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Lamictal® (Lamotrigine) Uses, Dosage, Side Effects and Drug Interactions

MEDICATIONS

Lamictal® – lamotrigine (View the FDA label)

LAMICTAL is an antiepileptic drug (AED) indicated for: Epilepsy—adjunctive therapy in patients ≥2 years of age: (1.1)

  • partial seizures.
  • primary generalized tonic-clonic seizures.
  • generalized seizures of Lennox-Gastaut syndrome.

Epilepsy—monotherapy in patients >=16 years of age: conversion to monotherapy in patients with partial seizures who are receiving treatment with carbamazepine, phenobarbital, phenytoin, primidone, or valproate as the single AED. (1.1)

Bipolar Disorder in patients >=18 years of age: 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. (2.2, 2.4)

To avoid an increased risk of rash, the recommended initial dose and subsequent dose escalations should not be exceeded. LAMICTAL Starter Kits and LAMICTAL ODT Patient Titration Kits are available for the first 5 weeks of treatment. (2.1, 16)

Do not restart LAMICTAL in patients who discontinued due to rash unless the potential benefits clearly outweigh the risks. (2.1)

Adjustments to maintenance doses will in most cases be required in patients starting or stopping estrogen-containing oral contraceptives. (2.1, 5.8)

LAMICTAL should be discontinued over a period of at least 2 weeks (approximately 50% reduction per week). (2.1, 5.9)

Epilepsy

Adjunctive therapy—See Table 1 for patients >12 years of age and Tables 2 and 3 for patients 2 to 12 years. (2.2)

Conversion to monotherapy—See Table 4. (2.3) Bipolar Disorder: See Tables 5 and 6. (2.4)

Most common adverse reactions (incidence >=10%) in adult epilepsy clinical studies were dizziness, headache, diplopia, ataxia, nausea, blurred vision, somnolence, rhinitis, and rash. Additional adverse reactions (incidence >=10%) reported in children in epilepsy clinical studies included vomiting, infection, fever, accidental injury, pharyngitis, abdominal pain, and tremor. (6.1)

Most common adverse reactions (incidence >5%) in adult bipolar clinical studies were nausea, insomnia, somnolence, back pain, fatigue, rash, rhinitis, abdominal pain, and xerostomia. (6.1)

Life-threatening serious rash and/or rash-related death may result. (Boxed Warning, 5.1)

Fatal or life-threatening hypersensitivity reaction: Multiorgan hypersensitivity reactions, also known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), may be fatal or life threatening. Early signs may include rash, fever, and lymphadenopathy. These reactions may be associated with other organ involvement, such as hepatitis, hepatic failure, blood dyscrasias, or acute multiorgan failure. LAMICTAL should be discontinued if alternate etiology for this reaction is not found. (5.2)

Blood dyscrasias (e.g., neutropenia, thrombocytopenia, pancytopenia): May occur, either with or without an associated hypersensitivity syndrome. (5.3)

Suicidal behavior and ideation. (5.4)

Clinical worsening, emergence of new symptoms, and suicidal ideation/behaviors may be associated with treatment of bipolar disorder. Patients should be closely monitored, particularly early in treatment or during dosage changes. (5.5)  Aseptic meningitis reported in pediatric and adult patients. (5.6)

Medication errors involving LAMICTAL have occurred. In particular the names LAMICTAL or lamotrigine can be confused with names of other commonly used medications. Medication errors may also occur between the different formulations of LAMICTAL. (3.4, 5.7, 16, 17.10)

Valproate increases lamotrigine concentrations more than 2-fold. (7, 12.3)

Carbamazepine, phenytoin, phenobarbital, and primidone decrease lamotrigine concentrations by approximately 40%. (7, 12.3)

Oral estrogen-containing contraceptives and rifampin also decrease lamotrigine concentrations by approximately 50%. (7, 12.3)

Human Overdose Experience
Overdoses involving quantities up to 15 g have been reported for LAMICTAL, some of 960 which have been fatal. Overdose has resulted in ataxia, nystagmus, increased seizures, decreased 961 level of consciousness, coma, and intraventricular conduction delay.

Management of Overdose
There are no specific antidotes for lamotrigine. Following a suspected overdose, 964 hospitalization of the patient is advised. General supportive care is indicated, including frequent 965 monitoring of vital signs and close observation of the patient. If indicated, emesis should be 966 induced; usual precautions should be taken to protect the airway. It should be kept in mind that 967 lamotrigine is rapidly absorbed [see Clinical Pharmacology (12.3)]. It is uncertain whether 968 hemodialysis is an effective means of removing lamotrigine from the blood. In 6 renal failure 969 patients, about 20% of the amount of lamotrigine in the body was removed by hemodialysis 970 during a 4-hour session. A Poison Control Center should be contacted for information on the 971 management of overdosage of LAMICTAL.

Uses

LAMICTAL is an antiepileptic drug (AED) indicated for: Epilepsy—adjunctive therapy in patients ≥2 years of age: (1.1)

  • partial seizures.
  • primary generalized tonic-clonic seizures.
  • generalized seizures of Lennox-Gastaut syndrome.

Epilepsy—monotherapy in patients >=16 years of age: conversion to monotherapy in patients with partial seizures who are receiving treatment with carbamazepine, phenobarbital, phenytoin, primidone, or valproate as the single AED. (1.1)

Bipolar Disorder in patients >=18 years of age: 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. (2.2, 2.4)

To avoid an increased risk of rash, the recommended initial dose and subsequent dose escalations should not be exceeded. LAMICTAL Starter Kits and LAMICTAL ODT Patient Titration Kits are available for the first 5 weeks of treatment. (2.1, 16)

Do not restart LAMICTAL in patients who discontinued due to rash unless the potential benefits clearly outweigh the risks. (2.1)

Adjustments to maintenance doses will in most cases be required in patients starting or stopping estrogen-containing oral contraceptives. (2.1, 5.8)

LAMICTAL should be discontinued over a period of at least 2 weeks (approximately 50% reduction per week). (2.1, 5.9)

Epilepsy

Adjunctive therapy—See Table 1 for patients >12 years of age and Tables 2 and 3 for patients 2 to 12 years. (2.2)

Conversion to monotherapy—See Table 4. (2.3) Bipolar Disorder: See Tables 5 and 6. (2.4)

Side Effects

Most common adverse reactions (incidence >=10%) in adult epilepsy clinical studies were dizziness, headache, diplopia, ataxia, nausea, blurred vision, somnolence, rhinitis, and rash. Additional adverse reactions (incidence >=10%) reported in children in epilepsy clinical studies included vomiting, infection, fever, accidental injury, pharyngitis, abdominal pain, and tremor. (6.1)

Most common adverse reactions (incidence >5%) in adult bipolar clinical studies were nausea, insomnia, somnolence, back pain, fatigue, rash, rhinitis, abdominal pain, and xerostomia. (6.1)

Precautions

Life-threatening serious rash and/or rash-related death may result. (Boxed Warning, 5.1)

Fatal or life-threatening hypersensitivity reaction: Multiorgan hypersensitivity reactions, also known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), may be fatal or life threatening. Early signs may include rash, fever, and lymphadenopathy. These reactions may be associated with other organ involvement, such as hepatitis, hepatic failure, blood dyscrasias, or acute multiorgan failure. LAMICTAL should be discontinued if alternate etiology for this reaction is not found. (5.2)

Blood dyscrasias (e.g., neutropenia, thrombocytopenia, pancytopenia): May occur, either with or without an associated hypersensitivity syndrome. (5.3)

Suicidal behavior and ideation. (5.4)

Clinical worsening, emergence of new symptoms, and suicidal ideation/behaviors may be associated with treatment of bipolar disorder. Patients should be closely monitored, particularly early in treatment or during dosage changes. (5.5)  Aseptic meningitis reported in pediatric and adult patients. (5.6)

Medication errors involving LAMICTAL have occurred. In particular the names LAMICTAL or lamotrigine can be confused with names of other commonly used medications. Medication errors may also occur between the different formulations of LAMICTAL. (3.4, 5.7, 16, 17.10)

Interactions

Valproate increases lamotrigine concentrations more than 2-fold. (7, 12.3)

Carbamazepine, phenytoin, phenobarbital, and primidone decrease lamotrigine concentrations by approximately 40%. (7, 12.3)

Oral estrogen-containing contraceptives and rifampin also decrease lamotrigine concentrations by approximately 50%. (7, 12.3)

Overdose

Human Overdose Experience
Overdoses involving quantities up to 15 g have been reported for LAMICTAL, some of 960 which have been fatal. Overdose has resulted in ataxia, nystagmus, increased seizures, decreased 961 level of consciousness, coma, and intraventricular conduction delay.

Management of Overdose
There are no specific antidotes for lamotrigine. Following a suspected overdose, 964 hospitalization of the patient is advised. General supportive care is indicated, including frequent 965 monitoring of vital signs and close observation of the patient. If indicated, emesis should be 966 induced; usual precautions should be taken to protect the airway. It should be kept in mind that 967 lamotrigine is rapidly absorbed [see Clinical Pharmacology (12.3)]. It is uncertain whether 968 hemodialysis is an effective means of removing lamotrigine from the blood. In 6 renal failure 969 patients, about 20% of the amount of lamotrigine in the body was removed by hemodialysis 970 during a 4-hour session. A Poison Control Center should be contacted for information on the 971 management of overdosage of LAMICTAL.

Interpreting the GeneSight® Test:
Gene-Drug Interaction Chart

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