Lamotrigine

Lamotrigine
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Pratik Bahekar, MBBS [2]

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Overview

Lamotrigine is a anticonvulsant drug that is FDA approved for the {{{indicationType}}} of Bipolar I disorder Lennox-Gastaut syndrome; Adjunct Partial seizure, Adjunct or monotherapy Tonic-clonic seizure, Primary generalized; Adjunct. Common adverse reactions include rash abdominal pain, diarrhea, indigestion, nausea, vomiting, asthenia, ataxia, coordination problem, dizziness, headache, insomnia, somnolence, tremor, vertigo, blurred vision, diplopia , anxiety, depression, dysmenorrhea, rhinitis, pain.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• Bipolar I disorder

• 25 mg/day orally for 2 weeks, then 50 mg/day for 2 weeks, then 100 mg/day for 1 week, then 200 mg/day; usual maintenance dose of lamotrigine in patients not taking enzyme-inducing drugs or valproic acid is 200 mg/day

• Lennon-Gastaut syndrome; Adjunct

• 25 mg/day PO every alternate day for 2 weeks, then 25 mg/day for 2 weeks, increase dosage by 25 to 50 mg/day PO every 1 to 2 weeks to the usual maintenance dose of 100 to 400 mg/day in 1 to 2 divided doses; usual maintenance dose of patients adding lamotrigine to valproic acid alone ranges from 100 to 200 mg/day

• Partial seizure, Adjunct or monotherapy

• 25 mg/day PO every other day for 2 weeks, then 25 mg/day for 2 weeks; may increase dosage by 25 to 50 mg/day ORALLY every 1 to 2 weeks to the usual maintenance dose of 100 to 400 mg/day in 1 to 2 divided doses; usual maintenance dose of patients adding lamotrigine to valproic acid alone ranges from 100 to 200 mg/day

• Tonic-clonic seizure, Primary generalized; Adjunct

• 500 mg/day orally (in 2 divided doses), titrate lamotrigine to the targeted dose while maintaining the other drug at a fixed level, then withdraw the other drug by 20% decrements each week over a 4-week period

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information about Off-Label Guideline-Supported Use of Lamotrigine in adult patients.

Non–Guideline-Supported Use

• Bipolar disorder, depressed phase
• Convulsions in the newborn, Intractable
• Depression, Treatment-resistant; Adjunct
• Epilepsy, Refractory
• Migraine
• Obesity
• Obsessive-compulsive disorder, Resistant, as adjunct therapy to serotonin reuptake inhibitors
• Trigeminal neuralgia

There is limited information about Off-Label Non–Guideline-Supported Use of Lamotrigine in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Safety of extended-release lamotrigine in patients younger than 13 years has not been established.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information about Off-Label Guideline-Supported Use of Lamotrigine in pediatric patients.

Non–Guideline-Supported Use

There is limited information about Off-Label Non–Guideline-Supported Use of Lamotrigine in pediatric patients.

Contraindications

There is limited information regarding Lamotrigine Contraindications in the drug label.

Warnings

There is limited information regarding Lamotrigine Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Lamotrigine Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Lamotrigine Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Lamotrigine Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Lamotrigine in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Lamotrigine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Lamotrigine during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Lamotrigine in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Lamotrigine in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Lamotrigine in geriatric settings.

Gender

There is no FDA guidance on the use of Lamotrigine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Lamotrigine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Lamotrigine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Lamotrigine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Lamotrigine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Lamotrigine in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Lamotrigine Administration in the drug label.

Monitoring

There is limited information regarding Lamotrigine Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Lamotrigine and IV administrations.

Overdosage

There is limited information regarding Lamotrigine overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

Lamotrigine
Systematic (IUPAC) name
6-(2,3-Dichlorophenyl)-1,2,4-triazine-3,5-diamine
Identifiers
CAS number	84057-84-1
ATC code	N03AX09
PubChem	3878
DrugBank	DB00555
Chemical data
Formula	Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox
Mol. mass	256.091 g/mol
SMILES	eMolecules & PubChem
Pharmacokinetic data
Bioavailability	98%
Protein binding	55%
Metabolism	Hepatic (mostly UGT1A4-mediated)
Half life	29 hours
Excretion	Urine (65%), faeces (2%)
Therapeutic considerations
Licence data	US
Pregnancy cat.	D(AU) C(US)
Legal status	Prescription Only (S4)(AU) ?(CA) POM(UK) [[Prescription drug|Template:Unicode-only]](US)
Routes	Oral

Mechanism of Action

There is limited information regarding Lamotrigine Mechanism of Action in the drug label.

Structure

There is limited information regarding Lamotrigine Structure in the drug label.

Pharmacodynamics

There is limited information regarding Lamotrigine Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Lamotrigine Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Lamotrigine Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Lamotrigine Clinical Studies in the drug label.

How Supplied

There is limited information regarding Lamotrigine How Supplied in the drug label.

Storage

There is limited information regarding Lamotrigine Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Lamotrigine Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Lamotrigine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Lamotrigine Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Lamotrigine Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.