LAMOTRIGINE tablet LAMOTRIGINE- lamotrigine kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Torrent Pharmaceuticals Limited

INN (International Name):

LAMOTRIGINE

Composition:

LAMOTRIGINE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Adjunctive Therapy Lamotrigine tablets, USP 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, USP 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, USP 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, USP are indicated for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes (depression,

Product summary:

Lamotrigine Tablets, USP 25-mg White to off white, round shape, flat face beveled edge, uncoated tablets debossed with "45" on one side and break line on other side. Bottle of 30                       NDC-13668-045-30 Bottle of 60                       NDC-13668-045-60          Bottle of 100                     NDC-13668-045-01 Bottle of 500                     NDC-13668-045-05 Bottle of 6600                   NDC-13668-045-66 10 x 10 unit dose                NDC-13668-045-74 Lamotrigine Tablets, USP 100-mg White to off white, round shape, flat face beveled edge, uncoated tablets debossed with "1047"    on one side and break line on other side. Bottle of 30                       NDC-13668-047-30 Bottle of 60                       NDC-13668-047-60 Bottle of 100                     NDC-13668-047-01 Bottle of 500                     NDC-13668-047-05 Bottle of 2500                   NDC-13668-047-31 10 x 10 unit dose                NDC-13668-047-74 Lamotrigine Tablets, USP 150-mg White to off white, round shape, flat face beveled edge, uncoated tablets debossed with "1048"   on one side and break line on other side.  Bottle of 30                        NDC-13668-048-30  Bottle of 60                        NDC-13668-048-60  Bottle of 100                      NDC-13668-048-01  Bottle of 500                      NDC-13668-048-05  Bottle of 1600                    NDC-13668-048-16 9 x 10 unit dose                  NDC-13668-048-64 Lamotrigine Tablets, USP 200-mg White to off white, round shape, flat face beveled edge, uncoated tablets debossed with "1049"   on one side and break line on other side.  Bottle of 30                       NDC-13668-049-30  Bottle of 60                       NDC-13668-049-60  Bottle of 100                     NDC-13668-049-01     Bottle of 500                     NDC-13668-049-05  Bottle of 1300                   NDC-13668-049-13 9 x 10 unit dose                 NDC-13668-049-64 Lamotrigine Tablets, USP Starter Kit for Patients Not Taking Carbamazepine, Phenytoin, Phenobarbital, Primidone, or Valproate (Orange Kit). 25-mg, white to off white, round shape, flat face beveled edge, uncoated tablets debossed with "45" on one side and break line on other side. 100-mg, white to off white, round shape, flat face beveled edge, uncoated tablets debossed with "1047" on one side and break line on other side. Blister pack of 42, 25-mg tablets and 7, 100-mg tablets                                   NDC-13668-266-99 Lamotrigine Tablets, USP Starter Kit for Patients Taking Carbamazepine, Phenytoin, Phenobarbital, or Primidone and Not Taking Valproate (Green Kit). 25-mg, white to off white, round shape, flat face beveled edge, uncoated tablets debossed with "45" on one side and break line on other side. 100-mg, white to off white, round shape, flat face beveled edge, uncoated tablets debossed with "1047" on one side and break line on other side. Blister pack of 84, 25-mg tablets and 14, 100-mg tablets                                 NDC-13668-266-28 Lamotrigine Tablets, USP Starter Kit for Patients Taking Valproate (Blue Kit). 25-mg, white to off white, round shape, flat face beveled edge, uncoated tablets debossed with "45" on one side and break line on other side. Blister pack of 35 tablets                             NDC-13668-045-29 Storage Store at 20 o   to 25 o C (68 o   to 77 o F); excursions permitted to 15 o   to 30 o C (59 o   to 86 o F) [See USP Controlled Room Temperature]

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LAMOTRIGINE - LAMOTRIGINE
Torrent Pharmaceuticals Limited
----------
MEDICATION GUIDE
Lamotrigine (la-MOE-tri-jeen) Tablets, USP
What is the most important information I should know about
lamotrigine?
1. Lamotrigine 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, 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.
The risk of getting a serious skin rash is higher if you:
● take lamotrigine while taking valproate [DEPAKENE(valproic acid)
or
DEPAKOTE(divalproex sodium)].
● take a higher starting dose of lamotrigine than your healthcare
provider prescribed.
● increase your dose of lamotrigine 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.
2. Other serious reactions, including serious blood problems or liver
problems.
Lamotrigine 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, looking pale
● weakness, fatigue
● yellowing of your skin or the white part of your eyes
• trouble walking or seeing
• seizures for the first time or happening more often

Summary of Product characteristics

LAMOTRIGINE- LAMOTRIGINE TABLET
LAMOTRIGINE - LAMOTRIGINE
TORRENT PHARMACEUTICALS LIMITED
----------
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.
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 THERISK 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, Cardiac Rhythm and 3/2021
Conduction Abnormalities ( 5.4)
INDICATIONS AND USAGE
Lamotrigine, USP is 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 antiepileptic drug. ( 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
reco