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  • CLASSES

    Anti-wrinkle Agents, Rx
    Topical Retinoids for use for Acne

    DEA CLASS

    Rx

    DESCRIPTION

    Retinoid prodrug
    Used for psoriasis, acne, and facial wrinkles and pigmentation changes primarily due to photoaging
    Contraindicated in pregnancy; females of childbearing potential should use adequate birth control

    COMMON BRAND NAMES

    Avage, Fabior, Tazorac

    HOW SUPPLIED

    Avage/Tazarotene/Tazorac Topical Cream: 0.05%, 0.1%
    Fabior Topical Foam: 0.1%
    Tazorac Topical Gel: 0.05%, 0.1%

    DOSAGE & INDICATIONS

    For the treatment of stable plaque psoriasis.
    NOTE: According to the American Academy of Dermatology (AAD), tazarotene is best used in combination with a topical corticosteroid for the treatment of psoriasis. Combination therapy may produce a synergistic effect, increase duration of treatment benefit and length of remission, and potentially decrease steroid-induced atrophy.
    Topical dosage (0.05% or 0.1% Tazorac cream)
    Adults

    Apply once daily, in the evening, to psoriatic lesions, using enough (2 mg/cm2) to cover only the lesion with a thin film. If a bath or shower is taken prior to application, the skin should be dry before applying the cream. If emollients are used, they should be applied at least an hour before tazarotene.

    Topical dosage (0.05% or 0.1% Tazorac gel)
    Adults, Adolescents, and Children >= 12 years

    Apply once daily, in the evening, to psoriatic lesions, using enough (2 mg/cm2) to cover only the lesion with a thin film to no more than 20% of body surface area. The manufacturer recommends initiating therapy with the 0.05% strength and then increasing to the 0.1% strength if necessary. If a bath or shower is taken prior to application, the skin should be dry before applying the cream. If emollients are used, they should be applied at least an hour before tazarotene.

    For the topical treatment of acne vulgaris.
    Topical dosage (0.1% Tazorac cream or gel)
    Adults, Adolescents, and Children > 12 years

    Cleanse the face gently. After the skin is dry, apply a thin film (2 mg/cm2) once daily, in the evening, to the skin where acne lesions appear. Use enough to cover the entire affected area. The use of tazarotene has not been studied beyond 12 weeks.

    Topical dosage (Fabior foam)
    Adults, Adolescents, and Children >= 12 years

    Wash the area to be treated with a mild cleanser. After the skin is dry, apply a thin layer to the affected areas of the face and/or upper trunk once daily in the evening. Gently massage the foam into the skin until it disappears. The frequency of application should be reduced or interrupted if excessive irritation occurs (e.g., redness, peeling, discomfort). Treatment may be resumed once irritation subsides; however, treatment should be discontinued if irritation persists.

    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

    Adults

    1 application/day topically.

    Geriatric

    1 application/day topically.

    Adolescents

    17 years: 1 application/day topically.
    < 17 years: 1 application/day topically; safety and efficacy of Avage 0.1% cream have not been established.

    Children

    >= 12 years: 1 application/day topically; safety and efficacy of Avage 0.1% cream have not been established.
    < 12 years: Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed for topical administration.

    Renal Impairment

    No dosage adjustments are needed for topical administration.

    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, 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 (Fabior or Tazorac):
    According to the manufacturer of Fabior foam, moisturizers may be used as needed ; no specific recommendation is provided by the manufacturer of Tazorac.
    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 0.5%):
    If emollients are used, they should be applied at least one hour before application of tazarotene.

    STORAGE

    Avage:
    - Store at 77 degrees F
    Fabior:
    - Avoid exposure to heat
    - Do Not Store at Temperatures Above 120 degrees F (49 degrees C)
    - Flammable, keep away from heat and flame
    - Protect from freezing
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
    - Store upright
    Tazorac:
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    When possible, avoid weather extremes (i.e., wind or cold) because they may be more irritating to patients using tazarotene.

    Pregnancy

    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 2- 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.

    Breast-feeding

    According to the manufacturer, use caution when administering tazarotene to a nursing woman. It is not known whether tazarotene is distributed into human breast milk; however, the drug has been detected in the milk of lactating rats. 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, healthcare providers are encouraged to report the adverse effect to the FDA.

    Children, infants, neonates

    The safety and efficacy of tazarotene have not been established in neonates, infants, and children < 12 years. Although tazarotene cream is approved for use in adolescents and children >= 12 years for the treatment of acne, safety and efficacy of tazarotene cream for other indications have not been established in this population.  

    Eczema

    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.

    Retinoid hypersensitivity

    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.

    Benzyl alcohol hypersensitivity

    Tazarotene cream and gel contain benzyl alcohol as a preservative and should not be used in patients with benzyl alcohol hypersensitivity.

    Skin cancer, skin photosensitivity disorder, sunburn, sunlight (UV) exposure

    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.

    Accidental exposure, occlusive dressing, ocular exposure

    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.

    Contraception requirements, females, pregnancy testing

    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.

    ADVERSE REACTIONS

    Moderate

    erythema / Early / 10.0-34.0
    contact dermatitis / Delayed / 1.0-10.0
    bleeding / Early / 1.0-10.0
    edema / Delayed / 1.0-10.0
    peripheral edema / Delayed / 1.0-10.0
    hypertriglyceridemia / Delayed / 1.1-9.9

    Mild

    pruritus / Rapid / 10.0-30.0
    skin irritation / Early / 1.0-30.0
    xerosis / Delayed / 1.0-16.0
    skin discoloration / Delayed / 1.0-10.0
    rash (unspecified) / Early / 1.0-10.0
    cheilitis / Delayed / 1.0-1.0
    photosensitivity / Delayed / 10.0
    urticaria / Rapid / Incidence not known
    skin hyperpigmentation / Delayed / Incidence not known
    skin hypopigmentation / Delayed / Incidence not known

    DRUG INTERACTIONS

    Acetohexamide: (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.
    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; 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.
    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.
    Amlodipine; Hydrochlorothiazide, HCTZ; Olmesartan: (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.
    Amlodipine; Hydrochlorothiazide, HCTZ; Valsartan: (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.
    Bendroflumethiazide; Nadolol: (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.
    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.
    Chlorpropamide: (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.
    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.
    Chlorthalidone; Clonidine: (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.
    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.
    Glimepiride; Pioglitazone: (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.
    Glimepiride; Rosiglitazone: (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.
    Hydralazine; 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: (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; Irbesartan: (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; Lisinopril: (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; Losartan: (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; Methyldopa: (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; Metoprolol: (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.
    Hydrochlorothiazide, HCTZ; Olmesartan: (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; Propranolol: (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; Quinapril: (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; Spironolactone: (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; Telmisartan: (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; Triamterene: (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; Valsartan: (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.
    Levofloxacin: (Moderate) Use tazarotene with caution in patients who are also taking drugs known to be photosensitizers, such as levofloxacin, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
    Mesoridazine: (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.
    Methyclothiazide: (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.
    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.
    Norfloxacin: (Moderate) Use tazarotene with caution in patients who are also taking drugs known to be photosensitizers, such as norfloxacin, 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.
    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.
    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.
    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.
    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.
    Thiethylperazine: (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.
    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.
    Tolazamide: (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.
    Tolbutamide: (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.
    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.

    PREGNANCY AND LACTATION

    Pregnancy

    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 2- 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.

    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.

    MECHANISM OF ACTION

    Mechanism of Action: 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.

    PHARMACOKINETICS

    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.

    Topical Route

    An in vitro percutaneous absorption study indicated that 4—5% of the applied dose remained in the stratum corneum and 2—4% remained in the viable epidermis-dermis layer 24 hours after topical application.