LAMOTRIGINE tablet, extended release

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Dr.Reddy's Laboratories Limited

INN (Mezinárodní Name):

LAMOTRIGINE

Složení:

LAMOTRIGINE 25 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Lamotrigine extended-release tablets are indicated as adjunctive therapy for primary generalized tonic-clonic (PGTC) seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. Lamotrigine extended-release tablets are indicated for conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED). Safety and effectiveness of lamotrigine extended-release tablets have not been established (1) as initial monotherapy or (2) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs. Safety and effectiveness of lamotrigine extended-release tablets for use in patients younger than 13 years have not been established. Lamotrigine extended-release tablets are contraindicated in patients who have demonstrated hypersensitivity (e.g., rash, angioedema, acute urticaria, extensive pruritus, mucosal ulceration) to the drug or its ingredients [see Boxed Warning, Warn

Přehled produktů:

Lamotrigine extended-release tablets USP, 25 mg are yellow colored round, biconvex tablets imprinted in black ink with ‘R717’ on one side and plain on the other side and are supplied as unit-of-use bottles of 30’s and bottles of 500’s.  Bottles of 30                                       NDC 55111-717-30 Bottles of 500                                      NDC 55111-717-05 Lamotrigine extended-release tablets USP, 50 mg are light green colored round, biconvex tablets imprinted in black ink with ‘R718’ on one side and plain on the other side and are supplied as unit-of-use bottles of 30’s and bottles of 500’s. Bottles of 30                                       NDC 55111-718-30 Bottles of 500                                      NDC 55111-718-05 Lamotrigine extended-release tablets USP, 100 mg are orange colored round, biconvex tablets imprinted in black ink with ‘R719’ on one side and plain on the other side  and are supplied as unit-of-use bottles of 30’s and bottles of 500’s. Bottles of 30                                       NDC 55111-719-30 Bottles of 500                                      NDC 55111-719-05 Lamotrigine extended-release tablets USP, 200 mg are blue colored round, biconvex tablets imprinted in black ink with ‘R720’ on one side and plain on the other side and are supplied as unit-of-use bottles of 30’s and bottles of 500’s. Bottles of 30                                       NDC 55111-720-30 Bottles of 500                                      NDC 55111-720-05 Lamotrigine extended-release tablets USP, 250 mg are purple colored, oval shaped, biconvex tablets imprinted with 'R419' on one side and plain on the other side and are supplied as unit-of-use bottles of 30’s, bottles of 90’s and bottles of 500’s. Bottles of 30 NDC 55111-419-30 Bottles of 90 NDC 55111-419-90 Bottles of 500 NDC 55111-419-05 Lamotrigine extended-release tablets USP, 300 mg are grey colored modified capsule shaped, biconvex tablets imprinted with ‘R428’ on one side and plain on the other side and are supplied as unit-of-use bottles of 30’s, bottles of 90’s and bottles of 500’s. Bottles of 30                                        NDC 55111-428-30 Bottles of 90                                        NDC 55111-428-90 Bottles of 500                                      NDC 55111-428-05 Storage: Store at 20°–25° C (68°–77° F); [See USP Controlled Room Temperature].

Stav Autorizace:

Abbreviated New Drug Application

Informace pro uživatele

LAMOTRIGINE- lamotrigine tablet, extended release
Dr.Reddy's Laboratories Limited
----------
MEDICATION GUIDE
Lamotrigine Extended-Release Tablets, USP
(la-MOE-tri-jeen)
What is the most important information I should know about lamotrigine
extended-release tablets?
1. Lamotrigine extended-release 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 extended-release tablets, but
is more likely to happen within the first
2 to 8 weeks of treatment. Children aged between 2 and 16 years have a
higher chance of getting this serious
skin rash while taking lamotrigine extended-release tablets.
Lamotrigine extended-release tablets are not
approved for use in children younger than 13 years.
The risk of getting a serious skin rash is higher if you:
• take lamotrigine extended-release tablets while taking valproate
[DEPAKENE (valproic acid) or
DEPAKOTE (divalproex sodium)].
• take a higher starting dose of lamotrigine extended-release
tablets than your healthcare provider prescribed.
• increase your dose of lamotrigine extended-release 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 extended-release
tablets.
2. Other serious reactions, including serious blood problems or liver
problems. Lamotrigine extended-release
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 sym

Charakteristika produktu

LAMOTRIGINE- LAMOTRIGINE TABLET, EXTENDED RELEASE
DR.REDDY'S LABORATORIES LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LAMOTRIGINE EXTENDED-
RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR LAMOTRIGINE
EXTENDED-RELEASE TABLETS.
LAMOTRIGINE EXTENDED-RELEASE 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 INCLUDE:
• COADMINISTRATION WITH VALPROATE.
• EXCEEDING RECOMMENDED INITIAL DOSE OF LAMOTRIGINE EXTENDED-RELEASE
TABLETS .
• EXCEEDING RECOMMENDED DOSE ESCALATION FOR LAMOTRIGINE
EXTENDED-RELEASE TABLETS.
(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
EXTENDED-RELEASE
TABLETS 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 Conduction Abnormalities
(5.4) 3/2021
INDICATIONS AND USAGE
Lamotrigine extended-release tablets are indicated for:
adjunctive therapy for primary generalized tonic-clonic seizures and
partial-onset seizures with or
without secondary generalization in patients aged 13 years and older.
(1.1)
conversion to monotherapy in patients aged 13 years and older with
partial-onset seizures who are
receiving treatment with a single antiepileptic drug. (1.2)
Limitation of use: Safety and effectiveness in patients younger than
13 years have not been established.
(1.3)
DOSAGE AND ADMINISTRATION
Do not exceed the recommended initial dosage and subsequent dose
escalation. (2.1)
Initiation o