LAMOTRIGINE tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

St. Mary's Medical Park Pharmacy

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Adjunctive Therapy Lamotrigine tablets are indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: - partial-onset seizures. - primary generalized tonic-clonic (PGTC) seizures. - generalized seizures of Lennox-Gastaut syndrome. Monotherapy Lamotrigine tablets are 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 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. Lamotrigine tablets are indicated for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hyp

Resumo do produto:

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. NDCs 60760-050-30 BOTTLES OF 30 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] in a dry place. Dispense in tight, light-resistant container as defined in the USP.

Status de autorização:

Abbreviated New Drug Application

Folheto informativo - Bula

LAMOTRIGINE- LAMOTRIGINE TABLET
St. Mary's Medical Park Pharmacy
----------
MEDICATION GUIDE
Lamotrigine Tablets, USP
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 and teenagers aged between 2 and 17 years
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 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, lamotrigine tablets may

Características técnicas

LAMOTRIGINE- LAMOTRIGINE TABLET
ST. MARY'S MEDICAL PARK PHARMACY
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LAMOTRIGINE TABLETS USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LAMOTRIGINE TABLETS
USP.
LAMOTRIGINE TABLETS USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1994
WARNING: SERIOUS SKIN RASHES
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
Cases of life-threatening serious rashes, including Stevens-Johnson
syndrome and toxic epidermal necrolysis,
and/or rash-related death have been caused by lamotrigine. 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 valproate.
exceeding recommended initial dose of lamotrigine.
exceeding recommended dose escalation for lamotrigine. ( 5.1)
Benign rashes are also caused by lamotrigine; however, it is not
possible to predict which rashes will prove to be
serious or life threatening. Lamotrigine should be discontinued at the
first sign of rash, unless the rash is clearly
not drug related. ( 5.1)
RECENT MAJOR CHANGES
Warnings and Precautions, Hemophagocytic 5/2018
Lymphohistiocytosis ( 5.2)
INDICATIONS AND USAGE
Lamotrigine Tablets are indicated for:
Epilepsy—adjunctive therapy in patients aged 2 years and older:
partial-onset seizures.
primary generalized tonic-clonic seizures.
generalized seizures of Lennox-Gastaut syndrome. ( 1.1)
Epilepsy—monotherapy in patients aged 16 years and older: Conversion
to monotherapy in patients with partial-onset
seizures who are receiving treatment with carbamazepine, phenytoin,
phenobarbital, primidone, or valproate as the single
AED. ( 1.1)
Bipolar disorder: Maintenance treatment of bipolar I disorder to delay
the time to occurrence of mood episodes in patients
treated for acute mood episodes with standard therapy. ( 1.2)
LIMITATIONS OF USE: TREATMENT OF ACUTE MANIC OR MIXED EPISODES IS NOT
RECOMMENDED. EFFECTIVENESS OF
LAMOTRIGIN