Download The Relevance of Vehicle in Low-Potency

Supplement to the June 2010
&AGING
Series: Relevance of Low-Potency Topical Steroids in Dermatology
The Relevance of Vehicle in
Low-Potency Topical Steroids:
2 Case Studies of Pruritic Condition
Supplement supported by
®
HMP COMMUNICATIONS
83 GENERAL WARREN BLVD, SUITE 100, MALVERN, PA 19355 • (800) 237-7285 • (610) 560-0500 • FAX (610) 560-0501
EDITORIAL STAFF
DESIGN AND PRODUCTION
BUSINESS STAFF
EXECUTIVE EDITOR STEFANIE TULEYA
CREATIVE DIRECTOR VIC GEANOPULOS
VICE PRESIDENT/GROUP PUBLISHER RICK EHRLICH
MANAGING EDITOR ELLEN MEYER
ART DIRECTOR KAREN COPESTAKES
SPECIAL PROJECTS EDITOR STEPHANIE WASEK
PRODUCTION MANAGER MONICA McLAUGHLIN
2010-560-018-C
The Relevance of Vehicle in
Low-Potency Topical Steroids:
2 Case Studies of Pruritic Condition
Harold F. Farber, MD
Philadelphia, PA
V
ehicle selection in treating dermatologic disorders is
as important as the formulation you choose, as vehicle
greatly influences both treatment efficacy and patient
satisfaction. Lotions, gels, foams, creams and other vehicles
offer different benefits and drawbacks and, as a result, are appropriate for different conditions. This article will explore
considerations for vehicle selection in treating dermatologic
disorders and the importance of vehicle in topical steroid
therapy, as well as present two case studies.
DIFFERENTIATING THE VEHICLES
Vehicles such as ointments, creams and lotions are considered the gold standard for the treatment of atopic dermatitis
(AD) and other dry conditions because of their ability to
soothe and moisturize skin.1 Ointments are thought to be the
most hydrating of the three.1 Gels, solutions and powders are
more appropriate for “moist” conditions, such as contact dermatitis and infection.2 Foam-vehicle formulations are sometimes preferred for their easy spreadability.
Emollients will be the focus, as the case studies center on
AD and psoriasis.
CASE 1. Before: The patient presented with severe pruritus
and a severe flare limited to the forearms and dorsal surfaces of the hands. Cold weather, stress and exposure of
the extremities were contributing factors in the flare.
• Ointment. With a high oil content, ointment tends to be
greasy, which helps replace skin’s barrier function.3 Ideally,
this vehicle would be the basis of treatment for many dermatologic conditions. However, patients don’t like to use it —
often, they don’t like the feel, or find that ointments interfere
with their everyday activities. As such, it is generally recommended that this vehicle be prescribed only for chronic, thickened lesions.4,5 Ointments are often preservative-free, making
them less likely than certain other vehicles to cause allergy in
sensitive patients.3 However, patient preference scores for ointments are low, because they are greasy and messy.6
• Cream. Creams are less greasy and more spreadable than
ointments, so patients tend to like them better.This vehicle is more appropriate than ointments, but less so than
lotions, for use on weeping lesions in intertiginous zones
and on skin that is covered by hair.4,5 The greater water
content of creams usually requires additions to the formulation, which may be irritating to some patients.3
• Lotion.The high water content of lotions makes them easily
spreadable over large areas and tender areas, and less prone to
stain than ointments (and some creams).3,4 For these reasons,
CASE 1. After: Topical steroid therapy including Pramosone
TM
E Cream reduced the PGA of patient No. 1's lesions from
severe to excellent. His itch by VAS went from about 9 to
about 2.5.
S u p plem en t to S kin & A gin g
◆
Ju n e 20 10
3
EMOLLIENT LOW-POTENCY STEROIDS IN ATOPIC DERMATITIS
TABLE 1. VISUAL ANALOG SCALE (VAS) — MODIFIED
THE VAS IS A TOOL THAT ALLOWS PATIENTS TO ASSIGN QUANTITATIVE VALUES TO THEIR QUALITATIVE
EVALUATIONS OF THEIR SYMPTOMS, IN THIS CASE PRURITUS INTENSITY. THIS IS THE SCALE THAT WAS USED:
No pruritus
1
2
Mild
3
4
Moderate
5
6
Severe
7
8
Most severe pruritus
9
10
Note: Adapted from Aitken.10
lotions are well-accepted by patients. Lotions are also the ideal
vehicle for use on weeping lesions in intertiginous zones and
on skin that is covered by hair.4,5 However, as the water in a
lotion evaporates, it tends to dry the skin, so it may be important to add moisturizer to a regimen that will involve lotion.7
Patient satisfaction is tied closely to the treatment vehicle.
For example, asking a patient to use an ointment on AD in intertiginous areas can lead to a patient’s non-adherence with the
treatment plan, because the vehicle may be uncomfortable. Several vehicle characteristics have been shown to affect patient
preference, including ease or difficulty of use, messiness, odor
and staining.8 Further, studies show that patient preference and
adherence to the treatment regimen are linked more closely to
outcomes than the formulation of the therapy prescribed.2
VEHICLE AND TOPICAL STEROIDS
Patients are also less likely to adhere if they don’t feel the prescribed therapy is working.This is important with regard to vehicle selection, because the right choice can enhance the efficacy
of treatment with topical steroids.9 This means that vehicle affects
the disease process and, in turn, may affect patient compliance.8
The occlusion, bioavailability and lipid solubility are among the
vehicle factors that influence the potency of a steroid applied topically.5 The common wisdom is that steroid potency is highest in
oinment preparations, followed by creams and lotions.5 The knockon effect is that less steroid has to be used in the preparation, which
decreases the potential for steroid-related undesirable effects.1
The low-potency topical steroid (LPS) formulation of
Pramosone ETM Cream 2.5% combines hydrocortisone acetate
and pramoxine HCl to help treat conditions such as AD and
psoriasis. The low-strength hydrocortisone acetate in
Pramosone E Cream is a safe and effective LPS that acts as an
anti-inflammatory agent.10,11 Pramoxine hydrochloride is a
topical anesthetic with low irritation and sensitization potential that helps relieve the pain and pruritus associated with
these conditions, which helps break the itch-scratch cycle.10,11
The result is rapid onset and extended duration of itch relief that patients desire.12,13 Whenever possible and appropriate, use of a steroid-sparing agent is recommended.
CASE STUDY NO. 1: SEVERE, LIMITED FLARE
Patient No. 1, a 48-year-old male, has a 10-year history of atopic
dermatitis, including periods of moderate to severe flares. He pre4
Jun e 2010
◆
S up p lem en t t o Skin & Ag in g
sented with severe pruritus and a severe flare limited to the forearms and dorsal surfaces of the hands. Cold weather, stress and
exposure of the extremities were determined to be contributing
factors in the flare. On a visual analog scale (VAS), the patient
rated his pruritus intensity at 8 of 10 at baseline (see Table 1).14
Because of the severity of this flare, a high-potency topical
steroid was deemed appropriate. However, in order to minimize
potential steroid-related side effects, the high-potency steroid’s use
was pulsed with an LPS. Due to the isolated nature of this flare,
Pramosone ETM Cream was used for the latter purpose of minimizing steroid use. Potential secondary infection was checked for.
In terms of vehicle, cream provided the most concentrated
moisture in a vehicle that this particular patient found acceptable; i.e., it was unobtrusive and didn’t interfere with his work
and other daily activities. Because of its consistency, Pramosone
E Cream stays where it’s applied, which maximizes the benefit
for the affected areas and minimizes steroid effect on non-affected skin. (It’s important to note that the low-potency nature
of Pramosone E Cream means that undesirable effects such as
cutaneous atrophy are rare; however, it’s generally good practice to use steroid-sparing therapy wherever possible.)
The patient was started on combination therapy of potent
topical steroid pulsed with Pramosone E Cream. For the first
2 weeks, he used about 5 g of the potent topical steroid for 5
days, and 5 g of the Pramosone E Cream for 2 days, before repeating the cycle. For the second 2 weeks, the cycle was flipped:
Pramosone E Cream for 5 days, potent steroid for 2 days. Over
the last 2 weeks of treatment, the patient used Pramosone E
Cream 5 days a week and moisturizers every day.
At the end of 6 weeks’ treatment, the improvement in the
severity of his lesions, rated by physician’s global assessment
(PGA), was excellent (see Table 2), and the patient self-assessed
pruritus as mild (VAS 2 to 3).15 He uses moisturizers as the
bulk of his maintenance regimen. The patient also continues
to use the Pramosone E Cream on a strictly as-needed basis,
such as when triggers are present, or he starts to feel the
twinge that pruritus and a flare are imminent.
CASE STUDY NO. 2: MODERATE FLARE
Patient No. 2 is a 24-year-old male with a history of relatively mild whole-body atopic dermatitis. He presented with
a moderate flare over the legs and arms and a pruritus VAS of
6. Because of the diffuseness of his condition, Pramosone®
TABLE 2. PHYSICAN’S GLOBAL ASSESSMENT
THE PGA IS A FIVE-TIER SYSTEM IN WHICH A PHYSICIAN ASSIGNS A DEGREE OF IMPROVEMENT TO SUMMARIZE THE OVERALL QUALITY (ERYTHEMA, SCALING AND THICKNESS) AND EXTENT (BODY SURFACE AREA) OF
PLAQUES RELATIVE TO THE BASELINE ASSESSMENT.
Poor
0% to 24%
Fair
25% to 49%
Good
50% to 74%
Excellent
75% to 99%
Cleared
100%
Note: Adapted from Ashcroft.15
Lotion, which is easier to spread over large areas than an ointment, was deemed most appropriate. In addition, ointments
on large areas often inconvenience patients, as they take a long
time to dry and can make putting on clothes uncomfortable.
Along with minimizing triggers, the patient was started on
Pramosone® Lotion for 2 weeks: Pramosone Lotion BID, along
with a focus on using moisturizer.The following 2 weeks, lowpotent steroid therapy was tapered; the patient used Pramosone
lotion once a day for 5 days and kept up with moisturizer. For
the final 2 weeks, he used the Pramosone Lotion once every
other day and focused on moisturizing as often as possible.
At the end of 6 weeks’ treatment, the patient had achieved
almost-clear over the whole body, with little to no pruritus
(1 on the VAS). The patient’s maintenance therapy after this
point included using gentle cleanser and moisturizer, and
Pramosone lotion on a strictly as-needed basis.
CONCLUSION
Low-potency topical steroids such as the Pramosone line
are a key part of a maintenance regimen in which patients
should try to avoid triggers, use gentle cleansers, moisturize
adequately, and avoid hot showers and excessive water exposure. Patients who take all these steps are more likely to succeed, and patients are more likely to comply with treatment
if they have been well-educated by the clinician.
Many of the pruritic conditions we dermatologists see are
chronic and long-term, so patients must be involved in and educated to take ownership of their care. They know better than
anyone when they get those twinges that tell them they’re about
to have a flare — and they can use an LPS such as Pramosone
ETM Cream, for example, proactively rather than reactively.
When choosing among treatment options and vehicles, it’s
important to pick a product that’s safe for long-term use, with
minimal undesirable effects. Products in the Pramosone line
help reduce pruritus and reduce inflammation with a steroidsparing formulation that can be used solo or in combination
with other topical agents. The variety of vehicles lets you accommodate hydration needs, body geography and patient
preference for cosmetic acceptability.
There of course must be physician supervision, but enlisting
patients to join in the process can only help control their conditions. In teaching patients to prevent flares, there is a further
opportunity for dermatologists to offer patients the service
they desire — to not just treat them, but also enlist them in
minimizing their discomfort and the disruption of their daily
activities and in promoting quality of life. ■
References
1. Peterson JD, Chan LS. A Comprehensive management guide for atopic
dermatitis. Dermatol Nurs. 2006;18(6):531–542.
2. Marco CA. A Common Sense Guide to Dermatologic Therapy. Presented at: Scientific Assembly of the American College of Emergency
Physicians. Chicago, IL: October 29, 2008.
3. White GM, Cox NH. Diseases of the Skin: A Color Atlas and Text, 2nd Edition. St. Louis, MO: Mosby; 2005.
4. Tadicherla S, Ross K, Shenefelt PD, Fenske NA. Topical corticosteroids
in dermatology. J Drugs Dermatol. 2009;8(12):1093–105. Review.
5. Fitzpatrick JE, Aeling JL. Dermatology Secrets in Color, 2nd Edition.
Philadelphia, PA: Hanley and Belfus, Inc.; 2000.
6. Zivkovich AH, Feldman SR. Are ointments better than other vehicles for
corticosteroid treatment of psoriasis? J Drugs Dermatol. 2009;8(6):570–572.
7.Buck M, Roberts RJ, Hendrick AE, Rogers D. Topical corticosteroids in
children. Pediatric Pharmacotherapy. 1996;2(1):1–7.
8. Feldman SR, Housman TS. Patients’ vehicle preference for corticosteroid treatments of scalp psoriasis. Am J Clin Dermatol. 2003;4(4):221–224.
9. Ference JD, Last AR. Choosing topical corticosteroids. Am Fam Physician. 2009;79(2):135–140.
10. Littz J.Treatment of itching without corticosteroids. In: Bernhard J, editor. Itch
mechanisms and management of pruritus. New York: McGraw Hill; 1994, p. 383–397.
11. Mösges R, Domröse CM, Löffler J.Topical treatment of acute otitis externa: clinical comparison of an antibiotics ointment alone or in combination
with hydrocortisone acetate. Eur Arch Otorhinolaryngol. 2007;264(9):1087–1094.
12. University of Maryland Medical Center. Complimentary and Alternative Medicine Index: Pramoxine. 2009. Accessed April 10, 2010 at
http://www.umm.edu/altmed/drugs/pramoxine-104850.htm.
13. University of Maryland Medical Center. Complimentary and Alternative Medicine Index: Hydrocortisone. 2009. Accessed April 10, 2010 at
http://www.umm.edu/altmed/drugs/hydrocortisone-063400.htm.
14. Aitken RC. Measurement of feeling using visual analogue scales. Proc
RSocMed. 1969;62(10):989–993.
15. Ashcroft D, Li Wan Po A, Williams H, Griffiths C. Clinical measures of
disease severity and outcome in psoriasis: a critical appraisal of their quality.
Br J Dermatol. 1999;141(2):185–191.
S u p plemen t t o S kin & Ag in g
◆
Ju n e 20 10
5
Item #6957I
Rev
.: 09/09
Rev.:
Pramosone
Pram
osone
hydrocortisone acetate 2.5%
hydrocortisone
pramoxine
pramoxine HCl 1% Cream
2.5%
DESCRIPTION:
D
ESCRIPTION: Pramosone
Pramosone E ™ C
Cream
ream 2.5%
2.5% iis
s a ttopical
opical p
preparation
reparation c
containing
ontaining h
hydroydrocortisone
c
ortisone acetate
acetate 2.5%
2.5% w/w
w/w and
and pramoxine
pramoxine hydrochloride
hydrochloride 1
1%
% w/w
w/w in
in a H
Hydrolipid
ydrolipid™ base
base
containing
ceteth
mineral
c
ontaining cetostearyl
cetostearyl alcohol,
alcohol, c
eteth 20,
20, m
ineral oil,
oil, white
white petrolatum,
petrolatum, propylparaben,
propylparaben,
water..
triethanolamine lauryl sulfate, citric
c acid, sodium citrate, and purified water
Topical
T
opical corticosteroids
corticosteroids are
are anti-inflammatory
anti-inflammatory and
and anti-pruritic
anti-pruritic agents.
agents. The
The structural
structural formula,
formula,
the
the chemical
chemical name,
name, molecular
molecular formula
formula and
and molecular
molecular weight
weight for
for active
active ingredients
ingredients are
a re
presented
presented below.
below.
IInformation
nformation ffor
or tthe
he P
Patient:
atient: Patients
Patients using
using topical
topical corticosteroids
corticosteroids should
should receive
receive the
the
following information
inform
mation and instructions:
1. T
1.
This
his m
medication
edication iiss tto
ob
be
eu
used
sed a
ass d
directed
irected b
byy tthe
he physician.
physician. IItt iiss for
for e
external
xter nal u
use
se o
only.
nly.
A
Avoid
void contact
act with the eyes.
should
disorder
2. Patients sho
ould be advised not to use this medication
n for any disor
der other than for
which it was
was prescribed.
prescribed.
3. The treated
treated
d skin ar
area
ea should not be bandaged or ot
otherwise
herwise covered
covered or wrapped as
to be occlusive
sive unless directed
directed by the physician.
4. Patients should
ould rreport
eport any signs of local adverse reactions
reactions
ctions especially under occlusive
dressings.
dressings.
5. Par
Parents
ents of pediatric
p
patients should be advised not to
o use tight-fitting diapers or plastic
pants on a child being tr
treated
eated in the diaper ar
area,
ea, as these
t
garments may constitute
dressings.
occlusive d
ressings.
Laboratory
L
aboratory Tests:
Tests: The
The following
following ttests
ests may
may be
be h
helpful
elpful iin
ne
evaluating
valuating tthe
he HPA
HPA axis
axis suppression:
suppression:
Urinary fr
free
ee
e cortisol test
ulation test
ACTH stimulation
Carcinogenesis, M
utagenesis, a
nd IImpairment
mpairment of
of Fertility:
Fertility: Long-term
Long-term a
nimal sstudies
tudies
Carcinogenesis,
Mutagenesis,
and
animal
orr the
off
have
h
ave not
not been
been performed
performed to
to evaluate
evaluate the
the carcinogenic
carcinogenic potential
potential o
the effect
effect on
on ffertility
ertility o
corticosteroids.
Studies
determine
mutagenicity
with
prednisolone
and
hydrottopical
opical c
orticosteroids. S
tudies tto
od
etermine m
utagenicity w
ith p
rednisolone a
nd h
ydrocortisone have revealed
revealed negative results.
results.
Pregnancy:
P
regnancy: Teratogenic
Teratogenic Effects:
Effects: Pregnancy
Pregnancy Category
Category C:
C: C
Corticosteroids
orticosteroids a
are
re g
generally
enerally
animals
when
administered
att rrelatively
dosage
teratogenic iin
teratogenic
n llaboratory
aboratory a
nimals w
hen a
dministered ssystemically
ystemically a
elatively llow
ow d
osage
levels.
The
more
potent
have
be
after
dermal
levels. T
he m
ore p
otent corticosteroids
corticosteroids h
ave been
been sshown
hown tto
ob
e teratogenic
teratogenic a
fter d
ermal
application
animals.
There
are
adequate
and
well-controlled
application in
in llaboratory
aboratory a
nimals. T
h e re a
re no
no a
dequate a
nd w
ell-controlled sstudies
tudies in
in
pregnant
women
on
p
regnant w
omen o
n teratogenic
teratogenic effects
effects from
from topically
topically applied
applied corticosteroids.
corticosteroids. Therefore,
Therefore,
ttopical
opical c
corticosteroids
orticosteroids should
should b
be
e used
used d
during
uring pregnancy
pregnancy o
only
nly if
if the
the potential
potential benefit
benefit justifies
justifies
tthe
he p
potential
otential risk
risk tto
o tthe
he fetus.
fetus. D
Drugs
rugs o
off tthis
his c
class
lass sshould
hould n
not
ot b
be
eu
used
sed e
extensively
xtensively o
on
np
pregreglarge
prolonged
nant patients, iin
n lar
ge amounts, or for pr
olonged periods
ds of time.
CLINICAL PHARMACOLOGY:
CLINICAL
PHARMACOLOGY: T
Topical
opical c
corticosteroids
orticosteroids share
share a
anti-inflammatory,
nti-inflammatory, a
anti-pruritic
nti-pruritic
and vasoconstrictive actions.
The
The m
mechanism
echanism of
of a
anti-inflammatory
n t i- i n f la m m a to r y a
activity
c ti v i t y o
off ttopical
o p ic a l c
corticosteroids
orticosteroids iis
s unclear.
unclear. V
Various
a ri o u s
laboratory
assays,
are
used
compare
and
predict
laboratory methods,
methods, including
including vvasoconstrictor
asoconstrictor a
ssays, a
re u
sed tto
oc
ompare a
nd p
redict
potencies
p
otencies and/or
and/or clinical
clinical efficacies
efficacies of
of the
the topical
topical corticosteroids.
corticosteroids. There
There is
is some
some evidence
evidence
to
correlation
exists
between
potency
and
to ssuggest
uggest tthat
hat a rrecognizable
ecognizable c
orrelation e
xists b
etween vasoconstrictor
vasoconstrictor p
otency a
nd
therapeutic efficacy
efficacy in man.
Pramoxine
P
ramoxine hydrochloride
hydrochloride is
is a topical
topical anesthetic
anesthetic agent
agent which
which provides
provides temporary
temporary relief
relief from
from
itching and pain. It acts by stabilizing
stabilizin
ng the neuronal
neuronal membrane of nerve endings
endings with which
it comes into contact.
Pharmacokinetics: The
The extent
extent of
of percutaneous
percutaneous a
bsorption of
of ttopical
opical corticosteroids
corticosteroids is
is
Pharmacokinetics:
absorption
determined by many factors including
includin
ng the vehicle, the integrity of the epidermal
epiderm
mal barrier,
barrier, and
dressings.
the use of occlusive dr
essings.
Topical
T
opical corticosteroids
corticosteroids can
can be
be absorbed
absorbed from
from normal
normal intact
intact skin.
skin. Inflammation
Inflammation a
and/or
nd/or other
other
disease
d
isease processes
processes in
in the
the skin
skin increase
increase percutaneous
percutaneous absorption.
absorption. Occlusive
Occlusive dressings
dressings subsubstantially increase
increase the percutaneous
percutaneous absorption of topical corticosteroids.
corticosteroids. Th
Thus,
hus, occlusive
d
ressings may
may be
be a valuable
valuable therapeutic
therapeutic adjunct
adjunct for
for treatment
treatment of
of resistant
resistant dermatoses.
dermatoses.
dressings
(See DOSAGE AND ADMINISTRATION.)
ADMINISTRA
ATION.)
TION.)
O
nce absorbed
absorbed tthrough
hrough the
the skin,
skin, topical
topical corticosteroids
corticosteroids are
are h
andled through
through p
harmacoOnce
handled
pharmacokinetic pathways similar to systemically
systemiically administered
administered corticosteroids.
corticosteroids.
oids Corticosteroids
Cortic
costeroids are
are
bound to plasma proteins
proteins in varying
g degrees.
degrees. Corticosteroids
Corticosteroids are
are metabolized
metabolize
ed primarily in
tthe
he liver
liver and
and are
are then
then excreted
excreted by
by the
the kidneys.
kidneys. Some
Some of
of the
the topical
topical corticosteroids
corticosteroids and
and their
their
are
metabolites ar
e also excreted
excreted into the bile.
Nursing
N
ursing M
Mothers:
others: It
It is
is not
not known
known whether
whether topical
topical administration
administration of
of corticosteroids
corticosteroids could
could
result in
result
in sufficient
sufficient systemic
systemic absorption
absorption to
to produce
produce detectable
detectable amounts
amounts in
in breast
breast milk.
milk. SysSysttemically
emically a
administered
dministered c
corticosteroids
orticosteroids a
are
re ssecreted
ecreted into
into b
breast
reast milk
milk in
in quantities
quantities NOT
NOT likely
likely
tto
o have
have a deleterious
deleterious effect
effect on
on the
the infant.
infant. Nevertheless,
Nevertheless, caution
caution sshould
hould be
be e
exercised
xercised when
when
topical corticoster
corticosteroids
administered
woman.
steroids are
are administer
ed to a nursing wo
oman
oman.
Pediatric U
se: Pediatric
Pediatric patients
patients may
may demonstrate
demonstrate greater
gre
eater susceptibility
susceptibility to
to ttopical
opical corticortiPediatric
Use:
costeroid
c
osteroid iinduced
nduced HPA
HPA axis
axis suppression
suppression and
and Cushing's
Cushing's syndrome
syndro
ome than
than mature
mature patients
patients
because of a la
arger skin surface ar
rea to body weight rat
tio.
larger
area
ratio.
H
Hypothalamic-pituitary-adrenal
ypothalamic-pituitary-adrenal ((HPA)
HPA) a
axis
xis suppression,
suppression, C
Cushing's
ushing's ssyndrome,
yndrome, a
and
nd intraintrac
ranial h
ypertension h
ave b
e e n rreported
e p o r t e d iin
nc
h i l d re n rreceiving
e c e i v i n g ttopical
opical c
o r t i c o s t e ro i d s .
cranial
hypertension
have
been
children
corticosteroids.
Manifestations
M
anifestations of
of adrenal
adrenal suppression
suppression in
in c
children
hildren include
include linear
linear growth
growth rretardation,
etardation, delayed
delayed
weight
plasma
cortisol
and
absence
ACTH
weight gain,
gain, llow
ow p
lasma c
ortisol levels,
levels, a
nd a
bsence of
of response
response tto
oA
CTH sstimulation.
timulation.
Manifestations
off intracranial
hypertension
bulging
Manifestations o
intracranial h
ypertension iinclude
nclude b
ulging ffontanelles,
ontanelles, headaches,
headaches, and
and
bilateral papilledema.
papille
edema.
Administration
A
dministration of
of topical
topical corticosteroids
corticosteroids to
to children
children should
should be
be limited
limited to
to tthe
he least
least a
amount
mount
compatible
c
ompatible w
with
ith a
an
ne
effective
ffective ttherapeutic
herapeutic regimen.
regimen. C
Chronic
hronic corticosteroid
corticosteroid ttherapy
herapy m
may
ay iinternterfere with the growth
grrowth and development of children.
children.
fere
INDICATIONS AND
INDICATIONS
AND USAGE:
USAGE: Topical
Topical corticosteroids
corticosteroids are
are indicated
indicated for
for the
the relief
relief of
of the
the inflaminflammatory and pruritic manifestations of corticoster
oid-responsive dermatoses
s.
corticosteroid-responsive
dermatoses.
ADVERSE REACTIONS:
REACTIONS: The
The following
following local
local a
dverse rreactions
eactions are
are reported
reported infrequently
infrequently
ADVERSE
adverse
with topical
with
topical corticosteroids,
corticosteroids, b
but
ut may
may o
occur
ccur m
more
ore frequently
frequently with
with the
the use
use o
off o
occlusive
cclusive dresdresare
approximate
decreasing
order
occurrence:
sings. These rreactions
e
eactions
ar
e listed in an appr
oximate decr
reasing or
der of occurr
ence:
Burning
Bur
ning
Hypertrichosis
Maceration of the skin
Itching
Acneiform eruptions
Secondary infection
Irritation
Hypopigmentation
Skin atr
ophy
atrophy
Dryness
Striae
Perioral dermatitis
Folliculitiss
Allergic contact dermatitis
Miliaria
Allergic
CONTRAINDICATIONS: T
CONTRAINDICATIONS:
Topical
op ic al c
corticosteroids
orticosteroids a
are
re c
contraindicated
ontraindicated in
in those
t ho se p
patients
atients with
wi th a
history of hypersensitivity to any off the components of the pr
eparation.
preparation.
OVERDOSAGE:
O
VERDOSAGE: T
Topically
opically a
applied
pplied c
corticosteroids
orticosteroids can
can b
be
e absorbed
absorbed in
in sufficient
sufficient amounts
amounts
produce
systemic
effects.
to pr
oduce sys
stemic ef
fects. (See PRECAUTIONS.)
P
RECAUTIONS: G
eneral: S
ystemic a
bsorption o
opical c
orticosteroids h
as p
roduced
PRECAUTIONS:
General:
Systemic
absorption
off ttopical
corticosteroids
has
produced
reversible hypothalamic-pituitary-adrenal
reversible
hypothalamic-pituitary-ad
drenal (HPA)
(HP
PA) axis suppression,
suppression, manifestations
manifestattions of Cushing's syndrome,
syndrome, hyperglycemia,
hyperglycemia, and glucosuria in some patients. Conditions which
w
augment
ssystemic
ystemic a
bsorption include
include the
the application
application of
of tthe
he more
more potent
potent steroids,
steroids, use
use o
ver large
large
absorption
over
surface areas,
areas, pr
olonged use, and the addition of occlusive dr
essings.
prolonged
dressings.
Therefore,
T
herefore, patients receiving
receiving a large
large
e dose of a potent topical steroid
steroid applied to
t a large
large sursurfface
ace a
rea a
nd u
nder a
no
cclusive d
ressing sshould
hould b
ee
valuated p
eriodically ffor
or e
vidence of
area
and
under
an
occlusive
dressing
be
evaluated
periodically
evidence
of
HPA
H
PA axis
axis suppression
suppression by
by using
using the
the u
urinary
rinary free
free cortisol
cortisol and
and ACTH
ACTH stimulation
stimulation tests.
tests. If
If HPA
HPA
axis
a
xis suppression
suppression is
is noted,
noted, a
an
n attempt
attempt should
should be
be made
made to
to withdraw
withdraw the
the drug,
drug, to
to reduce
reduce the
the
frequency of application, or to substitute
subsstitute a less potent steroid.
steroid.
frequency
Recovery
R
ecovery of
of HPA
HPA axis
axis function
function is
is generally
generally prompt
prompt and
and complete
complete upon
upon discontinuation
discontinuation of
of
tthe
he d
rug. IInfrequently,
nfrequently, ssigns
igns a
nd ssymptoms
ymptoms o
t e ro i d w
ithdrawal m
ay o
ccur, rrequiring
equiring
drug.
and
off ssteroid
withdrawal
may
occur,
ssupplemental
upplemental systemic
systemic corticosteroids.
corticosteroids. Children
Children may
may absorb
absorb proportionally
proportionally larger
larger amounts
amounts
off topical
o
topical corticosteroids
corticosteroids and
and thus
thus be
be more
more susceptible
susceptible to
to systemic
systemic toxicity.
toxicity. (See
(See PrecauPrecautions-Pediatric Use.)
IIff irritation
irritation develops,
develops, topical
topical corticosteroids
corticosteroids should
should be
be discontinued
discontinued and
and appropriate
appropriate therapy
therapy
instituted.
IIn
n the
the presence
presence of
of dermatological
dermatological infections,
infections, the
the use
use of
of an
an appropriate
appropriate antifungal
antifungal or
or antiantibacterial agent should be instituted
d. If a favorable rresponse
esponse does not occurr pr
omptly the
instituted.
promptly
corticoster
oid should be discontinu
ued until the infection has been adequate
ely contr
olled.
corticosteroid
discontinued
adequately
controlled.
D
OSAGE AND
AND A
DMINISTRATION: T
opical c
orticosteroids a
re g
enerally a
pplied tto
o tthe
he
DOSAGE
ADMINISTRATION:
Topical
corticosteroids
are
generally
applied
a ff e c t e d a
re a a
s a tthin
hin ffilm
ilm tthree
hree tto
o ffour
our ttimes
imes d
aily d
epending o
n tthe
he sseverity
everity o
he
affected
area
as
daily
depending
on
off tthe
c
ondition. O
cclusive d
ressings m
ay b
eu
sed for
for tthe
he m
anagement o
psoriasis or
or recalrecalcondition.
Occlusive
dressings
may
be
used
management
off psoriasis
citrant conditions.
conditions. If
If an
an infection
infection d
evelops, tthe
he use
use o
cclusive d
ressings sshould
hould b
e
citrant
develops,
off o
occlusive
dressings
be
discontinued a
nd appropriate
appropriate antimicrobial
antimicrobial therapy instituted.
tituted.
and
H
OW SUPPLIED:
ED:
HOW
Pramosone E™ Cr
Cream
eam 2.5%
1 oz tube
2 oz tube
(NDC 0496-0708-04)
(NDC 0496-0708-03)
S
torage Conditions:
Conditions: S
tore a
5ºC (77ºF);
(77ºF); e
xcursions permitted
permitted to
to 1
5-30ºC (59-86ºF)
(59-86ºF)
Storage
Store
att 2
25ºC
excursions
15-30ºC
[see USP Controlled
Conttrolled Room T
emperature].
Temperature].
Pramosone
P
ramosone E™ and Hydrolipid™
Hydrolipid™ are
are trademark
trademarks
ks of Ferndale
Ferndale IP
IP,
P, Inc.
Protected
P
rotected under U.S. Patent No. 5,635,497
5,635,497
Item # 0726I
Rev.: 01/07
DESCRIPTION: Pramosone® Lotion is a topical preparation containing hydrocortisone
acetate 1% w/w or 2.5% w/w and pramoxine hydrochloride 1% w/w in a hydrophilic
lotion base containing stearic acid, cetyl alcohol, FORLAN-L (Contains: petrolatum, lanolin, hydrogenated coconut oil, sorbitan sesquioleate, stearyl alcohol, and cetyl alcohol),
glycerin, trolamine, polyoxyl 40 stearate, di-isopropyl adipate, povidone, dimethicone,
potassium sorbate, sorbic acid, and purified water.
Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural
formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below.
Information for the Patient: Patients using topical corticosteroids should receive the
following information and instructions:
1. This medication is to be used as directed by the physician. It is for external use only.
Avoid contact with the eyes.
2. Patients should be advised not to use this medication for any disorder other than
for which it was prescribed.
3. The treated skin area should not be bandaged or otherwise covered or wrapped as
to be occlusive unless directed by the physician.
4. Patients should report any signs of local adverse reactions especially under occlusive dressings.
5. Parents of pediatric patients should be advised not to use tight-fitting diapers or
plastic pants on a child being treated in the diaper area, as these garments may
constitute occlusive dressings.
Laboratory Tests: The following tests may be helpful in evaluating the HPA axis suppression:
Urinary free cortisol test
ACTH stimulation test
Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term animal studies
have not been performed to evaluate the carcinogenic potential or the effect on fertility
of topical corticosteroids. Studies to determine mutagenicity with prednisolone and
hydrocortisone have revealed negative results.
CLINICAL PHARMACOLOGY: Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions.
The mechanism of anti-inflammatory activity of topical corticosteroids is unclear. Various
laboratory methods, including vasoconstrictor assays, are used to compare and predict
potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence
to suggest that a recognizable correlation exists between vasoconstrictor potency and
therapeutic efficacy in man.
Pramoxine hydrochloride is a topical anesthetic agent which provides temporary relief
from itching and pain. It acts by stabilizing the neuronal membrane of nerve endings
with which it comes into contact.
Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is
determined by many factors including the vehicle, the integrity of the epidermal barrier,
and the use of occlusive dressings.
Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or
other disease processes in the skin increase percutaneous absorption. Occlusive
dressings substantially increase the percutaneous absorption of topical corticosteroids.
Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. (See DOSAGE AND ADMINISTRATION.)
Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids.
Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are
metabolized primarily in the liver and are then excreted by the kidneys. Some of the
topical corticosteroids and their metabolites are also excreted into the bile.
INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the
inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
CONTRAINDICATIONS: Topical corticosteroids are contraindicated in those patients
with a history of hypersensitivity to any of the components of the preparation.
PRECAUTIONS: General: Systemic absorption of topical corticosteroids has produced
reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of
Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Conditions which
augment systemic absorption include the application of the more potent steroids, use
over large surface areas, prolonged use, and the addition of occlusive dressings.
Therefore, patients receiving a large dose of a potent topical steroid applied to a large
surface area and under an occlusive dressing should be evaluated periodically for
evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw
the drug, to reduce the frequency of application, or to substitute a less potent steroid.
Recovery of HPA axis function is generally prompt and complete upon discontinuation
of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring
supplemental systemic corticosteroids. Children may absorb proportionally larger
amounts of topical corticosteroids and thus be more susceptible to systemic toxicity.
(See PRECAUTIONS-Pediatric Use.)
Pregnancy: Teratogenic Effects: Pregnancy Category C: Corticosteroids are generally
teratogenic in laboratory animals when administered systemically at relatively low dosage
levels. The more potent corticosteroids have been shown to be teratogenic after dermal
application in laboratory animals. There are no adequate and well-controlled studies in
pregnant women on teratogenic effects from topically applied corticosteroids. Therefore,
topical corticosteroids should be used during pregnancy only if the potential benefit
justifies the potential risk to the fetus. Drugs of this class should not be used extensively
on pregnant patients, in large amounts, or for prolonged periods of time.
Nursing Mothers: It is not known whether topical administration of corticosteroids could
result in sufficient systemic absorption to produce detectable amounts in breast milk.
Systemically administered corticosteroids are secreted into breast milk in quantities NOT
likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised
when topical corticosteroids are administered to a nursing woman.
Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical
corticosteroid induced HPA axis suppression and Cushing's syndrome than mature
patients because of a larger skin surface area to body weight ratio.
Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids.
Manifestations of adrenal suppression in children include linear growth retardation,
delayed weight gain, low plasma cortisol levels, and absence of response to ACTH
stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
Administration of topical corticosteroids to children should be limited to the least amount
compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may
interfere with the growth and development of children.
ADVERSE REACTIONS: The following local adverse reactions are reported infrequently
with topical corticosteroids, but may occur more frequently with the use of occlusive
dressings. These reactions are listed in an approximate decreasing order of occurrence:
Burning
Hypertrichosis
Maceration of the skin
Itching
Acneiform eruptions
Secondary infection
Irritation
Hypopigmentation
Skin atrophy
Dryness
Perioral dermatitis
Striae
Folliculitis
Allergic contact dermatitis
Miliaria
OVERDOSAGE: Topically applied corticosteroids can be absorbed in sufficient amounts
to produce systemic effects. (See PRECAUTIONS.)
DOSAGE AND ADMINISTRATION: Topical corticosteroids are generally applied to the
affected area as a thin film three to four times daily depending on the severity of the
condition. Lotion should be shaken well before use. Occlusive dressings may be used
for the management of psoriasis or recalcitrant conditions. If an infection develops, the
use of occlusive dressings should be discontinued and appropriate antimicrobial therapy
instituted.
HOW SUPPLIED: Pramosone® Lotion 1%
Pramosone® Lotion 2.5%
2 fl oz
4 fl oz
8 fl oz
2 fl oz
4 fl oz
(NDC 0496-0729-06)
(NDC 0496-0729-04)
(NDC 0496-0729-03)
(NDC 0496-0726-06)
(NDC 0496-0726-04)
Storage Conditions: Store at controlled room temperature 59º - 86ºF (15º - 30ºC).
If irritation develops, topical corticosteroids should be discontinued and appropriate
therapy instituted.
In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the
corticosteroid should be discontinued until the infection has been adequately controlled.
Pramosone® is a registered trademark of Ferndale IP, Inc.