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Each Tablet contains:
Lamotrigine 100Mg Tablet
MOTRICAL
(lamotrigine) Tablets
MOTRICAL
(lamotrigine) Chewable Dispersible Tablets
MOTRICAL ODT
(lamotrigine) Orally Disintegrating Tablets
INDICATIONS
:
MOTRICAL is used for the long-term treatment of bipolar I
disorder to lengthen the time between mood episodes in people 18
years or older who have been treated for mood episodes with
other medicine. It is not known if MOTRICAL is safe or effective
in children or teenagers under the age of 18 with mood disorders
such as bipolar disorder or depression
MOTRICAL is used, together with other medicines, to treat
certain types of seizures (partial seizures, primary generalized
tonic-clonic seizures, generalized seizures of Lennox-Gastaut
syndrome) in people 2 years or older, or alone when changing
from other medicines used to treat partial seizures in people
≥16 years. It is not known if MOTRICAL is safe or effective when
used alone as the first treatment of seizures in adults
WARNING: SERIOUS SKIN RASHES :
MOTRICAL® can cause serious rashes requiring hospitalization and
discontinuation of treatment. The incidence of these rashes,
which have included Stevens-Johnson syndrome, is approximately
0.8% (8 per 1,000) in pediatric patients (2 to 16 years of age)
receiving MOTRICAL as adjunctive therapy for epilepsy and 0.3%
(3 per 1,000) in adults on adjunctive therapy for epilepsy. In
clinical trials of bipolar and other mood disorders, the rate of
serious rash was 0.08% (0.8 per 1,000) in adult patients
receiving MOTRICAL as initial monotherapy and 0.13% (1.3 per
1,000) in adult patients receiving MOTRICAL as adjunctive
therapy. In a prospectively followed cohort of 1,983 pediatric
patients (2 to 16 years of age) with epilepsy taking adjunctive
MOTRICAL, there was 1 rash-related death. In worldwide
postmarketing experience, rare cases of toxic epidermal
necrolysis and/or rash-related death have been reported in adult
and pediatric patients, but their numbers are too few to permit
a precise estimate of the rate.
Other than age, there are as yet no factors identified that are
known to predict the risk of occurrence or the severity of rash
caused by MOTRICAL. There are suggestions, yet to be proven,
that the risk of rash may also be increased by (1)
coadministration of MOTRICAL with valproate (includes valproic
acid and divalproex sodium), (2) exceeding the recommended
initial dose of MOTRICAL, or (3) exceeding the recommended dose
escalation for MOTRICAL. However, cases have occurred in the
absence of these factors.
Nearly all cases of life-threatening rashes caused by MOTRICAL
have occurred within 2 to 8 weeks of treatment initiation.
However, isolated cases have occurred after prolonged treatment
(e.g., 6 months). Accordingly, duration of therapy cannot be
relied upon as means to predict the potential risk heralded by
the first appearance of a rash.
Althogh benign rashes are also caused by MOTRICAL, it is not
possible to predict reliably which rashes will prove to be
serious or life-threatening. Accordingly, MOTRICAL should
ordinarily be discontinued at the first sign of rash, unless the
rash is clearly not drug-related. Discontinuation of treatment
may not prevent a rash from becoming life-threatening or
permanently disabling or disfiguring [see WARNINGS AND
PRECAUTIONS].
MOTRICAL (lamotrigine), an AED of the phenyltriazine class, is
chemically unrelated to existing AEDs. Its chemical name is
3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular
formula is C9H7N5Cl2, and its molecular weight is 256.09.
Lamotrigine is a white to pale cream-colored powder and has a
pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17
mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at
25°C). The structural formula is:
MOTRICAL Tablets are supplied for oral administration as 25 mg
(white), 100 mg (peach), 150 mg (cream), and 200 mg (blue)
tablets. Each tablet contains the labeled amount of lamotrigine
and the following inactive ingredients: lactose; magnesium
stearate; microcrystalline cellulose; povidone; sodium starch
glycolate; FD&C Yellow No. 6 Lake (100 mg tablet only); ferric
oxide, yellow (150 mg tablet only); and FD&C Blue No. 2 Lake
(200 mg tablet only).
MOTRICAL Chewable Dispersible Tablets are supplied for oral
administration. The tablets contain 2 mg (white), 5 mg (white),
or 25 mg (white) of lamotrigine and the following inactive
ingredients: blackcurrant flavor, calcium carbonate,
low-substituted hydroxypropylcellulose, magnesium aluminum
silicate, magnesium stearate, povidone, saccharin sodium, and
sodium starch glycolate.
MOTRICAL ODT Orally Disintegrating Tablets are supplied for oral
administration. The tablets contain 25 mg (white to off-white),
50 mg (white to off-white), 100 mg (white to off-white), or 200
mg (white to off-white) of lamotrigine and the following
inactive ingredients: artificial cherry flavor, crospovidone,
ethylcellulose, magnesium stearate, mannitol, polyethylene, and
sucralose.
MOTRICAL ODT Orally Disintegrating Tablets are formulated using
technologies (Microcaps®* and AdvaTab®*) designed to mask the
bitter taste of lamotrigine and achieve a rapid dissolution
profile. Tablet characteristics including flavor, mouth-feel,
after-taste, and ease of use were rated as favorable in a study
of 108 healthy volunteers.
Important Safety Information About MOTRICAL® (lamotrigine)
Tablets and MOTRICAL® ODT™ (lamotrigine) Orally Disintegrating
Tablets
Prescription MOTRICAL Tablets are not for everyone. MOTRICAL ODT
is another form of MOTRICAL.
MOTRICAL may cause a serious skin rash that may cause you to
be hospitalized or to stop MOTRICAL; it may rarely cause death.
There is no way to tell if a mild rash will develop into a more
serious reaction. These serious skin reactions are more likely
to happen when you begin taking MOTRICAL, within the first 2-8
weeks of treatment. But it can happen in people who have taken
MOTRICAL for any period of time. Children between 2 to 16 years
of age have a higher chance of getting this serious skin
reaction while taking MOTRICAL.
The risk of getting a rash is higher if taking MOTRICAL while
taking valproate [Depakene* (valproic acid) or Depakote* (divalproex
sodium)], taking a higher starting dose of MOTRICAL than a
healthcare provider prescribed or increasing the dose of
MOTRICAL faster than prescribed.
MOTRICAL can also cause other types of allergic reactions or
serious problems which may affect organs and other parts of your
body like the 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 the
following: a skin rash, hives, fever, swollen lymph glands,
painful sores in the mouth or around the eyes, swelling of the
lips or tongue, yellowing of the skin or eyes, unusual bruising
or bleeding, severe fatigue or weakness, severe muscle pain or
frequent infections.
These symptoms may be the first signs of a serious reaction. A
healthcare provider should examine you to decide if you should
continue taking MOTRICAL.
MOTRICAL may cause suicidal thoughts or actions in a very
small number of people, about 1 in 500. Call a healthcare
provider right away if you have worsening depression, any
unusual changes in mood or behavior, or thoughts or actions
about suicide or self-harm, especially if they are new, worse,
or worry you (see Medication Guide).
You should not take MOTRICAL if you have had an allergic
reaction to lamotrigine or to any of the inactive ingredients.
Common side effects include dizziness, headache, blurred or
double vision, lack of coordination, sleepiness, nausea,
vomiting, insomnia, tremor, rash, fever, abdominal pain, back
pain, tiredness, and dry mouth. Tell your healthcare provider
about any side effect that bothers you or does not go away.
Also, tell your healthcare provider if you have any changes in
your menstrual pattern, such as breakthrough bleeding, while
taking MOTRICAL and birth control pills. These are not all the
possible side effects of MOTRICAL.
Proven Efficacy With
ONCE-A-DAY Convenience
MOTRICAL® XR™
(lamotrigine) Extended-Release Tablets
Pronounced: LAM-ic-tal
Generic name: Lamotrigine
Full MOTRICAL Prescribing Information
Why is this drug prescribed?
MOTRICAL is prescribed to control partial seizures in people
with epilepsy. It is also used to control a serious form of
epilepsy known as Lennox-Gastaut syndrome. MOTRICAL is used in
combination with other antiepileptic medications or as a
replacement for a medication such as Tegretol, Dilantin,
phenobarbital, or Mysoline.
Most important fact about this drug
You may develop a rash during the first 2 to 8 weeks of MOTRICAL
therapy, particularly if you are also taking Depakene. If this
happens, notify your doctor immediately. The rash could become
severe and even dangerous, particularly in children. A slight
possibility of this problem remains for up to 6 months.
How should you take this medication?
Take MOTRICAL exactly as prescribed by your doctor. Taking more
than the prescribed amount can increase your risk of developing
a serious rash. Do not stop taking this medication without first
discussing it with your doctor. An abrupt halt could increase
your seizures. Your doctor can schedule a gradual reduction in
dosage.
If you miss a dose
Take it as soon as you remember. If it is almost time for your
next dose, skip the one you missed and go back to your regular
schedule. Do not take 2 doses at once.
Storage instructions
Store in a tightly closed container at room temperature. Keep
dry and protect from light.
What side effects may occur?
Side effects cannot be anticipated. If any develop or change in
intensity, tell your doctor as soon as possible. Only your
doctor can determine if it is safe for you to continue taking
MOTRICAL.
*More common side effects may include: Blurred vision,
dizziness, double vision, headache, nausea, rash, sleepiness,
uncoordinated movements, vomitin
*Less common side effects may include: Abdominal pain,
accidental injury, anxiety, constipation, depression, diarrhea,
fever, "flu-like" symptoms, increased cough, inflammation of
vagina, irritability, painful menstruation, sore throat, tremor
*Rare side effects may include: Absence of menstrual periods,
chills, confusion, dry mouth, ear pain, emotional changes, heart
palpitations, hot flashes, joint disorders, memory decrease,
mind racing, muscle weakness, muscle spasm, poor concentration,
ringing in ears, sleep disorder, speech disorder
*Additional side effects in children may include: Bronchitis,
convulsions, ear problems, eczema, facial swelling, hemorrhage,
infection, indigestion, light sensitivity, lymph node problems,
nervousness, penis disorder, sinus infection, swelling, tooth
problems, urinary tract infection, vertigo, vision problems
Why should this drug not be prescribed?
If you are sensitive to or have ever had an allergic reaction to
MOTRICAL, you should not take this medication. Make sure your
doctor is aware of any drug reactions you have experienced.
Special warnings about this medication
MOTRICAL may cause some people to become drowsy, dizzy, or less
alert. Do not drive or operate dangerous machinery or
participate in any activity that requires full mental alertness
until you are certain the drug does not have this kind of effect
on you. Remember to be alert for development of any type of
rash, especially during the first 2 to 8 weeks of treatment.
Be sure to tell your doctor about any medical problems you have
before starting therapy with MOTRICAL. If you have kidney or
liver disease, or heart problems, MOTRICAL should be used with
caution.
MOTRICAL may cause vision problems. If any develop, notify your
doctor immediately. Also be quick to call your doctor if you
develop a fever or have any other signs of an allergic reaction.
Notify your doctor, too, if your seizures get worse.
Possible food and drug interactions when taking this medication
MOTRICAL is often combined with other medications used to
treat epilepsy, including the following:
Carbamazepine (Tegretol)
Phenobarbital (Donnatal, Quadrinal, others)
Phenytoin (Dilantin)
Primidone (Mysoline)
Valproic acid (Depakene)
Be sure to check with your doctor before combining any other
drugs with your seizure medications. MOTRICAL, in particular,
may inhibit the action of sulfa drugs such as Bactrim, Proloprim,
and Septra.
Special information if you are pregnant or breastfeeding
The effects of MOTRICAL during pregnancy have not been
adequately studied. If you are pregnant or plan to become
pregnant, tell your doctor immediately. MOTRICAL should be used
during pregnancy only if clearly needed. MOTRICAL appears in
breast milk. Because the effects of MOTRICAL on an infant
exposed to this medication are unknown, breastfeeding is not
recommended. |
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