LAMOTRIGINE tablet, orally disintegrating LAMOTRIGINE kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Lamotrigine (UNII: U3H27498KS) (Lamotrigine - UNII:U3H27498KS)

Available from:

Par Pharmaceutical, Inc.

INN (International Name):

LAMOTRIGINE

Composition:

LAMOTRIGINE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Adjunctive Therapy Lamotrigine orally disintegrating 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 orally disintegrating 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 orally disintegrating 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 orally disintegrating tablets are indicated for the maintenance treatment of bipolar I dis

Product summary:

Lamotrigine Orally Disintegrating Tablets 25-mg, white colored, round shaped, flat-faced, bevel-edged tablets debossed with “NT” on one side and “123” on the other side. Maintenance Packs of 30 (NDC 49884-484-11). 50-mg, white colored, round shaped, flat-faced, bevel-edged tablets debossed with “EP” on one side and “191” on the other side. Maintenance Packs of 30 (NDC 49884-485-11). 100-mg, Peach colored, round shaped, flat-faced, bevel-edged tablets debossed with “E” on one side and “432” on the other side. Maintenance Packs of 30 (NDC 49884-486-11). 200-mg, White colored, round shaped, flat-faced, bevel-edged tablets debossed with “EP” on one side and “433” on the other side. Maintenance Packs of 30 (NDC 49884-487-11). Store at 20° to 25°C (68° to 77°F); with excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Lamotrigine Orally Disintegrating Tablets Patient Titration Kit for Patients Taking Valproate (Blue ODT Kit) 25-mg, white colored, round shaped, flat-faced, bevel-edged tablets debossed with “NT” on one side and “123” on the other side and 50 mg, white colored, round shaped, flat-faced, bevel-edged tablets debossed with “EP” on one side and “191” on the other side, blister pack of 28 tablets (21/25-mg tablets and 7/50-mg tablets) (NDC 49884-880-99). Lamotrigine Orally Disintegrating Tablets Patient Titration Kit for Patients Taking Carbamazepine, Phenytoin, Phenobarbital, or Primidone and Not Taking Valproate (Green ODT Kit) 50-mg, white colored, round shaped, flat-faced, bevel-edged tablets debossed with “EP” on one side and “191” on the other side. and 100 mg, Peach colored, round shaped, flat-faced, bevel-edged tablets debossed with “E” on one side and “432” on the other side, blister pack of 56 tablets (42/50-mg tablets and 14/100-mg tablets) (NDC 49884-881-99). Lamotrigine Oally Disintegrating Tablets Patient Titration Kit for Patients Not Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate (Orange ODT Kit) 25-mg, white colored, round shaped, flat-faced, bevel-edged tablets debossed with “NT” on one side and “123” on the other side., 50 mg, white colored, round shaped, flat-faced, bevel-edged tablets debossed with “EP” on one side and “191” on the other side, and 100 mg, Peach colored, round shaped, flat-faced, bevel-edged tablets debossed with “E” on one side and “432” on the other side, blister pack of 35 tablets (14/25-mg tablets, 14/50-mg tablets, and 7/100-mg tablets) (NDC 49884-882-99). Store at 20°C to 25°C (68°F to 77°F); with excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]. Blister packs If the product is dispensed in a blister pack, the patient should be advised to examine the blister pack before use and not use if blisters are torn, broken, or missing.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LAMOTRIGINE- LAMOTRIGINE TABLET, ORALLY DISINTEGRATING
LAMOTRIGINE- LAMOTRIGINE
Par Pharmaceutical, Inc.
----------
MEDICATION GUIDE
Lamotrigine orally disintegrating tablets
(lă-mō’trī-jēn)
What is the most important information I should know about lamotrigine
orally disintegrating tablets?
1. Lamotrigine orally disintegrating 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 orally disintegrating
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 orally disintegrating tablets.
The risk of getting a serious skin rash is higher if you:
•
take lamotrigine orally disintegrating tablets while taking valproate
[DEPAKENE (valproic acid)
or DEPAKOTE (divalproex sodium)].
•
take a higher starting dose of lamotrigine orally disintegrating
tablets than your healthcare
provider prescribed.
•
increase your dose of lamotrigine orally disintegrating 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 orally
disintegrating tablets.
2. Other serious reactions, including serious blood problems or liver
problems. Lamotrigine orally
disintegrating 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:
•

Summary of Product characteristics

LAMOTRIGINE- LAMOTRIGINE TABLET, ORALLY DISINTEGRATING
LAMOTRIGINE- LAMOTRIGINE
PAR PHARMACEUTICAL, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LAMOTRIGINE ORALLY
DISINTEGRATING TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR LAMOTRIGINE
ORALLY DISINTEGRATING TABLETS.
LAMOTRIGINE ORALLY DISINTEGRATING TABLETS, 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
INC LUDE :
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 Lymphohistiocytosis (5.2)
8/2019
INDICATIONS AND USAGE
Lamotrigine orally disintegrating tablets are indicated for: (1)
Epilepsy—adjunctive therapy in patients aged 2 years and older: (1)
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
antiepileptic drug. (1.1) (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