Antiepileptic and mood stabilizer.
Lamotrigine is indicated as mono-
therapy in adults with partial seizures who are also receiv-
ing treatment with a single enzyme-inducing antiepileptic
drug and for use alone in individuals ages 16 or older who
are changing from other medications used to treat partial
seizures. Lamotrigine is indicated as adjunctive therapy in
adults and pediatric patients (ages 2 years and older) with
partial seizures, and as adjunctive therapy in the treatment of
Lennox-Gastaut syndrome — a disorder that causes seizures
— in pediatric and adult patients. It is also indicated for
treatment of bipolar disorder in individuals ages 18 and older.
Serious skin rashes: Cases of life-threatening serious rashes,
including Stevens-Johnson syndrome, toxic epidermal necrol-
ysis, and/or rash-related death, have been caused by lamo-
trigine. The rate of serious rash is greater in pediatric patients
than in adults. Additional factors that may increase the risk
of rash include coadministration with divalproex (Depakote),
exceeding the recommended initial dose, and exceeding the
recommended dose escalation. Benign rashes are also caused
by lamotrigine; however, because it is not possible to predict
which rashes will prove to be serious, lamotrigine should be
discontinued at the first sign of rash.
Serious immune system reaction: Treatment with lamotrigine
can cause a rare but very serious reaction, called hemo-
phagocytic lymphohistiocytosis, that excessively activates
the body’s infection-fighting immune system. This can cause
severe inflammation throughout the body and lead to hos-
pitalization and death, especially if the reaction is not diag-
nosed and treated quickly. Seek immediate medical attention
if you suddenly develop a fever or rash.
Suicidal ideation and behavior: Antiepileptic drugs, includ-
ing lamotrigine, increase the risk of suicidal thoughts or
behavior in patients taking these drugs for any indication.
Patients treated with lamotrigine for any indication should
be monitored for the emergence or worsening of depression,
suicidal thoughts or behavior, and/or any unusual changes in
mood or behavior.
Aseptic meningitis: Lamotrigine may cause a serious inflam-
mation of the protective membrane that covers the brain and
spinal cord. Call your health care provider right away if you
have any of the following symptoms: headache, fever, nau-
sea, vomiting, stiff neck, rash, unusual sensitivity to light,
muscle pain, chills, confusion, or drowsiness.
Birth control pills or female hormones: If you are taking
birth control pills or other female hormonal medicines, do
not start or stop these medicines before talking with your
health care provider. Tell your provider if you have any
changes in your menstrual pattern, such as breakthrough
bleeding. Stopping these medications may cause side effects
(such as dizziness, lack of coordination, or double vision).
Starting these medicines may lessen how well lamotrigine
works. Dosage adjustments will be necessary in most patients
who start or stop estrogen-containing oral contraceptives
while taking lamotrigine.
Pregnancy: It is not known whether lamotrigine will harm
your unborn baby. If you become pregnant while taking the
medication, talk to your health care provider about enrolling
in a registry that collects information about the safety of sei-
zure medicines during pregnancy.
Cleft lip and cleft palate in infants: Infants exposed to la-
motrigine during the first trimester of pregnancy may have a
greater chance of being born with a cleft lip or cleft palate.
If you take lamotrigine and are pregnant or are thinking of
becoming pregnant, talk with your doctor.
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, sleepi-
ness, or poor sucking. Call your baby’s health care provider
right away if you see any of these problems. Talk to your
health care provider about the best way to feed your baby if
you take lamotrigine.
Common but generally
not serious side effects associated with lamotrigine include
dizziness, unsteadiness or loss of balance, headache, double
or blurred vision, nausea, and vomiting. The rate of dose
increase may affect the occurrence of side effects such as
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