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Shire
Pharmaceuticals
recently
released
Daytrana for the
treatment of
AD/HD in
children aged
6-12. Daytrana,
previously known
as the
Methypatch, was
developed based
on technology
from Noven
Pharmaceuticals.
The active
ingredient,
methylphenidate
is the same
chemical used in
Ritalin and
Concerta.
However, since
the Daytrana
encases the
methylphenidate
is in a skin
patch, the child
does not need to
swallow a pill.
Skin patches
have been used
to deliver a
variety of
medications
through the
skin. Many women
may be familiar
with the
estrogen/progestone
patches used for
Those who have
read the
Joey Pigza
books by Jack
Gantos may
remember that
Joey's AD/HD
medication was
in patch form.
Considering the
dates of that
book series,
Joey might have
been using
Catapress-TTS,
a patch form of
clonidine. (Clonidine
is not FDA
approved for the
treatment of
AD/HD but is
sometimes used
as a second-line
treatment.)
Years ago, I
would sometimes
use the
Catapress-TTS
patch as an
adjunct
treatment for
children who had
an incomplete
response to
stimulant
treatment. The
Catapress-TTS
patch was
designed to be
worn for seven
days. However,
patients
complained of
itching and
would often pull
it off. More
recently, there
have been
advances in the
types of skin
adhesives and
the patch
delivery system.
Noven
Pharmacuetical
developed the
patch system
used in Daytrana
and
several other
medications.
Daytrana uses
Noven's Dot
Matrix
Technology. this
system allows
smaller patches
with a larger
amount of drug.
The patch has
three layers.
The outside
layer protects
the active drug
layer from the
elements. The
middle layer
contains the
active
methylphenidate
interspersed
with the
adhesive. The
inner layer is a
protective film
with is removed
and discarded
when the patch
is applied.
Why use a patch?
Depending on the
medication,
there might be
several reasons
for using a
transdermal
patch instead of
a pill.
-
A patch
eliminates
the need to
swallow a
pill. Some
children
have
difficulty
swallowing
pills.
Methylphenidate
is available
in a liquid
form, but
the liquid
preparation
is
short-acting
and may
require
multiple
doses each
day.
-
A patch may
have a
longer
duration of
action than
an oral
medication.
Some
medications
such as
estrogen or
clonidine
patches, can
be worn for
several
days.
-
A patch can
promote
greater
flexibility
of dose
duration.
For example,
the Daytrana,
the
methylphenidate
patch can be
removed
earlier on
days when
one does not
need a long
duration of
action. For
children who
have
problems
with
appetite
suppression,
one might
remove the
patch
earlier if
the child
does not
have
homework of
after-school
activities.
-
Elimination
of first
pass drug
metabolism.
Medications
delivered
through the
skin pass
into the
blood stream
without
going
through the
digestive
system. If
an oral
medication's
absorption
is affected
by food
intake, this
could be
significant.
What are the
disadvantages of
a patch?
-
Non-compliance.
My main
problem with
the
Catapress-TTS
patches was
that
patients
would pull
them off.
Usually this
was because
of itching.
-
Lag time. It
is
recommended
that the
Daytrana
patch be
applied 2
hours before
the time one
wants to see
a drug
effect.
After the
patch is
removed, the
drug effect
gradually
wears off
over several
hours.
-
Increased
stimulant
side
effects.
When
Daytrana was
submitted to
the FDA,
they turned
it down in
2003 because
its side
effect
profile was
worse than
Concerta.
Shire and
Noven then
studied the
Daytrana
patch when
it was
applied for
9 hours.
This time
the studies
showed
stimulant-type
side effects
no greater
than those
seen with
other
stimulants.
-
Skin
sensitization.
In a study
specifically
designed to
look at skin
sensitization.
Subjects
wore the
Daytrana
patch on the
same site
for three
weeks. the
subjects
then had two
weeks
without the
patch. After
this they
wore the
patch again.
Under these
conditions,
at least
13.5% of the
subjects
were judeged
to be
sensitized
to Daytrana.
When
subjects
used
Daytrana as
directed,
none of them
spontaneously
reported
skin
sensitization.
However, the
subjects
WERE NOT
systematically
checked for
skin
sensitization.
Thus we do
not actually
know the
true
incidence of
skin
sensitization
when
Daytrana is
used as
directed.
Theoretically,
if one
develops a
true
sensitization
to the
Daytrana
patch, one
might also
develop a a
sensitization
to oral
methylphenidate.
If this
happened,
one might
not be able
to take
methylphenidate
pills.
-
Variation in
skin
absorption.
Heat can
increase the
rate of
absorption
of Daytrana
through the
skin. The
rate of
absorption
also changes
over time
even when
the
medication
is used as
directed.
When
Daytrana is
administered
for several
weeks, it is
absorbed
more quickly
and the peak
concentrations
are higher.
Since
methylphenidate
is
metabolized
rapidly,
this effect
is not
related to a
drug buildup
in the
child's
system. this
may meant
that it
takes longer
to determine
the optimal
dose.
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New Drug: We
do not have
controlled
studies of
the effect
of this
medication
after seven
weeks. I am
always
cautious
about using
a new
medication
or a new
medication
delivery
system.
Daytrana comes
in doses of. It
should be
applied to the
hip and the
location should
be rotated each
day.
The patch should
stay on while
the child is
swimming or
bathing.
However, since
heat can
increase the
drug absorption,
the patch should
not be exposed
to a heating
pad, an electric
blanket or a
heated water
bed. If the
skin is
irritated the
absorption will
also be
significantly
increased.
The patch comes
in sizes that
release 10mg,
15mg, 20mg and
30mg over 9
hours.
Potential side
effects, (other
than skin
sensitization)
are the same
type of symptoms
seen with the
oral stimulants.
the more common
side effects
include appetite
suppression,
insomnia,
irritability,
stomach upset,
and weight loss.
Rarer, more
severe stimulant
side effects
could
potentially
include
seizures,
cardiac events,
elevated blood
pressure, tics,
psychosis and
mania.
Should you use
Daytrana? I
would not
recommend using
this medication
as a first line
treatment for
AD/HD. It might
fill a small
niche for
children who
need a
long-acting
stimulant but
who cannot
swallow pills.
Often, if a
child trouble
swallowing the
pills, one can
help this by
understanding
the child's
fears about the
medication or by
teaching the
child how to
swallow the
pills.
Daytrana needs
further study
including
extended time,
controlled
studies in which
the skin
sensitization is
assessed
systematically
for each
patient. If you
do not ask about
a side effect,
you will usually
get a lower
incidence than
if you always
look for a
specific side
effect. When
researchers did
not specifically
ask about sexual
side effects
with the SSRI
antidepressants,
they got a very
low spontaneous
report of this
side effect.
When later
studies
specifically
asked everyone
about sexual
side effects,
the incidence
went up
drastically.
Shire and Noven
Pharmaceuticals
are currently
working on a
patch which
would deliver
amphetamine. At
present it is in
the pre-clinical
(very early)
stages of
development.
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Copyright © 2006 Northern County
Psychiatric Associates
Last modified:
October 05, 2007 |
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