LAMOTRIGINE tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS)

Verfügbar ab:

H. J. Harkins Company Inc.

INN (Internationale Bezeichnung):

LAMOTRIGINE

Zusammensetzung:

LAMOTRIGINE 100 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

1.1 Epilepsy Adjunctive Therapy Lamotrigine tablets, USP is indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: Monotherapy Lamotrigine tablets, USP is indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED). Safety and effectiveness of lamotrigine tablets, USP have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs. 1.2 Bipolar Disorder Lamotrigine tablets, USP is indicated for the maintenance treatment of Bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therap

Produktbesonderheiten:

Lamotrigine Tablets, USP 25 mg, light pink, capsule-shaped, uncoated, biconvex tablet with "C148" debossed on one side and central breakline on the other side, supplied in bottles of 30 (NDC 69097-148-02), bottles of 100 (NDC 69097-148-07), bottles of 500 (NDC 69097-148-12) and bottles of 1000 (NDC 69097-148-15). 100 mg, light pink, capsule-shaped, uncoated, biconvex tablet with "C149" debossed on one side and central breakline on the other side, supplied in bottles of 30 (NDC 69097-149-02), bottles of 100 (NDC 69097-149-07), bottles of 500 (NDC 69097-149-12) and bottles of 1000 (NDC 69097-149-15). 150 mg, light pink, capsule-shaped, uncoated, biconvex tablet with "C151" debossed on one side and central breakline on the other side, supplied in bottles of 30 (NDC 69097-151-02), bottles of 60 (NDC 69097-151-03), bottles of 500 (NDC 69097-151-12) and bottles of 1000 (NDC 69097-151-15). 200 mg, light pink, capsule-shaped, uncoated, biconvex tablet with "C152" debossed on one side and central breakline on the other side, supplied in bottles of 30 (NDC 69097-152-02), bottles of 60 (NDC 69097-152-03), bottles of 500 (NDC 69097-152-12) and bottles of 1000 (NDC 69097-152-15). Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature] in a dry place and protect from light.

Berechtigungsstatus:

Abbreviated New Drug Application

Gebrauchsinformation

LAMOTRIGINE- LAMOTRIGINE TABLET
H. J. Harkins Company Inc.
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MEDICATION GUIDE
MEDICATION GUIDE
Lamotrigine Tablets, USP
(la moe'tri jeen)
What is the most important information I should know about lamotrigine
tablets, USP?
1. Lamotrigine tablets, USP may cause a serious skin rash that may
cause you to be hospitalized or even
cause death.
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 tablets, USP but is more
likely to happen within the first 2 to
8 weeks of treatment. Children and teenagers between 2 and 17 years
have a higher chance of getting this
serious skin rash while taking lamotrigine tablets, USP.
The risk of getting a serious skin rash is higher if you:
take lamotrigine tablets, USP while taking valproate
[DEPAKENE®(valproic acid) or
DEPAKOTE®(divalproex sodium)].
take a higher starting dose of lamotrigine tablets, USP than your
healthcare provider prescribed
increase your dose of lamotrigine tablets, USP faster than prescribed.
Call your healthcare provider right away if you have any of the
following:
a skin rash
blistering or peeling of your skin
hives
painful sores in your mouth or around your eyes
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 tablets, USP.
2. Other serious reactions, including serious blood problems or liver
problems. 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:
fever
frequent infections
severe muscle pain
swelling of your face, eyes, lips, or tongue
swollen lymph glands
unusual bruising or bleeding
weakness, fatigue
yellowing of your skin or the white part of your eyes
3. Like other antiepileptic drugs, lamotr

Fachinformation

LAMOTRIGINE- LAMOTRIGINE TABLET
H. J. HARKINS COMPANY INC.
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1150/1151/1165 LAMOTRIGINE 25/100/200MG
BOXED WARNING
WARNING: SERIOUS SKIN RASHES Lamotrigine can cause serious rashes
requiring
hospitalization and discontinuation of treatment. The incidence of
these rashes, which have
included ...
WARNING: SERIOUS SKIN RASHES
Lamotrigine can cause serious rashes requiring hospitalization and
discontinuation of treatment.
The incidence of these rashes, which have included Stevens- Johnson
syndrome, is approximately
0.3% to 0.8% in pediatric patients (aged 2 to 17 years) and 0.08% to
0.3% in adults receiving
lamotrigine. One rash-related death was reported in a prospectively
followed cohort of 1,983
pediatric patients (aged 2 to 16 years) with epilepsy taking
lamotrigine as adjunctive therapy. 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 lamotrigine. There are
suggestions, yet to be
proven, that the risk of rash may also be increased by (1)
coadministration of lamotrigine with
valproate (includes valproic acid and divalproex sodium), (2)
exceeding the recommended initial
dose of lamotrigine, or (3) exceeding the recommended dose escalation
for lamotrigine.
However, cases have occurred in the absence of these factors.
Nearly all cases of life-threatening rashes caused by lamotrigine 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.
Although benign rashes are also caused by lamotrigine, it is not
possible to predict reliably
which rashes will prove to be serious or lif