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tazarotene 0.1% cream generic tazorac

In stock Manufacturer PACIFIC/GREENST 60758056130
$282.00 / 30 Grams Tube

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Uses

Psoriasis

Tazarotene cream or gel is used topically in the management of stable plaque psoriasis. In 4 large, vehicle-controlled studies, 12 weeks of therapy with tazarotene 0.05 or 0.1% cream or gel resulted in substantial reductions in the severity of erythema, scaling, and plaque elevation with improvement noted as early as 1-2 weeks in some patients. In 2 of the studies, treatment effects were sustained for up to 12 weeks in approximately 30 or 50% of patients after discontinuance of tazarotene cream or gel, respectively. In these 4 studies, tazarotene 0.1% cream or gel was more effective than 0.05% cream or gel in improving manifestations associated with psoriasis, but the 0.05% cream or gel was associated with less local irritation.

Data from a phase III comparative trial indicate similar reductions from baseline in the severity of psoriatic lesions in patients receiving 12 weeks of therapy with tazarotene 0.05 or 0.1% gel versus topical fluocinonide 0.05% cream. In this study, while topical fluocinonide was more effective than topical tazarotene in reducing erythema during the treatment period, the likelihood of relapse during the 12-week period following discontinuance of treatment was less with tazarotene 0.1% gel than with fluocinonide 0.05% cream. Additional controlled, comparative studies are needed to establish the relative efficacy of topical tazarotene and other currently available topical agents used in the management of psoriasis.

Combined therapy consisting of tazarotene and a mid- or high-potency topical corticosteroid is more effective than therapy with either agent alone. In several studies in patients with plaque psoriasis, such combined therapy was associated with a more rapid response, a higher rate of treatment success (i.e., global improvement of at least 50%), and a longer remission period compared with monotherapy.

Acne

Tazarotene 0.1% cream or gel is used topically for the treatment of mild to moderate facial acne vulgaris. In controlled studies, tazarotene 0.1% cream or gel was more effective than vehicle in reducing the number of inflammatory and noninflammatory lesions as well as the total number of lesions.

Data from several randomized, double-blind, comparative studies indicate that tazarotene 0.1% gel may be more effective than adapalene or tretinoin gel in the treatment of mild to moderate facial acne vulgaris. In 2 randomized, double-blind, comparative studies in patients with mild to moderate facial acne vulgaris, therapy with tazarotene 0.1% gel for up to 12 weeks was associated with a higher rate of treatment success (i.e., global improvement of at least 50%), greater reductions in overall disease severity, and greater reductions in the number of noninflammatory lesions compared with therapy with adapalene 0.1% gel or tretinoin 0.1% gel containing microspheres; tazarotene 0.1% gel also was more effective than adapalene 0.1% gel in reducing the number of inflammatory lesions. In another randomized, double-blind, comparative study, tazarotene 0.1% gel was more effective than tretinoin 0.025% gel in reducing the number of open comedones and noninflammatory lesions. Although a higher incidence of certain adverse effects (e.g., irritation, burning, pruritus, erythema, peeling) was observed in patients receiving tazarotene 0.1% gel than in those receiving adapalene 0.1% or tretinoin 0.025% gel, such difference was transient and is unlikely to be clinically important. Some clinicians state that the tolerability of topical retinoid therapy depends more on skin sensitivity and susceptibility of the patient than on the particular retinoid used.

The manufacturer states that efficacy of tazarotene in the treatment of acne in patients resistant to oral antibiotics or previously treated with other retinoids has not been established.

Photoaging

Tazarotene is used topically as a 0.1% cream for palliative therapy to improve dermatologic changes (e.g., fine wrinkling, mottled hypopigmentation or hyperpigmentation, benign lentigines) associated with photodamage. Topical tazarotene therapy should be used under medical supervision as an adjunct to a comprehensive skin care plan and sun avoidance program that includes the use of effective sunscreens (minimum strength of SPF 15) and protective clothing. Patients should be advised that topical therapy with tazarotene does not eliminate or prevent wrinkles, repair photodamaged skin, reverse photoaging, or restore a more youthful or younger dermal histologic pattern. In addition, it must be noted that topical tazarotene has not demonstrated a mitigating effect on severe manifestations of chronic sunlight exposure (e.g., coarse or deep wrinkling, tactile roughness, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, dermal elastosis). The manufacturer states that safety and efficacy of topical tazarotene therapy for photoaging beyond 52 weeks have not been established.

Improved facial skin appearance, including improvements in fine wrinkles, mottled hypopigmentation or hyperpigmentation, and benign lentigines, has been demonstrated in several double-blind, controlled studies in patients (97% Caucasian) with mild to severe photodamage receiving topical tazarotene therapy for up to 24 weeks. In these studies in which tazarotene 0.1% cream or vehicle was applied to the face, clinical improvement (manifested as at least a 1-point reduction in a 5-point scale of photodamage severity) in fine wrinkling was observed in 40-58% of patients receiving tazarotene cream and in 16-23% of those receiving vehicle. Clinical improvement in mottled hyperpigmentation was observed in 59-82 or 18-40% of patients receiving tazarotene cream or vehicle, respectively. Improvements in mottled hyperpigmentation may be evident as early as 2 weeks following initiation of therapy, while improvements in fine wrinkling may be evident as early as 8 weeks. The duration of the mitigating effects on fine wrinkling, mottled hypopigmentation and hyperpigmentation, and benign lentigines following discontinuance of tazarotene 0.1% cream has not been evaluated.

Limited data suggest that tazarotene 0.1% cream is at least as effective as tretinoin 0.05% cream in improving fine wrinkling and mottled hyperpigmentation associated with photodamage. In a randomized, dose-ranging, comparative study in patients with at least moderate photodamage, therapy with tazarotene 0.1% cream or tretinoin 0.05% cream for approximately 24 weeks was associated with a treatment success (i.e., global improvement of at least 50%) rate of 67 or 55%, respectively. Although the overall improvement rates were not significantly different between the 2 groups, a trend toward a more rapid response was observed in patients receiving tazarotene 0.1% cream.

Safety and efficacy of tazarotene 0.1% cream have not been established in nonwhite patients (e.g., Asian, Hispanic) or in patients with Fitzpatrick skin types V and VI. Safety and efficacy of the drug in the prevention or treatment of actinic keratoses, skin neoplasms, or lentigo maligna also have not been established.

Dosage and Administration

Administration

Tazarotene is applied topically to the skin as a 0.05 or 0.1% cream or gel. Patients should be instructed carefully regarding proper use of the drug.(See Cautions: Precautions and Contraindications.)

Occlusive dressings or wrappings should not be used with tazarotene cream or gel, and hands should be washed after applying the drug (unless the hands are being treated for psoriasis). Patients should be advised not to use tazarotene cream or gel in amounts larger than instructed or more often than instructed, since such use of the drug will not lead to more rapid or better results but may result in marked redness, peeling, or discomfort.

Psoriasis

In patients with psoriasis, the skin should be dry before applying the cream or gel if a bath or shower has been taken prior to drug application. If a moisturizer is used to soften or lubricate the skin, it should be applied at least 1 hour prior to application of tazarotene cream or gel; tazarotene cream or gel should be applied only after ensuring that there is no more moisturizing cream or lotion on the surface of the skin. Application of tazarotene cream or gel to unaffected skin should be carefully avoided since these areas may be more susceptible to irritation.

Acne

Prior to application of the cream or gel in patients with acne, the affected areas should be cleansed and dried. Enough cream or gel should then be applied to cover the entire affected area with a thin film.

Photoaging

For palliative therapy to improve dermatologic changes of photoaging, patients should gently wash their face with a mild soap, pat the skin dry, and wait 20-30 minutes before applying tazarotene cream to affected areas (including the eyelids if desired), taking care to avoid the eyes and mouth. The topical cream is applied at bedtime using the minimum amount necessary to cover the affected area lightly.

Dosage

Application of tazarotene cream or gel may cause a transient feeling of pruritus, burning, or stinging. (See Cautions: Precautions and Contraindications.) If irritation is excessive, tazarotene should be discontinued temporarily until the integrity of the skin is restored, or dosing of the drug should be reduced to a lower concentration (in patients with psoriasis) or to an interval the patient can tolerate; tazarotene therapy may be resumed, or the drug concentration or frequency of application increased, as therapy with the drug becomes more tolerable. Frequency of dosing, therapeutic response, and skin tolerance should be monitored carefully during tazarotene therapy. The efficacy of reduced dosing frequencies (i.e., less than once daily) has not been established.

Safe use of tazarotene gel over more than 20% of body surface area has not been established.

Psoriasis

For the topical treatment of stable plaque psoriasis in adults, a sufficient amount (2 mg/cm) of tazarotene 0.05 or 0.1% cream or gel to provide a thin film should be applied once daily in the evening to the affected lesion(s) only. The manufacturer states that therapy with the cream generally should be initiated at a strength of 0.05%, with strength increased to 0.1% as tolerated and clinically indicated; conversely, patients currently receiving the 0.1% cream may be switched to the 0.05% strength if excessive skin irritation occurs. Improvement in psoriasis plaques and scales usually is detectable within 1-4 weeks of initiating topical therapy with the drug; however, improvement in erythema may take longer. The gel should not be applied to more than 20% of body surface area. Patients should be advised to contact their clinician if psoriasis worsens with tazarotene therapy.

Acne

For the topical treatment of mild to moderate facial acne vulgaris in adults and children 12 years of age and older, a thin film (2 mg/cm ) of tazarotene 0.1% cream or gel should be applied to the cleansed affected area once daily in the evening. The cream or gel should be applied in sufficient quantity to cover all lesions. Improvement usually is detectable within 4 weeks of initiating topical therapy with the drug. Most reported experience to date has been for treatment periods that did not exceed 12 weeks. Patients should be advised to contact their clinician if acne worsens with tazarotene therapy.

Photoaging

For palliative therapy to improve dermatologic changes of photoaging, tazarotene is applied once daily before retiring, using a pea-sized amount (approximately 5 mm or ¼ inch in diameter) of the 0.1% cream to cover the entire face (including the eyelids if desired) lightly. Moisturizers may be applied to the skin before or after application of tazarotene cream; however, the first topical preparation should be allowed to absorb into the skin and dry completely before applying the second preparation.

A comprehensive skin care plan and a sun avoidance program should be employed in conjunction with topical tazarotene therapy. The manufacturer recommends that a moisturizing sunscreen with a minimum strength of SPF 15 be applied every morning in patients receiving tazarotene therapy. Patients should be advised to consult their clinician regarding specific instructions for routine skin care and for use of cosmetics, moisturizers, and sunscreens.

Cautions

Adverse Effects

The most common adverse effects of topical tazarotene therapy involve the skin. Adverse effects occurring in approximately 10-30% of patients receiving tazarotene 0.05 or 0.1% cream or gel for management of psoriasis include pruritus, erythema, burning/stinging, worsening of psoriasis, irritation, and skin pain. Adverse effects occurring in approximately 1-10% of patients receiving the drug for management of psoriasis include desquamation, irritant dermatitis, eczema, rash, dry skin, skin inflammation, fissuring, bleeding, peripheral edema, and hypertriglyceridemia. The incidence of adverse effects associated with tazarotene 0.1% cream or gel appears to be approximately 1-5 percentage points higher than that observed with tazarotene 0.05% cream or gel.

Adverse effects occurring in approximately 10-30% of patients receiving tazarotene 0.1% cream or gel for management of acne include desquamation, dry skin, erythema, burning/stinging, and pruritus. Adverse effects occurring in approximately 1-10% of patients receiving the drug for the management of acne include irritation, face/skin pain, fissuring, localized edema, and skin discoloration.

Adverse effects occurring in approximately 10-40% of patients receiving tazarotene 0.1% cream for management of photoaging include desquamation, erythema, burning sensation, dry skin, irritation, and pruritus. Adverse effects occurring in approximately 1-8% of patients receiving the drug for management of photoaging include irritant dermatitis, stinging, acne, rash, and cheilitis. Adverse ocular or eyelid effects (e.g., edema, irritation, inflammation) were reported in 3.5 or 2.8% of patients receiving tazarotene 0.1% cream or vehicle, respectively; these effects generally were mild in nature.

Results of human dermal safety studies indicate that tazarotene 0.05 or 0.1% cream or gel does not appear to induce allergic contact sensitization, phototoxicity, or photoallergy. However the drug can increase sensitivity to sunlight, which increases the risk of burning.(See Cautions: Precautions and Contraindications.)

Precautions and Contraindications

Tazarotene topical cream and gel are intended for external use only. Care should be taken not to get tazarotene cream or gel into the eyes. In addition, contact of the drug with the mouth, eyelids (except when used in the management of photoaging), and other mucous membranes should be avoided. If contact with the eye(s) occurs, the eye(s) should be washed with large amounts of cool water; patients should consult a clinician if ocular irritation persists.

Tazarotene should not be used in patients with eczema, since the drug may produce severe irritation of eczematous skin.

Patients receiving topical tazarotene therapy should be cautioned to minimize exposure to sunlight or other UV rays, including sunlamps, unless deemed medically necessary; in such cases, exposure should be minimized during the use of tazarotene. Use of sunscreens (minimum strength of SPF 15) and protective clothing is recommended during tazarotene therapy. Patients with sunburn should not use tazarotene until full recovery occurs. In addition, patients should be cautioned to inform their clinician if they are using other drugs that potentially could increase the sensitivity of their skin to sunlight (e.g., fluoroquinolone or tetracycline anti-infectives, thiazide diuretics, sulfonamides, phenothiazines). Patients who may be subjected to considerable sun exposure because of their occupation and those with inherent sensitivity to the sun should exercise particular caution and ensure that all necessary precautions associated with tazarotene therapy are observed.

Application of tazarotene gel or cream may cause a transient feeling of pruritus, burning, or stinging. Patients should be advised to contact their clinician if increased sensitivity or irritation occurs. If pruritus, burning, erythema, or peeling is excessive, tazarotene should be discontinued temporarily until the integrity of the skin is restored, or dosing of the drug should be reduced to a lower concentration (in patients with psoriasis) or to an interval the patient can tolerate.(See Dosage and Administration: Dosage.) Weather extremes (e.g., wind, cold) may be irritating to patients receiving topical tazarotene therapy.

Patients should be advised that use of tazarotene with other topical drugs that have a strong skin-drying effect should be avoided. In patients who have used such agents, sufficient time should elapse for the effects of these drugs to subside before initiating tazarotene therapy. Use of topical preparations with high concentrations of alcohol, menthol, spices, or lime, such as shaving lotions, astringents, and perfume, also should be avoided. Patients also should avoid the use of irritating cosmetics (e.g., toners, peeling [desquamating] agents), permanent wave solutions, electrolysis, hair depilatories, or other preparations or processes that might dry or irritate the skin during topical therapy with tazarotene.

Tazarotene is contraindicated in patients who are or may become pregnant (see Cautions: Pregnancy, Fertility, and Lactation) and in those who are hypersensitive to the drug or any component in the formulation.

Pediatric Precautions

Safety and efficacy of tazarotene for the management of psoriasis, acne vulgaris, or photoaging in children younger than 18, 12, or 17 years of age, respectively, have not been established.

Geriatric Precautions

Of the approximately 2400 patients studied in clinical trials of tazarotene cream for psoriasis or photoaging, 344 were older than 65 years of age. Although no overall differences in safety or efficacy were observed between geriatric individuals and younger adults in these studies, and there currently is no other clinical experience regarding age-related differences, the possibility that some older patients may exhibit increased sensitivity to the drug cannot be ruled out. Safety and efficacy of tazarotene for the management of acne in patients 65 years of age and older have not been evaluated.

Pregnancy, Fertility, and Lactation

Pregnancy

Retinoids (e.g., isotretinoin) have been reported to cause serious fetal harm when administered orally to pregnant women. Single instances of known retinoid malformations (e.g., spina bifida, hydrocephaly, heart anomalies) have been reported in some species of animals (e.g., rabbits) following topical administration of tazarotene during gestation. Abnormal early embryonic development (e.g., decreased litter size, decreased number of live fetuses, decreased fetal body weights) was observed in animals receiving oral tazarotene in dosages 3.4 times the systemic exposure (AUC0-24 h) in human psoriasis patients treated topically with tazarotene 0.1% cream over 35% of body surface area, 11 times the systemic exposure in human acne patients treated topically with tazarotene 0.1% cream over 15% of body surface area, or 6.7 times the systemic exposure in human photoaging patients treated topically with tazarotene 0.1% cream over 15% of body surface area. Developmental delays, teratogenic effects, and postimplantation fetal loss also have been reported in animals receiving oral tazarotene in dosages 1.1-26 or 0.7-13 times the systemic exposure in human psoriasis patients treated topically with tazarotene 0.1% cream (over 35% of body surface area) or gel (over 20% of body surface area), respectively, 3.5-85 times the systemic exposure in human acne patients treated topically with tazarotene 0.1% cream (over 15% of body surface area), or 2.1-52 times the systemic exposure in human photoaging patients treated topically with tazarotene 0.1% cream (over 15% of body surface area).

Systemic exposure to tazarotene depends on the extent of body surface area treated. In patients treated topically over sufficient body surface area (over 35 or 20% of body surface area when used as a cream or gel, respectively, in psoriasis patients), systemic exposure to tazarotene could be of the same magnitude as in these orally treated animals. Although systemic exposure anticipated in the treatment of the face alone may be less as a result of the more limited area of application of the drug, it is not known what level of exposure produces teratogenic effects in humans.

There are no adequate and controlled studies to date using tazarotene topical cream or gel in pregnant women. The manufacturer states that the 8 women in clinical trials who were inadvertently exposed to tazarotene during pregnancy subsequently delivered healthy infants. The importance of these findings is unknown because the exact timing and extent of exposure to the drug in relation to gestation are uncertain. However, tazarotene is contraindicated in women who are or may become pregnant or who intend to become pregnant during treatment. Women of childbearing potential should be warned of the potential risk and should use adequate birth-control measures during treatment with tazarotene. If the drug is inadvertently administered during pregnancy or if the patient becomes pregnant while receiving the drug, the drug should be discontinued and the patient informed of the potential risks to the fetus. A negative result on a reliable blood pregnancy test (i.e., having a sensitivity of at least 50 mIU/mL for human chorionic gonadotropin [hCG]) should be obtained within 2 weeks prior to beginning tazarotene therapy and therapy should begin during the next normal menstrual period.

Fertility

Reproduction studies in male and female rats using topical doses of tazarotene gel up to 0.125 mg/kg daily (equivalent to 0.6 times the systemic exposure in human psoriasis patients treated topically with tazarotene 0.1% cream over 35% of body surface area, 2 times the systemic exposure in human acne patients treated topically with tazarotene 0.1% cream over 15% of body surface area, or 1.2 times the systemic exposure in human photoaging patients treated topically with tazarotene 0.1% cream over 15% of body surface area) have not revealed evidence of impaired fertility or reproductive capabilities (in female rats). In addition, reproduction studies in male rats receiving oral tazarotene dosages up to 1 mg/kg daily (equivalent to 1.9 times the systemic exposure in human psoriasis patients treated topically with tazarotene 0.1% cream over 35% of body surface area, 6.3 times the systemic exposure in human acne patients treated topically with tazarotene 0.1% cream over 15% of body surface area, or 3.7 times the systemic exposure in human photoaging patients treated topically with tazarotene 0.1% cream over 15% of body surface area) also have not revealed evidence of impaired mating performance or fertility. However, there was a decrease in the number of estrous stages and implantation sites in female rats receiving oral tazarotene dosages up to 2 mg/kg daily (approximately 3.4 times the systemic exposure in human psoriasis patients treated topically with tazarotene 0.1% cream over 35% of body surface area, 11 times the systemic exposure in human acne patients treated topically with tazarotene 0.1% cream over 15% of body surface area, or 6.7 times the systemic exposure in human photoaging patients treated topically with tazarotene 0.1% cream over 15% of body surface area).

Lactation

It is not known if topically applied tazarotene is distributed into human milk, but the drug appears to distribute into milk following topical application in lactating animals. The manufacturer states that caution should be exercised when tazarotene is administered to a nursing woman.

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