Tri-Luma (fluocinolone acetonide/tretinoin/hydroquinone)

To depigment hyperpigmented skin, a thin layer of hydroquinone cream or solution should be applied uniformly and rubbed into the pigmented area twice daily, in the morning and evening. Application of the drug should be limited to an area equal to that of the face and neck or hands and arms. Exposure to sunlight should be minimized during treatment (See Cautions: Precautions and Contraindications); the opaque base in some hydroquinone preparations (Eldopaque(R), Eldopaque Forte(R)) may provide sufficient protection from sunlight. If no depigmentation is evident after 2 months of hydroquinone treatment, the drug should be discontinued. When the desired degree of depigmentation is obtained, hydroquinone should be applied only as often as needed to maintain depigmentation.

Excessive application of tretinoin does not increase the therapeutic effects of the drug and may produce marked inflammatory reactions, including peeling and discomfort.

Fluocinolone acetonide shampoo should be prepared by a pharmacist at the time of dispensing the shampoo; contents of the 12-mg capsule should be mixed with the shampoo base supplied by the manufacturer. The extemporaneously prepared shampoo is stable for 3 months from the time of compounding. The extemporaneously prepared shampoo must be shaken well prior to administration.

Topical fluocinolone acetonide or fluocinonide cream, gel, ointment, and solution are applied sparingly in thin films and rubbed gently into the skin 2-4 times daily depending on the severity of the condition. Occlusive dressings may be used for severe or resistant dermatoses.

For the treatment of atopic dermatitis in adults, fluocinolone acetonide 0.01% topical oil is applied as a thin film 3 times daily.

For the treatment of moderate to severe atopic dermatitis in children 2 years of age or older, a thin film of fluocinolone acetonide 0.01% topical oil may be applied twice daily to affected areas for no longer than 4 weeks. The topical oil should not be applied to the face or diaper area. Application to intertriginous areas also should be avoided because of an increased risk of developing potentially irreversible adverse local effects (e.g., striae, atrophy, telangiectasia).

For the treatment of seborrheic dermatitis of the scalp in adults, no more than 30 mL of fluocinolone acetonide 0.01% shampoo is applied to the scalp once daily, lathered, and allowed to remain on the scalp for about 5 minutes. The hair and scalp are then rinsed thoroughly with water. Fluocinolone acetonide shampoo should not be used with occlusive dressings and patients should be warned that treated areas of the scalp should not be bandaged or otherwise covered or wrapped as to be occlusive, unless directed by a clinician.

For the treatment of psoriasis of the scalp in adults, a thin film of fluocinolone acetonide 0.01% topical oil should be applied to wet or dampened hair and scalp, massaged well, and covered with the manufacturer-supplied shower cap. The oil should be allowed to remain on the scalp overnight or for a minimum of 4 hours following application before being washed off with regular shampoo and rinsed thoroughly with water.

Preparations containing 2-4% hydroquinone are applied topically. Hydroquinone should not be administered orally.

Tretinoin is applied topically to the skin as a cream, gel, or solution. Patients should be instructed carefully in proper use of the drug, including associated precautions. (See Cautions: Precautions and Contraindications and also Drug Interactions.)

No dosing information is available for this tab.

Concomitant use of tretinoin with other topical medications (especially those containing keratolytic agents such as sulfur, resorcinol, benzoyl peroxide, or salicylic acid) should be undertaken with caution because of the possibility of interactions. In patients who have used keratolytic agents, sufficient time should elapse for the effects of these drugs to subside before initiating tretinoin therapy. Patients receiving tretinoin therapy should not wash their faces more frequently than 2 or 3 times daily, using a mild, bland soap. Medicated or drying soaps and abrasive soaps and cleansers generally should not be used. Use of topical preparations with high concentrations of alcohol, menthol, spices, or lime such as shaving lotions, astringents, and perfume should be avoided, since they may cause stinging of treated skin, especially during initial therapy. Patients also should avoid the use of irritating cosmetics (e.g., toners, peeling (desquamating) agents), permanent wave solutions, electrolysis, or hair depilatories during topical tretinoin therapy. Non-medicated cosmetics may be used by patients receiving tretinoin therapy, but the areas to be treated should be cleansed thoroughly before tretinoin is applied; medicated cosmetics should not be used.

There are no contraindication interactions for this drug.

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

Topical Tretinoin (PHOTODAMAGE)/Tetracyclines

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: The exact mechanism is unknown.

CLINICAL EFFECTS: Concurrent use of topical tretinoin with tetracyclines may increase the risk of phototoxicity(1) in some patients.(2)

PREDISPOSING FACTORS: Patients using topical tretinoin for the treatment of photodamage may be predisposed to photosensitivity.(2)

PATIENT MANAGEMENT: Concurrent use of topical tretinoin and tetracycline is standard practice in the treatment of acne.(3) However, patients taking tetracyclines should not use topical tretinoin (e.g Renova) for the treatment of photodamage.(1,2)

DISCUSSION: The concurrent use of topical tretinoin and tetracyclines may result in an increased risk of phototoxicity.(1,2)

There are no moderate interactions for this drug.

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There are no contraindication contraindications for this drug.

• Bacterial skin and skin structure infection
• Eczema
• Sunburn

• Hypothalamic-pituitary insufficiency

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Less Frequent

• Contact dermatitis
• Folliculitis
• Hypersensitivity drug reaction
• Purpura
• Skin and skin structure infection
• Skin atrophy

Rare or Very Rare

• Adrenocortical insufficiency
• Blistering skin
• Bullous dermatitis
• Cataracts
• Central serous chorioretinopathy
• Dyschromia
• Glaucoma
• Growth failure
• Hypothalamic-pituitary insufficiency
• Intracranial hypertension
• Ocular hypertension
• Skin hypopigmentation
• Skin striae
• Skin ulcer
• Urticaria

More Frequent

• Abnormal desquamation
• Dry skin
• Erythema
• Erythema
• Pruritus of skin
• Skin inflammation
• Skin irritation
• Skin photosensitivity
• Stinging of skin

Less Frequent

• Acute pain at drug application site
• Blurred vision
• Headache disorder
• Localized edema
• Paresthesia
• Pruritus of skin
• Skin rash
• Stinging of skin
• Telangiectasia
• Treatment site sequelae

Rare or Very Rare

• Acneiform eruption
• Alopecia
• Blistering skin
• Contact dermatitis
• Dry skin
• Dyschromia
• Dyschromia
• Glycosuria
• Hirsutism
• Hypercortisolism
• Hyperesthesia
• Hyperglycemia
• Miliaria
• Perioral dermatitis
• Skin irritation

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Reproductive studies in animals have not been performed with topical hydroquinone. It is not known whether hydroquinone can cause fetal harm when used topically by pregnant women. Topical hydroquinone should be used during pregnancy only when clearly needed.

Retinoids (e.g., isotretinoin) have been reported to cause serious fetal harm when administered to pregnant women. (See Cautions: Pregnancy, Fertility, and Lactation, in Isotretinoin 84:36.) Oral tretinoin has been shown to be teratogenic in rats, mice, rabbits, hamsters, and subhuman primates. Tretinoin was teratogenic in Wistar rats when given orally or topically in dosages exceeding 1 mg/kg daily (8 times the maximum human systemic dosage normalized for total body surface area). In the cynomolgus monkey, which metabolically is closer to humans for tretinoin than other species examined, fetal malformations were reported at oral dosages of 10 mg/kg daily or greater, but none were observed at 5 mg/kg daily (83 times the maximum human systemic dosage normalized for total body surface area), although increased skeletal variations were observed at all dosages. Dose-related increased embryolethality and abortion also were reported. Similar results also have been reported in pigtail macaques.

Topical tretinoin in animal teratogenicity tests has generated equivocal results. There is evidence for teratogenicity (shortened or kinked tail) of topical tretinoin in Wistar rats at dosages exceeding 1 mg/kg daily (8 times the maximum human systemic dosage normalized for total body surface area). Bone anomalies (short (13%) or bent (6%) humerus, incompletely ossified os parietal (14%)) also have been reported in rats when tretinoin 10 mg/kg daily was applied dermally. Topical tretinoin cream was associated with an increased incidence of cleft palate and hydrocephaly in rabbits when administered in a dosage 91 times the topical human dosage (based on topical application of 1 g of 0.1% tretinoin cream in a 50-kg adult). In New Zealand white rabbits treated with topical tretinoin at dosages 80 times the recommended human topical clinical dosage, an increased incidence of domed head and hydrocephaly was noted in some of the fetuses, typical of retinoid-induced fetal malformations in this species; no abnormalities were observed at dosages 3 times the maximum human systemic dosage of tretinoin after topical administration of 0.1% tretinoin gel (microsphere formulation), normalized for total body surface area. In addition, topical tretinoin in formulations other than the gel (microsphere formulation) was not teratogenic when given in dosages of 42 or 27 times the maximum human systemic topical dosage in rats or rabbits, respectively. However, delayed ossification of several bones, occurred in rabbits and a dose-dependent incease in supernumerary ribs was observed in rats at these topical dosages.

Oral tretinoin was fetotoxic in rats at dosages 21 times the maximum human systemic dosage normalized for total body surface area, resulting in skeletal variations and increased intrauterine death in rats. Topical tretinoin has been shown to be fetotoxic in rabbits when administered in dosages 8 times the maximum human systemic dosage applied topically and normalized for total body surface area), resulting in fetal resorption and variations in ossification.

When given subcutaneously to rabbits, tretinoin was teratogenic at a dosage of 2 mg/kg daily but not at 1 mg/kg daily. These dosages are approximately 400 and 200 times, respectively, the human topical dosage of tretinoin cream (based on topical application of 1 g of 0.025% tretinoin cream in a 50-kg adult).

With widespread use of any drug, a small number of birth defect reports associated with the administration of the drug would be expected by chance alone. During 2 decades of clinical use of one formulation of topical tretinoin (Retin-A(R)), 30 cases of temporally associated congenital malformations have been reported. Although no definite pattern of teratogenicity and no causal associations have been established from these cases, 5 of the reports described the rare birth defect category holoprosencephaly (defects associated with incomplete midline development of the forebrain). The relevance of these spontaneous reports in terms of risk to the fetus is unknown.

To date, there have been no adequate and well-controlled studies performed in pregnant women, and the teratogenic blood level of tretinoin is not known. The manufacturer of some topical tretinoin preparations (e.g., Retin-A(R)) state that topical tretinoin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, while manufacturers of other tretinoin formulations (e.g., Avita(R) cream, Renova(R) emollient cream) state that these products should not be used during pregnancy.

Since it is not known if topical hydroquinone is absorbed or distributed into human milk, the drug should be used with caution in nursing women.

It is not known whether topically applied tretinoin is excreted in human milk. Caution should be exercised when topical tretinoin is administered to a nursing woman.

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