Lamotrigine Extended Release 300 mg/1
lamotrigine extended release · TABLET · Par Health USA, LLC
Lamotrigine Extended Release is a prescription anti-epileptic medication used to treat seizure disorders and certain mood conditions. This extended-release tablet form allows for once-daily dosing of the medication.
Key Facts
- Brand Name
- Lamotrigine Extended Release
- Generic Name
- lamotrigine extended release
- NDC Code (Product)
49884-605- Manufacturer
- Par Health USA, LLC
- Strength
- 300 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA201791
- Drug Class
- Anti-epileptic Agent [EPC]; Mood Stabilizer [EPC]
- Marketing Start
- 01/18/2013
Recall History
Wockhardt Usa Inc.
CGMP Deviations: Firm did not adequately investigate customer complaints.
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Torrent Pharma Inc.
Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Lamotrigine extended-release tablets are indicated for: adjunctive therapy for primary generalized tonic-clonic seizures (PGTC) and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. ( 1.1 ) conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED). ( 1.2 ) Limitation of use: Safety and effectiveness in patients younger than 13 years have not been established. ( 1.3 ) 1.1 Adjunctive Therapy Lamotrigine extended-release tablets are indicated as adjunctive therapy for primary generalized tonic-clonic (PGTC) seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. 1.2 Monotherapy Lamotrigine extended-release tablets are indicated for conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED). Safety and effectiveness of lamotrigine extended-release tablets have not been established (1) as initial monotherapy or (2) for simultaneous conversion to monotherapy from …
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Lamotrigine extended-release tablets are taken once daily, with or without food. Tablets must be swallowed whole and must not be chewed, crushed, or divided. Do not exceed the recommended initial dosage and subsequent dose escalation. ( 2.1 ) Initiation of adjunctive therapy and conversion to monotherapy requires slow titration dependent on concomitant AEDs; the prescriber must refer to the appropriate algorithm in Dosage and Administration. ( 2.2 , 2.3 ) Adjunctive therapy: Target therapeutic dosage range is 200 to 600 mg daily and is dependent on concomitant AEDs. ( 2.2 ) Conversion to monotherapy: Target therapeutic dosage range is 250 to 300 mg daily. ( 2.3 ) Conversion from immediate-release lamotrigine to lamotrigine extended-release tablets: The initial dose of lamotrigine extended-release tablets should match the total daily dose of the immediate-release lamotrigine. Patients should be closely monitored for seizure control after conversion. ( 2.4 ) Do not restart lamotrigine extended-release tablets in patients who discontinued due to rash unless the potential benefits clearly outweigh the risks. ( 2.1 , 5.1 ) Adjustments to maintenance doses wil…
Contraindications
4 CONTRAINDICATIONS Lamotrigine extended-release tablets are 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 lamotrigine are summarized in this section. Additional details of these drug interaction studies, which were conducted using immediate-release lamotrigine, are provided in the Clinical Pharmacology section [see Clinical Pharmacology ( 12.3 )] . 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 ) ] . Table 5. Established and Other Potentially Significant Drug Interactions Conco…
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 )] Most common adverse reactions with use as adjunctive therapy (treatment difference between lamotrigine extended-release tablets and placebo ≥4%) were dizziness, tremor/intention tremor, vomiting, and diplopia. ( 6.1 ) Most common adverse reactions with use as monotherapy were similar to those seen with previous trials conducted with immediate-release lamotrigine and lamotrigine extended-release tablets. ( 6.1 ) To report SUSPECTED AD…
Frequently Asked Questions
What is Lamotrigine Extended Release used for?
Lamotrigine Extended Release is a prescription anti-epileptic medication used to treat seizure disorders and certain mood conditions. This extended-release tablet form allows for once-daily dosing of the medication.
Is Lamotrigine Extended Release a controlled substance?
Lamotrigine Extended Release is not classified as a controlled substance by the DEA.
What is the generic name for Lamotrigine Extended Release?
The generic name for Lamotrigine Extended Release is lamotrigine extended release. There are no other listed brand versions of lamotrigine extended release.
What is the NDC code for Lamotrigine Extended Release 300 mg/1?
The NDC (National Drug Code) for Lamotrigine Extended Release 300 mg/1 is 49884-605, listed by Par Health USA, LLC.
Other Lamotrigine Extended Release Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)