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Topical
Gel USP,
EERYGEL
RYGEL(Erythromycin)
Topical Gel
USP,
2%2%
®
®
Front
For
For Dermatologic
DermatologicUse
UseOnly
Only- -Not
Notfor
forOphthalmic
OphthalmicUse
Use
Rx Only
Rx
DESCRIPTION
ERYGEL® Topical Gel USP, 2% contains erythromycin (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S
DESCRIPTION
L-ribo-hexopyranosyl)oxy]-14-ethyl-7,
12, 13-trihydroxy-3, 5, 7, 9, 11, 13-hexamethyl-6-[[3, 4, 6,-tride
oxy]oxacyclotetradecane-2,10-dione),
for topical dermatological use. Erythromycin is a macrolide antib
®
ERYGEL
Topical erythreus).
Gel USP,It2%
contains
erythromycin
(formerly
Streptomyces
is a base
and readily
forms salts with(3R*,
acids. 4S*,
5S*, 6R*,
7R*, 9R*,
11R*,
13S*,
14R*)-4-[(2,6-Dideoxy-3H67NO13.12R*,
It has the
following
structural formula:
Chemically,
erythromycin
is C37
al Gel USP, 2%
C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7,
12,
H C OH
HCH
CH
H
3
3
3
7, 9, 11, 13-hexamethyl-6-[[3, 4,
t for13-trihydroxy-3,
Ophthalmic5,Use
Rx6,-trideoxy-3Only
H
HO
CH3
H
H
(dimethylamino)-β-D-xylo-hexopyranosyl] HO
oxy]oxacyclotetradecaneCH
H
O
CH
C
2,10-dione), for topical dermatological use.H Erythromycin
is aH
N(CH )
H CH CH
O
O O
CH
macrolide
from
a strain
Saccaropolyspora
HO
hromycin
(3R*, antibiotic
4S*, 5S*,produced
6R*, 7R*,
9R*,
11R*,of12R*,
13S*,
14R*)-4-[(2,6-D
erythraea (formerly Streptomyces erythreus). It is a base and readily
3-trihydroxy-3, 5, 7, 9, 11, 13-hexamethyl-6-[[3, 4, 6,-trideoxy-3-(dimethylam
OCH
forms salts with acids.
CH
O
3
3
3
2
3 2
3
3
3
pical dermatological use. Erythromycin is a macrolide antibiotic produced from
Chemically,
H NO . It has the following strucErythromycin
haserythromycin
a molecular
weightis
ofC733.94.
37 67 It is13a white or slightly yellow, odorless or practically od
ase and
readily forms
salts with
acids.
in
very polar
organic solvents such as alcohols, acetone, chloroform, acetonitrile and ethyl acetate. It is
tural
formula:
s the dichloroethylene
following structural
formula:
and amyl acetate.
It is slightly soluble in nonpolar solvents such as hexane. It is very p
3
Each gram of ERYGEL® Topical Gel USP, 2% contains 20 mg of erythromycin USP in a vehicle consistin
H 3C H
H3C OH
CH
H
O
CLINICAL PHARMACOLOGY 3
H
The exact mechanism
by which erythromycin reduces lesions of acneCH
vulgaris is not fully known; howe
3
activity of the drug.
HO
H
O
O
H
MICROBIOLOGY
CH3
HO
H
Erythromycin acts by inhibition ofO protein synthesis in susceptible
organisms
by
reversibly binding to 50S
CH3
H 3C
transfer-RNA and
inhibiting polypeptide synthesis. Antagonism has been demonstrated in vitro between er
N(CH3)2
H CH2CH3
H
O
INDICATIONS AND USAGE
O O
CH
OH
for3 the topical treatment of acne vulgaris.
ERYGEL® Topical Gel USP, 2% is indicated
HO
CONTRAINDICATIONS
®
ERYGEL Topical Gel USP, 2% is contraindicated in those individuals who have shown hypersensitivity
OCH3
WARNINGS
CH3 with nearly all antibacterial agents, including erythrom
Pseudomembranous colitis has been reported
Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequen
with antibacterial agents alters the normal flora of the colon and may permit overgrowth of cl
.94. ItTreatment
is a white
or slightly
yellow, odorless or practically
odorless,
bitter cryst
difficile
is one primary
cause
of “antibiotic-associatedofcolitis”.
After It
theisdiagnosis
of pseudomembranou
Erythromycin
has
a molecular
733.94.
a white
or
ols, acetone,
chloroform,
acetonitrileweight
and ethyl
acetate.
It is
moderately
soluble
initiated. Mild
cases of pseudomembranous
colitis
usually respond
to drug
discontinuation
alone.
In mo
slightly
yellow,
odorless
or
practically
odorless,
bitter
crystalline
management
with fluids and
electrolytes,
protein
treatment
withsoluble
an antibacterial
tly soluble
in nonpolar
solvents
such
as supplementation
hexane. It isand
very
poorly
in wad
powder. Erythromycin is very soluble in very polar organic solvents
contains
of erythromycin
USP in a vehicle
consisting
of dehydrated alc
such20
asmg
alcohols,
acetone, chloroform,
acetonitrile
and ethyl
acetate. It is moderately soluble in less polar solvents such as ether,
n reduces
lesions of acne
is notItfully
known;soluble
however,
the effect appea
dichloroethylene
andvulgaris
amyl acetate.
is slightly
in nonpolar
395 as hexane. It is very poorly soluble in water.
solvents such
Each gram of ERYGEL® Topical Gel USP, 2% contains 20 mg of
thesiserythromycin
in susceptibleUSP
organisms
by reversibly
binding
to 50S ribosomal
subunits
in a vehicle
consisting
of dehydrated
alcohol and
esis. Antagonism
hascellulose.
been demonstrated in vitro between erythromycin, lincomy
hydroxypropyl
CLINICAL PHARMACOLOGY
or the topical treatment of acne vulgaris.
The exact mechanism by which erythromycin reduces lesions of
acne vulgaris is not fully known; however, the effect appears to be
ated indue
those
individuals
who have shown
to any of its compo
in part
to the antibacterial
activity hypersensitivity
of the drug.
MICROBIOLOGY
ted with nearly all antibacterial agents, including erythromycin, and may ran
Erythromycin
inhibition
of diarrhea
protein synthesis
in susceptible
iagnosis
in patientsacts
whobypresent
with
subsequent
to the administra
organisms
by reversibly
to 50Sovergrowth
ribosomal subunits,
thereby
e normal
flora of the
colon andbinding
may permit
of clostridia.
Studies in
inhibiting
translocation
of aminoacyl
transfer-RNA and inhibitssociated
colitis”.
After the diagnosis
of pseudomembranous
colitis has been e
polypeptide
synthesis.
Antagonism hasalone.
been demonstrated
colitising
usually
respond
to drug discontinuation
In moderate to severe ca
in vitro between erythromycin,
chloramphenicol,
and effecti
otein supplementation
and treatmentlincomycin,
with an antibacterial
drug clinically
clindamycin.
INDICATIONS AND USAGE
ERYGEL® Topical Gel USP, 2% is indicated for the topical treatment
of acne vulgaris.
Page 1
CONTRAINDICATIONS
ERYGEL® Topical Gel USP, 2% is contraindicated in those individuals
who have shown hypersensitivity to any of its components.
WARNINGS
Pseudomembranous colitis has been reported with nearly all
antibacterial agents, including erythromycin, and may range in
severity from mild to life-threatening. Therefore, it is important
to consider this diagnosis in patients who present with diarrhea
subsequent to the administration of antibacterial agents.
Treatment with antibacterial agents alters the normal flora of the
colon and may permit overgrowth of clostridia. Studies indicate that
a toxin produced by Clostridium difficile is one primary cause of
“antibiotic-associated colitis”. After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should
be initiated. Mild cases of pseudomembranous colitis usually
respond to drug discontinuation alone. In moderate to severe cases,
consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial
drug clinically effective against C. difficile colitis.
PRECAUTIONS
General - For topical use only; not for ophthalmic use. Concomitant
topical acne therapy should be used with caution because a possible
cumulative irritancy effect may occur, especially with the use of
peeling, desquamating or abrasive agents.
Avoid contact with eyes and all mucous membranes.
The use of antibiotic agents may be associated with the overgrowth
of antibiotic-resistant organisms. If this occurs, discontinue use and
take appropriate measures.
Information For Patients - Patients using ERYGEL® Topical Gel USP,
2% 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, nose, mouth,
and all mucous membranes.
2. This medication should not be used for any disorder other than
that for which it was prescribed.
3. Patients should not use any other topical acne medication
unless otherwise directed by their physician.
4. Patients should report to their physician any signs of local
adverse reactions.
Carcinogenesis, Mutagenesis, Impairment of Fertility - No
animal studies have been performed to evaluate carcinogenic and
mutagenic potential, or effects on fertility of topical erythromycin.
However, long-term (2-year) oral studies in rats with erythromycin
ethylsuccinate and erythromycin base did not provide evidence of
tumorigenicity. There was no apparent effect on male or female
fertility in rats fed erythromycin (base) at levels up to 0.25% of diet.
Pregnancy: Teratogenic Effects: Pregnancy Category B - There was
no evidence of teratogenicity or any other adverse effect on reproduction in female rats fed erythromycin base (up to 0.25% of diet)
prior to and during mating, during gestation and through weaning
of two successive litters. There are, however, no adequate and wellcontrolled studies in pregnant women. Because animal reproduction
studies are not always predictive of human response, this drug
should be used in pregnancy only if clearly needed. Erythromycin
Page 2
PRECAUTIONS
General - For topical use only; not for ophthalmic use. Concomita
has been
reported
to cross
thethe
placental
in humans,
but
may
occur,
especially
with
use ofbarrier
peeling,
desquamating
or ab
fetal plasma
levels
generally
low.
Avoid
contact
withareeyes
and all
mucous membranes.
Nursing
- It is agents
not known
whether
erythromycin
excretThe
useWomen
of antibiotic
may
be associated
withisthe
overgrowth
ed in human milk after topical application. However, erythromycin
®
Topical
Information
For
Patients
Patients
using
ERYGEL
is excreted in human milk following oral and parenteral erythromy-Gel USP
cin1.administration.
Therefore,
caution
be exercised
This medication
is to be
used should
as directed
by the when
physician. It is
erythromycin is administered to a nursing woman.
2. This medication should not be used for any disorder other than
Pediatric Use - Safety and effectiveness in pediatric patients have
3.been
Patients
should not use any other topical acne medication unle
not
established.
4.
Patients
shouldOF
report
to their physician any signs of local adv
KEEP OUT OF REACH
CHILDREN.
Carcinogenesis,
Mutagenesis, Impairment of Fertility - No anima
ADVERSE REACTIONS
topical erythromycin. However, long-term (2-year) oral studies in ra
In controlled clinical trials, the incidence of burning associated with
There
was no apparent effect on male or female fertility in rats fed e
ERYGEL® topical gel USP, 2% was approximately 25%. The followPregnancy:
Category
B - There wa
ing additionalTeratogenic
local adverse Effects:
reactionsPregnancy
have been reported
occasionally: peeling, dryness,
itching,
erythema,
and prior
oiliness.
Irritation
of mating
erythromycin
base (up
to 0.25%
of diet)
to and
during
the eyes and tenderness
skin have
also been
reportedanimal
with reprodu
well-controlled
studiesofinthe
pregnant
women.
Because
topicalneeded.
use of erythromycin.
A generalized
urticarial to
reaciftheclearly
Erythromycin
has been reported
cross the place
tion, possibly related to the use of erythromycin, which required
Nursing
Womentherapy
- It is has
not been
known
whether erythromycin is excreted
systemic steroid
reported.
and parenteral erythromycin administration. Therefore, caution sho
DOSAGE AND ADMINISTRATION
Pediatric
Use - Safety and effectiveness in pediatric patients have n
ERYGEL® Topical Gel USP, 2% should be applied sparingly as a
KEEP
OUT
OF REACH
OFonce
CHILDREN.
thin film
to affected
area(s)
or twice a day after the skin is
thoroughly cleansed
and patted dry. If there has been no improveADVERSE
REACTIONS
ment
after 6 toclinical
8 weeks,
or if the
worse,
In
controlled
trials,
thecondition
incidencebecomes
of burning
associated with
treatment should be discontinued, and the physician should be
have been reported occasionally: peeling, dryness, itching, erythem
reconsulted. Spread the medication lightly rather than rubbing it
use
of erythromycin. A generalized urticarial reaction, possibly relat
in. There are no data directly comparing the safety and efficacy of
b.i.d. versus
q.d.ADMINISTRATION
dosing.
DOSAGE
AND
®
Topical Gel USP, 2% should be applied sparingly as a thin
ERYGEL
HOW SUPPLIED
has been
no improvement after 6 to 8 weeks, or if the condition bec
ERYGEL® Topical Gel USP, 2% is available as follows:
medication
lightly rather than rubbing it in. There are no data directl
30 g sealed metal tube (NDC 40076-315-30)
HOW SUPPLIED
60 g®sealed
metal
Topical
Geltube
USP,(NDC
2% 40076-315-60)
is available as follows:
ERYGEL
STORAGE
30 g sealed metal tube (NDC 40076-315-30)
g sealed metal
40076-315-60)
Note - 60
FLAMMABLE.
Keeptube
away(NDC
from heat
and flame. Store and
dispense in original container. Keep tube tightly closed. Store at
STORAGE
20-25°C (68-77°F) [see USP Controlled Room Temperature].
Note
- FLAMMABLE. Keep away from heat and flame. Store and d
[see USP Controlled Room Temperature].
Manufactured for Prestium Pharma
Newtown, PA 18940
Manufactured by Perrigo
Manufactured for Prestium Pharma, Yeruham
Inc.
80500, Israel
Newtown, PA 18940
Made in Israel
000000000 Rev
Manufactured by Perrigo
Yeruham 80500, Israel
Made in Israel
Rev 8/13
395
COLORS
NFORMATION
PROD. #
hane
6J400
Page 3