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Highlights of Prescribing Information See 17 for Patient Counseling Information and Medication Guide. Revised: 05/2015 Full Prescribing Information: Contents* Warning: Serious Skin Rashes 1 Indications and Usage 1.1 Epilepsy 1.2 Bipolar Disorder 2 Dosage and Administration 2.1 General Dosing Conside
| Content Provider | Semantic Scholar |
|---|---|
| Author | Carbamazepine |
| Abstract | These highlights do not include all the information needed to use LAMOTRIGINE safely and effectively. See full prescribing information for LAMOTRIGINE. WARNING: SERIOUS SKIN RASHES See full prescribing information for complete boxed warning. • Cases of life-threatening serious rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis, and/or rash-related death have been caused by lamotrigine. The rate of serious rash is greater in pediatric patients than in adults. Additional factors that may increase the risk of rash include: • coadministration with valproate. • exceeding recommended initial dose of lamotrigine. • exceeding recommended dose escalation for lamotrigine. (5.1) • Benign rashes are also caused by lamotrigine; however, it is not possible to predict which rashes will prove to be serious or life threatening. Lamotrigine should be discontinued at the first sign of rash, unless the rash is clearly not drug related. Epilepsy—adjunctive therapy in patients aged 2 years and older: • partial-onset seizures. • primary generalized tonic-clonic seizures. • generalized seizures of Lennox-Gastaut syndrome. (1.1) Epilepsy—monotherapy in patients aged 16 years and older: Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single AED. (1.1) Bipolar disorder in patients aged 18 years and older: Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. (1.2) • Dosing is based on concomitant medications, indication, and patient age. (2.1, 2.2, 2.3, 2.4) • To avoid an increased risk of rash, the recommended initial dose and subsequent dose escalations should not be exceeded. Lamotrigine Starter Kits are available for the first 5 weeks of treatment. (2.1, 16) • Do not restart lamotrigine in patients who discontinued due to rash unless the potential benefits clearly outweigh the risks. (2.1, 5.1) • Adjustments to maintenance doses will be necessary in most patients starting or stopping estrogen-containing oral contraceptives. (2.1, 5.8) • Discontinuation: Taper over a period of at least 2 weeks (approximately 50% dose reduction per week). (2.1, 5.9) Epilepsy: • Adjunctive therapy-See Table 1 for patients older than 12 years and Tables 2 and 3 for patients aged 2 to 12 years. (2.2) • Conversion to monotherapy—See Table 4. (2.3) Bipolar disorder: See Tables 5 and 6. (2.4) • Life-threatening serious rash and/or rash-related death: Discontinue at the first sign of rash, unless the rash is clearly not drug … |
| File Format | PDF HTM / HTML |
| Alternate Webpage(s) | http://www.upsher-smith.com/wp-content/uploads/Lamotrigine-COL.pdf |
| Language | English |
| Access Restriction | Open |
| Content Type | Text |
| Resource Type | Research Highlight |
