Lamotrigine is the generic equivalent of the brand-name drug Lamotrigine. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Lamotrigine through Premier Pharma with same-day fulfillment on in-stock SKUs.
Clinical Identifiers
- RxCUI
- 103968198427198428198429282401850091900156
- Therapeutic Equivalence (TE) Code
ABTherapeutically equivalent — meets FDA bioequivalence requirements
- Pharmacologic Class
- ["Anti-epileptic Agent [EPC]","Decreased Central Nervous System Disorganized Electrical Activity [PE]","Dihydrofolate Reductase Inhibitors [MoA]","Mood Stabilizer [EPC]","Organic Cation Transporter 2 Inhibitors [MoA]"]
FDA Drug 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 par…
Adverse Reactions
6 ADVERSE REACTIONS 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 ADVERSE REACTIONS, contact Torrent Pharma Inc…
Drug Interactions
7 DRUG INTERACTIONS Valproate increases lamotrigine concentrations more than 2-fold. ( 7 , 12.3 ) Carbamazepine, phenytoin, phenobarbital, primidone, and rifampin decrease lamotrigine concentrations by approximately 40%. ( 7 , 12.3 ) Estrogen-containing oral contraceptives decrease lamotrigine concentrations by approximately 50%. ( 7 , 12.3 ) Protease inhibitors lopinavir/ritonavir and atazanavir/lopinavir decrease lamotrigine exposure by approximately 50% and 32%, respectively. ( 7 , 12.3 ) Coa…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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 dos…
Patient Counseling Information
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Rash Prior to initiation of treatment with lamotrigine extended-release tablets, inform patients that a rash or other signs or symptoms of hypersensitivity (e.g., fever, lymphadenopathy) may herald a serious medical event and instruct them to report any such occurrence to their healthcare providers immediately. Hemophagocytic Lymphohistiocytosis Prior to initiation of treatment with lamotrigine extended-release tablets, inform patients that excessive immune activation may occur wi…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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