In september of 2010, novartis pleaded guilty to attempting to market the drug, trileptal for depression, for the unapproved uses of treating bipolar disorder during the years of 2000 and 2001.
Information about Trileptal.
Do not drive or operate machinery until you know how TRILEPTAL affects youTRILEPTAL may slow your thinking and motor skillsDo not drink alcohol or take other drugs that make you sleepy or dizzy while taking TRILEPTAL until you talk to your healthcare providerTRILEPTAL taken with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.
Advise patients that TRILEPTAL may reduce the serum sodium concentrations especially if they are taking other medications that can lower sodiumInstruct patients to report symptoms of low sodium like nauseatirednesslack of energyconfusionand more frequent or more severe seizuressee WARNINGS AND PRECAUTIONS
There is no specific antidoteSymptomatic and supportive treatment should be administered as appropriateRemoval of the drug by gastric lavage and/or inactivation by administering activated charcoal should be considered.
There are no adequate and well-controlled clinical studies of TRILEPTAL in pregnant womenhoweverTRILEPTAL is closely related structurally to carbamazepinewhich is considered to be teratogenic in humansData on a limited number of pregnancies from pregnancy registries suggest congenital malformations associated with TRILEPTAL monotherapy usee.gcraniofacial defects such as oral clefts and cardiac malformations such as ventricular septal defectsTRILEPTAL should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
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