LAMOTRIGINE tablet LAMOTRIGINE tablet, chewable

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Zydus Lifesciences Limited

INN (International Name):

LAMOTRIGINE

Composition:

LAMOTRIGINE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Adjunctive Therapy Lamotrigine is indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: - partial-onset seizures. - primary generalized tonic-clonic seizures (PGTC) seizures. - generalized seizures of Lennox-Gastaut syndrome. Monotherapy Lamotrigine 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 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 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

Product summary:

Lamotrigine Tablets Lamotrigine Tablets USP, 25 mg are white to off-white, round, flat, beveled-edged tablets with bisect on one side; one side of the bisect is debossed with logo of "ZC" and other side is debossed with "79" and other side is plain and are supplied as follows: NDC 65841-682-11 in bottles of 25 tablets NDC 65841-682-16 in bottles of 90 tablets NDC 65841-682-01 in bottles of 100 tablets NDC 65841-682-05 in bottles of 500 tablets NDC 65841-682-10 in bottles of 1000 tablets Lamotrigine Tablets USP, 50 mg are white to off-white, round, flat, beveled-edged tablets with bisect on one side; one side of the bisect is debossed with logo of "ZC" and other side is debossed with "90" and other side is plain and are supplied as follows: NDC 65841-683-16 in bottles of 90 tablets NDC 65841-683-01 in bottles of 100 tablets NDC 65841-683-05 in bottles of 500 tablets NDC 65841-683-10 in bottles of 1000 tablets Lamotrigine Tablets USP, 100 mg are white to off-white, round, flat, beveled-edged tablets with bisect on one side; one side of the bisect is debossed with logo of "ZC" and other side is debossed with "80"and other side is plain and are supplied as follows: NDC 65841-684-16 in bottles of 90 tablets NDC 65841-684-01 in bottles of 100 tablets NDC 65841-684-05 in bottles of 500 tablets NDC 65841-684-10 in bottles of 1000 tablets Lamotrigine Tablets USP, 150 mg are white to off-white, round, flat, beveled-edged tablets with bisect on one side; one side of the bisect is debossed with logo of "ZC" and other side is debossed with "81" and other side is plain and are supplied as follows: NDC 65841-685-14 in bottles of 60 tablets NDC 65841-685-16 in bottles of 90 tablets NDC 65841-685-05 in bottles of 500 tablets Lamotrigine Tablets USP, 200 mg are white to off-white, round, flat, beveled-edged tablets with bisect on one side; one side of the bisect is debossed with logo of "ZC" and other side is debossed with "82" and other side is plain and are supplied as follows: NDC 65841-686-14 in bottles of 60 tablets NDC 65841-686-16 in bottles of 90 tablets NDC 65841-686-05 in bottles of 500 tablets Lamotrigine Tablets USP, 250 mg are white to off-white, round, flat, beveled-edged tablets with bisect on one side; one side of the bisect is debossed with logo of "ZC" and other side is debossed with "91"and other side is plain and are supplied as follows: NDC 65841-687-14 in bottles of 60 tablets NDC 65841-687-16 in bottles of 90 tablets NDC 65841-687-05 in bottles of 500 tablets Lamotrigine Tablets for Oral Suspension, USP (Chewable, Dispersible Tablets) Lamotrigine Tablets for Oral Suspension, USP (Chewable, Dispersible Tablets), 5 mg are white to off-white, round, flat- faced, radial-edged tablets with bisect on one side and plain on other side; one side of the bisect is debossed with "Z" and other side is debossed with "13" and are supplied as follows: NDC-65841-689-16 in bottle of 90 tablets NDC-65841-689-01 in bottle of 100 tablets NDC-65841-689-05 in bottle of 500 tablets Lamotrigine Tablets for Oral Suspension, USP (Chewable, Dispersible Tablets), 25 mg are white to off-white, round, flat- faced, radial-edged tablets debossed with logo of "Z" and "12" on one side and plain on the other side and are supplied as follows: NDC-65841-690-16 in bottle of 90 tablets NDC-65841-690-01 in bottle of 100 tablets NDC-65841-690-05 in bottle of 500 tablets Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] in a dry place. Dispense in a tight, light-resistant container as defined in the USP.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LAMOTRIGINE- LAMOTRIGINE TABLET, CHEWABLE
Zydus Lifesciences Limited
----------
SPL MEDGUIDE
Revised: 9/2023
Document Id: 470c8a7a-67d9-412a-a890-4e7e59f319e8
34391-3
Set id: 0f2f7421-56d4-45d0-9d2d-dc1edaede039
Version: 10
Effective Time: 20230926
Zydus Lifesciences Limited

Summary of Product characteristics

LAMOTRIGINE- LAMOTRIGINE TABLET
LAMOTRIGINE- LAMOTRIGINE TABLET, CHEWABLE
ZYDUS LIFESCIENCES LIMITED
----------
LAMOTRIGINE TABLETS AND LAMOTRIGINE TABLETS (CHEWABLE,
DISPERSIBLE).
SPL MEDGUIDE
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Lamotrigine Tablets (Chewable, Dispersible), 5 mg
NDC 65841-689-01 in bottle of 100 tablets
100 tablets
Rx only
LAMOTRIGINE TABLETS (CHEWABLE, DISPERSIBLE), 5 MG
Lamotrigine Tablets (Chewable, Dispersible), 25 mg
NDC 65841-690-01 in bottle of 100 tablets
100 tablets
Rx only
LAMOTRIGINE TABLETS (CHEWABLE, DISPERSIBLE), 25 MG
Lamotrigine Tablets USP, 25 mg
NDC 65841-682-01 in bottle of 100 tablets
100 tablets
Rx only
LAMOTRIGINE TABLETS USP, 25 MG
Lamotrigine Tablets USP, 50 mg
NDC 65841-683-01 in bottle of 100 tablets
100 tablets
Rx only
LAMOTRIGINE TABLETS USP, 50 MG
Lamotrigine Tablets USP, 100 mg
NDC 65841-684-01 in bottle of 100 tablets
100 tablets
Rx only
LAMOTRIGINE TABLETS USP, 100 MG
Lamotrigine Tablets USP, 150 mg
NDC 65841-685-14 in bottle of 60 tablets
60 tablets
Rx only
LAMOTRIGINE TABLETS USP, 150 MG
Lamotrigine Tablets USP, 200 mg
NDC 65841-686-14 in bottle of 60 tablets
60 tablets
Rx only
LAMOTRIGINE TABLETS USP, 200 MG
Lamotrigine Tablets USP, 250 mg
NDC 65841-687-05 in bottle of 500 tablets
500 tablets
Rx only
LAMOTRIGINE TABLETS USP, 250 MG
LAMOTRIGINE
lamotrigine tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-682
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS)
LAMOTRIGINE
25 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
POVIDONE (UNII: FZ989GH94E)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
PRODUCT CHARACTERISTICS
COLOR
WHITE (WHITE TO OFF- WHITE)
SCORE
2 pieces
SHAPE
ROUND (ROUND)
SIZE
6mm
FLAVOR
IMPRINT CODE
Z C;79
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
M