LAMOTRIGINE- lamotrigine tablet LAMOTRIGINE- lamotrigine

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sandoz Inc

INN (International Name):

LAMOTRIGINE

Composition:

LAMOTRIGINE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

LAMOTRIGINE is an antiepileptic drug (AED) indicated for: Epilepsy—adjunctive therapy in patients ≥ 2 years of age: (1.1) - partial seizures. - generalized seizures of Lennox-Gastaut syndrome. Epilepsy—monotherapy in patients ≥ 16 years of age: conversion to monotherapy in patients with partial seizures who are receiving treatment with carbamazepine, phenobarbital, phenytoin, primidone, or valproate as the single AED. (1.1) Bipolar Disorder in patients ≥ 18 years of age: 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) Adjunctive Therapy: Lamotrigine tablets are indicated as adjunctive therapy for the following seizure types in patients ≥2 years of age: - partial 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 carbamaze

Product summary:

LAMOTRIGINE (lamotrigine) Tablets Lamotrigine tablets are available as follows: 25 mg, white to off-white, round tablets debossed ‘SZ’ with a scoreline between S and Z on one side and ‘372’ on the other side. NDC 0781-5122-31, bottle of 30 tablets NDC 0781-5122-60, bottle of 60 tablets NDC 0781-5122-01, bottle of 100 tablets NDC 0781-5122-10, bottle of 1000 tablets NDC 0781-5122-13, in unit of use pack of 100 tablets (10 blister cards, each containing 10 tablets). 100 mg, peach colored, slightly mottled round tablets debossed ‘SZ’ with a scoreline between S and Z on one side and ‘373’ on the other side. NDC 0781-5123-31, bottle of 30 tablets NDC 0781-5123-60, bottle of 60 tablets NDC 0781-5123-01, bottle of 100 tablets NDC 0781-5123-10, bottle of 1000 tablets NDC 0781-5123-13, in unit of use pack of 100 tablets (10 blister cards, each containing 10 tablets). 150 mg, light yellowish, slightly mottled, round tablets debossed ‘SZ’ with scoreline between S and Z on one side and ‘374’ on the other side. NDC 0781-5124-31, bottle of 30 tablets NDC 0781-5124-60, bottle of 60 tablets NDC 0781-5124-01, bottle of 100 tablets NDC 0781-5124-10, bottle of 1000 tablets NDC 0781-5124-13, in unit of use pack of 100 tablets (10 blister cards, each containing 10 tablets). 200 mg, light blue, slightly mottled, round tablets debossed ‘SZ’ with a scoreline between S and Z on one side and ‘375’ on other side. NDC 0781-5125-31, bottle of 30 tablets NDC 0781-5125-60, bottle of 60 tablets NDC 0781-5125-01, bottle of 100 tablets NDC 0781-5125-10, bottle of 1000 tablets NDC 0781-5125-13, in unit of use pack of 100 tablets (10 blister cards, each containing 10 tablets). Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature] in a dry place. Protect from moisture. Dispense in a tight, light-resistant container. Lamotrigine Tablet Starter Kit for Patients Taking Valproate (Text in Blue Bar) 25 mg, white to off-white, round tablets debossed ‘SZ’ with a scoreline between S and Z on one side and ‘372’ on the other side., blisterpack of 35 tablets (NDC 0781-5122-35). Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature] in a dry place. Protect from light.   Lamotrigine Tablet Starter Kit for Patients Not Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, Rifampin, or Valproate (Text in Orange Bar) 25 mg, white to off-white, round tablets debossed ‘SZ’ with a scoreline between S and Z on one side and ‘372’ on the other side and 100 mg, peach, colored, slightly mottled round tablets debossed ‘SZ’ with a scoreline between S and Z on one side and ‘373’ on the other side blisterpack of 49 tablets (42/25mg tablets and 7/100 mg tablets) (NDC 0781-4040-67). Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature] in a dry place. Protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LAMOTRIGINE- LAMOTRIGINE TABLET
LAMOTRIGINE- LAMOTRIGINE
SANDOZ INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LAMOTRIGINE TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR LAMOTRIGINE TABLETS.
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, 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
(5.1 ):
COADMINISTRATION WITH VALPROATE
EXCEEDING RECOMMENDED INITIAL DOSE OF LAMOTRIGINE
EXCEEDING RECOMMENDED DOSE ESCALATION OF LAMOTRIGINE
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 TABLETS SHOULD BE DISCONTINUED AT THE FIRST SIGN OF RASH,
UNLESS THE RASH IS CLEARLY NOT DRUG-
RELATED. (5.1)
RECENT MAJOR CHANGES
DOSAGE AND ADMINISTRATION (2.6) MAY/2009
WARNINGS AND PRECAUTIONS, SUICIDAL BEHAVIOR AND IDEATION (5.5)
APRIL/2009
INDICATIONS AND USAGE
LAMOTRIGINE is an antiepileptic drug (AED) indicated for:
EPILEPSY—ADJUNCTIVE THERAPY IN PATIENTS ≥ 2 YEARS OF
AGE: (1.1)
partial seizures.
generalized seizures of Lennox-Gastaut syndrome.
EPILEPSY—MONOTHERAPY IN PATIENTS ≥ 16 YEARS OF AGE: conversion to
monotherapy in patients with partial seizures
who are receiving treatment with carbamazepine, phenobarbital,
phenytoin, primidone, or valproate as the single AED.
(1.1)
BIPOLAR DISORDER IN PATIENTS ≥ 18 YEARS OF AGE: maintenance
treatment o Bipolar I Disorder to delay the time to
occurrence of mood episodes in patients treated for acute mood
episodes with standard therapy.(1.2)
DOSAGE AND ADMINISTRATION
Dosing is based on concomitant medications, indication, and patient
age.
(2.2), (2.4)
To avoid an incre