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Patients taking SUBVENITE® ORAL SUSPENSION for more than 16 weeks should be periodically reassessed to determine the need for maintenance treatment.

SUBVENITE is indicated for:
Epilepsy—adjunctive therapy in patients aged 2 years and older:

  • partial-onset seizures.
  • primary generalized tonic-clonic seizures.
  • generalized seizures of Lennox-Gastaut syndrome.

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.

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.

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*Program Restrictions: Not eligible if prescriptions are paid by any state or federally funded programs, including, but not limited to Medicare, Medicaid, VA, DOD, Tricare, or Medigap. Void where prohibited by law. Not valid for an OWP prescription reimbursed in full by any third-party payer. May not be combined with any other coupon, discount, savings card, or other offer. May not be accepted at all pharmacies. Limited to one prescription per person for any 35-day period. No substitutions permitted.

For general questions or inquiries please contact us at: info@owppharma.com.  For SUBVENITE (lamotrigine) Oral Suspension medical questions please contact us at: medinfo.OWP@apcerls.com or call 1-800-273-6729 and follow the prompts for medical information requests.  For SUBVENITE (lamotrigine) Oral Suspension safety-related concerns please contact us at: safety.OWP@apcerls.com or call 1-800-273-6729 and follow the prompts for medical adverse events reporting.

SUBOS1015V2 2/26

DISCLAIMER:

Titration calculation is based on FDA-approved Prescribing Information and is provided for informational purposes only. This Dosing Calculator is not a substitute for the independent medical judgment of the prescribing healthcare provider. Patients should always take SUBVENITE® (lamotrigine) Oral Suspension exactly as prescribed by their healthcare provider. Note: Doses for weights entered in kilograms may not be equivalent to those entered in pounds after conversion.

SUBVENITE® (lamotrigine) Oral Suspension

Dosing Calculator

Pediatrics (Epilepsy)
Adult (Bipolar or Epilepsy)
2-12 yrs. old Adjunctive Therapy
12+ yrs. old Patients older than 12 years
16+ yrs. old Epilepsy-Conversion from adjunctive therapy to monotherapy
Bipolar
Epilepsy
Minimum patient weight must be equal-to or greater than 14.8lbs / 6.7kg

Weeks 1 and 2

Weeks 3 and 4

Weeks 5 Onward to Maintenance

Usual Maintenance Dose

Maintenace dose in patients < 30 kg

Maintenace dose in patients < 30 kg

Discontinuation of Psychotropic Drugs (excluding Valproatea, Carbamazepine, Phenytoin, Phenobarbital, or Primidoneb)

Weeks 1, 2, and 3

Maintain current dose of SUBVENITE

After Discontinuation of Valproatea
Current Dose of SUBVENITE 100 (mg/day)

Week 1
Week 2
Week 3

150
200
200
After Discontinuation of Carbamazepine, Phenytoin, Phenobarbital, or Primidoneb
Current Dose of SUBVENITE 400 (mg/day)

Week 1
Week 2
Week 3

400
300
200

a Valproate has been shown to inhibit glucuronidation and decrease the apparent clearance of lamotrigine [see Drug Interactions (7), Clinical Pharmacology (12.3)].

b Drugs that induce lamotrigine glucuronidation and increase clearance, other than the specified antiepileptic drugs, include estrogen-containing oral contraceptives, rifampin, and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir. Dosing recommendations for oral contraceptives and the protease inhibitor atazanavir/ritonavir can be found in General Dosing Considerations [see Dosage and Administration (2.1)]. Patients on rifampin and the protease inhibitor lopinavir/ritonavir should follow the same dosing titration/maintenance regimen used with antiepileptic drugs that induce glucuronidation and increase clearance [see Dosage and Administration (2.1), Drug Interactions (7), Clinical Pharmacology (12.3)].

If a decision is made to discontinue therapy with SUBVENITE, a step-wise reduction of dose over at least 2 weeks (approximately 50% per week) is recommended unless safety concerns require a more rapid withdrawal [see Warnings and Precautions (5.10)].
mg to mL Conversion
=
mL
X

Other drugs that induce glucuronidation

Drugs that induce lamotrigine glucuronidation and increase clearance, other than the specified antiepileptic drugs, include estrogen-containing oral contraceptives, rifampin, and the protease inhibitors lopinavir/ritonavir and atazanavir/ritonavir. Dosing recommendations for oral contraceptives and the protease inhibitor atazanavir/ritonavir can be found in General Dosing Considerations (see Dosage and Administration (2.1)]. Patients on rifampin and the protease inhibitor lopinavir/ritonavir should follow the same dosing titration/maintenance regimen used with antiepileptic drugs that induce glucuronidation and increase clearance [see Dosage and Administration (2.1), Drug Interactions (7), Clinical Pharmacology (12.3)].
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Important Safety Information & Resources

WARNING: SERIOUS SKIN RASHES

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 active ingredient in SUBVENITE. 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 SUBVENITE.
  • exceeding recommended dose escalation of SUBVENITE. (5.1)

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

Please refer to the full Prescribing Information for SUBVENITE at www.subvenite.com.
 

SUBVENITE 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.
 

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.

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.

Limitations of Use: Treatment of acute manic or mixed episodes is not recommended. Effectiveness of SUBVENITE 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. (2.1, 16)
  • Do not restart SUBVENITE 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

  • Oral Suspension: 10 mg/mL (3)
 

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)
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity: Discontinue if no alternate etiology. (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 arrhythmias 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 the product 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 for SUBVENITE at www.subvenite.com.

09/2025
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