fluocinolone/tretinoin/hydroquinone (Rx)

Brand and Other Names:Tri-Luma

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

fluocinolone/tretinoin/hydroquinone

cream

  • (0.01%/0.05%/4%)/30g

Melasma

Indicated for short-term treatment of moderate to severe melasma

Apply to face qHS, at least 30 min before bedtime

Wash face gently before application; rinse & pat dry

Apply thin film of Tri-Luma to hyperpigmented area & 1/2 inch surrounding skin

Do not use occlusive dressing

Safety & efficacy not established

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Interactions

Interaction Checker

and fluocinolone/tretinoin/hydroquinone

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 

            Contraindicated (3)

            • doxycycline

              doxycycline, tretinoin. Either increases toxicity of the other by unspecified interaction mechanism. Contraindicated. Both tretinoin and tetracyclines can cause increased intracranial pressure.

            • minocycline

              minocycline, tretinoin. Either increases toxicity of the other by Other (see comment). Contraindicated. Comment: Both tretinoin and tetracyclines can cause increased intracranial pressure.

            • tetracycline

              tetracycline, tretinoin. Either increases toxicity of the other by unspecified interaction mechanism. Contraindicated. Both tretinoin and tetracyclines can cause increased intracranial pressure.

            Serious - Use Alternative (34)

            • aminolevulinic acid oral

              aminolevulinic acid oral, tretinoin. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid administering other phototoxic drugs with aminolevulinic acid oral for 24 hr during perioperative period.

            • aminolevulinic acid topical

              tretinoin, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.

            • chlorothiazide

              chlorothiazide, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • chlorpromazine

              chlorpromazine, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • chlorthalidone

              chlorthalidone, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • ciprofloxacin

              ciprofloxacin, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Both drugs have increased risk of phototoxicity, use caution with concomitant use.

            • demeclocycline

              demeclocycline, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • doxycycline

              doxycycline, tretinoin. Either increases levels of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • etrasimod

              etrasimod, tretinoin. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Risk of additive immune system effects with etrasimod has not been studied in combination with antineoplastic, immune-modulating, or noncorticosteroid immunosuppressive therapies. Avoid coadministration during and in the weeks following administration of etrasimod.

            • fluphenazine

              fluphenazine, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • gemifloxacin

              gemifloxacin, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • hydrochlorothiazide

              hydrochlorothiazide, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • indapamide

              indapamide, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • levofloxacin

              levofloxacin, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • methyclothiazide

              methyclothiazide, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • methyl aminolevulinate

              tretinoin, methyl aminolevulinate. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.

            • metolazone

              metolazone, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • minocycline

              minocycline, tretinoin. Either increases levels of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • moxifloxacin

              moxifloxacin, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • ofloxacin

              ofloxacin, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • omadacycline

              tretinoin increases toxicity of omadacycline by Mechanism: unknown. Avoid or Use Alternate Drug. Concomitant use of oral retinoids with tetracyclines may increase risk of pseudotumor cerebri/intracranial hypertension. .

            • palifermin

              palifermin increases toxicity of tretinoin by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hr before, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.

            • palovarotene

              tretinoin, palovarotene. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Vitamin A in doses higher than the recommended daily allowance and/or other oral retinoids coadministered with palovarotene increases risk of hypervitaminosis A. .

            • perphenazine

              perphenazine, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • prochlorperazine

              prochlorperazine, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • promazine

              promazine, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • promethazine

              promethazine, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • sarecycline

              tretinoin increases toxicity of sarecycline by Mechanism: unknown. Avoid or Use Alternate Drug. Concomitant use of oral retinoids with tetracyclines may increase risk of pseudotumor cerebri/intracranial hypertension. .

            • sulfadiazine

              sulfadiazine, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • sulfamethoxazole

              sulfamethoxazole, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • sulfisoxazole

              sulfisoxazole, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • tetracycline

              tetracycline, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • thioridazine

              thioridazine, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • trifluoperazine

              trifluoperazine, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            Monitor Closely (16)

            • cannabidiol

              cannabidiol will increase the level or effect of tretinoin by decreasing metabolism. Modify Therapy/Monitor Closely. Cannabidiol may potentially inhibit CYP2C8 activity. Consider reducing the dose when concomitantly using CYP2C8 substrates.

            • dichlorphenamide

              dichlorphenamide, tretinoin. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Both drugs can cause metabolic acidosis.

            • ketoconazole

              ketoconazole increases levels of tretinoin by decreasing metabolism. Use Caution/Monitor.

            • levoketoconazole

              levoketoconazole increases levels of tretinoin by decreasing metabolism. Use Caution/Monitor.

            • methotrexate

              methotrexate, tretinoin. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Patients receiving other agents that may cause hepatotoxicity, including systemic retinoids, could be at increased risk of liver-related side effects of methotrexate and such patients should be monitored closely during methotrexate therapy.

            • mifepristone

              mifepristone will increase the level or effect of tretinoin by Other (see comment). Use Caution/Monitor. Inhibits CYP2C8/2C9; use smallest recommended doses for substrates and monitor

            • ofatumumab SC

              ofatumumab SC, tretinoin. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.

            • omaveloxolone

              omaveloxolone will decrease the level or effect of tretinoin by Other (see comment). Use Caution/Monitor. Omaveloxolone may reduce systemic exposure of sensitive CYP2C8 substrates. Check prescribing information of substrate if dosage modification is needed.

            • siponimod

              siponimod and tretinoin both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

            • stiripentol

              stiripentol will increase the level or effect of tretinoin by Other (see comment). Modify Therapy/Monitor Closely. Stiripentol is a CYP2C8 inhibitor. Consider dosage reduction for CYP2C8 substrates if adverse effects are experienced when coadministered.

            • tecovirimat

              tecovirimat will increase the level or effect of tretinoin by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor. Tecovirimat is a weak inhibitor of CYP2C8 and CYP2C19. Monitor for adverse effects if coadministered with sensitive substrates of these enzymes.

            • teriflunomide

              teriflunomide increases levels of tretinoin by Other (see comment). Use Caution/Monitor. Comment: Teriflunomide inhibits CYP2C8; caution when coadministered with CYP2C8 substrates.

            • tobramycin inhaled

              tobramycin inhaled and tretinoin both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity

            • tranexamic acid oral

              tranexamic acid oral, tretinoin. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration may increase procoagulant effect.

            • trastuzumab

              trastuzumab, tretinoin. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy.

            • trastuzumab deruxtecan

              trastuzumab deruxtecan, tretinoin. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy.

            Minor (1)

            • benazepril

              tretinoin, benazepril. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May increase risk of hypotension.

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            Adverse Effects

            >10%

            Erythema (41-45%)

            Desquamation (36-40%)

            Burning (16-20%)

            Dryness (11-15%)

            Pruritis (11-15%)

            1-10%

            Acne (5%)

            Telangiectasia (3%)

            Hyperesthesia (2%)

            Rosacea (1%)

            Vesicles (1%)

            Xerostomia (1%)

            Paresthesia (3%)

            <1%

            Acneiform

            Eruptions

            HPA axis suppression

            Hypopigmentation

            Itching

            Ochronosis

            Miliaria

            Skin atrophy

            Perioral dermatitis

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            Warnings

            Contraindications

            Hypersensitivity

            Cautions

            Not indicated for maintenance treatment of melasma

            Topical cream contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening asthmatic episodes in susceptible individuals; if anaphylaxis, asthma or other clinically significant hypersensitivity reactions occur, institute appropriate therapy and discontinue therapy

            Product contains hydroquinone, which may produce exogenous ochronosis, a gradual blue-black darkening of skin, the occurrence of which should prompt discontinuation of therapy; majority of patients developing this condition are Black, but may also occur in Caucasians and Hispanics

            Effects on endocrine system

            • Cream contains corticosteroid fluocinolone acetonide; systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with potential for glucocorticosteroid insufficiency after withdrawal of treatment; manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria can be produced by systemic absorption of topical corticosteroid while on treatment
            • If HPA axis suppression noted, use should be discontinued; recovery of HPA axis function generally occurs upon discontinuation of topical corticosteroids;
            • ACTH or cosyntropin stimulation test may be helpful in evaluating patients for HPA axis suppression

            Cutaneous reactions

            • Cutaneous hypersensitivity to active ingredients of this product reported in literature; product contains hydroquinone and tretinoin that may cause mild to moderate irritation; local irritation, such as skin reddening, peeling, mild burning sensation, dryness, and pruritus may be expected at site of application
            • Transient skin reddening or mild burning sensation does not preclude treatment; if a reaction suggests hypersensitivity or chemical irritation, use of medication should be discontinued
            • Patients should avoid medicated or abrasive soaps and cleansers, soaps and cosmetics with drying effects, products with high concentrations of alcohol and astringents, and other irritants or keratolytic drugs while on treatment
            • Patients are cautioned on concomitant use of medications known to be photosensitizing
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            Pregnancy & Lactation

            Pregnancy

            There are no adequate and well-controlled studies in pregnant women; product should be used during pregnancy only if potential benefit justifies potential risk to fetus; cream contains teratogen, tretinoin, which may cause embryo-fetal death, altered fetal growth, congenital malformations, and potential neurologic deficits

            In clinical trials the treatment of facial melasma, women of child-bearing potential initiated treatment only after having had a negative pregnancy test and used effective birth control measures during therapy; however, some women became pregnant during treatment; most of pregnancy outcomes are unknown; three women gave birth to apparently healthy babies; one pregnancy was terminated prematurely, and another ended in miscarriage

            In general, use of drugs should be reduced to a minimum in pregnancy; if a patient has been inadvertently exposed to therapy in pregnancy, she should be counseled on risk of teratogenesis due to exposure

            Risk of teratogenesis due to topical exposure may be considered low; however, exposure during period of organogenesis in first trimester is theoretically more likely to produce adverse outcome than in later pregnancy

            Tretinoin is considered to be highly teratogenic upon systemic administration; animal reproductive studies are not available with topical hydroquinone

            Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels; some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals

            Lactation

            Corticosteroids, when systemically administered, appear in human milk; not known whether topical application of could result in sufficient systemic absorption to produce detectable quantities of fluocinolone acetonide, hydroquinone, or tretinoin in human milk; because many drugs are secreted in human milk, caution should be exercised when therapy is administered to nursing woman; care should be taken to avoid contact between infant being nursed and cream

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Absorbed: minimal

            Mechanism of Action

            Hydroquinone: Inhibits melanocyte metabolic processes that produce melanin; incr excretion of melanin from melanocytes

            Fluocinolone: Corticosteroids decrease inflammation by stabilizing leukocyte lysosomal membranes

            Tretinoin: Follicular epithelium irritant

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            A Patient Handout is not currently available for this monograph.
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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.