Country: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
LAMOTRIGINE (UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS)
Zydus Lifesciences Limited
LAMOTRIGINE
LAMOTRIGINE 25 mg
ORAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
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 Прочитајте комплетан документ
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 Прочитајте комплетан документ