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Galderma has a wide range of specialized products covering everything from skin
care to topical treatments for major dermatological conditions.
Capex® Shampoo is a low to medium potency corticosteroid indicated
for the treatment of seborrheic dermatitis of the scalp.
Treatment is simple and quick. Just once a day for five minutes is all it takes
for Capex® Shampoo to treat the inflammatory diseases related to
seborrheic dermatitis.
Millions of Americans are affected by seborrheic dermatitis. This noncontagious
skin disorder may appear as red, inflamed skin covered by greasy or dry scales that
are often white, yellowish, or gray. Anyone at any age can develop seborrheic dermatitis.
Not for use on patients under 12 years of age.
Capex® Shampoo is contraindicated in those patients with a history
of hypersensitivity to any of the components of the preparation. If irritation develops,
Capex® Shampoo should be discontinued and appropriate therapy instituted.
Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal
(HPA) axis suppression with the potential for glucocorticoid insufficiency after
withdrawal of treatment. Manifestations of Cushing’s syndrome, hyperglycemia and
glucosuria can also be produced in some patients by systemic absorption of topical
corticosteroids while on treatment.
Full Prescribing Information
Maintaining healthy skin throughout your life takes discipline and diligence. Following
a skin care regimen that includes daily use of Cetaphil® products
is the first step toward healthy skin.
Whether you're looking for moisturizers, cleansers or non-soap bars, Cetaphil®
products are an ideal complement to treatments for a host of common skin conditions.
They gently cleanse, soothe and soften dry skin without harming your skin's natural
protective barrier or normal pH balance.
To find out which Cetaphil® product is right for you, visit www.cetaphil.com.
Interested in seeing a dermatologist Locate one in your area with the DermFinder.
 Clindagel®
topical gel is a clinically proven once-a-day treatment for acne. It reduces the
inflammation and blemishes caused by acne. It’s oil-free and alcohol-free; its gel
formulation is easy to spread, absorbs quickly and feels smooth on your skin.
Acne is one of the most common of all skin problems. It affects most teenagers and
even many adults. Acne shows up as whiteheads, blackheads, pimples, and in some
people, deep painful bumps that look and feel like boils.
Clindagel® is contraindicated in patients with a history of hypersensitivity
to clindamycin or lincomycin, regional enteritis or ulcerative colitis, or antibiotic-associated
colitis. Use during pregnancy only if clearly needed. Clindagel®
is for topical use only. Orally and parenterally administered clindamycin has been
associated with severe colitis, which may result in patient death. Use of the topical
formulation of clindamycin results in absorption of the antibiotic from the skin
surface. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis)
have been reported with the use of topical and systemic clindamycin. When significant
diarrhea occurs, the drug should be discontinued.
Full Prescribing Information
To locate a dermatologist in your area, use DermFinder.
Clobex® (clobetasol propionate) Spray, 0.05% is a powerful initial
treatment for moderate to severe plaque psoriasis that comes in easy-to-use 2 oz
and 4.5 oz bottles with a focused 360°, non-aerosol, measured dose spray.
Clobex® (clobetasol propionate) Lotion, 0.05% provides the strength
of clobetasol cream with the light consistency of a lotion, which is alcohol, preservative
and fragrance free. Clobex Lotion provides powerful treatment for steroid responsive
dermatoses in a lotion. It’s easy-to-use, absorbs quickly into the skin.
Clobex® (clobetasol propionate) Shampoo, 0.05% combines the power
of clobetasol with the convenience of a washout shampoo. An easy-to-use scalp psoriasis
product, Clobex® Shampoo is applied just once a day for up to four
weeks providing relief from itching and flaking associated with moderate to severe
scalp psoriasis.
Important Safety Information for Clobex® Products
Clobex® (clobetasol propionate) Spray, Shampoo and Lotion, 0.05%,
are indicated to treat moderate to severe plaque psoriasis and are not recommended
for use on anyone younger than 18 years of age. Use only as directed. The
drug in Clobex® (clobetasol propionate) Spray, Shampoo and Lotion,
0.05%, can pass through your skin. Too much of the drug passing through your skin
may cause harm to your adrenal glands. To reduce this risk, your total combined
use of these products should not exceed 50g per week (50mL or 2 fl oz. Spray or
50mL or 1.75 fl oz. Shampoo or Lotion). Adrenal gland impairment can cause nausea,
vomiting, fever, low blood pressure, heart attack and even death, so be sure to
notify your doctor immediately if you experience any symptoms. Do not apply Clobex®
Spray, Lotion or Shampoo to your face, underarms, or groin, and avoid contact with
eyes and lips.
Other possible side effects with Clobex® Shampoo include mild burning,
itching, redness, dry skin, thinning of the skin, and widening of small blood vessels
in the skin. You should use Clobex® Shampoo, Clobex®
Spray, or Clobex® Lotion, 0.05%, for your psoriasis only for the
minimum period necessary to achieve desired results, as directed by your doctor.
You are encouraged to report negative side effects of prescription drugs to the
FDA. Visit www.fda.gov/medwatch,
or call 1-800-FDA-1088 (1-800-332-1088).
Click here for Full Prescribing Information:
Clobex® Spray,
Clobex® Lotion, and
Clobex® Shampoo
For more information on Clobex® Lotion, 0.05%, Clobex®
Shampoo, and Clobex® Spray, visit www.clobex.com.
Psoriasis is a disorder in which skin grows and replaces itself too rapidly, causing
a buildup of red, thickened areas with silvery scales. Psoriasis usually develops
on the scalp, elbows, knees and lower back.
To locate a dermatologist in your area, use DermFinder.
Differin (adapalene) products are proven medicines that get deep into pores to help
clear the acne you have and help keep new acne from starting. The Differin product
ingredients work under the skin's surface at the source of the problem. Topical
retinoids, like any Differin product, are the only class of drugs proven to treat
those blemishes that are present and prevent the formation of new ones.
Which Differin Product Is Right for Me?
Differin products come two ways: two different strengths, one in a gel and one in
a lotion (only a doctor can determine which is best for you). Whatever form you
use, Differin products help clear pimples.
• Differin (adapalene) Gel, 0.3% Pump is a clear gel with a powerful formulation
for those with more challenging acne. It comes with a convenient, easy-to-use pump
that dispenses 100% of the contents listed on the label. It works under the skin's
surface to unclog pores and clear up pimples.
• Differin (adapalene) Lotion, 0.1% Pump is the first lotion to contain adapalene,
which helps control the buildup that leads to acne. It comes in a convenient, easy-to-use
pump dispenser. Differin Lotion, 0.1% Pump helps prevent the formation of new acne,
and can also help treat acne that's already present.
Make an appointment and ask your doctor if a Differin Product would be right for
you.
Important Safety Information
Indication: DIFFERIN® GEL, 0.3% and DIFFERIN LOTION, 0.1%
are prescription medications known as retinoids and are indicated for the topical
treatment of acne vulgaris in patients 12 years and older. Adverse Events:
In controlled clinical studies, the most commonly reported (≥1%) adverse events
in patients treated with DIFFERIN GEL, 0.3% were dry skin, skin discomfort, pruritus,
desquamation, and sunburn. The most commonly reported (≥1%) adverse events in patients
treated with DIFFERIN LOTION, 0.1% were erythema, scaling, dryness, and stinging/burning.
Warnings/Precautions: The following apply to both DIFFERIN GEL, 0.3% and
DIFFERIN LOTION, 0.1%. Patients should minimize exposure to sunlight, including
sunlamps, while using DIFFERIN. If exposure cannot be avoided, sunscreen products
and protective apparel should be used. Weather extremes, such as wind or cold, may
be irritating to patients undergoing treatment. Avoid contact with the eyes, lips,
angles of the nose and mucous membranes. Do not use on cuts, abrasions, eczematous
or sunburned skin. As with other retinoids, use of waxing should be avoided on skin
treated with adapalene. Patients should use caution with use of DIFFERIN in combination
with products that are potentially irritating, have high concentrations of astringents
or alcohol, or contain sulfur, resorcinol, or salicylic acid.
You are encouraged to report negative side effects of prescription drugs to the
FDA. Visit www.fda.gov/medwatch
or call 1‐800‐FDA‐1088.
Click here for Full Prescribing Information: Differin Gel, 0.3% and Differin Lotion, 0.1%
For more information on Differin Gel 0.3% and Differin Lotion, 0.1%, visit www.differin.com
METROGEL® (metronidazole) 1% is the most powerful strength of topical
metronidazole available in a gel formulation to treat the inflammatory lesions associated
with rosacea. MetroGel 1% is now available in the innovative pump delivery system,
which offers measured dosing for consistent delivery. According to a Consumer Packaging
Preference Study involving 207 diagnosed rosacea patients, 69% preferred the pump
over the tube, believing it offers greater convenience for dispensing a prescription
rosacea medication*. These patients also reported that the innovative pump delivery
system is easy to use and wastes less medication.1
More than 16 million Americans are estimated to have rosacea, and while there is
no cure, proper treatment can make it manageable.2 In one study, patients
who used MetroGel 1% experienced a 71% median reduction in inflammatory lesions
(bumps and blemishes) after 10 weeks of treatment.3 MetroGel 1% has an
exclusive formula that contains HSA-3®, which is a combination of
ingredients including betadex, niacinamide (vitamin B3), and propylene glycol. In
a 92% water-based gel, these ingredients work together to help skin retain moisture
while enhancing absorption of metronidazole.
IMPORTANT SAFETY INFORMATION
Indication: METROGEL® 1% is indicated for the topical treatment
of the inflammatory lesions of rosacea. Adverse Events: In controlled clinical
studies, the most commonly reported adverse events (>2%) in patients treated with
METROGEL 1% were nasopharyngitis, upper respiratory tract infection, and headache.
Other adverse experiences reported when using topical metronidazole include skin
irritation, transient redness, metallic taste, tingling or numbness of the extremities
and nausea. Warnings/Precautions: METROGEL 1% should not be used by patients
who are allergic to metronidazole or any ingredient in METROGEL 1%. Avoid contact
of METROGEL 1% with the eyes as it may cause tearing. METROGEL 1% should be used
with caution in patients with evidence of, or a history of, blood dyscrasia, and
with patients taking blood thinning agents as they may experience prolonged prothrombin
times. METROGEL 1% treatment should be discontinued if numbness or paresthesia of
any extremity should occur.
You are encouraged to report negative side effects of prescription drugs to the
FDA. Visit www.fda.gov/medwatch
or call 1-800-FDA-1088.
Click here for Full Prescribing Information
*Claims are based on a Consumer Packaging Preference Study of 207 physician-diagnosed,
male and female rosacea patients aged 25 to 65 years. Patients were asked to complete
a self-administered Internet survey following video presentations highlighting the
steps involved when applying medication from a pump and a tube.
References:
1. Data on File. Galderma Laboratories, L.P.
2. The National Rosacea Society. “What Is Rosacea”. http://www.rosacea.org/index.php. Accessed on November 15,
2010.
3. MetroGel 1% Prescribing Information
Rosanil® Cleanser combines the active ingredients sodium sulfacetamide
10% and sulfur 5% and is indicated in the topical control of acne vulgaris, acne
rosacea and seborrheic dermatitis. Sodium sulfacetamide and sulfur help prevent
the growth of bacteria and fungi on the skin, which can cause pustules and papules
associated with acne, rosacea or seborrheic dermatitis.
Rosanil® Cleanser is unique to other sodium sulfacetamide/sulfur
cleansers on the market because it contains no masking fragrances that can irritate
sensitive skin.
ROSANIL® Cleanser is contraindicated for use by patients having known
hypersensitivity to sulfonamides, sulfur or any other component of this preparation.
ROSANIL® Cleanser is not to be used by patients with kidney disease.
Although rare, sensitivity to sodium sulfacetamide may occur. Therefore, caution
and careful supervision should be observed when prescribing this drug for patients
who may be prone to hypersensitivity to topical sulfonamides. Patients should be
carefully observed for possible local irritation or sensitization during long-term
therapy. If irritation develops, use of the product should be discontinued. For
external use only.
Full Prescribing Information
If you would like to visit a dermatologist and need to locate one in your area,
use DermFinder.
TRI-LUMA® (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin
0.05%) Cream is a medicine with three active components. You put TRI-LUMA Cream
on your face to treat a skin condition called melasma. Melasma consists of dark
(hyperpigmented) spots on facial skin, especially on the cheeks and forehead. This
condition usually happens with hormone changes.
This powerful combination of three active ingredients is more effective than any
of the individual components in reducing the darkened skin caused by melasma.*
Visible proof can be seen in as little as 4 weeks, with maximum results seen in
8 weeks. This convenient, well-tolerated cream is applied nightly before bed. To
learn whether Tri-Luma® Cream is right for you, visit www.triluma.com.
Important Safety Information
Indication: TRI‐LUMA® Cream is indicated for the short‐term
(up to 8 weeks) treatment of moderate to severe melasma of the face in the presence
of measures for sun avoidance, including the use of sunscreens. Adverse Events:
In the controlled clinical trials, the most frequently reported events were redness,
peeling, burning, dryness, and itching at the site of application. Warnings/Precautions:
TRI‐LUMA contains sulfites which may cause severe, life‐threatening allergic reactions
in people allergic to sulfites. TRI‐LUMA contains hydroquinone, which may cause
a gradual blue‐black darkening of the skin. If you are pregnant, nursing or trying
to become pregnant you should not use TRI‐LUMA. Safety and efficacy have not been
established in individuals with darker skin. Reversible HPA axis (adrenal function)
suppression may result from exposure to the topical corticosteroid, fluocinolone
acetonide, so discontinue use if signs and symptoms of this condition occur. Avoid
products that may dry or irritate the skin, such as abrasive cleansers, scrubs,
or skin‐peeling agents. Exposure to sunlight, sunlamps, or UV light and extreme
heat, wind, or cold should be avoided. If exposure cannot be avoided, sunscreen
products [SPF 30 or more] and protective apparel should be used.
You are encouraged to report negative side effects of prescription drugs to the
FDA. Visit www.fda.gov/medwatch
or call 1‐800‐FDA‐1088.
Click here for Full Prescribing Information
If you would like to visit a dermatologist and need to locate one in your area,
use DermFinder.
* Data on file, Galderma Laboratories, L.P.
DesOwen® Lotion is a low-potency topical steroid used to treat a
variety of skin disorders such as eczema and atopic dermatitis. This white, creamy,
moisturizing lotion spreads easily and is especially suitable for treating large
body areas and thin skin areas. It is more effective than hydrocortisone lotion
2.5% and safe hydrocortisone 1.0%.
DesOwen® Lotion is well tolerated. DesOwen® products
come in lotion, cream and ointment form and are available by prescription only.
Eczema is a term to describe specific skin diseases, including atopic dermatitis,
contact dermatitis, hand dermatitis and asteatotic eczema. It is an itchy, red,
scaling, weeping, oozing skin condition. Seborrheic dermatitis is a noncontagious
skin disorder that may appear as red, inflamed skin covered by greasy or dry scales
that are often white, yellowish or gray.
In controlled clinical trials, the total incidence of adverse reactions associated
with the use of desonide was approximately 8%. These were stinging and burning approximately
3%; irritation, contact dermatitis, condition worsened, peeling of the skin, itching,
intense transient erythema, and dryness/scaliness, each less than 2%.
If you would like to visit a dermatologist and need to locate one in your area,
use DermFinder.
Full Prescribing Information
Benzac® AC Gel and Wash are therapeutic, water-based benzoyl peroxide
treatments especially formulated for women with adult acne and teens with adolescent
acne.
Benzac® AC incorporates acrylates copolymer technology to deliver
moisturizing glycerin to dry, sensitive skin and absorb excess facial sebum. Micronized
benzoyl peroxide assures a smooth-textured, consistent formulation.
Benzac® AC Gel is indicated for the topical treatment of acne. Its
moisturizing formulation is perfect for treating women with adult acne, who can
have both acne and dry, sensitive skin. Teenagers with adolescent acne who have
extremely dry or sensitive skin are also good candidates for treating with Benzac®
AC Gel.
Benzac® AC Wash is a therapeutic water-based skin cleansing lotion
that moisturizes while it treats acne. It effectively and gently cleanses the skin
prior to further acne treatment.
Acne is one of the most common of all skin problems. Caused by an increase in the
production of hormones, acne affects most teenagers and even many adults.
If you think you may have eczema, seborrheic dermatitis or acne, use our Self-Assess
Your Skin Tool to find out more. To locate a dermatologist in your area, use DermFinder.
Allergic contact dermatitis and dryness have been reported with topical benzoyl peroxide
therapy.
If you would like to visit a dermatologist and need to locate one in your area,
use DermFinder.
Click here for Full Prescribing Information:
Benzac AC and Benzac W
Living with rosacea can sometimes be challenging because it is a chronic condition
caused by inflammation—but there is hope. Although rosacea cannot be cured, it can
be managed with proper treatment. Early diagnosis and treatment are recommended
by the NRS Expert Committee because symptoms of rosacea can get worse over time.
Therefore, the sooner you begin treatment the better. It’s important for you to
talk with your dermatologist to find out about the treatment options available.
ORACEA® (OR-RAY-SHA) (doxycycline, USP) 40 mg* is the first and only
oral therapy approved by the FDA to treat the bumps and blemishes of rosacea. In
clinical trials, many patients saw results in a little as 3 weeks, and these continued
through the full 16-week course of treatment.
Additionally, ORACEA is a convenient, offered in a once-daily pill, and is not an
antibiotic dose. Unlike traditional doses of doxycyclines (antibiotic at doses that
kill bacteria), the low-dose formulation of ORACEA does not work by killing bacteria;
instead, it reduces the bumps and blemishes of rosacea because of its anti-inflammatory
properties. That’s important because rosacea is a chronic, inflammatory skin condition-
not a bacterial infection. In clinical trials, ORACEA has not been shown to contribute
to antibiotic resistance.
One of your best defenses against any disease is knowledge. Ask your doctor if ORACEA
is right for you.
*30 mg immediate release & 10 mg delayed release beads
Important Safety Information
Indication: ORACEA® is indicated for the treatment of only
inflammatory lesions (papules and pustules) of rosacea in adult patients. Adverse
Events: In controlled clinical studies, the most commonly reported adverse
events (>2%) in patients treated with ORACEA were nasopharyngitis, sinusitis, diarrhea,
hypertension and aspartate aminotransferase increase. Warnings/Precautions:
ORACEA should not be used to treat or prevent infections. ORACEA should not be taken
by patients who have a known hypersensitivity to doxycycline or other tetracyclines.
ORACEA should not be taken during pregnancy, by nursing mothers, or during tooth
development (up to the age of 8 years). Although photosensitivity was not observed
in clinical trials, ORACEA patients should minimize or avoid exposure to natural
or artificial sunlight. The efficacy of ORACEA treatment beyond 16 weeks and safety
beyond 9 months have not been established.
You are encouraged to report negative side effects of prescription drugs to the
FDA. Visit www.fda.gov/medwatch
or call 1-800-FDA-1088.
Click here for Full Prescribing Information
Epiduo (adapalene and benzoyl peroxide) Gel 0.1%/2.5% is a prescription medication
for acne. It contains two acne-fighting ingredients, a retinoid called adapalene
and benzoyl peroxide. It’s the only FDA-approved topical acne treatment with this
powerful combination.
To learn more about Epiduo Gel and getting the most out of your Epiduo treatment,
visit Epiduo.com. If you are
a physician or healthcare professional and want to learn more about Epiduo Gel,
visit our HCP information site at hcp.epiduo.com.
Click here for Full Prescribing Information
Important Safety Information
Indication: EPIDUO® Gel is indicated for the topical treatment
of acne vulgaris in patients 12 years of age and older. Adverse Events: In
controlled clinical studies, the most commonly reported adverse events (≥1%) in
patients treated with EPIDUO Gel were dry skin, contact dermatitis, application
site burning, application site irritation and skin irritation. Warnings/Precautions:
Patients taking EPIDUO Gel should avoid exposure to sunlight and sunlamps and wear
sunscreen when sun exposure cannot be avoided. Erythema, scaling, dryness, stinging/
burning, irritant and allergic contact dermatitis may occur with use of EPIDUO Gel
and may necessitate discontinuation.
You are encouraged to report negative side effects of prescription drugs to the
FDA. Visit www.fda.gov/medwatch
or call 1‐800‐FDA‐1088.
Vectical® (calcitriol) Ointment is the only vitamin D3 ointment containing
calcitriol available for the treatment of mild to moderate plaque psoriasis.
Important Safety Information
Indication: VECTICAL® Ointment is indicated for the topical
treatment of mild to moderate plaque psoriasis in adults 18 years and older. Adverse
Events: In controlled clinical studies, the most commonly reported adverse
reactions (≥ 3%) were lab test abnormality, urine abnormality, psoriasis, hypercalciuria,
pruritus, and skin discomfort. Warnings/Precautions: The maximum weekly dose
should not exceed 200 g. Avoid contact with eyes, lips and face. VECTICAL®
Ointment should be used with caution in patients receiving medications known to
increase the serum calcium level, such as thiazide diuretics and in patients receiving
calcium supplements or high doses of Vitamin D. If aberrations in parameters of
calcium metabolism are noted discontinue VECTICAL® Ointment until
these normalize. Avoid excessive exposure of VECTICAL® Ointment treated
areas to either natural or artificial sunlight.
You are encouraged to report negative side effects of prescription drugs to the
FDA. Visit www.fda.gov/medwatch
or call 1‐800‐FDA‐1088.
Click here for Full Prescribing Information
The combination of Metvixia® (methyl aminolevulinate) Cream, 16.8%
(“Metvixia”) and Galderma’s Aktilite® CL128 LED (light-emitting diode)
lamp represent the next generation of photodynamic therapy for the treatment of
actinic keratoses (“AK”).
Actinic keratoses are very common lesions that occur on sun-damaged skin and are
widely considered to be a precursor to squamous cell carcinoma.
Metvixia Cream is a topical porphyrin precursor used in photodynamic therapy. When
applied to actinic keratosis lesions, Metvixia Cream is selectively absorbed into
precancerous cells causing a build-up of endogenous porphyrins. These endogenous
porphyrins are illuminated with the Aktilite CL128 lamp emitting a narrow output
spectrum of red light with a peak wavelength at 630 nm. Subsequently, a reaction
occurs that results in the destruction of the precancerous cells. Metvixia Cream
with PDT selectively targets precancerous cells so the surrounding healthy cells
are less subjected to the treatment, therein minimizing scarring and ensuring more
acceptable cosmetic outcomes for patients.
Important Safety Information
Indication: Metvixia Cream, a porphyrin precursor, in combination with the
Aktilite CL128 lamp, a narrowband, red light illumination source, is indicated for
treatment of thin and moderately thick, non-hyperkeratotic, non-pigmented actinic
keratoses of the face and scalp in immunocompetent patients when used in conjunction
with lesion preparation in the physician’s office when other therapies are considered
medically less appropriate. Adverse Events: Most common related adverse reactions
(incidence greater than 10% and greater than placebo) are erythema; pain, burning
and discomfort; pruritus; scabbing, crusting and erosions; edema and exfoliation
of the skin. Warnings/Precautions: Metvixia Cream is intended for topical
use in the physician’s office by physicians only. The recurrence rate of treated
lesions is unknown. Patients and providers should wear protective eyewear before
operating the Aktilite lamp. Patients should be cautioned with regard to protective
clothing after exposure to Metvixia. Do not apply to the eyes or to mucous membranes.
Metvixia Cream has demonstrated a high rate of contact sensitization.
Click here for Full Prescribing Information
Pliaglis® Cream is a topical anesthetic cream indicated for use on
intact skin in adults (18-65 yrs old) to provide topical, local anesthesia for cosmetic
and dermatological treatments such as laser procedures and dermal fillers.2
Pliaglis® Cream, the first and only FDA-approved topical anesthetic
that combines the highest concentrations of two powerful ingredients, lidocaine
7% plus tetracaine 7%, for rapid onset and lasting effect with the ability to form
its own occlusive barrier 1,2,3.
Product features:
. FDA approved prescription product3
. Packaged in two convenient options for medical
professionals - 30g or 100g tube
. Active ingredients: Lidocaine 7% and Tetracaine
7%
Product performance:
. When applied, the self-occluding cream is
easy to remove by hand or with gauze
. Works effectively on either the face or body
. Simple, comfortable application
. Onset of action:
- As early as 20 to 30 minutes; designed for
laser treatments, dermal fillers other superficial dermatological procedures 2
- 60 minutes for major dermatological procedures
(tattoo removal, leg vein ablation) 2
Pliaglis is not for home use by patient
Important Safety Information
Indication: PLIAGLIS® Cream 7% / 7% is indicated for use on
intact skin in adults to provide topical local analgesia for superficial dermatological
procedures such as dermal filler injection, pulsed dye laser therapy, facial laser
resurfacing, and laser‐assisted tattoo removal. Contraindications: PLIAGLIS®
Cream is contraindicated in patients with a known history of sensitivity to lidocaine
or tetracaine, or local anesthetics of the amide or ester type and is also contraindicated
in patients with sensitivity to para‐aminobenzoic acid (PABA) or any component of
the product. Adverse Events: In clinical studies, the most common local reactions
were erythema (47%), skin discoloration (16%), and edema (14%). The most common
systemic adverse events were headache, vomiting, dizziness, and fever, all of which
occurred with a frequency of <1%. Warnings/Precautions: Methemoglobinemia
has been associated with use of local anesthetics such as tetracaine. PLIAGLIS®
Cream should be used with caution in patients with severe hepatic disease. When
using PLIAGLIS® Cream in conjunction with other local anesthetic
agents, the total dose of anesthetic should be considered due to the potential for
additive systemic toxic effects. Contact with the eyes should be avoided.
You are encouraged to report negative side effects of prescription drugs to the
FDA. Visit www.fda.gov/medwatch
or call 1‐800‐FDA‐1088.
Click here for Full Prescribing Information
References:
1. Alster TS. The lidocaine/tetracaine pel: a novel topical anesthetic for dermatologic
procedures in adult patients. Dermatol Surg. 2007;33: 1073-1081.
2. Pliaglis® Prescribing Information; Galderma Laboratories. L.P.,
Fort Worth, TX; 2012
3. Electronic Orange Book. http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm.
Accessed September 10, 2012
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