{ "schema_version": 1, "kind": "drug_profile", "generic": "lamotrigine", "review_status": "reviewed", "origin": "openfda", "sections": { "adult": [ { "text": "The dose increases should begin at the same time that the oral contraceptive is introduced and continue, based on clinical response, no more rapidly than 50 to 100 mg/day every week.", "source": "US FDA label for lamotrigine (Lamotrigine), section 'dosage and administration', retrieved 2026-08-29", "cached_file": "labels/lamotrigine.json", "verbatim": true }, { "text": "Increase by 50 mg/day every 1 to 2 weeks.", "source": "US FDA label for lamotrigine (Lamotrigine), section 'dosage and administration', retrieved 2026-08-29", "cached_file": "labels/lamotrigine.json", "verbatim": true }, { "text": "Increase by 100 mg/day every 1 to 2 weeks.", "source": "US FDA label for lamotrigine (Lamotrigine), section 'dosage and administration', retrieved 2026-08-29", "cached_file": "labels/lamotrigine.json", "verbatim": true } ], "child": [ { "text": "Epilepsy Lamotrigine is indicated as adjunctive therapy in patients aged 2 years and older for partial-onset seizures, the generalized seizures of Lennox-Gastaut syndrome, and PGTC seizures. Safety and efficacy of lamotrigine used as adjunctive treatment for partial-onset seizures were not demonstrated in a small, randomized, double-blind, placebo-controlled withdrawal trial in very young pediatric patients (aged 1 to 24 months).", "source": "US FDA label for lamotrigine (Lamotrigine), section 'pediatric use', retrieved 2026-08-29", "cached_file": "labels/lamotrigine.json", "verbatim": true }, { "text": "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 Orally Disintegrating Tablets Patient Titration Kits are available for the first 5 weeks of treatment.", "source": "US FDA label for lamotrigine (Lamotrigine), section 'dosage and administration', retrieved 2026-08-29", "cached_file": "labels/lamotrigine.json", "verbatim": true }, { "text": "Juvenile Animal Data In a juvenile animal study in which lamotrigine (oral doses of 0, 5, 15, or 30 mg/kg) was administered to young rats from postnatal day 7 to 62, decreased viability and growth were seen at the highest dose tested and long-term neurobehavioral abnormalities (decreased locomotor activity, increased reactivity, and learning deficits in animals tested as adults) were observed at the 2 highest doses.", "source": "US FDA label for lamotrigine (Lamotrigine), section 'pediatric use', retrieved 2026-08-29", "cached_file": "labels/lamotrigine.json", "verbatim": true } ], "renal": [ { "text": "Patients with Renal Impairment Initial doses of lamotrigine orally disintegrating tablets should be based on patients’ concomitant medications (see Tables 1 to 3 and 5); reduced maintenance doses may be effective for patients with significant renal impairment [see Use in Specific Populations (8.7) , Clinical Pharmacology (12.3) ].", "source": "This line points to a numbered table that this card does not show - read that table in the label before you dose. US FDA label for lamotrigine (Lamotrigine), section 'dosage and administration', retrieved 2026-08-29", "cached_file": "labels/lamotrigine.json", "verbatim": true }, { "text": "Few patients with severe renal impairment have been evaluated during chronic treatment with lamotrigine orally disintegrating tablets.", "source": "US FDA label for lamotrigine (Lamotrigine), section 'dosage and administration', retrieved 2026-08-29", "cached_file": "labels/lamotrigine.json", "verbatim": true }, { "text": "( 2.1 , 8.6 ) Renal impairment: Reduced maintenance doses may be effective for patients with significant renal impairment.", "source": "US FDA label for lamotrigine (Lamotrigine), section 'use in specific populations', retrieved 2026-08-29", "cached_file": "labels/lamotrigine.json", "verbatim": true } ], "hepatic": [ { "text": "Patients with Hepatic Impairment Experience in patients with hepatic impairment is limited.", "source": "US FDA label for lamotrigine (Lamotrigine), section 'dosage and administration', retrieved 2026-08-29", "cached_file": "labels/lamotrigine.json", "verbatim": true }, { "text": "Based on a clinical pharmacology study in 24 subjects with mild, moderate, and severe liver impairment , the following general recommendations can be made [see Use in Specific Populations (8.6) , Clinical Pharmacology (12.3) ] .", "source": "US FDA label for lamotrigine (Lamotrigine), section 'dosage and administration', retrieved 2026-08-29", "cached_file": "labels/lamotrigine.json", "verbatim": true }, { "text": "No dosage adjustment is needed in patients with mild liver impairment.", "source": "US FDA label for lamotrigine (Lamotrigine), section 'dosage and administration', retrieved 2026-08-29", "cached_file": "labels/lamotrigine.json", "verbatim": true } ], "pregnancy": [ { "text": "Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, including lamotrigine, during pregnancy.", "source": "US FDA label for lamotrigine (Lamotrigine), section 'pregnancy', retrieved 2026-08-29", "cached_file": "labels/lamotrigine.json", "verbatim": true }, { "text": "Encourage women who are taking lamotrigine during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/ .", "source": "US FDA label for lamotrigine (Lamotrigine), section 'pregnancy', retrieved 2026-08-29", "cached_file": "labels/lamotrigine.json", "verbatim": true }, { "text": "Risk Summary Data from several prospective pregnancy exposure registries and epidemiological studies of pregnant women have not detected an increased frequency of major congenital malformations or a consistent pattern of malformations among women exposed to lamotrigine compared with the general population (see Data) .", "source": "US FDA label for lamotrigine (Lamotrigine), section 'pregnancy', retrieved 2026-08-29", "cached_file": "labels/lamotrigine.json", "verbatim": true } ], "lactation": [ { "text": "When pregnant rats were administered lamotrigine (oral doses of 0, 5, 10, or 20 mg/kg) during the latter part of gestation and throughout lactation, increased offspring mortality (including stillbirths) was seen at all doses.", "source": "US FDA label for lamotrigine (Lamotrigine), section 'use in specific populations', retrieved 2026-08-29", "cached_file": "labels/lamotrigine.json", "verbatim": true }, { "text": "When administered to pregnant rats, lamotrigine decreased fetal folate concentrations at doses greater than or equal to 5 mg/kg/day, which is less than the human dose of 400 mg/day on a mg/m 2 basis. 8.2 Lactation Risk Summary Lamotrigine is present in milk from lactating women taking lamotrigine (see Data) .", "source": "US FDA label for lamotrigine (Lamotrigine), section 'use in specific populations', retrieved 2026-08-29", "cached_file": "labels/lamotrigine.json", "verbatim": true }, { "text": "Events including rash, apnea, drowsiness, poor sucking, and poor weight gain (requiring hospitalization in some cases) have been reported in infants who have been human milk-fed by mothers using lamotrigine; whether or not these events were caused by lamotrigine is unknown.", "source": "US FDA label for lamotrigine (Lamotrigine), section 'use in specific populations', retrieved 2026-08-29", "cached_file": "labels/lamotrigine.json", "verbatim": true } ] } }