Тазорак инструкция по применению цена отзывы

DESCRIPTION

TAZORAC (tazarotene) Gel, 0.05% and 0.1% is for topical use and contains the active ingredient, tazarotene. Each gram of TAZORAC Gel, 0.05% and 0.1% contains 0.5 and 1 mg of tazarotene, respectively in a translucent, aqueous gel.

Tazarotene is a member of the acetylenic class of retinoids. Chemically, tazarotene is ethyl 6-[(4,4- dimethylthiochroman-6-yl)ethynyl]nicotinate. The compound has an empirical formula of C₂₁H₂₁NO₂S and molecular weight of 351.46. The structural formula is shown below:

TAZORAC Gel contains the following inactive ingredients: benzyl alcohol 1%;ascorbic acid; butylated hydroxyanisole; butylated hydroxytoluene; carbomer homopolymer type B; edetate disodium; hexylene glycol; poloxamer 407; polyethylene glycol 400; polysorbate 40; purified water; and tromethamine.

INDICATIONS

Plaque Psoriasis

TAZORAC® (tazarotene) Gel, 0.05% and 0.1% are indicated
for the topical treatment of patients with plaque psoriasis of up to 20% body
surface area involvement.

Acne Vulgaris

TAZORAC (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 TAZORAC Gel in the treatment of acne
previously treated with other retinoids or resistant to oral antibiotics has
not been established.

Limitations Of Use

The safety of TAZORAC Gel use on more than 20% body
surface area has not been established in psoriasis or acne [see WARNINGS AND
PRECAUTIONS and Use In Specific Populations].

DOSAGE AND ADMINISTRATION

TAZORAC Gel is for topical use only. TAZORAC Gel is not
for ophthalmic, oral, or intravaginal use. Avoid accidental transfer of TAZORAC
Gel into eyes, mouth, or other mucous membranes. If contact with mucous
membranes occurs, rinse thoroughly with water [see WARNINGS AND PRECAUTIONS].

Wash hands thoroughly after application.

Psoriasis

It is recommended that treatment starts with TAZORAC Gel,
0.05%, with strength increased to 0.1% if tolerated and medically indicated.
Apply a thin film (2 mg/cm²) of TAZORAC Gel once per day, in the evening, to
cover only the psoriatic lesions on 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 TAZORAC Gel. Because unaffected skin may be more
susceptible to irritation, application of tazarotene to these areas should be
carefully avoided. TAZORAC Gel was investigated for up to 12 months during
clinical trials for psoriasis.

Acne

Cleanse the face gently. After the skin is dry, apply a
thin layer (2 mg/cm²) of TAZORAC Gel 0.1% once per day, in the evening, to the
skin where acne lesions appear. Use enough to cover the entire affected area.
TAZORAC Gel was investigated for up to 12 weeks during clinical trials for
acne. Use effective sunscreens and wear protective clothing while using TAZORAC
Gel [see WARNINGS AND PRECAUTIONS].

HOW SUPPLIED

Dosage Forms And Strengths

Gel, 0.05% and 0.1%, in 30 g and 100 g tubes. Each gram
of TAZORAC Gel, 0.05% and 0.1% contains 0.5 mg and 1 mg of tazarotene,
respectively in a translucent, aqueous gel.

Storage And Handling

TAZORAC (tazarotene) Gel is a translucent, aqueous gel,
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.

TAZORAC Gel 0.05% 30 g NDC 0023-8335-03
TAZORAC Gel 0.05% 100 g NDC 0023-8335-10
TAZORAC Gel 0.1% 30 g NDC 0023-0042-03
TAZORAC Gel 0.1% 100 g NDC 0023-0042-10

Storage

Store at 20°C to 25°C (68°F
to 77°F). Excursions permitted from 15°C to 30°C (59°F
to 86°F).

Distributed by: Allergan USA, Inc. Revised: Apr 2018

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Embryofetal Toxicity

Based on data from animal reproduction studies, retinoid
pharmacology and the potential for systemic absorption, TAZORAC Gel may cause
fetal harm when administered to a pregnant female and is contraindicated during
pregnancy. Tazarotene elicits malformations and developmental effects associated
with retinoids after topical and oral administration to pregnant rats and
rabbits during organogenesis.

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 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,
tazarotene is a teratogenic substance and causes fetal malformations in animals,
and it is not known what level of exposure is required for teratogenicity in
humans [see CLINICAL PHARMACOLOGY].

There were thirteen reported pregnancies in subjects who
participated in the clinical trials for topical tazarotene. Nine of the
subjects had been treated with topical tazarotene, and the other four had been
treated with vehicle. One of the subjects who was treated with tazarotene cream
elected to terminate the pregnancy for non-medical reasons unrelated to
treatment. The other eight pregnant women who were inadvertently exposed to
topical tazarotene during the 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.

Females Of Child-bearing Potential

Females of child-bearing potential should be warned of
the potential risk and use adequate birthcontrol measures when TAZORAC Gel is
used. The possibility that a female of child-bearing potential is pregnant at
the time of institution of therapy should be considered.

A negative result for pregnancy test should be obtained
within 2 weeks prior to TAZORAC Gel therapy. TAZORAC Gel therapy should begin
during a normal menstrual period [see Use In Specific Populations].

Local Irritation And Hypersensitivity Reactions

Application of TAZORAC Gel may cause excessive irritation
in the skin of certain sensitive individuals. Local reactions (including
blistering and skin desquamation, pruritus, burning, erythema) and
hypersensitivity adverse reactions (including urticaria) have been observed
with topical tazarotene.

If these adverse reactions occur, consider discontinuing
the medication or reducing the dosing frequency, as appropriate, until the
integrity of the skin is restored. Alternatively, patients with psoriasis who
are being treated with the 0.1% concentration can be switched to the lower concentration.
Frequency of application should be closely monitored by careful observation of
the clinical therapeutic response and skin tolerance. Therapy can be resumed,
or the drug concentration or frequency of application can be increased as the
patient becomes able to tolerate treatment.

Concomitant topical 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 treatment with TAZORAC Gel is initiated.

TAZORAC Gel, should not be used on eczematous skin, as it
may cause severe irritation.

Weather extremes, such as wind or cold, may be more
irritating to patients using TAZORAC Gel.

Photosensitivity And Risk For Sunburn

Because of heightened burning susceptibility, exposure to
sunlight (including sunlamps) should be avoided unless deemed medically
necessary, and in such cases, exposure should be minimized during the use of
TAZORAC Gel. Patients must be warned to use sunscreens and protective clothing when
using TAZORAC Gel. Patients with sunburn should be advised not to use TAZORAC
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 TAZORAC Gel.

TAZORAC 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.

Patient Counseling Information

Advise the patient to read the FDA-approved patient
labeling (PATIENT INFORMATION).

Embryofetal Toxicity

Inform females of reproductive potential of the potential
risk to a fetus. Advise these patients to use effective contraception during
treatment with TAZORAC Gel. Advise patients to inform their healthcare provider
of a known or suspected pregnancy [see WARNINGS AND PRECAUTIONS and Use
In Specific Populations].

Photosensitivity And Risk of Sunburn

Advise patients to avoid excessive sun exposure and to
use of sunscreens and protective measures (hat, visor). Advise patients to
avoid using TAZORAC Gel if also taking other medicines may increase sensitivity
to sunlight.

Important Administration Instructions

Advise the patient of the following:

1. For the patient with psoriasis, apply TAZORAC Gel only to
   psoriasis skin lesions, avoiding uninvolved skin.
2. If undue irritation (redness, peeling, or discomfort)
   occurs, reduce frequency of application or temporarily interrupt treatment.
   Treatment may be resumed once irritation subsides [see DOSAGE AND ADMINISTRATION].
3. Moisturizers may be used as frequently as desired.
4. Patients with psoriasis may use a cream or lotion to
   soften or moisten skin at least 1 hour before applying TAZORAC Gel.
5. Avoid contact with the eyes. If TAZORAC Gel gets in or
   near eyes, rinse thoroughly with water. Seek medical attention if eye
   irritation continues.
6. TAZORAC Gel is for topical use only. Do not apply to
   eyes, mouth, or other mucous membrane. Not for ophthalmic, oral, or
   intravaginal use.
7. Wash hands thoroughly after applying TAZORAC Gel.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

A long-term study of tazarotene 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 in the rat 0.3 times that seen in
subjects treated with the MRHD of tazarotene gel, 0.1%.

A long-term study with topical administration of up to
0.1% tazarotene 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. Systemic exposure at the
highest dose was 2 times that seen in subjects treated with the MRHD of
tazarotene gel, 0.1%.

Tazarotene was non-mutagenic in the Ames assay and did
not produce structural chromosomal aberrations in a human lymphocyte assay.
Tazarotene was 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 tazarotene gel up to 0.125 mg/kg/day. Based on data from
another study, the systemic drug exposure in the rat at the highest dose was
0.3 times that observed in subjects treated with the MRHD of tazarotene gel,
0.1%.

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 tazarotene, which produced systemic exposure that was
approximately equivalent to that observed in subjects treated with the MRHD of
tazarotene gel, 0.1%.

No impairment of mating performance or fertility was
observed in female rats treated for 15 days prior to mating and continuing
through gestation day 7 with oral doses of tazarotene 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 that dose, which produced systemic
exposure 2 times that observed in subjects treated with the MRHD of tazarotene
gel, 0.1% [see Use In Specific Populations].

Use In Specific Populations

Pregnancy

Risk Summary

Based on data from animal reproduction studies, retinoid
pharmacology, and the potential for systemic absorption, TAZORAC Gel may cause
fetal harm when administered to a pregnant female and is contraindicated during
pregnancy. Safety in pregnant females has not been established. The potential
risk to the fetus outweighs the potential benefit to the mother from TAZORAC
Gel during pregnancy; therefore, TAZORAC Gel should be discontinued as soon as
pregnancy is recognized [see CONTRAINDICATIONS, WARNINGS AND
PRECAUTIONS, CLINICAL PHARMACOLOGY]. Limited case reports of
pregnancy in females enrolled in clinical trials for TAZORAC Gel have not
established a clear association with tazarotene and major birth defects or
miscarriage risk. Because the exact timing and extent of exposure in relation
to the gestational age are not certain, the significance of these findings is
unknown.

In animal reproduction studies with pregnant rats,
tazarotene dosed topically during organogenesis at 0.5 times the maximum
systemic exposure in subjects treated with the maximum recommended human dose
(MRHD) of tazarotene gel, 0.1% resulted in reduced fetal body weights and
reduced skeletal ossification. In animal reproduction studies with pregnant
rabbits dosed topically with tazarotene gel at 7 times the maximum systemic
exposure in subjects treated with the MRHD of tazarotene gel, 0.1%, there were
single incidences of known retinoid malformations, including spina bifida,
hydrocephaly, and heart anomalies.

In animal reproduction studies with pregnant rats and
rabbits, tazarotene dosed orally during organogenesis at 0.5 and 13 times,
respectively, the maximum systemic exposure in subjects treated with the MRHD
of tazarotene gel, 0.1% resulted in malformations, fetal toxicity, developmental
delays, and/or behavioral delays. In pregnant rats, tazarotene dosed orally
prior to mating through early gestation resulted in decreased litter size,
decreased numbers of live fetuses, decreased fetal body weights, and increased
malformations at doses approximately 2 times higher than the maximum systemic
exposure in subjects treated with the MRHD of tazarotene gel, 0.1% [see Data].

The background risk of major birth defects and
miscarriage for the indicated population is unknown. Adverse outcomes in pregnancy
occur regardless of the health of the mother or the use of medications. In the
U.S. general population, the estimated background risk of major birth defects
and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%,
respectively.

Data

Animal Data

In rats, a tazarotene gel, 0.05% formulation dosed
topically during gestation days 6 through 17 at 0.25 mg/kg/day, which
represented 0.5 times the maximum systemic exposure in subjects treated with
the MRHD of tazarotene gel, 0.1% (i.e., 2 mg/cm² over a 20% body surface area),
resulted in reduced fetal body weights and reduced skeletal ossification.
Rabbits dosed topically with 0.25 mg/kg/day tazarotene gel, which represented 7
times the maximum systemic exposure in subjects treated with the MRHD of
tazarotene gel, 0.1%, during gestation days 6 through 18 were noted with single
incidences of known retinoid malformations, including spina bifida,
hydrocephaly, and heart anomalies.

When tazarotene was given orally to animals, developmental
delays were seen in rats, and malformations and post-implantation loss were
observed in rats and rabbits at doses producing 0.5 and 13 times, respectively,
the maximum systemic exposure in subjects treated with the MRHD of tazarotene
gel, 0.1%.

In female rats orally administered 2 mg/kg/day of
tazarotene from 15 days before mating through gestation day 7, which
represented 2 times the maximum systemic exposure in subjects treated with the
MRHD of tazarotene gel, 0.1%, classic developmental effects of retinoids were
observed including decreased number of implantation sites, decreased litter
size, decreased numbers of live fetuses, and decreased fetal body weights. A
low incidence of retinoid-related malformations was observed at that dose.

In a pre- and postnatal development toxicity study,
topical administration of tazarotene gel (0.125 mg/kg/day) to pregnant female
rats from gestation day 16 through lactation day 20 reduced pup survival, but
did not affect the reproductive capacity of the offspring. Based on data from
another study, the maximum systemic exposure in the rat would be 0.3 times the
maximum systemic exposure in subjects treated with the MRHD of tazarotene gel,
0.1%.

Lactation

Risk Summary

There is no information regarding the presence of
tazarotene in human milk, the effects on the breastfed infant, or the effects
on milk production. After single topical doses of 14C-tazarotene gel to the
skin of lactating rats, radioactivity was detected in rat milk. The lack of
clinical data during lactation precludes a clear determination of the risk of
TAZORAC Gel to an infant during lactation; therefore, the developmental and
health benefits of breastfeeding should be considered along with the mother’s
clinical need for TAZORAC Gel and any potential adverse effects on the
breastfed child from TAZORAC Gel or from the underlying maternal condition.

Females And Males Of Reproductive Potential

Pregnancy Testing

Pregnancy testing is recommended for females of
reproductive potential within 2 weeks prior to initiating TAZORAC Gel therapy
which should begin during a menstrual period.

Contraception

Females

Based on animal studies, TAZORAC Gel may cause fetal harm
when administered to a pregnant woman [see Use In Specific Populations].
Advise females of reproductive potential to use effective contraception during
treatment with TAZORAC Gel.

Pediatric Use

The safety and efficacy of TAZORAC Gel have not been established
in pediatric patients with psoriasis or acne under the age of 12 years.

Geriatric Use

Of the total number of subjects in clinical trials of
TAZORAC Gel 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 TAZORAC Gel compared with those 65 years of age and younger.
Currently there is no other clinical experience on the differences in responses
between the elderly and younger subjects, but greater sensitivity of some older
individuals cannot be ruled out. Tazarotene gel for the treatment of acne has
not been clinically evaluated in persons over the age of 65.

CLINICAL PHARMACOLOGY

Mechanism Of Action

Tazarotene is a retinoid prodrug which is converted to
its active form, the carboxylic acid of tazarotene, by deesterification.
Tazarotenic acid binds to all three members of the retinoic acid receptor (RAR)
family: RARα, RARβ, and RARγ, but shows relative
selectivity for RARβ, and RARγ and may modify gene expression.
The clinical significance of these findings for the treatment of plaque
psoriasis and facial acne vulgaris is unknown.

Pharmacodynamics

The pharmacodynamics of TAZORAC Gel in the treatment of
plaque psoriasis and facial acne vulgaris are unknown.

Pharmacokinetics

Following topical application, tazarotene undergoes
esterase hydrolysis to form its active metabolite, tazarotenic acid. Little
parent compound could be detected in the plasma. Tazarotenic acid was highly bound
to plasma proteins (greater than 99%).

Tazarotene and tazarotenic acid were metabolized to
sulfoxides, sulfones and other polar metabolites which were eliminated through
urinary and fecal pathways. The half-life of tazarotenic acid was approximately
18 hours, following topical application of tazarotene to normal, acne or
psoriatic skin. The human in vivo studies described below were conducted with
tazarotene gel applied topically at approximately 2 mg/cm² and left on the skin
for 10 to 12 hours. Both the peak plasma concentration (Cmax) and area under
the plasma concentration time curve (AUC) refer to the active metabolite only.

Two single, topical dose studies were conducted using 14C-tazarotene
gel. Systemic absorption, as determined from radioactivity in the excreta, was
less than 1% of the applied dose (without occlusion) in six subjects with
psoriasis and approximately 5% of the applied dose (under occlusion) in six healthy
subjects. One non-radiolabeled single-dose study comparing the 0.05% gel to the
0.1% gel in healthy subjects indicated that the Cmax and AUC were 40% higher
for the 0.1% gel.

After 7 days of topical dosing with measured doses of
tazarotene 0.1% gel on 20% of the total body surface without occlusion in 24
healthy subjects, the Cmax for tazarotenic acid was 0.72 ± 0.58 ng/mL (mean ±
SD) occurring 9 hours after the last dose, and the AUC0-24hr for tazarotenic
acid was 10.1 ± 7.2 ng·hr/mL. Systemic absorption was 0.91 ± 0.67% of the
applied dose.

In a 14-day study in five subjects with psoriasis,
measured doses of tazarotene 0.1% gel were applied daily by nursing staff to
involved skin without occlusion (8 to 18% of total body surface area; mean ±
SD: 13 ± 5%). The Cmax for tazarotenic acid was 12.0 ± 7.6 ng/mL
occurring 6 hours after the final dose, and the AUC0-24hr for tazarotenic acid
was 105 ± 55 ng·hr/mL. Systemic absorption was 14.8 ± 7.6% of the
applied dose. Extrapolation of these results to represent dosing on 20% of
total body surface yielded estimates for tazarotenic acid with Cmax of 18.9 ±
10.6 ng/mL and AUC0-24hr of 172 ± 88 ng·hr/mL.

An in vitro percutaneous absorption study, using
radiolabeled drug and freshly excised human skin or human cadaver skin,
indicated that approximately 4 to 5% of the applied dose was in the stratum corneum
(tazarotene: tazarotenic acid = 5:1) and 2 to 4% was in the viable
epidermis-dermis layer (tazarotene: tazarotenic acid = 2:1) 24 hours after
topical application of the gel.

Clinical Studies

Psoriasis

In two large vehicle-controlled clinical trials, TAZORAC
Gel, 0.05% and 0.1% applied once daily for 12 weeks was significantly more
effective than vehicle in reducing the severity of the clinical signs of plaque
psoriasis covering up to 20% of body surface area. In one of the studies,
subjects were followed up for an additional 12 weeks following cessation of
therapy with TAZORAC Gel. Mean baseline scores and changes from baseline
(reductions) after treatment in these two trials are shown in Table 1.

Table 1: Plaque Elevation, Scaling, and Erythema in
Two Controlled Clinical Trials for Psoriasis

Global improvement over baseline at the end of 12 weeks
of treatment in these two trials is shown in Table 2.

Table 2: Global Improvement over Baseline after Twelve
Weeks of Treatment in Two Controlled Clinical Trials for Psoriasis

The 0.1% gel was more effective than the 0.05% gel, but
the 0.05% gel was associated with less local irritation than the 0.1% gel [see ADVERSE
REACTIONS].

Acne

In two large vehicle-controlled trials, TAZORAC Gel, 0.1%
applied once daily was significantly more effective than vehicle in the
treatment of facial acne vulgaris of mild to moderate severity. Percent
reductions in lesion counts after treatment for 12 weeks in these two trials
are shown in Table 3.

Table 3: Reduction in Lesion Counts after Twelve Weeks
of Treatment in Two Controlled Clinical Trials for Acne

Global improvement over baseline at the end of 12 weeks
of treatment in these two trials is shown in Table 4.

Table 4: Global Improvement over Baseline after Twelve
Weeks of Treatment in Two Controlled Clinical Trials for Acne

PATIENT INFORMATION

TAZORAC®
(TAZ-or-ac)
(tazarotene) Gel, 0.05% and 0.1%

Important information: TAZORAC Gel is for use on
skin only. Do not use TAZORAC Gel in your eyes, mouth, or vagina.

What is the most important information I should know
about TAZORAC Gel?

TAZORAC Gel may cause birth defects if used during
pregnancy.

• Females must not be pregnant when they start using
  TAZORAC Gel or become pregnant during treatment with TAZORAC Gel.
• For females who can become pregnant:
  • Your doctor will order a pregnancy test for you within 2
    weeks before you begin treatment with TAZORAC Gel to be sure that you are not
    pregnant. Your doctor will decide when to do the test.
  • Begin treatment with TAZORAC Gel during a normal
    menstrual period.
  • Use an effective form of birth control during treatment
    with TAZORAC Gel. Talk with your doctor about birth control options that may be
    used to prevent pregnancy during treatment with TAZORAC Gel.
  • Stop using TAZORAC Gel and tell your doctor right away
    if you become pregnant while using TAZORAC Gel.

What is TAZORAC Gel?

• TAZORAC Gel 0.05% and 0.1% is a prescription medicine
  used on the skin (topical) to treat people with stable plaque psoriasis on up
  to 20% of your body surface.
• TAZORAC Gel 0.1% is also used on the skin to treat people
  with mild to moderate facial acne vulgaris.

It is not known if TAZORAC Gel is:

• safe and effective for use in children under 12 years of
  age.
• effective for the treatment of acne in people who have
  been treated with retinoid medicines or have acne that does not respond to
  treatment with oral antibiotics.
• safe if used over more than 20% of your body for the
  treatment of psoriasis or acne.

Who should not use TAZORAC Gel?

Do not use TAZORAC Gel if you:

• are pregnant or plan to become pregnant. See “What is the
  most important information I should know about TAZORAC Gel?” at the beginning
  of this leaflet.
• are allergic to tazarotene or any of the ingredients in
  TAZORAC Gel. See the end of this leaflet for a complete list of ingredients in
  TAZORAC Gel.

What should I tell my doctor before using TAZORAC Gel?

Before you use TAZORAC Gel, tell your doctor about all
of your medical conditions, including if you:

• have eczema or any other skin problems
• are breastfeeding or plan to breastfeed. It is not known
  if TAZORAC Gel passes into your breast milk. Talk to your doctor about using
  TAZORAC Gel while breastfeeding.

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.

Keep a list of your medicines to show to your doctor and
pharmacist when you get a new medicine.

How should I use TAZORAC Gel?

• Use TAZORAC Gel exactly as your doctor tells you to use
  it.
• Apply TAZORAC Gel 1 time each day, in the evening.
• Do not get TAZORAC Gel in your eyes, on your
  eyelids, or in your mouth. If TAZORAC Gel gets in or near your eyes, rinse them
  well with water. Call your doctor or get medical help if you have eye
  irritation that does not go away.
• Wash your hands after applying TAZORAC Gel.

Follow these instructions for applying TAZORAC Gel:

• If you have psoriasis:
  • If you shower or bathe before applying TAZORAC Gel, your
    skin should be dry before applying the gel.
  • You may use a cream or lotion to soften or moisten your
    skin at least 1 hour before you apply TAZORAC Gel.
  • Apply a thin layer of TAZORAC Gel to cover only the
    psoriasis lesions.
• If you have acne:
  • Gently wash and dry your face before applying TAZORAC
    Gel.
  • Apply a thin layer of TAZORAC Gel to cover only the acne
    lesions.
• If you swallow TAZORAC Gel, call your doctor or go to the
  nearest hospital emergency room right away.

What should I avoid while using TAZORAC Gel?

• Avoid sunlight, including sunlamps, during treatment with
  TAZORAC Gel. TAZORAC Gel can make you more sensitive to the sun, and the light
  from sunlamps and tanning beds. You could get a severe sunburn. Use sunscreen
  and wear a hat and clothes that cover your skin if you have to be in sunlight.
• Talk to your doctor if you get a sunburn during treatment
  with TAZORAC Gel. If you get a sunburn, do not use TAZORAC Gel until your
  sunburn is healed.
• Avoid using cosmetics or topical medicines that may make
  your skin more sensitive to sunlight or make your skin dry.
• Avoid using TAZORAC Gel on unaffected skin or skin with
  eczema because it may cause severe irritation.

What are the possible side effects of TAZORAC Gel?

TAZORAC Gel may cause serious side effects, including:

• Skin irritation and allergic reactions
  (hypersensitivity). TAZORAC Gel may cause increased skin irritation
  (including blistering and skin peeling) and allergic reactions (including hives).
  Tell your doctor if you develop itching, burning, redness, blistering or
  peeling of your skin during treatment with TAZORAC Gel. If you develop skin
  irritation or hives, your doctor may tell you to temporarily stop using TAZORAC
  Gel until your skin heals, tell you to use TAZORAC Gel less often, or change
  your TAZORAC Gel dose. Also, wind or cold weather may be more irritating to
  your skin while you are using TAZORAC Gel.
• Sensitivity to sunlight and risk of sunburn. See
  “What should I avoid while using TAZORAC Gel?”

The most common side effects of TAZORAC Gel in people
with plaque psoriasis include itching, burning, redness, worsening of
psoriasis, irritation and skin pain.

The most common side effects of TAZORAC Gel in people
with acne include peeling, burning, dry skin, redness and itching.

These are not all the possible side effects of TAZORAC
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 TAZORAC Gel?

• Store TAZORAC Gel at 68°F to 77°F (20°C to 25°C).
• Keep TAZORAC Gel and all medicines out of the reach of
  children.

General information about the safe and effective use
of TAZORAC Gel.

Medicines are sometimes prescribed for purposes other
than those listed in a Patient Information leaflet. Do not use TAZORAC Gel for
a condition for which it was not prescribed. Do not give TAZORAC 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 TAZORAC Gel that is written
for health professionals.

What are the ingredients in TAZORAC Gel?

Active ingredient: tazarotene

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

This Patient Information has been approved by the U.S.
Food and Drug Administration.

From

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.