Lamotrigine

DRUG INFORMATION

  ADULT
    - 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
    - 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
    - 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

  CHILD
    - 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
    - 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
    - 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

  RENAL IMPAIRMENT
    - 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
    - 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
    - ( 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

  HEPATIC IMPAIRMENT
    - 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
    - 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
    - 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

  PREGNANCY
    - 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
    - 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
    - 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

  BREASTFEEDING
    - 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
    - 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
    - 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