Tazarotene is a retinoid prodrug of tazarotenic acid for the treatment of psoriasis, acne vulgaris, and photoaging of the skin. As vitamin A (retinol) derivatives, retinoids are important regulators of cell reproduction and cell proliferation and differentiation; however, unlike vitamin A, retinoids are not converted into rhodopsin, which is needed for night vision. In addition, it should be noted that tazarotene has not demonstrated a mitigating effect on significant signs of chronic sunlight exposure such as coarse or deep wrinkling, tactile roughness, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis. According to the manufacturer of tazarotene cream, the drug does not eliminate or prevent wrinkles, repair sun-damaged skin, reverse photoaging, or restore more youthful or younger skin. Tazarotene is contraindicated for use during pregnancy; females of childbearing potential should undergo pregnancy testing within 2 weeks of initiating treatment, and use adequate birth control during treatment.
In clinical trials evaluating the safety and efficacy of tazarotene for psoriasis, the onset of clinical response occurred as early as 1 week and the therapeutic effect was sustained throughout the 12 week post-treatment period. Treatment with tazarotene resulted in statistically significant reductions in the severity of the clinical signs of psoriasis (i.e., plaque elevation, scaling, and erythema) compared to the vehicle alone. Erythema was less responsive to tazarotene therapy than plaque elevation and scaling, possibly because retinoid-induced erythema is common with topical retinoid therapy. A clinical trial comparing tazarotene (0.1% and 0.05%) to fluocinonide (0.05%) demonstrated tazarotene is at least as effective as fluocinonide, and tazarotene demonstrated significantly better maintenance of therapeutic effect after discontinuation of therapy. Combining tazarotene with a corticosteroid yields better efficacy than tazarotene alone and may result in greater efficacy than a corticosteroid alone while potentially reducing the incidence of local adverse events. When used in the treatment of acne vulgaris, tazarotene produces a reduction in both inflammatory and noninflammatory lesions. In a clinical trial, the use of tazarotene resulted in significant reduction in multiple signs of photodamage (i.e., fine wrinkling, mottled hyperpigmentation, lentigines, elastosis, pore size, irregular depigmentation, tactile roughness, and coarse wrinkling) compared to vehicle.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Topical Administration
-Women of childbearing potential should have a negative pregnancy test within 2 weeks prior to beginning tazarotene treatment. Tazarotene treatment should begin during a normal menstrual period.
-Tazarotene is administered topically to the skin. Because unaffected skin may be more susceptible to irritation, application to unaffected areas should be carefully avoided. Avoid contact with the eyes and mouth. Do not use on eczematous or abraded skin as severe irritation may occur.
-Application may cause excessive irritation in the skin of certain sensitive individuals. If therapy must be temporarily discontinued or if the dosing needs to be reduced to an interval that the patient can tolerate, therapy may be resumed, or the frequency of application may be increased as the patient becomes able to tolerate the treatment.
-For external use only. Avoid contact with mouth, eyes, paranasal creases, and mucous membranes. If accidental contact occurs, rinse well with water.
-Wash hands thoroughly after application.
Facial wrinkles (Avage):
-If emollients or moisturizers are used, they can be applied either before or after application of tazarotene cream ensuring that the first cream or lotion has absorbed into the skin and has dried completely.
-Tazarotene should be used for facial wrinkles as adjunct to a proper skin care and sunlight avoidance program, including the use of effective sunscreens (minimum SPF 15) and protective clothing.
Acne vulgaris (Arazlo, Fabior, or Tazorac):
-Avoid concurrent use with medications and cosmetics that have a strong drying effect. According to the manufacturers of Fabior foam and Arazol lotion, moisturizers may be used as needed; no specific recommendation is provided by the manufacturer of Tazorac.
-The manufacturer of Arazlo lotion recommends use of effective sunscreens and protective clothing to cover the treated areas. Avoid application on sunburnt skin.
-For tazarotene foam (Fabior), apply enough foam to lightly cover the affected areas with a thin layer. Gently massage the foam into the skin until it disappears.
Psoriasis (Tazorac):
-If a bath or shower is taken prior to application, ensure the skin is dry before applying tazarotene.
-If emollients are used, apply the emollient at least 1 hour before application of tazarotene.
Dermatologic adverse reactions reported with tazarotene include burning and stinging (1% to 30%), contact dermatitis (1% to 10%), desquamation or exfoliation (1% to 40%), erythema (2% to 49%), pruritus (1% to 30%), rash (1% to 10%), skin discoloration (1% to 10%), skin inflammation, fissuring, and bleeding (1% to 10%), skin irritation (1% to 30%), skin or application site pain (1% to 30%), and xerosis (1% to 16%). Worsening psoriasis was reported with tazarotene (1% to 30%) during clinical trials for psoriasis. Increases in psoriasis worsening and sun-induced erythema were noted in some subjects over the fourth to twelfth months as compared to the first 3 months of a 1-year study involving tazarotene. Cheilitis (1%) is among commonly reported adverse reactions attributed to tazarotene during clinical trials for the treatment of facial fine wrinkling, mottled hypo- and hyperpigmentation, and benign facial lentigines. During postmarketing use, dermatitis, skin blistering, skin exfoliation, skin hyperpigmentation, skin hypopigmentation, swelling at or near the application site, and urticaria have been reported. If undue irritation (i.e., redness, peeling, or discomfort) occurs, reduce the frequency of application or temporarily interrupt treatment. Treatment may be resumed once irritation subsides. Discontinue treatment if irritation persists.
Tazarotene causes photosensitivity. Patients should use protective clothing and sunscreens with a minimum SPF of 15 during the day when being treated with tazarotene.
Hypertriglyceridemia was reported in more than 1% but less than 10% of patients in clinical trials of tazarotene cream for the treatment of psoriasis.
Localized edema was reported at an incidence of 1% to 10% in clinical trials of tazarotene gel and less than 1% in trials of the foam formulation for the treatment of acne vulgaris. Peripheral edema was reported at an incidence of 1% to 10% in clinical trials of tazarotene cream for the treatment of psoriasis.
When possible, avoid weather extremes (i.e., wind or cold) because they may be more irritating to patients using tazarotene.
Tazarotene is contraindicated for use during pregnancy and in women who may become pregnant. To ensure tazarotene is not given during pregnancy, the drug should be initiated during a normal menstrual period. Retinoids may cause fetal harm when administered to a pregnant woman. During animal pregnancy studies, topical doses of tazarotene 1- to 26-times the human topical dose were associated with known retinoid malformations such as spina bifida, hydrocephaly, and heart abnormalities. Six pregnant women who were inadvertently exposed to tazarotene gel during clinical trials subsequently delivered healthy babies. As the exact timing and extent of exposure in relation to gestation are not known, the significance of these findings is not known. If tazarotene is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued and the patient apprised of the potential risks to the fetus.
There are no data regarding the presence or tazarotene in human milk, or the drug's effect on the breast-fed infant or milk production. To minimize potential drug exposure to the nursing infant via breast milk, use tazarotene for the shortest duration possible while breast-feeding. Advise the mother not to apply the drug directly to the nipple or areola. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.
The safety and efficacy of tazarotene have not been established in neonates or infants; however, Arazlo 0.045% topical lotion is approved for use in children as young as 9 years of age. Other formulations are approved for use in adolescents and children as young as 12 years for the treatment of acne and psoriasis; safety and efficacy of tazarotene cream for photoaging have not been established in this population.
Tazarotene should be used with caution in patients with a history of local tolerability reactions or local hypersensitivity. Use of tazarotene on abraded or eczematous skin may cause severe irritation and may worsen eczema.
Tazarotene should be used cautiously in patients who experience retinoid hypersensitivity reactions to oral vitamin A or retinoid derivatives because cross-sensitivity between agents is possible. Hypersensitivity reactions (e.g., urticaria) and local application site reactions (e.g., blistering, skin desquamation, pruritus, burning, erythema) have been observed with topical tazarotene. If these adverse reactions occur, consider discontinuing the medication or reducing the dosing frequency until the integrity of the skin is restored. Alternatively, patients with psoriasis being treated with the 0.1% concentration formulation can be switched to a lower concentration product. Therapy can be resumed, or the drug concentration or frequency of application can be increased as the patient becomes able to tolerate treatment.
Tazarotene cream and gel contain benzyl alcohol as a preservative and should not be used in patients with benzyl alcohol hypersensitivity.
Retinoids may cause photosensitivity. Patients with a skin photosensitivity disorder should not be treated with tazarotene. Do not use tazarotene until skin has fully recovered from sunburn. Because of heightened burning susceptibility, exposure to sunlight (UV) exposure (including sunlamps) should be avoided unless deemed medically necessary, and in such cases, exposure should be minimized. Use tazarotene with caution in patients with a personal or family history of skin cancer due to the increased risk of sunburn associated with the drug. Patients must be advised to use sunscreens (minimum SPF of 15) and protective clothing while using tazarotene. Patients who may have considerable sun exposure due to their occupation should exercise particular caution when using tazarotene and ensure that appropriate sun avoidance is observed.
Tazarotene is for external use only. Avoid ocular exposure and contact with the mouth or mucous membranes. If eye contact occurs, rinse thoroughly with large amounts of water. Apply only to affected areas; accidental exposure to unaffected skin may cause irritation. Do not cover the treated areas with an occlusive dressing.
Because retinoids may cause fetal harm when administered to pregnant women, females of childbearing potential must undergo pregnancy testing within 2 weeks prior to starting tazarotene treatment. In addition, effective contraception requirements are recommended for females of reproductive potential. If tazarotene is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued and the patient apprised of the potential risks to the fetus.
For the treatment of plaque psoriasis:
Topical dosage (0.05% or 0.1% Tazorac cream):
Adults: Apply a thin layer (2 mg/cm2) topically to the affected skin area(s) once daily. Start treatment with 0.05% and increase to 0.1% if tolerated and needed. Guidelines recommend tazarotene for mild to moderate skin psoriasis and nail psoriasis. The use of mid- or high-potency topical corticosteroid in combination with tazarotene for 8 to 16 weeks is more effective than monotherapy with tazarotene and is recommended for the treatment of mild to moderate psoriasis; the use of corticosteroids in combination with tazarotene decreases the duration of treatment as well as increases the length of remission. The combination of topical tazarotene and narrow band ultraviolet B (NB-UVB) has been shown to be effective and allow a reduction in total use of NB-UVB.
Topical dosage (0.05% or 0.1% Tazorac gel):
Adults: Apply a thin layer (2 mg/cm2) topically to the affected skin area(s) once daily. Start treatment with 0.05% and increase to 0.1% if tolerated and needed. Guidelines recommend tazarotene for mild to moderate skin psoriasis and nail psoriasis. The use of mid- or high-potency topical corticosteroid in combination with tazarotene for 8 to 16 weeks is more effective than monotherapy with tazarotene and is recommended for the treatment of mild to moderate psoriasis; the use of corticosteroids in combination with tazarotene decreases the duration of treatment as well as increases the length of remission. The combination of topical tazarotene and narrow band ultraviolet B (NB-UVB) has been shown to be effective and allow a reduction in total use of NB-UVB.
Children and Adolescents 12 to 17 years: Apply a thin layer (2 mg/cm2) topically to the affected skin area(s) once daily. Start treatment with 0.05% and increase to 0.1% if tolerated and needed. Guidelines recommend tazarotene as monotherapy or in combination with topical corticosteroids for the treatment of localized pediatric skin or nail psoriasis.
For the treatment of acne vulgaris:
Topical dosage (0.1% Tazorac cream or gel):
Adults: Apply a thin layer (2 mg/cm2) topically to the affected skin area(s) once daily in the evening. Use enough to cover the entire affected area.
Children and Adolescents 12 to 17 years: Apply a thin layer (2 mg/cm2) topically to the affected skin area(s) once daily in the evening. Use enough to cover the entire affected area.
Topical dosage (Fabior foam):
Adults: Apply a thin layer topically to the affected skin area(s) once daily in the evening.
Children and Adolescents 12 to 17 years: Apply a thin layer topically to the affected skin area(s) once daily in the evening.
Topical dosage (Arazlo lotion):
Adults: Apply a thin layer topically to the affected skin area(s) once daily.
Children and Adolescents 9 to 17 years: Apply a thin layer topically to the affected skin area(s) once daily.
For adjunctive treatment of fine facial wrinkles and facial mottled hyperpigmentation (i.e., 'liver spots') and hypopigmentation associated with photoaging:
Topical dosage (Avage 0.1% cream):
Adults and Adolescents 17 years and older: Cleanse face gently. After the skin is dry, apply a pea-sized amount once daily before bedtime to lightly cover the entire face, including the eyelids if desired. Frequency of application should be monitored by careful observation of the therapeutic response and skin tolerance.
Maximum Dosage Limits:
-Adults
1 application per day topically.
-Geriatric
1 application per day topically.
-Adolescents
17 years: 1 application per day topically.
less than 17 years: 1 application per day topically; safety and efficacy of Avage 0.1% cream have not been established.
-Children
12 years: 1 application per day topically; safety and efficacy of Avage 0.1% cream have not been established.
9 to 12 years: 1 application per day topically for Arazlo 0.045% lotion; safety and efficacy of other formulations have not been established
less than 9 years: Safety and efficacy have not been established.
-Infants
Safety and efficacy have not been established.
-Neonates
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed for topical administration.
Patients with Renal Impairment Dosing
No dosage adjustments are needed for topical administration.
*non-FDA-approved indication
Adapalene; Benzoyl Peroxide: (Moderate) Concomitant use of tazarotene and dermatologic products containing benzoyl peroxide should be avoided. The manufacturer suggests that a patient's skin rest until the effects of such preparations subside before using tazarotene. When used together as part of acne therapy, these medications should be used separately at different times of the day to minimize skin irritation, unless directed otherwise by the prescriber. If skin irritation occurs, a decrease in dose or frequency of one or both agents may be necessary.
Aliskiren; Hydrochlorothiazide, HCTZ: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as thiazide diuretics, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Amiloride; Hydrochlorothiazide, HCTZ: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as thiazide diuretics, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Aminolevulinic Acid: (Moderate) Tazarotene may increase the effects of photosensitizing agents used during photodynamic therapy; concurrent use of photosensitizing agents is often recommended against by the specific photodynamic therapy, or doses of the therapy may require adjustment.
Amlodipine; Valsartan; Hydrochlorothiazide, HCTZ: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as thiazide diuretics, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Atenolol; Chlorthalidone: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as thiazide diuretics, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Azilsartan; Chlorthalidone: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as thiazide diuretics, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Benazepril; Hydrochlorothiazide, HCTZ: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as thiazide diuretics, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Benzoyl Peroxide: (Moderate) Concomitant use of tazarotene and dermatologic products containing benzoyl peroxide should be avoided. The manufacturer suggests that a patient's skin rest until the effects of such preparations subside before using tazarotene. When used together as part of acne therapy, these medications should be used separately at different times of the day to minimize skin irritation, unless directed otherwise by the prescriber. If skin irritation occurs, a decrease in dose or frequency of one or both agents may be necessary.
Benzoyl Peroxide; Clindamycin: (Moderate) Concomitant use of tazarotene and dermatologic products containing benzoyl peroxide should be avoided. The manufacturer suggests that a patient's skin rest until the effects of such preparations subside before using tazarotene. When used together as part of acne therapy, these medications should be used separately at different times of the day to minimize skin irritation, unless directed otherwise by the prescriber. If skin irritation occurs, a decrease in dose or frequency of one or both agents may be necessary.
Benzoyl Peroxide; Erythromycin: (Moderate) Concomitant use of tazarotene and dermatologic products containing benzoyl peroxide should be avoided. The manufacturer suggests that a patient's skin rest until the effects of such preparations subside before using tazarotene. When used together as part of acne therapy, these medications should be used separately at different times of the day to minimize skin irritation, unless directed otherwise by the prescriber. If skin irritation occurs, a decrease in dose or frequency of one or both agents may be necessary.
Benzoyl Peroxide; Sulfur: (Moderate) Concomitant use of tazarotene and dermatologic products containing benzoyl peroxide should be avoided. The manufacturer suggests that a patient's skin rest until the effects of such preparations subside before using tazarotene. When used together as part of acne therapy, these medications should be used separately at different times of the day to minimize skin irritation, unless directed otherwise by the prescriber. If skin irritation occurs, a decrease in dose or frequency of one or both agents may be necessary.
Bismuth Subcitrate Potassium; Metronidazole; Tetracycline: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as tetracyclines, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Bismuth Subsalicylate; Metronidazole; Tetracycline: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as tetracyclines, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Bisoprolol; Hydrochlorothiazide, HCTZ: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as thiazide diuretics, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Candesartan; Hydrochlorothiazide, HCTZ: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as thiazide diuretics, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Captopril; Hydrochlorothiazide, HCTZ: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as thiazide diuretics, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Chlorothiazide: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as thiazide diuretics, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Chlorpromazine: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as phenothiazines, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Chlorthalidone: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as thiazide diuretics, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Ciprofloxacin: (Moderate) Use tazarotene with caution in patients who are also taking drugs known to be photosensitizers, such as ciprofloxacin, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Clindamycin; Adapalene; Benzoyl Peroxide: (Moderate) Concomitant use of tazarotene and dermatologic products containing benzoyl peroxide should be avoided. The manufacturer suggests that a patient's skin rest until the effects of such preparations subside before using tazarotene. When used together as part of acne therapy, these medications should be used separately at different times of the day to minimize skin irritation, unless directed otherwise by the prescriber. If skin irritation occurs, a decrease in dose or frequency of one or both agents may be necessary.
Codeine; Phenylephrine; Promethazine: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as phenothiazines, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Codeine; Promethazine: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as phenothiazines, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Demeclocycline: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as tetracyclines, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Doxycycline: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as tetracyclines, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Enalapril; Hydrochlorothiazide, HCTZ: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as thiazide diuretics, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Eprosartan; Hydrochlorothiazide, HCTZ: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as thiazide diuretics, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Fluphenazine: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as phenothiazines, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Fosinopril; Hydrochlorothiazide, HCTZ: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as thiazide diuretics, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Gemifloxacin: (Moderate) Use tazarotene with caution in patients who are also taking drugs known to be photosensitizers, such as gemifloxacin, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Glimepiride: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as sulfonylureas, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Glipizide: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as sulfonylureas, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Glipizide; Metformin: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as sulfonylureas, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Glyburide: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as sulfonylureas, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Glyburide; Metformin: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as sulfonylureas, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Griseofulvin: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as griseofulvin, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Hydrochlorothiazide, HCTZ: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as thiazide diuretics, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Hydrochlorothiazide, HCTZ; Moexipril: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as thiazide diuretics, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Indapamide: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as thiazide diuretics, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Irbesartan; Hydrochlorothiazide, HCTZ: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as thiazide diuretics, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Levofloxacin: (Moderate) Use tazarotene with caution in patients who are also taking drugs known to be photosensitizers, such as levofloxacin, due to the increased possibility of augmented phototoxicity.
Lisinopril; Hydrochlorothiazide, HCTZ: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as thiazide diuretics, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Losartan; Hydrochlorothiazide, HCTZ: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as thiazide diuretics, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Metolazone: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as thiazide diuretics, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Metoprolol; Hydrochlorothiazide, HCTZ: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as thiazide diuretics, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Minocycline: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as tetracyclines, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Moxifloxacin: (Moderate) Use tazarotene with caution in patients who are also taking drugs known to be photosensitizers, such as moxifloxacin, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Ofloxacin: (Moderate) Use tazarotene with caution in patients who are also taking drugs known to be photosensitizers, such as ofloxacin, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Olmesartan; Amlodipine; Hydrochlorothiazide, HCTZ: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as thiazide diuretics, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Olmesartan; Hydrochlorothiazide, HCTZ: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as thiazide diuretics, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Omadacycline: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as tetracyclines, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Perphenazine: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as phenothiazines, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Perphenazine; Amitriptyline: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as phenothiazines, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Phenothiazines: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as phenothiazines, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Photosensitizing agents (topical): (Moderate) Tazarotene may increase the effects of photosensitizing agents used during photodynamic therapy; concurrent use of photosensitizing agents is often recommended against by the specific photodynamic therapy, or doses of the therapy may require adjustment.
Pioglitazone; Glimepiride: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as sulfonylureas, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Prochlorperazine: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as phenothiazines, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Promethazine: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as phenothiazines, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Promethazine; Dextromethorphan: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as phenothiazines, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Promethazine; Phenylephrine: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as phenothiazines, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Quinapril; Hydrochlorothiazide, HCTZ: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as thiazide diuretics, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Sarecycline: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as tetracyclines, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Spironolactone; Hydrochlorothiazide, HCTZ: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as thiazide diuretics, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
St. John's Wort, Hypericum perforatum: (Moderate) In theory it is possible that additive photosensitizing effects may result from the concomitant use of St. John's wort with other photosensitizing drugs such as retinoids.
Sulfonylureas: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as sulfonylureas, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Telmisartan; Hydrochlorothiazide, HCTZ: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as thiazide diuretics, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Tetracycline: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as tetracyclines, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Tetracyclines: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as tetracyclines, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Thiazide diuretics: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as thiazide diuretics, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Thioridazine: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as phenothiazines, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Tretinoin; Benzoyl Peroxide: (Moderate) Concomitant use of tazarotene and dermatologic products containing benzoyl peroxide should be avoided. The manufacturer suggests that a patient's skin rest until the effects of such preparations subside before using tazarotene. When used together as part of acne therapy, these medications should be used separately at different times of the day to minimize skin irritation, unless directed otherwise by the prescriber. If skin irritation occurs, a decrease in dose or frequency of one or both agents may be necessary.
Triamterene; Hydrochlorothiazide, HCTZ: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as thiazide diuretics, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Trifluoperazine: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as phenothiazines, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Valsartan; Hydrochlorothiazide, HCTZ: (Moderate) The manufacturer states that tazarotene should be administered with caution in patients who are also taking drugs known to be photosensitizers, such as thiazide diuretics, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
Retinoids are intracrine and paracrine mediators of cell differentiation and proliferation, apoptosis (programmed cell death), and reproduction. Cells regulate the formation of specific retinoid isomers depending upon the cellular action required. The numerous effects of retinoids reflect the complex biology of the nuclear receptors that mediate retinoid activity.
Retinoids exert their effects through binding to specific nuclear retinoid receptors, which are members of the steroid-thyroid superfamily of nuclear receptors. Retinoid receptors are divided into retinoid X receptors (RXRs) and retinoic acid receptors (RARs); both types can be further divided into 3 subtypes: Alpha, beta, and gamma. These receptor subtypes are further divided into many isoforms. Retinoid receptors are structurally similar but have different affinities for different types of retinoids and distribution varies throughout the body resulting in a wide range of actions. Following topical application, tazarotene undergoes esterase hydrolysis to the active form, tazarotenic acid (AGN 190299), which is the cognate carboxylic acid of tazarotene. This active metabolite binds to all three members of the RAR family (e.g., RAR-alpha, RAR-beta, RAR-gamma), but shows relative specificity for beta and gamma subtypes. Tazarotene has multiple effects on keratinocyte differentiation and proliferation, as well as inflammation processes that contribute to psoriasis; however, the exact mechanism of action is unclear. In animal studies, topical tazarotene blocks induction of ornithine decarboxylase (ODC) activity, which is associated with cell proliferation and expression. In vitro skin models and cell cultures show that tazarotene suppresses expression of MRP8, a marker of inflammation present in high levels in the epidermis of psoriasis patients and inhibits cornified envelope formation, whose build-up is an element of psoriasis scale expression. Tazarotene also induces the expression of TIG3 (tazarotene-induced gene 3), a suppressor gene that may inhibit epidermal hyperproliferation in treated plaques. Tazarotene appears to decrease fine wrinkles and mottled hyperpigmentation in facial skin by increasing the number of granular cell layers and causing epidermal edema.
Tazarotene is administered topically to the skin. Minimal systemic absorption occurs because of rapid metabolism in the skin to the active metabolite, tazarotenic acid, which is systemically absorbed and further metabolized. Tazarotenic acid is hydrophilic and is quickly metabolized systemically, causing no apparent accumulation within body tissues. Greater than 99% of tazarotenic acid is bound to plasma proteins. Metabolism of tazarotene to tazarotenic acid occurs via esterase hydrolysis in skin; tazarotenic acid is further metabolized in skin and, after systemic absorption, hepatically metabolized to sulfoxides, sulfones, and other metabolites for elimination via fecal and renal pathways. Tazarotenic acid exhibits a half-life of approximately 18 hours in both normal and psoriatic patients.
Affected cytochrome P450 isoenzymes: none
-Route-Specific Pharmacokinetics
Topical Route
Systemic tazarotene exposures were evaluated in 28 subjects (age 9 years and older) with moderate to severe acne who received approximately 4 grams of the 0.045% lotion topically once daily for 14 days. Most of the collected tazarotene (parent drug) samples had concentrations that were below the limit of quantification (0.005 ng/mL). The mean Cmax and AUC for tazarotene from quantifiable samples were 0.007 ng/mL and 0.164 ng x hour/mL on day 14 to 15, respectively. For tazarotenic acid (active metabolite), concentrations were measurable in most samples following single and repeated topical administrations. The mean Cmax and AUC for tazarotenic acid from quantifiable samples were 0.365 ng/mL and 5.72 ng x hour/mL on day 14 to 15, respectively.
-Special Populations
Pediatrics
Data from a pharmacokinetic study involving 28 subjects with moderate-to-severe acne who received daily application of tazarotene topical lotion, showed children (aged 9 to 11 years) achieved higher systemic concentrations of both the parent drug (tazarotene) and the active metabolite (tazarotenic acid), as compared to older individuals. Specifically, the mean Cmax and AUC of tazarotene in subjects 9 to 11 years was approximately 3.7- and 3.6-fold higher, respectively, than the values observed in subjects 12 years and older. Similarly, the mean Cmax and AUC of tazarotenic acid were approximately 2.4- and 2.3-fold higher, respectively.