solage (mequinol and tretinoin) solution
[Barrier Therapeutics, Inc.]
Solagé® Topical Solution
contains mequinol 2% and tretinoin 0.01%, by weight, in
a solution base of ethyl alcohol (77.8% v/v), polyethylene
glycol 400, butylated hydroxytoluene, ascorbic acid, citric acid,
ascorbyl palmitate, edetate disodium and purified water.
Mequinol is
4- hydroxyanisole, the monomethyl ether of hydroquinone or
1-hydroxy-4-methoxybenzene. It has the chemical formula,
C7H8O2, a molecular weight of
124.14, and the structural formula:
The chemical name for tretinoin, a retinoid, is (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid, also referred to as all-trans-retinoic acid. It has the chemical formula, C20H28O2, a molecular weight of 300.44, and the structural formula:
Solar lentigines are localized, pigmented, macular lesions of the
skin on the areas of the body which have been chronically exposed to
sunlight.
Biopsy specimens of solar lentigines were collected in a
clinical study with Solagé
Solution at baseline, at the end of a 24 week treatment period and at
the end of a subsequent 24 week, no treatment, follow-up period. The end
of treatment specimens showed a decrease in melanin pigmentation in both
melanocytes and keratinocytes, and an increased lymphocytic
infiltration, which may have been the result of irritation or an
immunologic reaction. The end of follow-up period specimens showed
repigmentation of the melanocytes and keratinocytes to a state similar
to the baseline specimens. These results indicate that there is no
assurance that any improvement obtained would persist upon
discontinuation of drug therapy.
The mechanism of action of mequinol
is unknown. Although mequinol is a substrate for the enzyme tyrosinase
and acts as a competitive inhibitor of the formation of melanin
precursors, the clinical significance of these findings is unknown. The
mechanism of action of tretinoin as a depigmenting agent also is unknown.
The percutaneous absorption of tretinoin and the systemic exposure to tretinoin and mequinol were assessed in healthy subjects (n=8) following two weeks of twice daily topical treatment of Solagé Solution. Approximately 0.8 mL of Solagé Solution was applied to a 400 cm2 area of the back, corresponding to a dose of 37.3 μg/cm2 for mequinol and 0.23μg/cm2 for tretinoin. The percutaneous absorption of tretinoin was approximately 4.4%, and systemic concentrations did not increase over endogenous levels. The mean Cmax for mequinol was 9.92 ng/mL (range 4.22 to 23.62 ng/mL) and the Tmax was 2 hours (range 1 to 2 hours).
(To understand fully the indication for this product, please read
the entire INDICATIONS
AND USAGE section of the labeling).
Solagé (mequinol 2%, tretinoin
0.01%) Topical Solution is indicated for the treatment of solar
lentigines.
Solagé
Solution should only be used under medical supervision as an adjunct to
a comprehensive skin care and sun avoidance program where the patient
should primarily either avoid the sun or use protective
clothing.
Neither the safety nor effectiveness of Solagé Solution for the
prevention or treatment of melasma or postinflammatory hyperpigmentation
has been established.
The efficacy of using Solagé Solution daily for
greater than 24 weeks has not been established.
The local cutaneous safety of using Solagé
Solution in non-Caucasians has not been adequately
established (see Clinical
Studies section).
The combination of mequinol and tretinoin may cause fetal harm
when administered to a pregnant woman. Due to the known effects of these
active ingredients, Solagé
Topical Solution should not be used in women of childbearing
potential.
In a dermal teratology study in New Zealand White
rabbits, there were no statistically significant differences among
treatment groups in fetal malformation data; however, marked
hydrocephaly with visible doming of the head was observed in one
mid-dose litter (12 and 0.06 mg/kg or 132 and 0.66 mg/m2 of
mequinol and tretinoin, respectively) and two fetuses in one high dose
litter (40 and 0.2 mg/kg or 440 and 2.2 mg/m2 of mequinol and
tretinoin, respectively) of Solagé Solution, and two high-dose tretinoin (0.2
mg/kg, 2.2 mg/m2) treated litters. These malformations were
considered to be treatment related and due to the known effects of
tretinoin. This was further supported by coincident appearance of other
malformations associated with tretinoin, such as cleft palate and
appendicular skeletal defects. No effects attributed to treatment were
observed in rabbits in that study treated topically with mequinol alone
(dose 40 mg/kg, 440 mg/m2). A no-observed-effect level (NOEL) for
teratogenicity in rabbits was established at 4 and 0.02 mg/kg (44 and 0.22 mg/m2 mequinol and tretinoin, respectively) for Solagé Solution which is
approximately the maximum possible human daily dose, based on clinical
application to 5% of total body surface area. Plasma tretinoin
concentrations were not raised above endogenous levels, even at
teratogenic doses. Plasma mequinol concentrations in rabbits at the NOEL
at one hour after application were 124 ng/mL or approximately twelve
times the mean peak plasma concentrations of that substance seen in
human subjects in a clinical pharmacokinetic study.
In a repeated
study in pregnant rabbits administered the same dose levels as the study
described above, additional precautionary measures were taken to prevent
ingestion, although there is no evidence to confirm that ingestion
occurred in the initial study. Precautionary measures additionally
limited transdermal absorption to a six hour exposure period, or
approximately one-fourth of the human clinical daily continuous exposure
time. This study did not show any significant teratogenic effects at
doses up to approximately 13 times the human dose on a mg/m2 basis.
However, a concurrent tretinoin dose group (0.2 mg/kg/day) did include
two litters with limb malformations.
In a published study in albino
rats (J. Am. Coll. Toxicology 4(5):31–63, 1985), topical
application of 5% of mequinol in a cream vehicle during
gestation was embryotoxic and embryolethal. Embryonic loss prior to
implantation was noted in that study where animals were treated
throughout gestation. Coincidentally, mean preimplantation embryonic
loss was increased in the first rabbit study in all mequinol treated
groups, relative to control, and in the high dose mequinol/tretinoin and
tretinoin only treated groups in the second study. In those studies,
dosing began at gestation day 6, when implantation is purported to
occur. Increased preimplantation loss was also noted at the high
combination dose in a study of early embryonic effects in rats, as was
decreased body weight in male pups; these findings are consistent with
the published study.
Solagé Solution was not teratogenic in
Sprague-Dawley rats when given in topical doses of 80 and 0.4 mg/kg
mequinol and tretinoin, respectively (480 and 2.4 mg/m2 or 11
times the maximum human daily dose). The maximum human dose is defined
as the amount of solution applied daily to 5% of the total body
surface area.
With widespread use of any drug, a small number of
birth defect reports associated temporally with the administration of
the drug would be expected by chance alone. Thirty cases of
temporally-associated congenital malformations have been reported during
two decades of clinical use of another formulation of topical tretinoin.
Although no definite pattern of teratogenicity and no casual association
has been established from these cases, 6 of the reports describe the
rare birth defect category holoprosencephaly (defects associated with
incomplete midline development of the forebrain). The significance of
these spontaneous reports in terms of risk to the fetus is not
known.
No adequate or well-controlled trials have been conducted
with Solagé Solution in
pregnant women.
Solagé
Topical Solution is contraindicated in individuals with a history of
sensitivity reactions to any of its ingredients. It should be
discontinued if hypersensitivity to any of its ingredients is
noted.
SolagéSolution is a
dermal irritant and the results of continued irritation of the skin for
greater than 52 weeks in chronic, long-term use are not known. Tretinoin
has been reported to cause severe irritation on eczematous skin and
should be used only with utmost caution in patients with this
condition.
Safety and effectiveness of SolagéSolution in individuals with moderately
or heavily pigmented skin have not been established.
SolagéSolution should not be
administered if the patient is also taking drugs known to be
photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones,
phenothiazines, sulfonamides) because of the possibility of augmented
phototoxicity.
Because of heightened burning susceptibility,
exposure to sunlight (including sunlamps) to treated areas should be
avoided or minimized during the use of SolagéSolution. Patients must be advised to use
protective clothing and comply with a comprehensive sun avoidance
program when using SolagéSolution. Data are not available to establish how or whetherSolagéSolution is
degraded (either by sunlight or by normal interior lighting) following
application to the skin. Patients with sunburn should be advised not to
use SolagéSolution 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 SolagéSolution and ensure that
the precautions outlined in the Patient Medication Guide are
observed.
SolagéSolution should be kept out of the eyes, mouth, paranasal
creases, and mucous membranes. SolagéSolution may cause skin irritation, erythema, burning,
stinging or tingling, peeling, and pruritis. If the degree of such local
irritation warrants, patients should be directed to use less medication,
decrease the frequency of application, discontinue use temporarily, or
discontinue use altogether. The efficacy at reduced frequencies of
application has not been established.
SolagéSolution should be used with caution by
patients with a history, or family history, of vitiligo. One patient in
the trials, whose brother had vitiligo, experienced hypopigmentation in areas that had not been treated with study medication. Some of these
areas continued to worsen for at least one month post treatment withSolagéSolution. Six
weeks later the severity of the hypopigmentation had decreased from
moderate to mild and 106 days post treatment, the patient had resolution
of some but not all lesions.
Application of larger amounts of
medication than recommended will not lead to more rapid or better
results, and marked redness, peeling, discomfort, or hypopigmentation of
the skin may occur.
For external use only.
SolagéSolution should only be used as
an adjunct to a comprehensive skin care and sun avoidance program. (See INDICATIONS AND USAGE section).
If a drug sensitivity, chemical
irritation, or a systemic adverse reaction develops, use ofSolagéSolution
should be discontinued.
Weather extremes, such as wind or
cold, may be more irritating to patients using SolagéSolution.
Patients require detailed instruction to obtain maximal benefits and to understand all the precautions necessary to use this product with greatest safety. The Patient Medication Guide is attached to this Package Insert.
Concomitant topical products with a strong skin drying
effect, products with high concentrations of alcohol,
astringents, spices or lime, medicated soaps or shampoos,
permanent wave solutions, electrolysis, hair depilatories or
waxes, or other preparations that might dry or irritate the skin
should be used with caution in patients being treated withSolagéSolution
because they may increase irritation when used with SolagéSolution.
SolagéSolution should not be administered if the patient is
also taking drugs known to be photosensitizers (e.g., thiazides,
tetracyclines, fluoroquinolones, phenothiazines, sulfonamides)
because of the possibility of augmented
phototoxicity.
Although a dermal carcinogenicity study in CD-1 mice
indicated that SolagéSolution applied topically at daily doses up to 80 and
0.4 mg/kg (240 and 1.2 mg/m2 ) of mequinol and
tretinoin, respectively, representing approximately 5 times the
maximum possible systemic human exposure was not carcinogenic,
in a photocarcinogenicity study utilizing Crl:Skh-1(hr/hr BR)
hairless albino mice, median time to onset of tumors decreased.
Also, the number of tumors increased in all dose groups
administered 1.4, 4.3 or 14 μl of SolagéSolution/cm2 of skin (24 and 0.12, 72 and
0.36, or 240 and 1.2 mg/m2 of mequinol and tretinoin,
respectively; 0.6, 1.9, or 6.5 times the daily human dose on a
mg/m2 basis) following chronic topical dosing
with intercurrent exposure to ultraviolet radiation for up to 40
weeks. Similar animal studies have shown an increased
tumorigenic risk with the use of retinoids when followed by
ultraviolet radiation.
Although the significance of these
studies to human use is not clear, patients using this product
should be advised to avoid or minimize exposure to either
sunlight or artificial ultraviolet irradiation
sources.
Mequinol was non-mutagenic in the Ames/Salmonella
assay using strains TA98, TA100, TA1535, and TA1537, all of
which are insensitive to mutagenic effects of
structurally-related quinones. SolagéSolution was non-genotoxic in anin vivo dermal
micronucleus assay in rats, but exposure of bone marrow to drug
was not demonstrated.
A dermal reproduction study withSolagéSolution
in Sprague-Dawley rats at a daily dose of 80 and 0.4 mg/kg (480
and 2.4 mg/m2) of mequinol and tretinoin,
respectively, approximately 11 times the corresponding maximum
possible human exposure, assuming 100% bioavailability
following topical application to 5% of the total body
surface area, showed no impairment of fertility.
Although the magnitude of the potential for teratogenicity may not be well-defined, SolagéSolution is labeled as an “X” because the potential risk of the use of this drug to treat this particular indication (solar lentigines) in a pregnant woman clearly outweighs any possible benefit (see CONTRAINDICATIONS section).
Nursing Mothers: It is not known to what extent mequinol and/or tretinoin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when SolagéSolution is administered to a nursing woman.
Pediatric Use: The safety and effectiveness of this product have not been established in pediatric patients. SolagéSolution should not be used on children.
Geriatric Use: Of the total number of patients in clinical studies of SolagéSolution, approximately 43% were 65 and older, while approximately 8% were 75 and over. No overall differences in effectiveness or safety were observed between these patients and younger patients.
In clinical trials, adverse reactions were primarily mild to
moderate in intensity, occurring in 66% and 30% of
patients, respectively. The majority of these events were limited to the
skin and 64% had an onset of a skin related adverse reaction early in treatment (by week 8).
The most frequent adverse reactions
in patients treated with SolagéSolution were erythema (49% of patients), burning,
stinging, or tingling (26%), desquamation (14%),
pruritus (12%), and skin irritation (5%).
Some
patients experienced temporary hypopigmentation of treated lesions
(5%) or of the skin surrounding treated lesions (7%).
Ninety-four of 106 patients (89%) had resolution of
hypopigmentation upon discontinuation of treatment to the lesion, and/or
re-instruction on proper application to the lesion only. Another
8% (9/106) of patients with hypopigmentation events had
resolution within 120 days after the end of treatment. Three of the 106
patients (2.8%) had persistence of hypopigmentation beyond 120
days. Approximately 6% of patients discontinued study
participation with SolagéSolution due to adverse reactions. These discontinuations were
due primarily to skin redness (erythema) or related cutaneous adverse
reactions. SolagéSolution
was generally well tolerated.
Body System | Solage Solution (mequinol 2%, tretinoin 0.01%) |
Tretinoin, 0.01% |
Mequinol, 2%, |
Vehicle |
||||
---|---|---|---|---|---|---|---|---|
Skin and Appendages |
N |
% |
N |
% |
N |
% |
N |
% |
549 |
44.6 |
261 |
55.3 |
13 |
5.1 |
8 |
4.6 |
|
Burning/Stinging/ Tingling |
270 |
21.9 |
173 |
36.7 |
26 |
10.2 |
20 |
11.4 |
Desquamation |
155 |
12.6 |
93 |
19.7 |
7 |
2.8 |
2 |
1.1 |
Pruritus |
135 |
11.0 |
66 |
14.0 |
12 |
4.7 |
3 |
1.7 |
Irritation Skin |
90 |
7.3 |
25 |
5.3 |
1 |
0.4 |
1 |
0.6 |
Halo Hypopigmentation |
76 |
6.2 |
16 |
3.4 |
2 |
0.8 |
2 |
1.1 |
Hypopigmentation |
50 |
4.1 |
8 |
1.7 |
2 |
0.8 |
0 |
0.0 |
Skin Dry |
38 |
3.1 |
18 |
3.8 |
3 |
1.2 |
1 |
0.6 |
Rash |
31 |
2.5 |
21 |
4.4 |
0 |
0.0 |
1 |
0.6 |
Crusting |
30 |
2.4 |
18 |
3.8 |
0 |
0.0 |
1 |
0.6 |
Rash Vesicular Bullae |
18 |
2.1 |
8 |
1.7 |
0 |
0.0 |
0 |
0.0 |
Dermatitis |
25 |
2.0 |
0 |
0.0 |
0 |
0.0 |
0 |
0.0 |
If SolagéSolution is applied excessively, no more rapid or better results will be obtained and marked redness, peeling, discomfort, or hypopigmentation may occur. Oral ingestion of the drug may lead to the same adverse effects as those associated with excessive oral intake of vitamin A (hypervitaminosis A). If oral ingestion occurs, the patient should be monitored, and appropriate supportive measures should be administered as necessary. The maximal no-effect level for oral administration of SolagéSolution in rats was 5.0 mL/kg (30 mg/m2). Clinical signs observed were attributed to the high alcohol content (77%) of the drug formulation.
Patients require detailed instruction to obtain maximal benefits
and to understand all the precautions necessary to use this product with
greatest safety. The physician should review the Patient Medication
Guide.
Apply SolagéSolution to the solar lentigines using the applicator tip
while avoiding application to the surrounding skin. Use twice daily,
morning and evening at least 8 hours apart, or as directed by a
physician. Patients should not shower or bathe the treatment areas for
at least 6 hours after application of SolagéSolution. Special caution should be taken
when applying SolagéSolution to avoid the eyes, mouth, paranasal creases, and
mucous membranes.
Application of SolagéSolution may cause transitory stinging,
burning or irritation.
Improvement continues gradually through the
course of therapy and should be apparent by 24 weeks. Patients should
avoid exposure to sunlight (including sunlamps) or wear protective clothing while using SolagéSolution. Data are not available to establish how or
whether SolagéSolution
is degraded (either by sunlight or by normal interior lighting)
following application to the skin.
With discontinuation of SolagéSolution therapy, a
majority of patients will experience some repigmentation over time of
their lesions.
Applications of larger amounts of medication or more
frequently than recommended will not lead to more rapid or better
results, and marked redness, peeling, irritation, or hypopigmentation
(abnormal lightening) of the skin may occur.
Patients treated withSolagéSolution may use
cosmetics but should wait 30 minutes before applying.
Two adequate and well-controlled trials evaluated changes in treated hyperpigmented lesions on the face, forearms/back of hands in 421 patients treated with SolagéTopical Solution, 422 patients treated with tretinoin topical solution, 209 patients treated with mequinol topical solution and 107 patients treated with vehicle for up to 24 weeks. In these studies, patients were to avoid sun exposure and use protective clothing, and use of suncreens was prohibited. Patients were allowed to apply Moisturel® Lotion 30 minutes after application of SolagéSolution. Physicians assessed the extent of improvement or worsening of all the treated lesions from the baseline condition on a 7 point scale. The results of these evaluations are shown below.
Face | Forearms/Back of Hands |
|||
---|---|---|---|---|
Solagé Solution | Vehicle | Solagé Solution | Vehicle | |
Moderate Improvement |
57% |
15% |
54% |
14% |
Slight Improvement |
28% |
36% |
26% |
33% |
No Change2 |
15% |
49% |
20% |
53% |
1 Includes the following grades: Moderate Improvement,
Marked Improvement, Almost Clear, Completely Clear. Moderate Improvement
or greater was considered clinically meaningful.
2
Includes the following grades: No Change, Worse (less than 1% of
patients treated with SolagéSolution were rated as worse).
Improvement (lightening) of
the solar lentigines occurred gradually over time during the 24 week
treatment period. At 24 weeks of treatment, 57% and 54%
of patients experienced moderate improvement or greater, and 3% and 1% of patients were completely clear of all treated lesions
for the face and forearms/back of hands, respectively. It should be
noted that approximately 9% of patients, from both treatment
areas in these studies, with moderate improvement or greater also
experienced hypopigmentation of the skin surrounding at least one
treated lesion. There are no vehicle-controlled effectiveness data on
the course of lesions treated beyond 24 weeks.
After 24 weeks of
treatment, for the forearm/back of hands treatment site, the percentage
of patients treated with tretinoin topical solution with moderate
improvement or greater, slight improvement, or no change, were
38%, 37%, and 26%, respectively, and for
mequinol topical solution were 24%, 40%, and
36%, respectively. For the face treatment site, the percentage
of patients treated with tretinoin topical solution with moderate
improvement or greater, slight improvement, or no change, were
46%, 33%, and 21%, respectively, and for
mequinol topical solution were 33%, 30%, and 37%
respectively.
The duration of effect was investigated during a
period of up to 24 weeks following the discontinuation of treatment.
Results from these studies showed that patients may maintain the level
of clinical improvement of their treated lesions from the end of
treatment through the 24 week follow-up period. However, some degree of
repigmentation of treated lesions was observed over time, demonstrating
reversibility of the depigmenting action of SolagéSolution.
In the clinical studies,
some patients experienced temporary hypopigmentation of treated lesions
(5%) or of the skin surrounding treated lesions (7%).
Hypopigmentation of the skin surrounding treated lesions occurs even in
the setting of proper application of the drug within the lesion border.
The majority (94/106 - 89%) resolved upon discontinuation of
treatment to the lesion, and/or re-instruction on proper application to
the lesion only. Another 8% (9/106) of patients with
hypopigmentation events had resolution within 120 days after the end of
treatment.
Three of the 106 patients (2.8%) had persistence
of hypopigmentation beyond 120 days. This further demonstrates the
reversibility of the depigmenting action of SolagéSolution.
Over 150 patients usedSolagéSolution twice
daily for 52 weeks in an open label clinical study. The safety profile
for SolagéSolution in this
long-term study was similar to that seen in the 24 week studies although
burning/stinging/tingling, desquamation, pruritis, and irritation of the
skin occurred at lower rates and halo hypopigmentation and
hypopigmentation occurred at a slightly greater rate.
Over 90
patients used SolagéSolution twice daily and a concomitant sunscreen
(PreSun® 29) daily for up to 24 weeks in an open label clinical
study. The safety profile for SolagéSolution in this study was similar to that seen in studies
which prohibited sunscreen use although desquamation, pruritis, and halo
hypopigmentation occurred at slightly lower rates.
The clinical
studies of SolagéSolution
included 1794 individuals of Skin Type I-V, 94.5% of whom were
Caucasian. The trials also included 5% of individuals who were
Asian/Pacific Islander (1.2%), African-American (0.8%),
and Hispanic/Latino (3.5%). Safety in Asian/Pacific Islander,
African-American, and Hispanic/Latino individuals has not been
adequately established. Safety and effectiveness of SolagéSolution in individuals
with Skin Type VI (never burns from the sun, deeply pigmented skin) or
women of childbearing potential have not been established (see CONTRAINDICATIONS).
HOW SUPPLIED: Solagé(mequinol 2%, tretinoin 0.01%) Topical Solution is available in 30 mL plastic bottles with an applicator.NDC 13478-001-01
STORAGE: The bottle should be protected from light by continuing to store in the carton after opening. Store at 25° C (77° F): excursions permitted to 15-30° C (59-86° F).
Note: FLAMMABLE. Keep away from heat and open flame.
Marketed by:
Barrier Therapeutics, Inc.
Princeton, New
Jersey 08540-6697 USA
Manufactured by:
Bristol-Myers Squibb,
Buffalo, NY 14213 USA
SO-001 Revised February 2005
Solagé® Topical Solution
Medication Guide
(mequinol 2%, tretinoin 0.01%) SO-002
INFORMATION FOR PATIENTS
Please read this Medication Guide carefully before you start to use your medicine. If you have any questions, or are not sure about any of the information on Solagé Solution, ask your doctor.
The active ingredients in SolagéSolution (pronounced so-la-JAY) are
mequinol and tretinoin.
SolagéSolution also contains ethyl alcohol (77.8% v/v),
polyethylene glycol 400, butylated hydroxytoluene, ascorbic acid, citric
acid, ascorbyl palmitate, edetate disodium, and purified water.
What is the Most Important Information about Solagé Solution?
SolagéSolution is a
prescription medication. It should only be used under supervision of
your doctor as part of a sun avoidance program. This program should also
include avoiding exposure to artificial sunlight (sunlamps) and
avoidance of direct sunlight by wearing protective
clothing.
SolagéSolution does not permanently “cure” solar
lentigines, also known as brown “age” or“liver” spots. In clinical trials, most patients
experienced some degree of darkening of their spots over
time.
Follow the instructions for application of SolagéSolution carefully. Avoid
getting the medication on your normal-toned skin, in your eyes, nose, or
mouth.
SolagéSolution can cause the side effect, halo hypopigmentation,
which is lightening of the skin surrounding the spot being treated,
within the 6 month treatment period.
Warning: Solagé Solution should not
be used if you are pregnant, attempting to become pregnant, or at a
high risk of pregnancy. Consult your doctor for adequate birth
control measures if you are a female of child-bearing potential.
Avoid sunlight and any other medicines that may increase your
sensitivity to sunlight (see below).
There is very limited information on the safety of SolagéSolution in people with
moderately or darkly pigmented skin.
What Can I Expect From Solagé Solution?
SolagéSolution is a
prescription medication used for the topical treatment of solar
lentigines, also known as brown “age” or“liver” spots.
Studies show that after 24 weeks,
for lesions of the face, 57% of patients using SolagéSolution had moderate
improvement or greater, with 3% experiencing complete clearing
of all treated lesions. Another 28% of patients had slight
improvement and 15% had no change or worse (less than 1%
of patients had worsening of their lesions).
After 24 weeks for
lesions of the forearms/back of hands, 54% of patients usingSolagéSolution
experienced moderate improvement or greater, with 1%
experiencing complete clearing of all treated lesions. Another 26% had slight improvement and 20% had no change or
worse (less than 1% of patients had worsening of their
lesions).
Approximately 9% of patients who had success in
the treatment of their age spots also experienced the side effect, halo
hypopigmentation, which is lightening of skin surrounding the treated
spot. Evidence has not been established concerning the effectiveness ofSolagéSolution in the
treatment of other hyperpigmented conditions of the
skin.
Improvement in the color of the treated age spots occurs
gradually. Don’t be discouraged if you see no immediate
improvement. Be patient.
If SolagéSolution is going to have a beneficial
effect for you, it may take up to six months of treatment before full
beneficial effects are seen. After stopping treatment with SolagéSolution, the age spots
may darken again over time.
The effectiveness of SolagéSolution in treating
solar lentigines, also known as brown “age” or“liver” spots, beyond 6 months has not been
established.
Who should not use Solagé Solution?
SolagéSolution
should not be used if you are pregnant, attempting to become pregnant,
or at a high risk of pregnancy. Consult your doctor for adequate birth
control measures if you are a female of child-bearing potential.
It
is not known if SolagéSolution is passed to infants through breast milk. Do not useSolagéSolution if you
intend to breast feed, unless advised otherwise by your
doctor.
SolagéSolution should not be used on children.
Do not useSolagéSolution if you
are allergic to any ingredients in this medicine. If you are allergic to
any of the ingredients, tell your doctor.
If you are sunburned, do
not use SolagéSolution
until you have fully recovered.
Do not use SolagéSolution if you have a skin condition
called eczema or other inflamed or irritated chronic skin
conditions.
Do not use SolagéSolution if you are inherently sensitive to sunlight or taking
other drugs that increase your sensitivity to sunlight. You should tell
your physician if you are also using other medicines that increase
sensitivity to sunlight. These medications include but are not limited
to: thiazides (used to treat high blood pressure), tetracyclines,
fluroquinolones or sulfonamides (used to treat infection), and
phenothiazines (used to treat serious emotional problems). If you are
taking any prescription medicines, non-prescription medicines or using any facial or skin creams, check with your physician to make sure they
do not interact with SolagéSolution.
There is very limited information on the safety
of SolagéSolution in
people with moderately or darkly pigmented skin.
If you, or a family
member, have a history of vitiligo (a skin condition consisting of white
patches on various parts of the body), consult your doctor before usingSolagéSolution.
How should I use Solagé Solution?
SolagéSolution is
to be used twice daily, at least eight hours apart, or as directed by
your doctor. It is a drug for topical use only and is not a cosmetic
preparation. Do not use SolagéSolution around your eyes, lips, creases of the nose or mucous membranes. SolagéSolution
may cause severe redness, itching, burning, stinging, and peeling if
applied to these areas. If the product gets in your eyes, rinse
thoroughly with water and contact your doctor.
Apply SolagéSolution to the age spots
using the applicator provided with the medication. Avoid application ofSolagéSolution to the
surrounding, normally colored skin. Only enough SolagéSolution should be applied to make the lesion appear moist – running or dripping
of the medication should be avoided. Applications of larger amounts ofSolagéSolution, or
more frequent applications than recommended, will not lead to more rapid
or better results, and marked redness, peeling, irritation or
hypopigmentation may occur. You should not shower or bathe the treatment
areas for at least 6 hours after application of SolagéSolution.
Stop
treating any age spots that become the same color or lighter than your
normally colored skin. If the skin surrounding an age spot becomes
lighter than your normally colored skin, stop treating that age spot and
contact your doctor regarding continued use of SolagéSolution to that age spot.
If you
forget or miss a dose of SolagéSolution, do not try to “make it up.”
Return to your normal application schedule as soon as you can.
If
sensitivity or increased irritation occurs, stop use of SolagéSolution and contact your
doctor.
If the age spots become darker with treatment, stop use ofSolagéSolution and
contact your doctor.
Do not use SolagéSolution for any condition other than for
which it was prescribed by your doctor. Do not give it to other persons
or allow other persons to use it.
You may use cosmetics after
applying SolagéSolution
but you should wait 30 minutes before applying.
What should I avoid while using Solagé Solution?
SolagéSolution
increases your sensitivity to sunlight. Sun exposure (natural or
artificial) to areas of the skin treated with SolagéSolution should be avoided. Wear
protective clothing if exposure to the sun cannot be avoided. Patients
using SolagéSolution
should practice a comprehensive sun protection program. Following
discontinuation of SolagéSolution, patients should continue to practice a comprehensive
sun protection program.
SolagéSolution should be used with caution if you are also using
other topical products with a strong drying effect on the skin, products
with high concentrations of alcohol, astringents, spices or lime,
medicated soaps, or shampoos, permanent wave solutions, electrolysis,
hair removal products or waxes, or other preparations or processes that
may dry or irritate your skin. If you are using any of these types of
products, tell your doctor before using SolagéSolution.
What are the possible or reasonably likely side effects of Solagé Solution?
SolagéSolution may
cause redness, stinging, burning or irritation on areas of the skin
where it is applied. It may also cause peeling and itching of the areas
where applied.
Excessive or prolonged application of SolagéSolution may cause the
treated age spots or surrounding skin to become temporarily lighter than
your normally colored skin. Discontinue application of SolagéSolution to any such
affected areas.
How can I get additional information?
This leaflet summarizes the most important information aboutSolagéSolution. If you would like more information, talk to your doctor.
How should Solagé Solution be stored?
SolagéSolution
should be protected from light by returning the bottle to the carton
after each use. Store at 25º C (77º F): excursions
permitted to 15-30ºC (59-86º F).
Solagé Solution is FLAMMABLE. Keep
away from heat or open flame.
Keep this and all medication out
of reach of children.
Marketed by:
Barrier Therapeutics, Inc.
Princeton, NJ
08540-6697 USA
Manufactured by:
Bristol-Myers
Squibb
Buffalo, NY 14213 USA
Revised February 2005
SO-002 For customer information call
866-440-5508
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Revised: 03/2007