Topiramate
and
Neuropathy
Brand names Topamax®
Why is this medication prescribed?
Topiramate is used
with alone or with other medications to treat certain
types of seizures in people who have epilepsy.
Topiramate is also used with other medications to
control seizures in people who have Lennox-Gastaut
syndrome (a disorder that causes seizures and
developmental delays). Topiramate is used to treat
patients who continue to have seizures even when they
take other anti-seizure medications. Topiramate is also
used to prevent migraine headaches, but not to relieve
the pain of migraine headaches when they occur.
Topiramate is in a class of medications called
anticonvulsants. It works by decreasing abnormal
excitement in the brain.
How should this medicine be used?
Topiramate comes as a
tablet and a sprinkle capsule (capsule that contains
small beads of medication that can be sprinkled on food)
to take by mouth. It is usually taken with or without
food twice a day in the morning and evening. Take
topiramate at around the same times every day. Follow
the directions on your prescription label carefully, and
ask your doctor or pharmacist to explain any part you do
not understand. Take topiramate exactly as directed. Do
not take more or less of it or take it more often than
prescribed by your doctor.
There is another
medication with a name similar to the brand name for
topiramate. You should be sure that you receive
topiramate and not the similar medication each time you
fill your prescription. Be sure that the prescription
your doctor gives you is clear and easy to read. Talk to
your pharmacist to be sure that you are given topiramate.
After you receive your medication, compare the tablets
to the pictures in the manufacturer's patient
information sheet. If you think you were given the wrong
medication, talk to your pharmacist. Do not take any
medication unless you are certain it is the medication
that your doctor prescribed.
Topiramate tablets
have a bitter taste and lose their effectiveness quickly
when broken, so you should swallow them whole. Do not
split, chew, or crush them.
Your doctor will
probably start you on a low dose of topiramate and
gradually increase your dose, not more than once every
week.
Topiramate may
control your seizures or migraines, but will not cure
your condition. Continue to take topiramate even if you
feel well. Do not stop taking topiramate without talking
to your doctor. If you suddenly stop taking topiramate,
you may have severe seizures, even if you have not had
seizures in the past. Your doctor will probably decrease
your dose gradually.
The sprinkle capsules
may be swallowed whole or opened and poured over food.
To take the sprinkle capsule with food, follow these
steps:
- Prepare a teaspoonful of soft
food such as applesauce, custard, ice cream,
oatmeal, pudding, or yogurt.
- Hold the capsule upright over the
food. You should be able to read the word 'TOP' on
the capsule.
- Twist off the clear part of the
capsule and pour the entire contents onto the
spoonful of food.
- Swallow the entire mixture
immediately without chewing.
- Drink fluids right after
swallowing to wash down the mixture and to be sure
that you swallow all of it.
Other uses for this medicine
Topiramate is also
used for the management of alcohol dependence. Talk to
your doctor about the risks of using this medication for
your condition.
What special precautions should I
follow?
Before taking
topiramate,
- tell your doctor and pharmacist
if you are allergic to topiramate or any other
medications.
- tell your doctor and pharmacist
what prescription and nonprescription medications,
vitamins, nutritional supplements, and herbal
products you are taking. Be sure to mention any of
the following: acetazolamide (Diamox);
amitriptyline; antidepressants; antihistamines;
dichlorphenamide (Daranide); digoxin (Lanoxin,
Digitek); ipratropium (Atrovent); iron; isoniazid
(INH, Nydrazid); hydrochlorothiazide (Microzide,
Oretic); lithium (Eskalith, Lithobid); medications
for anxiety, irritable bowel disease, mental
illness, motion sickness, Parkinson's disease,
ulcers, or urinary problems; metformin (Glucophage);
methazolamide; oral contraceptives (birth control
pills); other medications for seizures such as
carbamazepine (Tegretol) and phenytoin (Dilantin,
Phenytek); pioglitazone (Actos); risperidone
(Risperdal); salicylate pain relievers such as
aspirin, choline magnesium trisalicylate
(Trisalate), choline salicylate (Arthropan),
diflunisal (Dolobid), magnesium salicylate (Doan's,
others), and salsalate (Argesic, Disalcid,
Salgesic); sedatives; sleeping pills; tranquilizers;
valproic acid (Depakene, Depakote); and zonisamide
(Zonegran). Your doctor may need to change the doses
of your medications or monitor you carefully for
side effects.
- tell your doctor if you or any
family members have or have ever had kidney stones,
if you drink or have ever drunk large amounts of
alcohol, and if you have ever thought about killing
yourself or tried to do so. Also tell you doctor if
you have or have ever had metabolic acidosis (a
disturbance in the body's acid-base balance that
results in excessive acidity of the blood.);
osteopenia, osteomalacia, or osteoporosis
(conditions in which the bones are soft or brittle
and may break easily); diabetes; glaucoma (a type of
eye disease); any disease that affects your
breathing such as asthma or chronic obstructive
pulmonary disease (COPD); depression or abnormal
moods; a growth problem; or liver or kidney disease.
Also tell your doctor if you have diarrhea or if you
develop diarrhea during your treatment.
- tell your doctor if you are
pregnant, plan to become pregnant, or are
breast-feeding. If you become pregnant while taking
topiramate, call your doctor.
- if you are having surgery,
including dental surgery, tell the doctor or dentist
that you are taking topiramate.
- you should know that topiramate
may make you drowsy, dizzy, confused, or unable to
concentrate. Do not drive a car or operate machinery
until you know how this medication affects you.
- if you are taking topiramate to
control seizures, you should know that you may
continue to have seizures during your treatment. You
may need to avoid activities such as swimming,
driving, and climbing so that you will not harm
yourself or others if you lose consciousness during
a seizure.
- ask your doctor about the safe
use of alcoholic beverages while you are taking
topiramate.
- if you are taking oral
contraceptives (birth control pills), tell your
doctor if unexpected bleeding or spotting occurs.
Topiramate can decrease the effectiveness of oral
contraceptives.
- you should know that topiramate
can prevent you from sweating and make it harder for
your body to cool down when it gets very hot. This
happens most often in warm weather and to children
who take topiramate. Avoid exposure to heat, drink
plenty of fluids and tell your doctor if you have a
fever, headache, muscle cramps, or an upset stomach,
or if you are not sweating as usual.
- you should know that you may be
more likely to develop a kidney stone while you are
taking topiramate. Drink 6-8 glasses of water every
day to prevent kidney stones from forming.
What special dietary instructions
should I follow?
Talk to your doctor
about increasing the amount of food you eat if you lose
weight while you are taking topiramate.
Talk to your doctor
before changing your diet or beginning any type of
weight loss program. Do not follow a ketogenic diet (a
high-fat, low-carbohydrate diet used to control
seizures) or any other high-fat, low-carbohydrate diet,
such as the Atkins diet, while you are taking this
medication.
What should I do if I forget a dose?
Take the missed dose
as soon as you remember it. However, if it is less than
6 hours before you are scheduled to take your next dose,
skip the missed dose and continue your regular dosing
schedule. Do not take a double dose to make up for a
missed one.
What side effects can this medication
cause?
Topiramate may cause
other side effects. Tell your doctor if any of these
symptoms are severe or do not go away:
- numbness, burning, or tingling in
the hands or feet
- slowed reactions
- difficulty concentrating
- speech problems, especially
difficulty thinking of specific words
- memory problems
- lack of coordination
- confusion
- nervousness
- aggressive behavior
- irritability
- mood swings
- depression
- headache
- drowsiness
- weakness
- excessive movement
- uncontrollable shaking of a part
of the body
- uncontrollable eye movements
- extreme thirst
- weight loss
- constipation
- diarrhea
- gas
- heartburn
- change in ability to taste food
- swelling of the tongue
- overgrowth of the gums
- dry mouth
- increased saliva
- trouble swallowing
- nosebleed
- teary or dry eyes
- back, muscle, or bone pain
- missed menstrual periods
- excessive menstrual bleeding
- skin problems or changes in skin
color
- dandruff
- hair loss
- growth of hair in unusual places
- ringing in the ears
- difficulty falling or staying
asleep
- swelling of the hands, arms,
feet, ankles, or lower legs
- difficulty urinating or pain when
urinating
Some side effects can
be serious. If you experience any of the following
symptoms, call your doctor immediately:
- blurred vision
- double vision
- eye pain
- worsening of seizures
- slow heart rate
- pounding or irregular heartbeat
- chest pain
- trouble breathing
- fast, shallow breathing
- inability to respond to things
around you
- excessive tiredness
- nausea
- vomiting
- stomach pain
- loss of appetite
- intense back or side pain
- bloody, cloudy, or foul smelling
urine
- constant need to urinate
- fever
- chills
Topiramate may cause
osteoporosis (a condition in which bones can break more
easily) in adults and rickets (abnormal, curved bone
growth) in children. Topiramate may also slow the growth
of children and may decrease the final height that
children reach. Talk to your doctor about the risks of
taking topiramate.
Topiramate may cause
other side effects. Call your doctor if you have any
unusual problems while taking this medication.
If you experience a
serious side effect, you or your doctor may send a
report to the Food and Drug Administration's (FDA)
MedWatch Adverse Event Reporting program online [at
http://www.fda.gov/MedWatch/index.html] or by phone
[1-800-332-1088].
What storage conditions are needed
for this medicine?
Keep this medication
in the container it came in, tightly closed, and out of
reach of children. Tablets should be stored at room
temperature and away from excess heat and moisture (not
in the bathroom). Sprinkle capsules should be stored at
or below 77 °F. Never store broken tablets or mixtures
of sprinkles and soft food. These should be used right
away or thrown away. Throw away any medication that is
outdated or no longer needed. Talk to your pharmacist
about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose,
call your local poison control center at 1-800-222-1222.
If the victim has collapsed or is not breathing, call
local emergency services at 911.
Symptoms of overdose
may include:
- seizures
- drowsiness
- speech problems
- blurred vision
- double vision
- trouble thinking
- tiredness
- loss of coordination
- loss of consciousness
- dizziness
- stomach pain
- vomiting
- agitation
- depression
- loss of appetite
- pounding or irregular heartbeat
- fast, shallow breathing
What other information should I know?
Keep all appointments
with your doctor and the laboratory. Your doctor will
order certain lab tests to check your body's response to
topiramate.
Do not let anyone
else take your medication. Ask your pharmacist any
questions you have about refilling your prescription.
It is important for
you to keep a written list of all of the prescription
and nonprescription (over-the-counter) medicines you are
taking, as well as any products such as vitamins,
minerals, or other dietary supplements. You should bring
this list with you each time you visit a doctor or if
you are admitted to a hospital. It is also important
information to carry with you in case of emergencies.
|
Posted
01/31/2008] FDA informed healthcare
professionals that the Agency has analyzed
reports of suicidality (suicidal behavior or
ideation) from placebo-controlled clinical
studies of eleven drugs used to treat epilepsy
as well as psychiatric disorders, and other
conditions. In the FDA's analysis, patients
receiving antiepileptic drugs had approximately
twice the risk of suicidal behavior or ideation
(0.43%) compared to patients receiving placebo
(0.22%). The increased risk of suicidal behavior
and suicidal ideation was observed as early as
one week after starting the antiepileptic drug
and continued through 24 weeks. The results were
generally consistent among the eleven drugs. The
relative risk for suicidality was higher in
patients with epilepsy compared to patients who
were given one of the drugs in the class for
psychiatric or other conditions.
Healthcare
professionals should closely monitor all
patients currently taking or starting any
antiepileptic drug for notable changes in
behavior that could indicate the emergence or
worsening of suicidal thoughts or behavior or
depression.
The drugs
included in the analyses include (some of these
drugs are also available in generic form):
- Carbamazepine (marketed
as Carbatrol, Equetro, Tegretol, Tegretol XR)
- Felbamate (marketed as
Felbatol)
- Gabapentin (marketed as
Neurontin)
- Lamotrigine (marketed as
Lamictal)
- Levetiracetam (marketed
as Keppra)
- Oxcarbazepine (marketed
as Trileptal)
- Pregabalin (marketed as
Lyrica)
- Tiagabine (marketed as
Gabitril)
- Topiramate (marketed as
Topamax)
- Valproate (marketed as
Depakote, Depakote ER, Depakene, Depacon)
- Zonisamide (marketed as
Zonegran)
Although the
11 drugs listed above were the ones included in
the analysis, FDA expects that the increased
risk of suicidality is shared by all
antiepileptic drugs and anticipates that the
class labeling changes will be applied broadly.
For more information visit the FDA website at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Antiepileptic
and
http://www.fda.gov/cder/drug/InfoSheets/HCP/antiepilepticsHCP.htm. |
Last Revised
- 02/01/2008
info Provided by: www.nlm.nih.gov/