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DRUGS & SUPPLEMENTS
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When are you taking this medicine? |
Zorac ® (tazarotene) Gel 0.05% and 0.1% are indicated for the topical treatment of patients with stable plaque psoriasis of up to 20% body surface area involvement.
Zorac ® (tazarotene) Gel 0.1% is also indicated for the topical treatment of patients with facial acne vulgaris of mild to moderate severity.
The efficacy of Zorac ® Gel in the treatment of acne previously treated with other retinoids or resistant to oral antibiotics has not been established.
Retinoids may cause fetal harm when administered to a pregnant woman.
In rats, tazarotene 0.05% gel, administered topically during gestation days 6 through 17 at 0.25 mg/kg/day (1.5 mg/m2/day) resulted in reduced fetal body weights and reduced skeletal ossification. Rabbits dosed topically with 0.25 mg/kg/day (2.75 mg/m2 total body surface area/day) Zorac gel during gestation days 6 through 18 were noted with single incidences of known retinoid malformations, including spina bifida, hydrocephaly, and heart anomalies. Systemic daily-exposure (AUCde) to tazarotenic acid at topical doses of 0.25 mg/kg/day Zorac in a gel formulation in rats and rabbits represented 0.62 and 6.7 times, respectively, the AUC0-24h observed in psoriatic patients treated with 2 mg/cm2 of Zorac gel 0.1% (extrapolated for topical application over a 20% body surface area), and 0.78 and 8.4 times, respectively, the maximum AUC0-24h in acne patients treated with 2 mg/cm2 of Zorac gel 0.1% over a 15% (targeted) body surface area.
As with other retinoids, when Zorac was given orally to experimental animals, developmental delays were seen in rats, and teratogenic effects and post-implantation loss were observed in rats and rabbits at AUCde values that were 0.55 and 13.2 times, respectively, the AUC0-24h observed in psoriatic patients treated with 2 mg/cm2 of Zorac gel 0.1% (extrapolated for topical application over a 20% body surface area), and 0.68 and 16.4 times, respectively, the maximum AUC0-24h in acne patients treated with 2 mg/cm2 of Zorac gel 0.1% over a 15% (targeted) body surface area.
In a study of the effect of oral Zorac on fertility and early embryonic development in rats, decreased number of implantation sites, decreased litter size, decreased numbers of live fetuses, and decreased fetal body weights, all classic developmental effects of retinoids, were observed when female rats were administered 2 mg/kg/day from 15 days before mating through gestation day 7. A low incidence of retinoid-related malformations at that dose was reported to be related to treatment. This dose produced an AUCde that was 1.7 times the AUC0-24h observed in psoriatic patients treated with 2 mg/cm2 Zorac gel 0.1% (extrapolated for topical application over a 20% body surface area) and 2.1 times the maximum AUC0-24h in acne patients treated with 2 mg/cm2 of Zorac gel 0.1% over a 15% (targeted) body surface area.
SYSTEMIC EXPOSURE TO TAZAROTENIC ACID IS DEPENDENT UPON THE EXTENT OF THE BODY SURFACE AREA TREATED. IN PATIENTS TREATED TOPICALLY OVER SUFFICIENT BODY SURFACE AREA, EXPOSURE COULD BE IN THE SAME ORDER OF MAGNITUDE AS IN THESE ORALLY TREATED ANIMALS. ALTHOUGH THERE MAY BE LESS SYSTEMIC EXPOSURE IN THE TREATMENT OF ACNE OF THE FACE ALONE DUE TO LESS SURFACE AREA FOR APPLICATION, Zorac IS A TERATOGENIC SUBSTANCE, AND IT IS NOT KNOWN WHAT LEVEL OF EXPOSURE IS REQUIRED FOR TERATOGENICITY IN HUMANS.
There were thirteen reported pregnancies in patients who participated in clinical trials for topical Zorac. Nine of the patients were found to have been treated with topical Zorac, and the other four had been treated with vehicle. One of the patients who was treated with Zorac cream elected to terminate the pregnancy for non-medical reasons unrelated to treatment. The other eight pregnant women who were inadvertently exposed to topical Zorac during clinical trials subsequently delivered apparently healthy babies. As the exact timing and extent of exposure in relation to the gestation times are not certain, the significance of these findings is unknown.
Zorac ® Gel is contraindicated in women who are or may become pregnant. If this drug 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 hazard to the fetus. Women of child-bearing potential should be warned of the potential risk and use adequate birth-control measures when Zorac ® Gel is used. The possibility that a woman of child-bearing potential is pregnant at the time of institution of therapy should be considered. A negative result for pregnancy test having a sensitivity down to at least 50 mIU/mL for human chorionic gonadotropin (hCG) should be obtained within 2 weeks prior to Zorac ® Gel therapy, which should begin during a normal menstrual period.
Zorac ® Gel is contraindicated in individuals who have shown hypersensitivity to any of its components.
See CONTRAINDICATIONS section. Women of child-bearing potential should be warned of the potential risk and use adequate birth-control measures when Zorac ® Gel is used. The possibility that a woman of child-bearing potential is pregnant at the time of institution of therapy should be considered. A negative result for pregnancy test having a sensitivity down to at least 50 mIU/mL for hCG should be obtained within 2 weeks prior to Zorac ® Gel therapy, which should begin during a normal menstrual period.
Zorac ® Gel should be applied only to the affected areas. For external use only. Avoid contact with eyes, eyelids, and mouth. If contact with eyes occurs, rinse thoroughly with water. The safety of use of Zorac ® Gel over more than 20% of body surface area has not been established in psoriasis or acne.
Retinoids should not be used on eczematous skin, as they may cause severe irritation.
Because of heightened burning susceptibility, exposure to sunlight should be avoided unless deemed medically necessary, and in such cases, exposure should be minimized during the use of Zorac ® Gel. Patients must be warned to use sunscreens (minimum SPF of 15) and protective clothing when using Zorac ® Gel. Patients with sunburn should be advised not to use Zorac ® Gel until fully recovered. Patients who may have considerable sun exposure due to their occupation and those patients with inherent sensitivity to sunlight should exercise particular caution when using Zorac ® Gel and ensure that the precautions outlined in the Information for Patients subsection are observed.
Zorac ® Gel should be administered with caution if the patient is also taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the increased possibility of augmented photosensitivity.
Some individuals may experience excessive pruritus, burning, skin redness or peeling. If these effects occur, the medication should either be discontinued until the integrity of the skin is restored, or the dosing should be reduced to an interval the patient can tolerate. However, efficacy at reduced frequency of application has not been established. Alternatively, patients with psoriasis who are being treated with the 0.1% concentration can be switched to the lower concentration.
Weather extremes, such as wind or cold, may be more irritating to patients using Zorac ® Gel.
Concomitant dermatologic medications and cosmetics that have a strong drying effect should be avoided. It is also advisable to "rest" a patient's skin until the effects of such preparations subside before use of Zorac® Gel is begun.
In a study of 27 healthy female subjects between the ages of 20–55 years receiving a combination oral contraceptive tablet containing 1 mg norethindrone and 35 mcg ethynyl estradiol, concomitant use of Zorac did not affect the pharmacokinetics of norethindrone and ethynyl estradiol over a complete cycle.
The impact of Zorac on the pharmacokinetics of progestin only oral contraceptives has not been evaluated.
A long-term study of Zorac following oral administration of 0.025, 0.050, and 0.125 mg/kg/day to rats showed no indications of increased carcinogenic risks. Based on pharmacokinetic data from a shorter-term study in rats, the highest dose of 0.125 mg/kg/day was anticipated to give systemic exposure (AUCde) in the rat equivalent to 0.32 times the AUC0-24h observed in psoriatic patients treated with 2 mg/cm2 of Zorac gel 0.1% (extrapolated for topical application over a 20% body surface area), and 0.38 times the maximum AUC0-24h in acne patients treated with 2 mg/cm2 of Zorac gel 0.1% over a 15% (targeted) body surface area.
In evaluation of photo co-carcinogenicity, median time to onset of tumors was decreased and the number of tumors increased in hairless mice following chronic topical dosing with intercurrent exposure to ultraviolet radiation at Zorac concentrations of 0.001%, 0.005%, and 0.01% in a gel formulation for up to 40 weeks.
A long-term topical application study of up to 0.1% Zorac in a gel formulation in mice terminated at 88 weeks showed that dose levels of 0.05, 0.125, 0.25, and 1 mg/kg/day (reduced to 0.5 mg/kg/day for males after 41 weeks due to severe dermal irritation) revealed no apparent carcinogenic effects when compared to vehicle control animals; untreated control animals were not completely evaluated. Systemic exposure (AUC0-12h) at the highest dose was 2 times the AUC0-24h observed in psoriatic patients treated with 2 mg/cm2 of Zorac gel 0.1% (extrapolated for topical application over a 20% body surface area), and 2.5 times the maximum AUC0-24h in acne patients treated with 2 mg/cm2 of Zorac gel 0.1% over a 15% (targeted) body surface area.
Zorac was found to be non-mutagenic in the Ames assay using Salmonella and E. coli and did not produce structural chromosomal aberrations in a human lymphocyte assay. Zorac was also non-mutagenic in the CHO/HGPRT mammalian cell forward gene mutation assay and was non-clastogenic in the in vivo mouse micronucleus test.
No impairment of fertility occurred in rats when male animals were treated for 70 days prior to mating and female animals were treated for 14 days prior to mating and continuing through gestation and lactation with topical doses of Zorac gel of up to 0.125 mg/kg/day. Based on data from another study, the systemic drug exposure (AUCde) in the rat would be equivalent to 0.31 times the AUC0-24h observed in psoriatic patients treated with 2 mg/cm2 of Zorac gel 0.1% (extrapolated for topical application over a 20% body surface area), and 0.38 times the maximum AUC0-24h in acne patients treated with 2 mg/cm2 of Zorac gel 0.1% over a 15% (targeted) body surface area.
No impairment of mating performance or fertility was observed in male rats treated for 70 days prior to mating with oral doses of up to 1 mg/kg/day Zorac, which produced an AUCde that was 0.95 times the AUC0-24h observed in psoriatic patients treated with 2 mg/cm2 of Zorac gel 0.1% (extrapolated for topical application over a 20% body surface area), and 1.2 times the maximum AUC0-24h in acne patients treated with 2 mg/cm2 of Zorac gel 0.1% over a 15% (targeted) body surface area.
No effect on parameters of mating performance or fertility was observed in female rats treated for 15 days prior to mating and continuing through day 7 of gestation with oral doses of Zorac up to 2 mg/kg/day. However, there was a significant decrease in the number of estrous stages and an increase in developmental effects at 2 mg/kg/day. This dose produced an AUC0-24h which was 1.7 times that observed in psoriatic patients treated with 2 mg/cm2 of Zorac gel 0.1% (extrapolated for topical application over a 20% body surface area), and 2.1 times the maximum AUC0-24h in acne patients treated with 2 mg/cm2 of Zorac gel 0.1% over a 15% (targeted) body surface area.
Reproductive capabilities of F1 animals, including F2 survival and development, were not affected by topical administration of Zorac gel to female F0 parental rats from gestation day 16 through lactation day 20 at the maximum tolerated dose of 0.125 mg/kg/day. Based on data from another study, the systemic drug exposure (AUCde) in the rat would be equivalent to 0.31 times the AUC0-24h observed in psoriatic patients treated with 2 mg/cm2 of Zorac gel 0.1% (extrapolated for topical application over a 20% body surface area), and 0.38 times the maximum AUC0-24h in acne patients treated with 2 mg/cm2 of Zorac gel 0.1% over a 15% (targeted) body surface area.
See CONTRAINDICATIONS section. Women of child-bearing potential should use adequate birth-control measures when Zorac ® Gel is used. The possibility that a woman of child-bearing potential is pregnant at the time of institution of therapy should be considered. A negative result for pregnancy test having a sensitivity down to at least 50 mIU/mL for hCG should be obtained within 2 weeks prior to Zorac ® Gel therapy, which should begin during a normal menstrual period. There are no adequate, well-controlled studies in pregnant women. Although there may be less systemic exposure in the treatment of acne of the face alone due to less surface area for application, Zorac is a teratogenic substance, and it is not known what level of exposure is required for teratogenicity in humans.
After single topical doses of 14C-tazarotene to the skin of lactating rats, radioactivity was detected in milk, suggesting that there would be transfer of drug-related material to the offspring via milk. It is not known whether this drug is excreted in human milk. Caution should be exercised when Zorac is administered to a nursing woman.
The safety and efficacy of Zorac ® Gel have not been established in pediatric patients under the age of 12 years.
Of the total number of subjects in clinical studies of Zorac gels, 0.05% and 0.1% for plaque psoriasis, 163 were over the age of 65. Subjects over 65 years of age experienced more adverse events and lower treatment success rates after 12 weeks of use of Zorac ® Gel compared with those 65 years of age and younger. Currently there is no other reliable clinical experience on the differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals can not be ruled out. Zorac gel for the treatment of acne has not been clinically evaluated in persons over the age of 65.
In human dermal safety studies, Zorac 0.05% and 0.1% gels did not induce allergic contact sensitization, phototoxicity or photoallergy.
Psoriasis: The most frequent adverse events reported with Zorac ® Gel 0.05% and 0.1% were limited to the skin. Those occurring in 10 to 30% of patients, in descending order, included pruritus, burning/stinging, erythema, worsening of psoriasis, irritation, and skin pain. Events occurring in 1 to 10% of patients included rash, desquamation, irritant contact dermatitis, skin inflammation, fissuring, bleeding, and dry skin. Increases in “psoriasis worsening” and “sun-induced erythema” were noted in some patients over the 4th to 12th months as compared to the first three months of a 1 year study. In general, the incidence of adverse events with Zorac ® Gel 0.05% was 2 to 5% lower than that seen with Zorac ® Gel 0.1%.
Acne: The most frequent adverse events reported with Zorac ® Gel 0.1% in the treatment of acne occurring in 10 to 30% of patients, in descending order, included desquamation, burning/stinging, dry skin, erythema and pruritus. Events occurring in 1 to 10% of patients included irritation, skin pain, fissuring, localized edema and skin discoloration.
The following adverse reactions have been identified during postapproval use of Zorac. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Skin and subcutaneous tissue disorders: blister, dermatitis, urticaria, skin exfoliation, skin discoloration (including skin hyperpigmentation or skin hypopigmentation), swelling at or near application sites, and pain.
Excessive topical use of Zorac ® Gel may lead to marked redness, peeling, or discomfort.
Zorac ® Gels 0.05% and 0.1% are not for oral use. Oral ingestion of the drug may lead to the same adverse effects as those associated with excessive oral intake of Vitamin A (hypervitaminosis A) or other retinoids. If oral ingestion occurs, the patient should be monitored, and appropriate supportive measures should be administered as necessary.
General: Application may cause excessive irritation in the skin of certain sensitive individuals. In cases where it has been necessary to temporarily discontinue therapy, or the dosing has been reduced to a lower concentration (in patients with psoriasis) or to an interval the patient can tolerate, therapy can be resumed, or the drug concentration or frequency of application can be increased as the patient becomes able to tolerate the treatment. Frequency of application should be closely monitored by careful observation of the clinical therapeutic response and skin tolerance .
Zorac Gel, 0.05% and 0.1%, are for topical use only. Zorac Gel, 0.05% and 0.1%, are not for ophthalmic, oral, or intravaginal use.
Avoid accidental transfer of Zorac Gel, 0.05% and 0.1%, into eyes, mouth, or other mucous membranes. If contact with mucous membranes occurs, rinse thoroughly with water .
Efficacy has not been established for less than once daily dosing frequencies.
For Psoriasis: It is recommended that treatment start with Zorac ® 0.05% Gel, with strength increased to 0.1% if tolerated and medically indicated. Apply Zorac ® Gel once a day, 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. If a bath or shower is taken prior to application, the skin should be dry before applying the gel. If emollients are used, they should be applied at least an hour before application of Zorac ® Gel. Because unaffected skin may be more susceptible to irritation, application of Zorac to these areas should be carefully avoided. Zorac ® Gel was investigated for up to 12 months during clinical trials for psoriasis.
For Acne: Cleanse the face gently. After the skin is dry, apply a thin film of Zorac ® Gel 0.1% (2 mg/cm2) once a day, in the evening, to the skin where acne lesions appear. Use enough to cover the entire affected area. Zorac ® Gel was investigated for up to 12 weeks during clinical trials for acne.
Zorac ® (tazarotene) Gel is available in concentrations of 0.05% and 0.1%. It is available in a collapsible aluminum tube with a tamper-evident aluminum membrane over the opening and a white propylene screw cap, in 30 g and 100 g sizes.
Zorac ® Gel 0.05% | Zorac ® Gel 0.1% | |
30 g | NDC 0023-8335-03 | NDC 0023-0042-03 |
100 g | NDC 0023-8335-10 | NDC 0023-0042-10 |
Storage: Store at 25°C (77°F): excursions permitted to 15-30°C (59-86°F).
Revised: 07/2017
© 2017 Allergan. All rights reserved.
All trademarks are the property of their respective owners.
Irvine, CA 92612
Made in the U.S.A.
71722US15
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This Patient Information has been approved by the U.S. Food and Drug Administration | Revised: July/2017 | |
PATIENT INFORMATION Zorac ® (TAZ-or-ac) (tazarotene) Gel, 0.05% and 0.1% | ||
Important information: Zorac Gel is for use on skin only. Do not use Zorac Gel in your eyes, mouth, or vagina. | ||
What is the most important information I should know about Zorac Gel? Zorac Gel may cause birth defects if used during pregnancy.
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What is Zorac Gel?
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It is not known if Zorac Gel is:
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Who should not use Zorac Gel? Do not use Zorac Gel if you:
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What should I tell my doctor before using Zorac Gel? Before you use Zorac Gel, tell your doctor about all of your medical conditions, including if you:
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Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain medicines, vitamins, or supplements may make your skin more sensitive to sunlight. Also, tell your doctor about any cosmetics you use, including moisturizers, creams, lotions, or products that can dry out your skin. | ||
How should I use Zorac Gel?
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Follow these instructions for applying Zorac Gel:
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If you swallow Zorac Gel, call your doctor or go to the nearest hospital emergency room right away. | ||
What should I avoid while using Zorac Gel?
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What are the possible side effects of Zorac Gel? Zorac Gel may cause serious side effects, including:
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The most common side effects of Zorac Gel in people with plaque psoriasis include itching, burning, redness worsening of psoriasis, irritation and skin pain. The most common side effects of Zorac Gel in people with acne vulgaris include peeling, burning, dry skin, redness and itching. These are not all the possible side effects of Zorac Gel. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. | ||
How should I store Zorac Cream?
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General information about the safe and effective use of Zorac Gel. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Zorac Gel for a condition for which it was not prescribed. Do not give Zorac Gel to other people, even if they have the same symptoms you have. It may harm them. You can ask your doctor or pharmacist for information about Zorac Gel that is written for health professionals. | ||
What are the ingredients in Zorac Gel? Active ingredient: Zorac Inactive ingredients: ascorbic acid, benzyl alcohol, butylated hydroxyanisole, butylated hydroxytoluene, carbomer homopolymer type B, edetate disodium, hexylene glycol, poloxamer 407, polyethylene glycol 400, polysorbate 40, purified water, and tromethamine | ||
Manufactured by: Allergan Sales, LLC., Waco, Texas © 2017 Allergan. All rights reserved. All trademarks are the property of their respective owners. Irvine, CA 92612 Made in the U.S.A. For more information, call 1-800-678-1605 or go to www.tazorac.com | |
71722US15
NDC 0023-0042-10
Rx only
Zorac ®
(tazarotene) gel 0.1%
100 grams
For Dermatologic Use Only
Not for Ophthalmic Use
ALLERGAN ®
Carton
NDC 0023-8335-10
Rx only
Zorac ®
(tazarotene) gel 0.05%
100 grams
For Dermatologic Use Only
Not for Ophthalmic Use
ALLERGAN ®
Carton
Depending on the reaction of the Zorac after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Zorac not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Zorac addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology