LAMOTRIGINE- lamotrigine tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hikma Pharmaceutical

INN (International Name):

LAMOTRIGINE

Composition:

LAMOTRIGINE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Teratogenic Effects: Pregnancy Category C. No evidence of teratogenicity was found in mice, rats, or rabbits when lamotrigine was orally administered to pregnant animals during the period of organogenesis at doses up to 1.2, 0.5, and 1.1 times, respectively, on a mg/m2 basis, the highest usual human maintenance dose (i.e., 500 mg/day). However, maternal toxicity and secondary fetal toxicity producing reduced fetal weight and/or delayed ossification were seen in mice and rats, but not in rabbits at these doses. Teratology studies were also conducted using bolus intravenous administration of the isethionate salt of lamotrigine in rats and rabbits. In rat dams administered an intravenous dose at 0.6 times the highest usual human maintenance dose, the incidence of intrauterine death without signs of teratogenicity was increased. A behavioral teratology study was conducted in rats dosed during the period of organogenesis. At day 21 postpartum, offspring of dams receiving 5 mg/kg/day or higher displayed a signifi

Product summary:

Lamotrigine Tablets 25 mg, white, scored, round tablets debossed with W67 on one side, bottles of 100 and 1000. 100 mg, peach, scored, round tablets debossed with WW966 on one side, bottles of 100 and 1000. 150 mg, cream, scored, round tablets debossed with WW965 on one side, bottles of 60 and 1000. 200 mg, blue, scored, round tablets debossed with WW964 on one side, bottles of 60 and 1000. Store at 20º - 25°C (68º - 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LAMOTRIGINE- LAMOTRIGINE TABLET
Hikma Pharmaceutical
----------
MEDICATION GUIDE
Lamotrigine Tablets, USP
Read this Medication Guide before you start taking lamotrigine and
each time you get a refill. There may be
new information. This information does not take the place of talking
with your healthcare provider about
your medical condition or treatment. If you have questions about
lamotrigine, ask your healthcare provider or
pharmacist.
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 to stop lamotrigine; it
may rarely cause death.
There is no way to tell if a mild rash will develop into a more
serious reaction. These serious skin reactions
are more likely to happen when you begin taking lamotrigine, within
the first 2 to 8 weeks of treatment. But
it can happen in people who have taken lamotrigine for any period of
time. Children between 2 to 16 years of
age have a higher chance of getting this serious skin reaction while
taking lamotrigine.
The risk of getting a 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.
Lamotrigine can also cause other types of allergic reactions or
serious problems which may affect organs and
other parts of your body like the 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 the
following:
•
a skin rash
•
hives
•
fever
•
swollen lymph glands
•
painful sores in the mouth or around your eyes
•
swelling of your lips or tongue
•
yellowing of your skin or eyes
•
unusual bruising or bleeding
•
severe fatigue or weakness
•
severe muscle pain
•
frequent infections
These symptoms may be the first signs of a serious reaction. A
healthcare provider shoul

Summary of Product characteristics

LAMOTRIGINE- LAMOTRIGINE TABLET
HIKMA PHARMACEUTICAL
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LAMOTRIGINE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR LAMOTRIGINE.
LAMOTRIGINE TABLETS
INITIAL U.S. APPROVAL: 1994
WARNINGS AND PRECAUTIONS
• Life-threatening serious rash and/or rash-related death may
result. (Boxed Warning, 5.1)
• Fatal or life-threatening hypersensitivity reaction: Multiorgan
hypersensitivity reactions, also known as Drug Reaction
with Eosinophilia and Systemic Symptoms (DRESS) may be fatal or
life-threatening. Early signs may include rash, fever
and lymphadenopathy.
These reactions may be associated with other organ involvement, such
as hepatitis, hepatic failure, blood dyscrasias, or
acute multiorgan failure. Lamotrigine should be discontinued if
alternate etiology for this reaction is not found. (5.2)
• Blood dyscrasias (e.g., neutropenia, thrombocytopenia,
pancytopenia: May occur, either with or without an associated
hypersensitivity syndrome. (5.3)
• Suicidal behavior and ideation. (5.4)
• Clinical worsening, emergence of new symptoms, and suicidal
ideation/behaviors may be associated with treatment of
bipolar disorder. Patients should be closely monitored, particularly
early in treatment or during dosage changes. (5.5)
• Aseptic meningitis reported in pediatric and adult patients. (5.6)
• Medication errors involving lamotrigine have occurred. In
particular the name lamotrigine can be confused with names of
other commonly used medications. (3.4, 5.7, 16, 17.10) (2)
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥10%) in adult epilepsy
clinical studies were dizziness, headache, diplopia,
ataxia, nausea, blurred vision, somnolence, rhinitis, and rash.
Additional adverse reactions (incidence ≥10%) reported in
children in epilepsy clinical studies included vomiting, infection,
fever, accidental injury, pharyngitis, abdominal pain, and
tremor. (6.1)
Most common adverse reactions (