Halobetasol; tazarotene is a topical product that combines a very high potency, fluorinated corticosteroid with a retinoid to treat plaque psoriasis in adults. The drug is dosed once daily, and should not be applied to the face, groin, or in the axillae. Long-term or extensive use may lead to systemic side effects, including hypothalamic-pituitary-adrenal (HPA) axis suppression. Halobetasol; 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.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Topical Administration
-For topical dermatologic use only. Not for ophthalmic, oral, or intravaginal use.
-Avoid contact with the eyes. Not recommended for use on the face, groin, or in the axillae.
-Women of childbearing potential should have a negative pregnancy test within 2 weeks prior to beginning therapy. Treatment should begin during a menstrual period.
Cream/Ointment/Lotion Formulations
-Ensure skin is dry before applying lotion.
-Apply a thin layer to the affected area(s) of the skin. Rub lotion in gently and completely.
-Restrict application to the affected area(s) and try to avoid the normal surrounding skin. Do not use on eczematous 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.
-Do not cover the treated area(s) with occlusive dressings.
-Wash hands thoroughly after application.
Dermatologic adverse reactions observed in patients receiving treatment with halobetasol; tazarotene during an 8 week clinical trial included contact dermatitis (7%), application site pain (3%), folliculitis (2%), skin atrophy (2%), excoriation (2%), rash (1%), skin abrasion (1%), and skin exfoliation (1%). Other localized adverse events that have been associated with the use of topical corticosteroids include striae and telangiectasia. In some cases, these adverse events may be irreversible. If signs and symptoms of a dermatologic adverse reaction develop, discontinue use of halobetasol; tazarotene until the skin integrity is restored; do not resume treatment if allergic contact dermatitis is identified.
Retinoids, such as tazarotene, cause photosensitivity. Instruct patients to use protective clothing and sunscreens during treatment with halobetasol; tazarotene.
Systemic absorption of topical corticosteroids, such as halobetasol, can produce reversible hypothalamic-pituitary-adrenal (HPA) suppression with possible adrenocortical insufficiency after stopping treatment. In some patients, systemic absorption can produce manifestations of Cushing's syndrome, hyperglycemia, and glycosuria. Percutaneous absorption of halobetasol is dependent on many factors including the integrity of the epidermal barrier, duration of use, and use of an occlusive dressing. Children may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. Systemic absorption may be significant if halobetasol is applied to a large surface area or under occlusion; halobetasol; tazarotene is not recommended for use with occlusive dressings. HPA axis suppression and increased intracranial pressure have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth inhibition, delayed weight gain, low plasma cortisol concentrations, and absence of response to ACTH stimulation. Clinical signs of increased intracranial pressure include bulging fontanelles, headache, and bilateral papilledema (i.e., pseudotumor cerebri). Halobetasol is a very high potency corticosteroid, and the risk of HPA axis suppression is greater than with other topical corticosteroids. Patients applying halobetasol to a large surface area or areas under occlusion should be evaluated periodically for evidence of HPA axis suppression (using the ACTH stimulation test). To minimize risk of HPA axis suppression, discontinue therapy when control is achieved. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, reduce the frequency of application, or substitute a less potent corticosteroid. Recovery of HPA axis function is usually rapid when halobetasol; tazarotene treatment is discontinued.
Use of topical corticosteroids, such as halobetasol, may increase the risk for posterior subcapsular cataracts and glaucoma (ocular hypertension). Any patient who develops visual impairment while receiving treatment with halobetasol; tazarotene should be referred to an ophthalmologist for evaluation.
In general, excessive use of corticosteroids can lead to impaired wound healing. Halobetasol; tazarotene should not be applied directly on or near healing wounds.
Halobetasole; tazarotene is contraindicated for use during pregnancy and in women who may become pregnant. To ensure the drug is not administered during pregnancy, treatment should be initiated during a menstrual period. Retinoids, such as tazarotene, may cause fetal harm when administered to a pregnant woman. During animal embryofetal development studies, topical doses of tazarotene [11- to 116-times the maximum recommended human dose (MRHD)] were associated with reduced fetal body weight, reduced skeletal ossification, and known retinoid malformations such as spina bifida, hydrocephaly, and heart abnormalities. When administered via the oral route at doses that produced exposures 9- to 228-times the MRHD, tazarotene was associated with developmental delays, malformations, and post-implantation losses in rats and rabbits. Avoid use of very potent topical corticosteroids, such as halobetasol, during pregnancy. Guidelines recommend mild to moderate potency agents over potent corticosteroids. Increased risk of low birthweight has been reported when use of potent or very potent topical corticosteroids exceeded 300 grams during the entire pregnancy. There are no adequate and well-controlled studies of teratogenic effects from topical application of halobetasol in pregnant women. Corticosteroids have been shown to be teratogenic after dermal, oral, and subcutaneous administration in animal studies. Halobetasol has greater potency, and thus greater teratogenic potential, than other topical corticosteroids. After systemic halobetasol propionate administration to pregnant mice and rabbits, increased malformations, such as cleft palate and skeletal abnormalities, were observed. If a patient becomes pregnant while using this drug, treatment should be immediately discontinued and the patient apprised of the potential risks to the fetus.
Retinoids, such as tazarotene, may cause fetal harm when administered to pregnant women; thus, females of childbearing potential must undergo pregnancy testing within 2 weeks prior to starting halobetasol; tazarotene treatment. In addition, effective contraception requirements are recommended for females of reproductive potential. If a patient becomes pregnant while taking halobetasol; tazarotene, treatment should be discontinued and the patient apprised of the potential risks to the fetus.
It is not known whether halobetasol; tazarotene is excreted in breast milk, produces adverse effects on nursing infants, or decreases milk production. If applied topically, care should be used to ensure the infant will not come into direct contact with the area of application, such as the breast. Advise breast-feeding women to avoid application 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, healthcare providers are encouraged to report the adverse effect to the FDA.
Halobetasol; tazarotene is for external use only; not intended for oral, ophthalmic, or intravaginal use. Do not administer halobetasol; tazarotene on the face, groin, or axillae. Apply only to affected areas; accidental exposure to unaffected skin may cause irritation (e.g., atrophy, striae, telangiectasias, folliculitis, contact dermatitis). If a local reaction occurs, discontinue treatment until the integrity of the skin is restored; do not resume treatment if allergic contact dermatitis is identified. Do not cover the treated areas with an occlusive dressing. Do not apply lotion to eczematous skin, as it may cause severe irritation and worsen eczema.
Avoid ocular exposure to halobetasol; tazarotene. Visual impairment and ocular hypertension have been reported with ocular exposure or facial application of other high potency topical corticosteroids. High potency corticosteroids have been noted to promote the progression of cataracts. Preexisting glaucoma may be aggravated if halobetasol; tazarotene is used in the periorbital area. There have been post-marketing reports of cataracts and glaucoma with topical corticosteroid therapy. Instruct patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.
Retinoids, such as tazarotene, may cause photosensitivity. Patients with a skin photosensitivity disorder should not be treated with halobetasol; tazarotene. For patients with a sunburn, therapy should not begin until the skin has fully recovered. 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. Caution should be utilized when halobetasol; tazarotene is administered to patients on other photosensitizing medications. Patients must be advised to use sunscreens and protective clothing while receiving treatment. Patients who may have considerable sun exposure due to their occupation should exercise particular caution when using halobetasol; tazarotene and ensure that appropriate sun avoidance is observed.
Systemic absorption of topical corticosteroids, such as halobetasol, has produced reversible hypothalamic-pituitary-adrenal (HPA) suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. One study evaluated the incidence of HPA axis suppression in patients with plaque psoriasis involving 20% or more of their body surface area who were administered halobetasol; tazarotene once daily for 8 weeks. In this study, 3 out of 20 (15%) patients receiving treatment developed HPA axis suppression at week 4; however, no patients had HPA axis suppression by week 8. Factors that predispose corticosteroid recipients to HPA axis suppression include the application of very high-potency corticosteroids (such as halobetasol), use over large surface areas, use in areas where the epidermal barrier is disrupted (i.e., skin abrasion), use of an occlusive dressing, hepatic disease, and young age. Patients receiving large doses of a potent topical corticosteroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression using adrenocorticotropic hormone (ACTH) stimulation test. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the topical corticosteroid. Infrequently, signs and symptoms of corticosteroid withdrawal may occur, requiring supplemental systemic corticosteroids. Due to the potential for glucose alterations, halobetasol; tazarotene should be used cautiously in patients with diabetes mellitus.
Halobetasol; tazarotene is not approved for use in pediatric patients (i.e., neonates, infants, children, adolescents). Children may absorb proportionally larger amounts of topical corticosteroids due to a larger skin surface area to body weight ratio, and therefore are more susceptible to developing systemic toxicity, especially with very-high-potency products. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, growth inhibition (linear growth retardation and delayed weight gain), and increased intracranial pressure have been reported in children receiving topical corticosteroids.
General Comparative Topical Corticosteroid Potency:NOTE: The following is a general representation. Check specific product formulations prior to making potency decisions.
Very High Potency
Betamethasone dipropionate (augmented)
Clobetasol
Diflorasone diacetate ointment
Halobetasol
High Potency
Amcinonide
Betamethasone dipropionate
Desoximetasone gel or ointment, or cream 0.25% or more
Diflorasone diacetate cream
Fluocinolone cream 0.2% or more
Fluocinonide
Halcinonide
Triamcinolone 0.5% or more
Medium Potency
Beclomethasone
Betamethasone benzoate
Betamethasone valerate
Clobetasone
Desoximetasone cream less than 0.25%
Diflucortolone
Fluocinolone ointment or topical solution or cream less than 0.2%
Flurandrenolide 0.025% or more
Fluticasone
Hydrocortisone butyrate
Hydrocortisone valerate
Mometasone
Prednicarbate
Triamcinolone less than 0.5%
Low Potency
Alclometasone
Clocortolone
Desonide
Dexamethasone
Flumethasone
Flurandrenolide less than 0.025%
Hydrocortisone base
Hydrocortisone acetate
For the treatment of plaque psoriasis:
Topical dosage:
Adults: Apply a thin layer topically to the affected skin area(s) once daily. Max: 50 g/week. Discontinue therapy when control is achieved. 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.
Maximum Dosage Limits:
-Adults
1 application per day topically; 50 grams per week topically.
-Geriatric
1 application per day topically; 50 grams per week topically.
-Adolescents
Safety and efficacy have not been established.
-Children
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.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*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.
Halobetasol; tazarotene is a topically applied product that combines a corticosteroid with a retinoid.
Halobetasol: Halobetasol is a very high potency, fluorinated corticosteroid. The precise mechanism of action in the treatment of plaque psoriasis is unclear; however, corticosteroids are known to play a role in cellular signaling, immune function, inflammation, and protein regulation. At the cellular level, corticosteroids induce peptides called lipocortins. Lipocortins antagonize phospholipase A2, an enzyme which causes the breakdown of leukocyte lysosomal membranes to release arachidonic acid. This action decreases the subsequent formation and release of endogenous inflammatory mediators including prostaglandins, kinins, histamine, liposomal enzymes, and the complement system. Early anti-inflammatory effects of topical corticosteroids include the inhibition of macrophage and leukocyte movement and activity in the inflamed area by reversing vascular dilation and permeability. Later inflammatory processes such as capillary production, collagen deposition, keloid (scar) formation also are inhibited by corticosteroids. Clinically, these actions correspond to decreased edema, erythema, pruritus, plaque formation and scaling of the affected skin.
Tazarotene: Tazarotene is a retinoid prodrug. Retinoids exert their pharmacologic effects through binding to specific retinoid 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. 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; the skin primarily contains RAR-gamma (90% of the total RARs) and alpha. Following topical application, tazarotene undergoes esterase hydrolysis to the active form, tazarotenic acid. Tazarotenic acid binds to all 3 members of the retinoic acid receptor (RAR) family; however, the drug show relative selectivity for RAR-beta and RAR-gamma. By binding to these receptors, tazarotenic acid may modify gene expression; however, the exact mechanism of this action in the treatment of plaque psoriasis is unknown. The drug appears to modulate psoriasis through 3 mechanisms: normalization of abnormal keratinocyte differentiation, reduction in keratinocyte proliferation, and decrease in the expression of inflammatory markers. In vitro skin models and cell cultures show that tazarotene suppresses expression of several inflammatory markers whose build-up is an element of psoriasis scale expression [e.g., TGase-K (keratinocyte transglutaminase), MRP-8 (migration inhibitory factor-related protein), SKALP (skin-derived antileukoproteinase), hyperproliferation keratin K6, and involucrin]. In animal studies, topical tazarotene blocks induction of ornithine decarboxylase (ODC) activity, which is associated with cell proliferation and expression. Tazarotene has also been found to induce the expression of TIG-1, TIG-2, and TIG-3 (tazarotene-induced genes-1, 2, and 3), suppressor genes that may inhibit epidermal hyperproliferation in treated plaques.
Halobetasol; tazarotene is administered topically to the skin.
-Halobetasol: Once in the systemic circulation, halobetasol is metabolized in the liver, but systemic metabolism has not been fully quantified. Excretion of halobetasol and its metabolites occurs via the urine and bile.
-Tazarotene: Tazarotene is rapidly metabolized in the skin by esterase hydrolysis to form the active metabolite, tazarotenic acid. After being systemically absorbed, tazarotenic acid is more than 99% bound to plasma proteins. Tazarotenic acid is hydrophilic and is quickly metabolized systemically to sulfoxides, sulfones, and other metabolites, causing no apparent accumulation within body tissues. Elimination of the metabolites occurs 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 and drug transporters: none
-Route-Specific Pharmacokinetics
Topical Route
Systemic exposures of halobetasol, tazarotene, and tazarotenic acid were evaluated in a pharmacokinetic study involving 22 adults with moderate to severe plaque psoriasis affecting at least 20% of the body surface area. After once daily dosing for 28 days, systemic concentrations of halobetasol and tazarotene were quantifiable in 13 and 18 patients, respectively. Tazarotenic acid was quantifiable in all 22 patients. For all three drug moieties, systemic exposures were at or near steady state by treatment day 28.