OWP Pharmaceuticals Logo
Lamotrigine Starter Kits Logo

Lamotrigine Tablets, USP Starter Kits

Accessibility Statement

Effective Date: September 21, 2026

OWP Pharmaceuticals, Inc. (“OWP”) is committed to providing reasonable access to the information and functionality available through lamotriginestarterkits.com for people with disabilities.

Accessibility Efforts

Accessibility is an ongoing process. OWP seeks to consider generally recognized accessibility practices, including relevant portions of the Web Content Accessibility Guidelines (“WCAG”) 2.2 Level AA, where reasonably practicable and appropriate.

Reference to WCAG does not constitute a representation, warranty, certification, or contractual promise that every page, feature, document, or item of content currently or continuously conforms to a particular standard.

Ongoing Evaluation

OWP may evaluate and improve Website accessibility as content, technology, assistive technologies, legal requirements, and recognized practices evolve. OWP may determine remediation methods, priorities, and timelines based on impact, feasibility, available technology, security, applicable law, and other relevant circumstances.

The existence, reporting, investigation, or correction of a barrier is not an admission that OWP has violated any law, regulation, or technical standard.

Third-Party Content

The Website may contain third-party videos, prescribing information, PDFs, savings materials, security tools, links, and services that OWP does not fully control. OWP does not warrant the accessibility or continuing availability of independently operated third-party content.

Alternative Access

If particular content is difficult to access, OWP will consider reasonable methods of providing access to the requested information, subject to availability, technical feasibility, the nature of the material, security, and applicable law.

OWP cannot guarantee that every requested format, modification, technology, or completion timeline will be available, but will consider reasonable alternatives where appropriate and required.

Requesting Assistance

Please identify the page or material, describe the difficulty, state the requested format if known, and provide a preferred contact method. Do not include diagnoses, prescriptions, medical records, patient names, or other sensitive medical information.

No Expansion or Waiver of Rights

This statement describes OWP’s accessibility efforts and does not create a contract, warranty, private right of action, or obligation beyond applicable law. Nothing waives or limits any right or obligation that cannot lawfully be waived or limited.

Contact Us

OWP Pharmaceuticals, Inc.
701 Warrenville Road, Suite 200
Lisle, IL 60532
Telephone: 1-800-273-6729
Email: info@owppharma.com

Lamotrigine Starter Kits Logo
OWP Pharmaceuticals Logo

© 2024 OWP Pharmaceuticals, Inc. All rights reserved.
Naperville, IL 60563. Developed in USA.

You are now leaving LamotrigineStarterKits.com

Links to all outside sites are provided as a resource to our visitors. OWP Pharmaceuticals accepts no responsibility for the content of the sites that are not owned and operated by OWP Pharmaceuticals.

Continue
Cancel

You are now leaving LamotrigineStarterKits.com

Links to all outside sites are provided as a resource to our visitors. OWP Pharmaceuticals accepts no responsibility for the content of the sites that are not owned and operated by OWP Pharmaceuticals.

Continue
Cancel
Important Safety Information

WARNING: SERIOUS SKIN RASHES

See full prescribing information for complete boxed warning.

Cases of life-threatening serious rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis, and/or rash-related death have been caused by lamotrigine. The rate of serious rash is greater in pediatric patients than in adults. Additional factors that may increase the risk of rash include:

  • coadministration with valproate.
  • exceeding recommended initial dose of lamotrigine.
  • exceeding recommended dose escalation for lamotrigine.
  • presence of the HLA-B*1502 allele. (5.1)

Benign rashes are also caused by lamotrigine; however, it is not possible to predict which rashes will prove to be serious or life threatening. Lamotrigine should be discontinued at the first sign of rash, unless the rash is clearly not drug related. (5.1)

 

Lamotrigine 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 lamotrigine in the acute treatment of mood episodes has not been established.

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. Lamotrigine Starter Kits are available for the first 5 weeks of treatment. (2.1, 16)
  • Do not restart lamotrigine 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)

DOSAGE FORMS AND STRENGTHS

  • Tablets: 25 mg, 100 mg; scored. (3.1, 16)
 

CONTRAINDICATIONS

Hypersensitivity to the drug or its ingredients. (Boxed Warning, 4)

WARNINGS & PRECAUTIONS

  • Life-threatening serious rash and/or rash-related death: Discontinue at the first sign of rash, unless the rash is clearly not drug related. (Boxed Warning, 5.1).
  • Hemophagocytic lymphohistiocytosis: Consider this diagnosis and evaluate patients immediately if they develop signs or symptoms of systemic inflammation. Discontinue lamotrigine if an alternative etiology is not established. (5.2)
  • Fatal or life-threatening hypersensitivity reaction: Multiorgan hypersensitivity reactions, also known as drug reaction with eosinophilia and systemic symptoms, may be fatal or life threatening. Early signs may include rash, fever, and lymphadenopathy. These reactions may be associated with other organ involvement, such as hepatitis, hepatic failure, blood dyscrasias, or acute multiorgan failure. Lamotrigine should be discontinued if alternate etiology for this reaction is not found.(5.3)
  • Cardiac rhythm and conduction abnormalities: Based on in vitro findings, lamotrigine could cause serious arrhythmias and/or death in patients with certain underlying cardiac disorders or arrhythmias. Any expected or observed benefit of lamotrigine in an individual patient with clinically important structural or functional heart disease must be carefully weighed against the risk for serious arrythmias and/or death for that patient. (5.4)
  • Blood dyscrasias (e.g., neutropenia, thrombocytopenia, pancytopenia): May occur, either with or without an associated hypersensitivity syndrome. Monitor for signs of anemia, unexpected infection, or bleeding. (5.5)
  • Suicidal behavior and ideation: Monitor for suicidal thoughts or behaviors. (5.6)
  • Aseptic meningitis: Monitor for signs of meningitis. (5.7)
  • Medication errors due to product name confusion: Strongly advise patients to visually inspect to verify the received drug is correct. (5.8, 16, 17)
 

ADVERSE REACTIONS

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 were nausea, insomnia, somnolence, back pain, fatigue, rash, rhinitis, abdominal pain, and xerostomia. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact OWP Pharmaceuticals Inc. at 1-800-273-6729 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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)
  • Coadministration with organic cationic transporter 2 substrates with narrow therapeutic index is not recommended (7, 12.3)
 

USE IN SPECIFIC POPULATIONS

  • Pregnancy: Based on animal data may cause fetal harm. (8.1)
  • Hepatic impairment: Dosage adjustments required in patients with moderate and severe liver impairment. (2.1, 8.6)
  • Renal impairment: Reduced maintenance doses may be effective for patients with significant renal impairment. (2.1, 8.7)
 

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Please refer to the full Prescribing Information at www.lamotriginestarterkits.com.

Revised: 08/2026

Resources