Download Ketoprofen and Gabapentin in Anhydrous Gel Base for Migraines

Did You Know?
A patient’s pain may not come from
the site where it is perceived.
W I N T E R
Did You Know?
Compounded preparations often allow
lower dosages than commercially
available medications.
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Volume 7, Number 1
I N T E R V I E W
Compounding for Orofacial Pain Management
SAMPLE
An Interview with Gary M. Heir, DMD, AAOP
Gary M. Heir, DMD, an expert in the management of orofacial pain, is an associate clinical
professor in the Department of Oral Medicine at
the Newark campus of the University of Medicine
and Dentistry of New Jersey. A past president
of the American Academy of Orofacial Pain
(AAOP), he maintains a solo private dental
practice in Bayonne, New Jersey. Here, Dr. Heir
explains the use of compounded medications to
treat chronic pain disorders that affect the head,
neck, and face.
Explain the pathogenesis of orofacial pain.
Contrary to popular belief, temporomandibular disorders account for only a portion of
orofacial pain, which is defined as any chronic
complex pain disorder of neurologic, muscular,
vascular, or psychogenic origin that affects the
head, neck, and/or face. Orofacial pain is not
caused by the average toothache or a locked
temporomandibular joint, and it is not an
acute-onset condition for which an immediate
cause and effect can be established and an
C A S E
obvious treatment identified. It is usually
caused by one or more chronic conditions that
can elude diagnosis, and it may persist for
months or years if an effective treatment is
not identified.
Describe some of the most common types of
orofacial pain and how compounds are used to
treat them.
The more peripheral the pain, the more likely
I am to prescribe a compounded medication.
Compounds are very effective in treating
orofacial pain because they can be formulated
for the specific medical needs of the patient.
Trigeminal deafferentation toothache
(atypical odontalgia)
A very small number of dental patients
experience trigeminal deafferentation
toothache, which can develop weeks, months,
or (occasionally) years after trauma to a tooth
or even after an innocuous dental treatment
Continued on reverse
R E P O R T
Ketoprofen and Gabapentin in Anhydrous Gel Base
for Migraines
Leo Blais, RPh
Beverly Blais, CPhT
Leigh Corbin
Pawtuxet Valley Prescription and Surgical
Center, Inc.
Coventry, Rhode Island
A 42-year-old white woman was referred to us
by a local neurologist in September 2002. She
had had severe, debilitating migraines for the
past 13 years. During that time, she had taken a
variety of medications, both prescription and
nonprescription, without relief. At the time of
the consultation, she was having eight to ten
migraines per month. She had been prescribed
the antimigraine agent zolmitriptan (Zomig)
5 mg tablets and would take 1 tablet as soon as
she felt a headache coming on, but got little
relief. She rated the headache pain as 9 or 10
on a 10-point scale with 10 as most severe. The
pain was severe enough that she would have to
stay home from work, and she was missing
about 8 days of work each month.
The patient was in good general health and
had no other medical problems. She took
no other medications. Tired of living with
the pain, she consulted a neurologist. He
Continued on reverse
In one of my patients, facial postherpetic
neuralgia affected an area in one ear. The pain
from that condition prevented her from lying
comfortably with her head on a pillow,
holding a telephone receiver to her ear, and
going outside, because the pressure of wind on
the affected area was painful. I knew that a
tricyclic antidepressant (the first choice of
therapy) would produce a constellation of
adverse effects such as increased appetite,
thirst, urinary retention, and somnolence. A
standard dosage of gabapentin (Neurontin)
might have relieved the pain, but the patient
may then have been too sleepy to work. This
patient’s facial postherpetic neuralgia has been
successfully relieved by a compounded antiepileptic medication formulated for topical
application. When occasional breakthrough
pain occurs, she applies a standard lidocaine
patch (Lidoderm patch 5%) that she has cut to
the size of a 50-cent piece and wears it for the
remainder of that day.
had to refill their appliance 6 to 10 times daily
eventually reduced the number of stent refills
to once daily or a couple of times weekly, and
their need for systemic medication was
reduced or eliminated.
How are compounds used to relieve pain
caused by other oral disorders?
A variety of compounds containing medications such as corticosteroids or other antiinflammatory drugs are useful in everyday
practice to treat orofacial pain of musculoskeletal origin. Guaifenesin is also effective in the
treatment of muscle pain and in myofascial
trigger-point therapy, especially when combined with physical therapy. This regimen has
shown promise in many patients.
Dentists can use compounds containing
misoprostol and lidocaine to resolve intraoral
ulcers caused by autoimmune disease, chemotherapy, or radiation therapy. Viral ulcers may
respond to therapy with 2-deoxy-D-glucose.
The list of helpful compounded medications is
lengthy. In the future, topical opioids and other
medications now thought to act only on the
central nervous system may be used to treat
chronic orofacial pain.
Traumatic trigeminal neuralgia
Compounded medications are also effective
in the treatment of traumatic trigeminal
neuralgia, which is characterized by bright,
sharp bolts of paroxysmal pain that may be
spontaneous or triggered by innocuous light
touch. As a test for that disorder, I apply a
Lidoderm 5% patch to the area of suspected
neuropathic pain. If the patch provides relief,
I know that topical analgesics may work.
Neurologically active medications (lidocaine,
capsaicin, ketoprofen, ketamine, carbamazepine, gabapentin, and sometimes clonidine)
that stabilize the membranes of sensitized
nerves can then be compounded for topical
application either as monotherapy or in
various combinations. Patients can also relieve
their traumatic trigeminal neuralgia or
trigeminal deafferentation toothache by using
Orabase Protective Paste (pectin/gelatin/
sodium carboxymethylcelluose in plasticized
hydrocarbon gel) to affix a neurosensory stent
(a custom-made acrylic appliance designed to
fit over the affected area) filled with the
prescribed compound. The medication is
conveyed directly to the site of the patient’s
pain, and the appliance can be refilled and
reapplied to sustain relief. For many patients,
that treatment has proven remarkably
effective. Some of my patients who initially
SA
M
PL
Postherpetic neuralgia
Facial postherpetic neuralgia can develop
when herpes simplex virus that was dormant
in the trigeminal nerve ganglion for years
somehow becomes reactivated. As the virus
leaves the ganglion of the trigeminal nerve and
makes its way along the nerve route to the
peripheral innervation, tiny ulcers erupt and
the patient notices a tingling sensation in the
distribution of the affected nerve. The erupted
ulcers eventually coalesce, form a crust, dry,
and resolve. Most patients experience no
residual symptoms. In some cases, however,
any of several factors (the virulence of the
virus, the immunoresistance of the patient,
and the extent of damage to the nerve route or
the sites on the skin at which the eruptions
occurred) may produce an enduring, painful
sensitization of the peripheral receptors.
Damage to the primary afferent nociceptor
nerves can also cause postherpetic pain, as can
central neuroplastic changes in the dorsal root
ganglion of the spinal cord. Selectively compounded pharmacologic agents can target
those pain-trigger sites and provide relief. A
compounded topical analgesic that targets
injured tissue is often the only medication
necessary to produce long-term relief, or it may
augment necessary systemic medications that
can then be given at a reduced dose. Eliminating or reducing the use of systemic medications
limits or prevents the adverse effects caused by
many of the medications used to treat
postherpetic neuralgia. This is important
because many patients afflicted with that
disorder are medically compromised or elderly.
E
Heir Continued
such as an endodontic procedure or the use of
deep curettage in dental cleaning. Recognizing
the source of that pain is very important. The
pain is caused by damage to the sensory
innervation of the treated oral region and is
characterized by chronic pressure, pain, or a
burning sensation that can spread into the
gum and cheek and may be referred to the
opposite side of the oral cavity. Treatment with
common analgesics such as aspirin, acetaminophen, or codeine is ineffective. Attempting
to relieve that pain by repeating an endodontic
procedure in a patient with no obvious dental
pathology or performing an apicoectomy may
be a mistake, as is removing the painful tooth.
In fact, additional invasive procedures may
worsen the symptoms. Because deafferentation
toothache is a type of neuropathic pain that
affects the central nervous system, it cannot
be eliminated with a local injection of an
anesthetic such as procaine (Novocain). A
compounded formulation of medications
including lidocaine, an antiepileptic or antiinflammatory drug, and (occasionally)
capsaicin often provides rapid relief.
What should your colleagues know
about the use of compounds to treat
orofacial pain?
The effective management of orofacial pain
involves understanding pain mechanisms and
appropriately targeting pain triggers. Compounds can be individualized in formulation
and dosage form for each patient. As a result,
they are more effective than mass-produced
drugs and produce fewer adverse effects,
they can often be used in lower doses than
commercially available medications, and they
can reduce or eliminate the need for other
analgesic medications. Although compounds
may not always replace systemic medications,
they often can be used to augment conventional pharmacotherapies while causing few or
no adverse effects. Because chronic orofacial
pain is difficult to diagnose and treat, an
imaginative approach to the management of
more refractory disease is often necessary. The
adage “If you can think of it, they can make it”
certainly applies to the skill of my compounding pharmacists, whose efforts help to ensure a
successful treatment outcome.
For additional information, contact Gary M.
Heir, DMD, 718 Broadway, Bayonne, New Jersey
07002. E-mail: [email protected].
Migraines Continued
recommended a topical preparation that has
been shown to alleviate pain in a variety of
strengths.1-3 He prescribed a combination of
ketoprofen 4% and gabapentin 5% in an
anhydrous gel base for good skin penetration.
The medication was dispensed on September
27, 2002, and the patient was instructed to
apply a small dab (smaller than a pea) to a
trigger point on her forehead every day,
regardless of whether she had a migraine.
The woman followed the neurologist’s advice
and began using the gel preparation as
prescribed. She applied the gel every evening
before going to bed. Within weeks she
experienced substantial relief of her migraines. After 14 months, she continues to
use the gel daily. At a recent follow-up
consultation with pharmacy staff, she
reported that she is having only one or two
migraines per month and that the severity of
the pain is greatly reduced. She continues to
take one 5-mg zolmitriptan tablet at the first
sign of migraine. She rated the severity of her
migraine pain as 3 on the 10-point scale. She
has experienced no adverse effects or other
problems using the topical preparation. She
is very pleased with the treatment, and so is
her employer.
According to the National Headache Foundation (NHF), more than 45 million Americans
suffer from headache. The pain and associated
symptoms (nausea, vomiting, impaired vision)
can be so severe that the person’s ability to perform everyday work, school, family, and social
activities is adversely affected. The NHF
estimates industry losses of approximately $50
billion per year owing to absenteeism, lost
RxTriad-A publication of the International Journal of Pharmaceutical Compounding. © 2004 IJPC. All rights reserved.
productivity, and medical expenses due
to headache.4
References
1. Jones M. Chronic neuropathic pain: Pharmacological interventions in the new millennium: A theory
of efficacy. IJPC 2000; 4: 6-15.
2. Jones M. Clinical nuggets and pearls: Chronic
neuropathic pain and opioid tolerance. IJPC 2002;
6: 4-6.
3. Pratt S. Case report: Ketoprofen 5% and
gabapentin 5% gel for neuropathy. IJPC RxTriad
August 2003; 6(10): 1-2.
4. Simons S. Take control of your headaches, take
control of your life. National Headache Awareness
Week, June 1-7, 2003 [press release]. Chicago, IL:
National Headache Foundation; May 9, 2003.
Available at: http://www.headaches.org/consumer/
presskit/NHAW03 NHAWnewsrelease.pdf.
Accessed December 2, 2003.