A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Lamictal Online, Description, Chemistry, Ingredients - Lamotrigine
Lamictal Online, Description, Chemistry, Ingredients - Lamotrigine
LAMICTAL ® (lamotrigine)Tablets
LAMICTAL ® (lamotrigine)Chewable Dispersible
Tablets
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SERIOUS RASHES REQUIRING HOSPITALIZATION
AND DISCONTINUATION OF TREATMENT HAVE BEEN REPORTED IN ASSOCIATION WITH
THE USE OF LAMICTAL. THE INCIDENCE OF THESE RASHES, WHICH HAVE INCLUDED
STEVENS-JOHNSON SYNDROME, IS APPROXIMATELY 0.8% (8 PER 1,000) IN PEDIATRIC
PATIENTS (AGE <16 YEARS) RECEIVING LAMICTAL AS ADJUNCTIVE THERAPY FOR
EPILEPSY AND 0.3% (3 PER 1,000) IN ADULTS ON ADJUNCTIVE THERAPY FOR EPILEPSY.
IN CLINICAL TRIALS OF BIPOLAR AND OTHER MOOD DISORDERS, THE RATE OF SERIOUS
RASH WAS 0.08% (0.8 PER 1,000) IN ADULT PATIENTS RECEIVING LAMICTAL AS
INITIAL MONOTHERAPY AND 0.13% (1.3 PER 1,000) IN ADULT PATIENTS RECEIVING
LAMICTAL AS ADJUNCTIVE THERAPY. IN A PROSPECTIVELY FOLLOWED COHORT OF
1,983 PEDIATRIC PATIENTS WITH EPILEPSY TAKING ADJUNCTIVE LAMICTAL, THERE
WAS 1 RASH-RELATED DEATH. IN WORLDWIDE POSTMARKETING EXPERIENCE, RARE
CASES OF TOXIC EPIDERMAL NECROLYSIS AND/OR RASH-RELATED DEATH HAVE BEEN
REPORTED IN ADULT AND PEDIATRIC PATIENTS, BUT THEIR NUMBERS ARE TOO FEW
TO PERMIT A PRECISE ESTIMATE OF THE RATE.
BECAUSE THE RATE OF SERIOUS RASH IS GREATER IN PEDIATRIC
PATIENTS THAN IN ADULTS, IT BEARS EMPHASIS THAT LAMICTAL IS APPROVED ONLY
FOR USE IN PEDIATRIC PATIENTS BELOW THE AGE OF 16 YEARS WHO HAVE SEIZURES
ASSOCIATED WITH THE LENNOX-GASTAUT SYNDROME OR IN PATIENTS WITH PARTIAL
SEIZURES (SEE INDICATIONS). OTHER THAN
AGE, THERE ARE AS YET NO FACTORS IDENTIFIED THAT ARE KNOWN TO PREDICT
THE RISK OF OCCURRENCE OR THE SEVERITY OF RASH ASSOCIATED WITH LAMICTAL.
THERE ARE SUGGESTIONS, YET TO BE PROVEN, THAT THE RISK OF RASH MAY ALSO
BE INCREASED BY (1) COADMINISTRATION OF LAMICTAL WITH VALPROATE (INCLUDES
VALPROIC ACID AND DIVALPROEX SODIUM), (2) EXCEEDING THE RECOMMENDED INITIAL
DOSE OF LAMICTAL, OR (3) EXCEEDING THE RECOMMENDED DOSE ESCALATION FOR
LAMICTAL. HOWEVER, CASES HAVE BEEN REPORTED IN THE ABSENCE OF THESE FACTORS.
NEARLY ALL CASES OF LIFE-THREATENING RASHES ASSOCIATED
WITH LAMICTAL HAVE OCCURRED WITHIN 2 TO 8 WEEKS OF TREATMENT INITIATION.
HOWEVER, ISOLATED CASES HAVE BEEN REPORTED AFTER PROLONGED TREATMENT (E.G.,
6 MONTHS). ACCORDINGLY, DURATION OF THERAPY CANNOT BE RELIED UPON AS A
MEANS TO PREDICT THE POTENTIAL RISK HERALDED BY THE FIRST APPEARANCE OF
A RASH.
ALTHOUGH BENIGN RASHES ALSO OCCUR WITH LAMICTAL, IT IS
NOT POSSIBLE TO PREDICT RELIABLY WHICH RASHES WILL PROVE TO BE SERIOUS
OR LIFE THREATENING. ACCORDINGLY, LAMICTAL SHOULD ORDINARILY BE DISCONTINUED
AT THE FIRST SIGN OF RASH, UNLESS THE RASH IS CLEARLY NOT DRUG RELATED.
DISCONTINUATION OF TREATMENT MAY NOT PREVENT A RASH FROM BECOMING LIFE
THREATENING OR PERMANENTLY DISABLING OR DISFIGURING.
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DESCRIPTION
LAMICTAL (lamotrigine), an antiepileptic drug (AED) of the
phenyltriazine class, is chemically unrelated to existing antiepileptic drugs.
Its chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular
formula is C9H7N5Cl2, and its molecular
weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has
a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C)
and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C).
LAMICTAL Tablets are supplied for oral administration as 25-mg
(white), 100-mg (peach), 150-mg (cream), and 200-mg (blue) tablets. Each tablet
contains the labeled amount of lamotrigine and the following inactive ingredients:
lactose; magnesium stearate; microcrystalline cellulose; povidone; sodium starch
glycolate; FD&C Yellow No. 6 Lake (100-mg tablet only); ferric oxide, yellow
(150-mg tablet only); and FD&C Blue No. 2 Lake (200-mg tablet only).
LAMICTAL Chewable Dispersible Tablets are supplied for oral
administration. The tablets contain 2 mg (white), 5 mg (white), or 25 mg (white)
of lamotrigine and the following inactive ingredients: blackcurrant flavor,
calcium carbonate, low-substituted hydroxypropylcellulose, magnesium aluminum
silicate, magnesium stearate, povidone, saccharin sodium, and sodium starch
glycolate.
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