Lamotrigine

Lamotrigine

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses


1.1 Epilepsy

Adjunctive Therapy:

Lamotrigine tablets are indicated as adjunctive therapy for the following seizure types in patients ≥ 2 years of age:
partial seizures
primary generalized tonic-clonic seizures
generalized seizures of Lennox-Gastaut syndrome

Monotherapy:

Lamotrigine tablets are indicated for conversion to monotherapy in adults (≥16 years of age) with partial seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED).

Safety and effectiveness of lamotrigine tablets have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from AEDs other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs.

1.2 Bipolar Disorder

Lamotrigine tablets are indicated for the maintenance treatment of Bipolar I Disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in adults (≥18 years of age) treated for acute mood episodes with standard therapy. The effectiveness of lamotrigine tablets in the acute treatment of mood episodes has not been established.

The effectiveness of lamotrigine tablets as maintenance treatment was established in 2 placebo-controlled trials in patients with Bipolar I Disorder as defined by DSM-IV [see Clinical Studies (14.2)]. The physician who elects to prescribe lamotrigine tablets for periods extending beyond 16 weeks should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

History

There is currently no drug history available for this drug.

Other Information

  • Lamotrigine, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Its chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine is very slightly soluble in water (0.17 mg/mL at 25°C) and slightly soluble in 0.1 M HCl (4.1 mg/mL at 25°C). The structural formula is:

    image description

    Lamotrigine tablets USP are supplied for oral administration as 25 mg, 100 mg, 150 mg or 200 mg tablets. Each tablet contains the labeled amount of lamotrigine and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. In addition, the 200 mg tablets contain FD&C Blue No. 2 Lake.

Lamotrigine Manufacturers


  • Direct Rx
    Lamotrigine Tablet [Direct Rx]
  • Avpak
    Lamotrigine (Lamotrigine) Tablet [Avpak]
  • Proficient Rx Lp
    Lamotrigine Tablet [Proficient Rx Lp]
  • Remedyrepack Inc.
    Lamotrigine Tablet [Remedyrepack Inc. ]
  • Global Pharmaceuticals, Division Of Impax Laboratories Inc.
    Lamotrigine Tablet, Orally Disintegrating [Global Pharmaceuticals, Division Of Impax Laboratories Inc.]
  • Direct Rx
    Lamotrigine Tablet [Direct Rx]
  • State Of Florida Doh Central Pharmacy
    Lamotrigine Tablet [State Of Florida Doh Central Pharmacy]
  • State Of Florida Doh Central Pharmacy
    Lamotrigine (Lamotrigine ) Tablet [State Of Florida Doh Central Pharmacy]
  • State Of Florida Doh Central Pharmacy
    Lamotrigine Tablet [State Of Florida Doh Central Pharmacy]
  • Sandoz Inc
    Lamotrigine Tablet Lamotrigine Kit [Sandoz Inc]
  • Mckesson Packaging Services Business Unit Of Mckesson Corporation
    Lamotrigine Tablet [Mckesson Packaging Services Business Unit Of Mckesson Corporation]
  • Mckesson Packaging Services A Buisness Unit Of Mckesson Corporation
    Lamotrigine Tablet [Mckesson Packaging Services A Buisness Unit Of Mckesson Corporation]
  • Stat Rx Usa Llc
    Lamotrigine Tablet [Stat Rx Usa Llc]
  • Pd-rx Pharmaceuticals, Inc.
    Lamotrigine (Lamotrigine ) Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Lamotrigine (Lamotrigine ) Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Lamotrigine (Lamotrigine ) Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Lamotrigine (Lamotrigine ) Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Remedyrepack Inc.
    Lamotrigine Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Lamotrigine Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Lamotrigine Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Lamotrigine Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Lamotrigine Tablet, Chewable [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Lamotrigine Tablet [Remedyrepack Inc. ]
  • West-ward Pharmaceutical Corp
    Lamotrigine Tablet [West-ward Pharmaceutical Corp]
  • Hikma Pharmaceutical
    Lamotrigine Tablet [Hikma Pharmaceutical]
  • Ncs Healthcare Of Ky, Inc Dba Vangard Labs
    Lamotrigine Tablet [Ncs Healthcare Of Ky, Inc Dba Vangard Labs]
  • Remedyrepack Inc.
    Lamotrigine Tablet [Remedyrepack Inc. ]
  • Rebel Distributors Corp
    Lamotrigine Tablet [Rebel Distributors Corp]
  • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    Lamotrigine Tablet [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]
  • Mylan Pharmaceuticals Inc.
    Lamotrigine Tablet, Chewable [Mylan Pharmaceuticals Inc.]
  • Cadila Healthcare Limited
    Lamotrigine Tablet Lamotrigine Tablet, Chewable [Cadila Healthcare Limited]
  • Unichem Pharmaceuticals (Usa), Inc.
    Lamotrigine Tablet [Unichem Pharmaceuticals (Usa), Inc.]
  • Cardinal Health
    Lamotrigine Tablet [Cardinal Health]
  • Unit Dose Services
    Lamotrigine Tablet [Unit Dose Services]
  • Dr. Reddy’s Laboratories Limited
    Lamotrigine Tablet, Chewable [Dr. Reddy’s Laboratories Limited]
  • Dr.reddy’s Laboratories Limited
    Lamotrigine Tablet [Dr.reddy’s Laboratories Limited]
  • Bryant Ranch Prepack
    Lamotrigine Tablet [Bryant Ranch Prepack]