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You are here: Home » eGM Resources » Health Information & Resources Portal|Home » RX Drug List (listed alphabetically) » Drug Reference (L's) » Lamotrigine



DESCRIPTION

WARNING

SEVERE, POTENTIALLY LIFE-THREATENING RASHES HAVE BEEN REPORTED IN ASSOCIATION WITH THE USE OF LAMOTRIGINE. THESE REPORTS, OCCURRING IN APPROXIMATELY ONE IN EVERY THOUSAND ADULTS, HAVE INCLUDED STEVENS-JOHNSON SYNDROME (SJS) AND, RARELY, TOXIC EPIDERMAL NECROLYSIS (TEN). RARE DEATHS HAVE BEEN REPORTED, BUT THEIR NUMBERS ARE TOO FEW TO PERMIT A PRECISE ESTIMATE OF THE RATE.



THE INCIDENCE OF SEVERE, POTENTIALLY LIFE-THREATENING RASH IN PEDIATRIC PATIENTS, HOWEVER, IS VERY MUCH HIGHER THAN THAT REPORTED IN ADULTS USING LAMOTRIGINE; SPECIFICALLY, REPORTS FROM CLINICAL TRIALS SUGGEST AS MANY AS 1 IN 50 TO 1 IN 100 PEDIATRIC PATIENTS DEVELOP A POTENTIALLY LIFE-THREATENING RASH. IT BEARS EMPHASIS, ACCORDINGLY, THAT LAMOTRIGINE IS NOT APPROVED FOR USE IN PATIENTS BELOW THE AGE OF 16 (SEE INDICATIONS AND USAGE).

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 LAMOTRIGINE. THERE ARE SUGGESTIONS, YET TO BE PROVEN, THAT THE RISK OF RASH MAY ALSO BE INCREASED BY 1) COADMINISTRATION OF LAMOTRIGINE WITH VALPROIC ACID (VPA), 2) EXCEEDING THE RECOMMENDED INITIAL DOSE OF LAMOTRIGINE, OR 3) EXCEEDING THE RECOMMENDED DOSE ESCALATION FOR LAMOTRIGINE. HOWEVER, CASES HAVE BEEN REPORTED IN THE ABSENCE OF THESE FACTORS.

NEARLY ALL CASES OF LIFE-THREATENING RASHES ASSOCIATED WITH LAMOTRIGINE 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 R.L.E. UPON AS A MEANS TO PREDICT THE POTENTIAL RISK HERALDED BY THE FIRST APPEARANCE OF A RASH.

ALTHOUGH BENIGN RASHES ALSO OCCUR WITH LAMOTRIGINE, IT IS NOT POSSIBLE TO PREDICT RELIABLY WHICH RASHES WILL PROVE TO BE LIFE-THREATENING. ACCORDINGLY, LAMOTRIGINE SHOULD 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.


Lamictal, an antiepileptic drug of the phenyltriazine class, is chemically unrelated to existing antiepileptic drugs(AED's). Its chemical name is 6-(2,3-dichlorophenyl)-1,2,4-triazine-3,5-diamine, its molecular formula is C9H7Cl2N5 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 is 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); FD&C Blue No. 2 Lake (200 mg tablet only).

CATEGORIES, BRAND NAMES

CATEGORIES: Convulsions; Epilepsy; Seizures; FDA Class 1P (Priority Review); FDA Approved 1994 Dec; Pregnancy Category C; Orphan Drugs

FDA Drug Class: Anticonvulsants

BRAND NAMES: Lamictal

COST OF THERAPY: $1,346.36 (Epilepsy; Tablet; 150 mg; 2/day; 365 days)





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