LAMICTAL ODT 100 mg/1
lamotrigine · TABLET, ORALLY DISINTEGRATING · GlaxoSmithKline LLC
Lamictal ODT is a prescription anti-epileptic medication used to treat seizures and certain mood disorders like bipolar depression. The orally disintegrating tablet dissolves on your tongue, making it easy to take without water.
Key Facts
- Brand Name
- LAMICTAL ODT
- Generic Name
- lamotrigine
- NDC Code (Product)
0173-0776- Manufacturer
- GlaxoSmithKline LLC
- Strength
- 100 mg/1
- Dosage Form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Marketing Status
- Application #
- NDA022251
- Drug Class
- Anti-epileptic Agent [EPC]; Mood Stabilizer [EPC]
- Marketing Start
- 06/05/2009
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE LAMICTAL is indicated for: Epilepsy—adjunctive therapy in patients aged 2 years and older: • partial-onset seizures. • primary generalized tonic-clonic (PGTC) 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 antiepileptic drug. ( 1.1 ) Bipolar disorder: 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 ) Limitations of Use: Treatment of acute manic or mixed episodes is not recommended. Effectiveness of LAMICTAL in the acute treatment of mood episodes has not been established. 1.1 Epilepsy Adjunctive Therapy LAMICTAL is indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: • partial-onset seizures. • primary generalized tonic-clonic (PGTC) seizures. • generalized seizures of Lennox-Gastaut syndrome. Monotherapy LAMICTAL is indicated for conversion t…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • 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. 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 , 5.1 ) • Adjustments to maintenance doses will be necessary in most patients starting or stopping estrogen-containing products, including oral contraceptives. ( 2.1 , 5.9 ) • Discontinuation: Taper over a period of at least 2 weeks (approximately 50% dose reduction per week). ( 2.1 , 5.10 ) 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 ) 2.1 General Dosing Considerations Rash There are suggestions that the risk of severe, potentially life-threatening rash may be increased by (1) coadministration of LA…
Contraindications
4 CONTRAINDICATIONS LAMICTAL is contraindicated in patients who have demonstrated hypersensitivity (e.g., rash, angioedema, acute urticaria, extensive pruritus, mucosal ulceration) to the drug or its ingredients [see Boxed Warning , Warnings and Precautions ( 5.1 , 5.3 )] . Hypersensitivity to the drug or its ingredients. ( Boxed Warning , 4 )
Drug Interactions
7 DRUG INTERACTIONS Significant drug interactions with LAMICTAL are summarized in this section. Uridine 5´-diphospho-glucuronyl transferases (UGT) have been identified as the enzymes responsible for metabolism of lamotrigine. Drugs that induce or inhibit glucuronidation may, therefore, affect the apparent clearance of lamotrigine. Strong or moderate inducers of the cytochrome P450 3A4 (CYP3A4) enzyme, which are also known to induce UGT, may also enhance the metabolism of lamotrigine. Those drugs that have been demonstrated to have a clinically significant impact on lamotrigine metabolism are outlined in Table 13 . Specific dosing guidance for these drugs is provided in the Dosage and Administration section, and, for women taking estrogen‑containing products, including oral contraceptives, in the Warnings and Precautions section [see Dosage and Administration ( 2.1 ), Warnings and Precautions ( 5.9 )] . Additional details of these drug interaction studies are provided in the Clinical Pharmacology section [see Clinical Pharmacology ( 12.3 )] . Table 13. Established and Other Potentially Significant Drug Interactions ↓ = Decreased (induces lamotrigine glucuronidation). ↑ = Increased (…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described in more detail in the Warnings and Precautions section of the labeling: • Serious Skin Rashes [see Warnings and Precautions ( 5.1 )] • Hemophagocytic Lymphohistiocytosis [see Warnings and Precautions ( 5.2 )] • Multiorgan Hypersensitivity Reactions and Organ Failure [see Warnings and Precautions ( 5.3 )] • Cardiac Rhythm and Conduction Abnormalities [see Warnings and Precautions ( 5.4 )] • Blood Dyscrasias [see Warnings and Precautions ( 5.5 )] • Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.6 )] • Aseptic Meningitis [see Warnings and Precautions ( 5.7 )] • Withdrawal Seizures [see Warnings and Precautions ( 5.10 )] • Status Epilepticus [see Warnings and Precautions ( 5.11 )] Epilepsy: Most common adverse reactions (incidence ≥10%) in adults were dizziness, headache, diplopia, ataxia, nausea, blurred vision, somnolence, rhinitis, pharyngitis, and rash. Additional adverse reactions (incidence ≥10%) reported in children included vomiting, infection, fever, accidental injury, diarrhea, abdominal pain, and tremor. ( 6.1 ) Bipolar disorder: Most common adverse reactions (incidence >5%) in adults…
Frequently Asked Questions
What is LAMICTAL ODT used for?
Lamictal ODT is a prescription anti-epileptic medication used to treat seizures and certain mood disorders like bipolar depression. The orally disintegrating tablet dissolves on your tongue, making it easy to take without water.
Is LAMICTAL ODT a controlled substance?
LAMICTAL ODT is not classified as a controlled substance by the DEA.
What is the generic name for LAMICTAL ODT?
The generic name for LAMICTAL ODT is lamotrigine. There are 12 other brand versions of lamotrigine.
What is the NDC code for LAMICTAL ODT 100 mg/1?
The NDC (National Drug Code) for LAMICTAL ODT 100 mg/1 is 0173-0776, listed by GlaxoSmithKline LLC.