LAMOTRIGINE tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Direct RX

INN (International ime):

LAMOTRIGINE

Sastav:

LAMOTRIGINE 200 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

1.1 Epilepsy Adjunctive Therapy: Lamotrigine tablets are indicated as adjunctive therapy for the following seizure types in patients ≥ 2 years of age: partial seizures primary generalized tonic-clonic seizures generalized seizures of Lennox-Gastaut syndrome Monotherapy: Lamotrigine tablets are indicated for conversion to monotherapy in adults (≥16 years of age) with partial seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED). Safety and effectiveness of lamotrigine tablets 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 are indicated for the maintenance treatment of Bipolar I Disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixe

Proizvod sažetak:

Lamotrigine Tablets USP, 25 mg White, caplet shaped, biconvex tablets with ‘U’ debossed on either side of break line on one side and ‘111’ debossed on other side. Bottles of 100:         NDC 29300-111-01 Bottles of 500:         NDC 29300-111-05 Bottles of 1000:       NDC 29300-111-10         Lamotrigine Tablets USP, 100 mg White, trigonal shaped, biconvex tablets with ‘U’ debossed on either side of break line on one side and ‘112’ debossed on other side. Bottles of 100:         NDC 29300-112-01 Bottles of 500:         NDC 29300-112-05 Bottles of 1000:       NDC 29300-112-10         Lamotrigine Tablets USP, 150 mg White, trigonal shaped, biconvex tablets with ‘U’ debossed on either side of break line on one side and ‘113’ debossed on other side. Bottles of 60:           NDC 29300-113-16 Bottles of 500:         NDC 29300-113-05 Bottles of 1000:       NDC 29300-113-10         Lamotrigine Tablets USP, 200 mg Light blue, trigonal shaped, biconvex tablets with ‘U’ debossed on either side of break line on one side and ‘114’ debossed on other side. Bottles of 60:           NDC 29300-114-16 Bottles of 500:         NDC 29300-114-05 Bottles of 1000:       NDC 29300-114-10 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature] in a dry place. Dispense in tight, light-resistant container as defined in the USP.

Status autorizacije:

Abbreviated New Drug Application

Uputa o lijeku

LAMOTRIGINE- LAMOTRIGINE TABLET
Direct RX
----------
SPL MEDGUIDE
•
LAMOTRIGINE TABLETS USP
Rx Only
Read this Medication Guide before you start taking lamotrigine tablets
and each time you get a
refill. There may be new information. This information does not take
the place of talking with
your healthcare provider about your medical condition or treatment. If
you have questions about
lamotrigine tablets, ask your healthcare provider or pharmacist.
What is the most important information I should know about Lamotrigine
tablets?
1. Lamotrigine tablets 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, but is more
likely to happen within the
first 2 to 8 weeks of treatment. Children between 2 to 16 years of age
have a higher chance of
getting this serious skin rash while taking lamotrigine tablets.
The risk of getting a serious skin rash is higher if you:
•
take lamotrigine tablets while taking valproate (valproic acid or
divalproex sodium)
•
take a higher starting dose of lamotrigine tablets than your
healthcare provider prescribed
•
increase your dose of lamotrigine tablets 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.
2. Other serious reactions, including serious blood problems or liver
problems.
Lamotrigine tablets 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

Svojstava lijeka

LAMOTRIGINE- LAMOTRIGINE TABLET
DIRECT RX
----------
LAMOTRIGINE
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
Stevens-Johnson syndrome, is
approximately 0.8% (8 per 1,000) in pediatric patients (2 to 16 years
of age) receiving
lamotrigine 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 lamotrigine
as initial monotherapy
and 0.13% (1.3 per 1,000) in adult patients receiving lamotrigine as
adjunctive therapy. In a
prospectively followed cohort of 1,983 pediatric patients (2 to 16
years of age) with epilepsy
taking adjunctive lamotrigine, 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 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 also caused by