E-DRUG: Lamotrigine (2)
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Dear Annalisa,
I am attaching information extracted from the South African package
insert for Lamictin (Lamotrigine) which you might find of interest. =
This was current last year (5/96) when we were hoping to put the
GlaxoWellcome products on our Internet site.
You may be interested to know that GlaxoWellcome have subsequently
refused permission for us to display any of their products on the
Internet and do not supply us with information updates.
Regards
Marland Holderness (Dip Pharm)
Malahyde Information Systems
e-mail: marland@intekom.co.za
internet: http://home.intekom.com/pharm/
telephone: (+27)(21)(7821578)
postal address: 74 Simon's Town Road, Fish Hoek, South Africa 7975
LAMICTIN tablets & dispersible tablets
WARNINGS
During clinical trials in over 4=3DA0000 patients receiving multiple
antiepileptical therapy including lamotrigine, there have rarely been
deaths following rapidly progessive illnesses with status
epilepticus, multi-organ dysfunction and disseminated intravascular
coagulation. The contribution of lamotrigine to these events remains
to be established.
Hepatic injury as the initiating event cannot be excluded in one
case.
It is recommended that the physician closely monitor patients
(including hepatic, renal and clotting parameters) who acutely
develop any combination of unexplained rash, fever, flu-like
symptoms, drowsiness or worsening of seizure control, especially
within the first month of starting treatment with lamotrigine. =
Available data suggest that exceeding the recommended dose at the
initiation of lamotrigine therapy may be associated with an increased
incidence of rash requiring withdrawal of therapy. Abrupt withdrawal
of LAMICTIN may provoke rebound seizures. The risk may be reduced by
tapering off the withdrawal of LAMICTIN over a period of two weeks.
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Children aged less than 2 years:
There is insufficient information on the use of LAMICTIN in children
aged less than two years.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Adverse experiences reported during LAMICTIN monotherapy trials
include headache, tiredness, rash, nausea, dizziness, drowsiness and
insomnia.
In double-blind, add-on clinical trials, transient skin rashes
occurred in up to 10% of patients taking lamotrigine . Skin rashes
led to the withdrawal of lamotrigine treatment in 2% of patients. =
The rash, usually maculopapular in appearance, generally appears
within four weeks of starting treatment and resolves on withdrawal of
lamotrigine. Rarely, severe skin rashes, including angioedema and
Stevens-Johnson syndrome, have been reported. Other frequent adverse
experiences reported during trials with LAMICTIN added on to standard
antiepileptic drug regimens have included diplopia, blurred vision,
nystagmus, dizziness, drowsiness, headache, unsteadiness, tiredness,
gastrointestinal disturbance (nausea and vomiting),
irritability/aggression, depression, tremor, vertigo and parasthesia.
--- Note from the moderator:
The SA database of package inserts is at:
http://home.intekom.com/pharm/ =
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