Dosing & Uses
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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.
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
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
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.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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