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3rd PartyASHP MedGuides Plus
ASHP MedGuides Plus
This package has 1 module with a total of 14,000 entries.
ASHP MedGuides Plus Module
This package maps FDA-approved Medication guides to 50,940 NDC codes. The guides are presented in flexible XML or PDF files for display and printing while mapping files allow seamless integration into pharmacy workflows.
Lamotrigine Medication Guide
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<table width='100%'>
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<tr>
<td align='left' colspan='7'>
This Medication Guide has been approved by the U.S. Food and Drug Administration.
</td>
</tr>
</tfoot>
<tbody>
<tr styleCode='Botrule'>
<td styleCode='Lrule Rrule' colspan='7' align='center'>
<content styleCode='italics'>
Dispense with Medication Guide available at: https://www.taro.com/usa-medication-guides
</content>
<br/>
<content styleCode='bold'>
MEDICATION GUIDE
<br/>
Lamotrigine (la moe' tri jeen) Tablets, USP
</content>
</td>
</tr>
<tr>
<td styleCode='Lrule Rrule' colspan='7'>
<content styleCode='bold' ID='Important'>
What is the most important information I should know about lamotrigine tablets?
</content>
<list>
<item>
<caption styleCode='bold'>
1.
</caption>
<content styleCode='bold'>
Lamotrigine tablets may cause a serious skin rash that may cause you to be hospitalized or
even cause death.
</content>
<br/>
There is no way to tell if a mild rash will become more serious. A serious skin rash can happen
at any time during your treatment with lamotrigine, but is more likely to happen within the
first 2 to 8 weeks of treatment. Children and teenagers aged between 2 and 17 years have a
higher chance of getting this serious skin rash while taking lamotrigine.
<br/>
The risk of getting a serious skin rash is higher if you:
<list listType='unordered' styleCode='disc'>
<item>
take lamotrigine while taking valproate [DEPAKENE (valproic acid) or DEPAKOTE (divalproex
sodium)].
</item>
<item>
take a higher starting dose of lamotrigine than your healthcare provider prescribed.
</item>
<item>
increase your dose of lamotrigine faster than prescribed.
</item>
</list>
<content styleCode='bold'>
Call your healthcare provider right away if you have any of the following:
</content>
</item>
</list>
</td>
</tr>
<tr>
<td styleCode='Lrule' colspan='2'/>
<td colspan='2'>
<list listType='unordered' styleCode='disc'>
<item>
<content styleCode='bold'>
a skin rash
</content>
</item>
<item>
<content styleCode='bold'>
blistering or peeling of your skin
</content>
</item>
</list>
</td>
<td styleCode='Rrule' colspan='3'>
<list listType='unordered' styleCode='disc'>
<item>
<content styleCode='bold'>
hives
</content>
</item>
<item>
<content styleCode='bold'>
painful sores in your mouth or around your eyes
</content>
</item>
</list>
</td>
</tr>
<tr>
<td styleCode='Lrule' colspan='2'/>
<td styleCode='Rrule' colspan='5'>
These symptoms may be the first signs of a serious skin reaction. A healthcare provider should
examine you to decide if you should continue taking lamotrigine.
</td>
</tr>
<tr>
<td styleCode='Lrule Rrule' colspan='7'>
<list>
<item>
<caption styleCode='bold'>
2.
</caption>
<content styleCode='bold'>
Other serious reactions, including serious blood problems or liver problems.
</content>
Lamotrigine can also cause other types of allergic reactions or serious problems that may
affect organs and other parts of your body like your liver or blood cells. You may or may not
have a rash with these types of reactions. Call your healthcare provider right away if you have
any of these symptoms:
</item>
</list>
</td>
</tr>
<tr>
<td styleCode='Lrule' colspan='2'/>
<td colspan='2'>
<list listType='unordered' styleCode='disc'>
<item>
fever
</item>
<item>
frequent infections
</item>
<item>
severe muscle pain
</item>
<item>
swelling of your face, eyes, lips, or tongue
</item>
<item>
swollen lymph glands
</item>
<item>
unusual bruising or bleeding, looking pale
</item>
</list>
</td>
<td styleCode='Rrule' colspan='3'>
<list listType='unordered' styleCode='disc'>
<item>
weakness, fatigue
</item>
<item>
yellowing of your skin or the white part of your eyes
</item>
<item>
trouble walking or seeing
</item>
<item>
seizures for the first time or happening more often
</item>
<item>
pain and/or tenderness in the area towards the top of your stomach (enlarged liver and/or
spleen)
</item>
</list>
</td>
</tr>
<tr>
<td styleCode='Lrule Rrule' colspan='7'>
<list>
<item>
<caption styleCode='bold'>
3.
</caption>
In patients with known heart problems, the use of lamotrigine may lead to a fast heart beat.
Call your healthcare provider right away if you:
</item>
</list>
</td>
</tr>
<tr>
<td styleCode='Lrule' colspan='2'/>
<td colspan='2'>
<list listType='unordered' styleCode='disc'>
<item>
have a fast, slow, or pounding heart beat.
</item>
<item>
feel your heart skip a beat.
</item>
<item>
have shortness of breath.
</item>
</list>
</td>
<td styleCode='Rrule' colspan='3'>
<list listType='unordered' styleCode='disc'>
<item>
have chest pain.
</item>
<item>
feel lightheaded.
</item>
</list>
</td>
</tr>
<tr>
<td styleCode='Lrule Rrule' colspan='7'>
<list>
<item>
<caption styleCode='bold'>
4.
</caption>
<content styleCode='bold'>
Like other antiepileptic drugs, lamotrigine tablets may cause suicidal thoughts or actions in
a very small number of people, about 1 in 500.
<br/>
Call a healthcare provider right away if you have any of these symptoms, especially if they
are new, worse, or worry you:
</content>
</item>
</list>
</td>
</tr>
<tr>
<td styleCode='Lrule' colspan='2'/>
<td colspan='2'>
<list listType='unordered' styleCode='disc'>
<item>
thoughts about suicide or dying
</item>
<item>
attempt to commit suicide
</item>
<item>
new or worse depression
</item>
<item>
new or worse anxiety
</item>
<item>
feeling agitated or restless
</item>
<item>
panic attacks
</item>
</list>
</td>
<td styleCode='Rrule' colspan='3'>
<list listType='unordered' styleCode='disc'>
<item>
trouble sleeping (insomnia)
</item>
<item>
new or worse irritability
</item>
<item>
acting aggressive, being angry, or violent
</item>
<item>
acting on dangerous impulses
</item>
<item>
an extreme increase in activity and talking (mania)
</item>
<item>
other unusual changes in behavior or mood
</item>
</list>
</td>
</tr>
<tr>
<td colspan='7' styleCode='Lrule Rrule'>
<content styleCode='bold'>
Do not stop lamotrigine tablets without first talking to a healthcare provider.
</content>
<list listType='unordered' styleCode='disc'>
<item>
Stopping lamotrigine suddenly can cause serious problems.
</item>
<item>
Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal
thoughts or actions, your healthcare provider may check for other causes.
</item>
</list>
<content styleCode='bold'>
How can I watch for early symptoms of suicidal thoughts and actions in myself or a family member?
</content>
<list listType='unordered' styleCode='disc'>
<item>
Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or
feelings.
</item>
<item>
Keep all follow-up visits with your healthcare provider as scheduled.
</item>
<item>
Call your healthcare provider between visits as needed, especially if you are worried about
symptoms.
</item>
</list>
</td>
</tr>
<tr>
<td styleCode='Lrule Rrule' colspan='7'>
<list>
<item>
<caption styleCode='bold'>
5.
</caption>
<content styleCode='bold'>
Lamotrigine tablets may cause aseptic meningitis, a serious inflammation of the protective
membrane that covers the brain and spinal cord.
<br/>
Call your healthcare provider right away if you have any of the following symptoms:
</content>
</item>
</list>
</td>
</tr>
<tr>
<td styleCode='Lrule' colspan='2'/>
<td>
<list listType='unordered' styleCode='disc'>
<item>
headache
</item>
<item>
fever
</item>
<item>
nausea
</item>
</list>
</td>
<td>
<list listType='unordered' styleCode='disc'>
<item>
vomiting
</item>
<item>
stiff neck
</item>
<item>
rash
</item>
</list>
</td>
<td>
<list listType='unordered' styleCode='disc'>
<item>
unusual sensitivity to light
</item>
<item>
muscle pains
</item>
<item>
chills
</item>
</list>
</td>
<td styleCode='Rrule' colspan='2'>
<list listType='unordered' styleCode='disc'>
<item>
confusion
</item>
<item>
drowsiness
</item>
</list>
</td>
</tr>
<tr>
<td styleCode='Lrule' colspan='2'/>
<td styleCode='Rrule' colspan='5'>
Meningitis has many causes other than lamotrigine, which your doctor would check for if you
developed meningitis while taking lamotrigine.
<br/>
<content styleCode='bold'>
Lamotrigine tablets can cause other serious side effects.
</content>
For more information ask your healthcare provider or pharmacist. Tell your healthcare provider if
you have any side effect that bothers you. Be sure to read the section below entitled "What are the
possible side effects of lamotrigine tablets?"
</td>
</tr>
<tr>
<td styleCode='Lrule Rrule' colspan='7'>
<list>
<item>
<caption styleCode='bold'>
6.
</caption>
<content styleCode='bold'>
People prescribed lamotrigine tablets have sometimes been given the wrong medicine because
many medicines have names similar to lamotrigine tablets, so always check that you receive
lamotrigine tablets.
</content>
<br/>
Taking the wrong medication can cause serious health problems. When your healthcare provider
gives you a prescription for lamotrigine:
<list listType='unordered' styleCode='disc'>
<item>
Make sure you can read it clearly.
</item>
<item>
Talk to your pharmacist to check that you are given the correct medicine.
</item>
<item>
Each time you fill your prescription, check the tablets you receive against the pictures of
the tablets below.
</item>
</list>
</item>
</list>
These pictures show the distinct wording, colors, and shapes of the tablets that help to identify
the right strength of lamotrigine tablets, USP. Immediately call your pharmacist if you receive a
lamotrigine tablet, USP that does not look like one of the tablets shown below, as you may have
received the wrong medication.
</td>
</tr>
<tr>
<td styleCode='Lrule Rrule' colspan='7' align='center'>
<content styleCode='bold'>
Lamotrigine Tablets, USP
</content>
</td>
</tr>
<tr>
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<td styleCode='Rrule Botrule' colspan='2' align='center'>
<content styleCode='bold'>
Lamotrigine Tablets USP 25 mg:
</content>
<br/>
Round, white, scored tablets. One side engraved with "TARO". Other side scored and engraved with
"LMT" above the score and "25" below the score.
</td>
<td styleCode='Rrule Botrule' align='center'>
<content styleCode='bold'>
Lamotrigine Tablets USP 100 mg:
</content>
<br/>
Round, light peach, scored tablets. One side engraved with "TARO". Other side scored and engraved
with "LMT" above the score and "100" below the score.
</td>
<td styleCode='Rrule Botrule' align='center'>
<content styleCode='bold'>
Lamotrigine Tablets USP 150 mg:
</content>
<br/>
Round, cream, scored tablets. One side engraved with "TARO". Other side scored and engraved with
"LMT" above the score and "150" below the score.
</td>
<td styleCode='Rrule Botrule' align='center'>
<content styleCode='bold'>
Lamotrigine Tablets USP 200 mg:
</content>
<br/>
Round, light blue, scored tablets. One side engraved with "TARO". Other side scored and engraved
with "LMT" above the score and "200" below the score.
</td>
<td styleCode='Lrule Rrule'/>
</tr>
<tr>
<td styleCode='Botrule Lrule Rrule' colspan='7'>
</td>
</tr>
<tr styleCode='Botrule'>
<td styleCode='Lrule Rrule' colspan='7'>
<content styleCode='bold'>
What is lamotrigine?
</content>
<list listType='unordered' styleCode='disc'>
<item>
Lamotrigine is a prescription medicine used:
<list listType='unordered' styleCode='circle'>
<item>
together with other medicines to treat certain types of seizures (partial-onset seizures,
primary generalized tonic-clonic seizures, generalized seizures of Lennox-Gastaut syndrome)
in people aged 2 years and older.
</item>
<item>
alone when changing from 1 other medicine used to treat partial-onset seizures in people
aged 16 years and older.
</item>
<item>
for the long-term treatment of bipolar I disorder to lengthen the time between mood episodes
in people who have been treated for mood episodes with other medicine.
</item>
</list>
</item>
<item>
It is not known if lamotrigine is safe or effective in people younger than 18 years with mood
episodes such as bipolar disorder or depression.
</item>
<item>
It is not known if lamotrigine is safe or effective when used alone as the first treatment of
seizures.
</item>
<item>
It is not known if lamotrigine is safe or effective for people with mood episodes who have not
already been treated with other medicines.
</item>
<item>
Lamotrigine should not be used for acute treatment of manic or mixed mood episodes.
</item>
</list>
</td>
</tr>
<tr styleCode='Botrule'>
<td styleCode='Lrule Rrule' colspan='7'>
<content styleCode='bold'>
Do not take lamotrigine tablets:
</content>
<list listType='unordered' styleCode='disc'>
<item>
if you have had an allergic reaction to lamotrigine or to any of the inactive ingredients in
lamotrigine tablets. See the end of this leaflet for a complete list of ingredients in
lamotrigine tablets.
</item>
</list>
</td>
</tr>
<tr styleCode='Botrule'>
<td styleCode='Lrule Rrule' colspan='7'>
<content styleCode='bold'>
Before taking lamotrigine, tell your healthcare provider about all of your health conditions,
including if you:
</content>
<list listType='unordered' styleCode='disc'>
<item>
have had a rash or allergic reaction to another antiseizure medicine.
</item>
<item>
have or have had depression, mood problems, or suicidal thoughts or behavior.
</item>
<item>
have a history of heart problems or irregular heart beats or any of your family members have any
heart problem, including genetic abnormalities.
</item>
<item>
have had aseptic meningitis after taking lamotrigine.
</item>
<item>
are taking oral contraceptives (birth control pills) or other female hormonal medicines. Do not
start or stop taking birth control pills or other female hormonal medicine until you have talked
with your healthcare provider. Tell your healthcare provider if you have any changes in your
menstrual pattern such as breakthrough bleeding. Stopping these medicines while you are taking
lamotrigine may cause side effects (such as dizziness, lack of coordination, or double vision).
Starting these medicines may lessen how well lamotrigine works.
</item>
<item>
are pregnant or plan to become pregnant. It is not known if lamotrigine may harm your unborn
baby. If you become pregnant while taking lamotrigine, talk to your healthcare provider about
registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in
this registry by calling 1-888-233-2334. The purpose of this registry is to collect information
about the safety of antiepileptic drugs during pregnancy.
</item>
<item>
are breastfeeding. Lamotrigine passes into breast milk and may cause side effects in a breastfed
baby. If you breastfeed while taking lamotrigine, watch your baby closely for trouble breathing,
episodes of temporarily stopping breathing, sleepiness, or poor sucking. Call your baby's
healthcare provider right away if you see any of these problems. Talk to your healthcare
provider about the best way to feed your baby if you take lamotrigine.
</item>
</list>
<content styleCode='bold'>
Tell your healthcare provider about all the medicines you take,
</content>
including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Lamotrigine and certain other medicines may interact with each other. This may cause serious side
effects.
<br/>
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist
when you get a new medicine.
</td>
</tr>
<tr styleCode='Botrule'>
<td styleCode='Lrule Rrule' colspan='7'>
<content styleCode='bold'>
How should I take lamotrigine tablets?
</content>
<list listType='unordered' styleCode='disc'>
<item>
Take lamotrigine exactly as prescribed.
</item>
<item>
Your healthcare provider may change your dose. Do not change your dose without talking to your
healthcare provider.
</item>
<item>
Do not stop taking lamotrigine without talking to your healthcare provider. Stopping lamotrigine
suddenly may cause serious problems. For example, if you have epilepsy and you stop taking
lamotrigine suddenly, you may have seizures that do not stop. Talk with your healthcare provider
about how to stop lamotrigine slowly.
</item>
<item>
If you miss a dose of lamotrigine, take it as soon as you remember. If it is almost time for
your next dose, just skip the missed dose. Take the next dose at your regular time.
<content styleCode='bold'>
Do not take 2 doses at the same time.
</content>
</item>
<item>
If you take too much lamotrigine, call your healthcare provider or your local Poison Control
Center or go to the nearest hospital emergency room right away.
</item>
<item>
You may not feel the full effect of lamotrigine for several weeks.
</item>
<item>
If you have epilepsy, tell your healthcare provider if your seizures get worse or if you have
any new types of seizures.
</item>
<item>
Swallow lamotrigine tablets whole.
</item>
<item>
If you have trouble swallowing lamotrigine tablets, tell your healthcare provider because there
may be another form of lamotrigine you can take.
</item>
<item>
If you receive lamotrigine in a blister pack, examine the blister pack before use. Do not use if
blisters are torn, broken, or missing.
</item>
</list>
</td>
</tr>
<tr styleCode='Botrule'>
<td styleCode='Lrule Rrule' colspan='7'>
<content styleCode='bold'>
What should I avoid while taking lamotrigine tablets?
</content>
<br/>
Do not drive, operate machinery, or do other dangerous activities until you know how lamotrigine
affects you.
</td>
</tr>
<tr>
<td styleCode='Lrule Rrule' colspan='7'>
<content styleCode='bold'>
What are the possible side effects of lamotrigine tablets?
<br/>
Lamotrigine tablets can cause serious side effects.
<br/>
See "
<linkHtml href='#Important'>
What is the most important information I should know about lamotrigine tablets?
</linkHtml>
"
<br/>
Common side effects of lamotrigine include:
</content>
</td>
</tr>
<tr>
<td styleCode='Lrule' colspan='3'>
<list listType='unordered' styleCode='disc'>
<item>
dizziness
</item>
<item>
tremor
</item>
<item>
headache
</item>
<item>
rash
</item>
<item>
blurred or double vision
</item>
<item>
fever
</item>
</list>
</td>
<td colspan='2'>
<list listType='unordered' styleCode='disc'>
<item>
lack of coordination
</item>
<item>
abdominal pain
</item>
<item>
infections, including seasonal flu
</item>
<item>
sleepiness
</item>
<item>
back pain
</item>
<item>
nausea, vomiting
</item>
</list>
</td>
<td styleCode='Rrule' colspan='2'>
<list listType='unordered' styleCode='disc'>
<item>
diarrhea
</item>
<item>
tiredness
</item>
<item>
insomnia
</item>
<item>
dry mouth
</item>
<item>
stuffy nose
</item>
<item>
sore throat
</item>
</list>
</td>
</tr>
<tr styleCode='Botrule'>
<td styleCode='Lrule Rrule' colspan='7'>
These are not all the possible side effects of lamotrigine.
<br/>
Call your doctor for medical advice about side effects. You may report side effects to FDA at
1-800-FDA-1088.
</td>
</tr>
<tr styleCode='Botrule'>
<td styleCode='Lrule Rrule' colspan='7'>
<content styleCode='bold'>
How should I store lamotrigine tablets?
</content>
<list listType='unordered' styleCode='disc'>
<item>
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
</item>
</list>
<content styleCode='bold'>
Keep lamotrigine tablets and all medicines out of the reach of children.
</content>
</td>
</tr>
<tr styleCode='Botrule'>
<td styleCode='Lrule Rrule' colspan='7'>
<content styleCode='bold'>
General information about the safe and effective use of lamotrigine tablets.
</content>
<br/>
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do
not use lamotrigine for a condition for which it was not prescribed. Do not give lamotrigine to
other people, even if they have the same symptoms that you have. It may harm them.
<br/>
If you take a urine drug screening test, lamotrigine may make the test result positive for another
drug. If you require a urine drug screening test, tell the healthcare professional administering the
test that you are taking lamotrigine.
<br/>
You can ask your healthcare provider or pharmacist for information about lamotrigine that is written
for health professionals.
</td>
</tr>
<tr>
<td styleCode='Lrule Rrule' colspan='7'>
<content styleCode='bold'>
What are the ingredients in lamotrigine tablets?
</content>
<br/>
Active ingredient: lamotrigine.
<br/>
Inactive ingredients: croscarmellose sodium, crospovidone, FD&C Blue #2 Aluminum Lake (200 mg
strength only), FD&C Yellow No. 6 Lake (100 mg strength only), lactose monohydrate, magnesium
stearate, microcrystalline cellulose, povidone, and yellow iron oxide (150 mg strength only).
<br/>
For more information about lamotrigine, call 1-866-923-4914 or visit www.taro.com.
<br/>
Trademarks are the property of their respective owners.
<br/>
Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761
<br/>
Dist. by:
<content styleCode='bold'>
Taro Pharmaceuticals U.S.A., Inc.
</content>
, Hawthorne, NY 10532
<br/>
Revised: April 2023
<br/>
5200692-0423-18
</td>
</tr>
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