effects. Management: Avoid excessive intake of vitamin A (cod liver oil, halibut fish oil).
In clinical trials, women of reproductive potential were required to have a negative pregnancy test prior to treatment.
Although pregnant women were excluded from the initial clinical studies, 13 pregnancies occurred during treatment. Three women gave birth to healthy babies, one pregnancy was terminated, and one ended in a miscarriage; outcomes of the remaining pregnancy are not known.
Refer to individual monographs for additional information.
It is not known if topical application results in sufficient systemic absorption to produce detectable concentrations of fluocinolone, hydroquinone, or tretinoin in breast milk.
The manufacturer recommends caution be used if administered to a breastfeeding woman. Avoid contact between breastfeeding infant and cream. Breastfeeding women were excluded from initial studies.
Signs/symptoms of HPA axis suppression
Fluocinolone is a topical corticosteroid and has low to intermediate range potency (dosage-form dependent). Topical corticosteroids have anti-inflammatory, antipruritic, and vasoconstrictive properties. May depress the formation, release, and activity of endogenous chemical mediators of inflammation (kinins, histamine, liposomal enzymes, prostaglandins) through the induction of phospholipase A2 inhibitory proteins (lipocortins) and sequential inhibition of the release of arachidonic acid. Hydroquinone may interrupt melanin synthesis (tyrosine-tyrosinase pathway); reduces hyperpigmentation. Tretinoin is a derivative of vitamin A. When used topically, it modifies epithelial growth and differentiation.
Absorption: Minimal
Metabolism: Hepatic for the small amount absorbed
Excretion: Urine and feces
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