SUBVENITE
LAMOTRIGINE · KIT · OWP Pharmaceuticals, Inc.
SUBVENITE is a kit containing lamotrigine. Manufactured by OWP Pharmaceuticals, Inc..
Key Facts
- Brand Name
- SUBVENITE
- Generic Name
- LAMOTRIGINE
- NDC Code (Product)
69102-300- Manufacturer
- OWP Pharmaceuticals, Inc.
- Dosage Form
- KIT
- Marketing Status
- Application #
- ANDA078947
- Drug Class
- Anti-epileptic Agent [EPC]; Mood Stabilizer [EPC]
- Marketing Start
- 04/14/2018
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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. ( 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 SUBVENITE in the acute treatment of mood episodes has not been established. 1.1 Epilepsy Adjunctive Therapy SUBVENITE is indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: partial-onset seizures. primary generalized tonic-clonic (PGTC) seizures. generalized seizures of Lennox-Gastaut syndrome. Monotherapy SUBVENITE is indicated for conversion to monother…
Dosage & Administration
2 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 ) 2.1 General Dosing Considerations Rash There are suggestions that the risk of severe, potentially life-threatening rash may be increased by (1) coadministration of lamotrigine with valproate, (2) exceeding the recommended initial dose of lamotrigine, or (3) exceeding the recommended dose es…
Contraindications
4 CONTRAINDICATIONS Hypersensitivity to the drug or its ingredients. ( Boxed Warning , 4 ) SUBVENITE is 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 )] .
Drug Interactions
7 DRUG INTERACTIONS Valproate increases lamot rigine 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 ) Significant drug interactions with SUBVENITE are summarized in this section. Uridine 5´-diphospho-glucuronyl transferases (UGT) have been identified as the enzymes responsible for metabolism of lamotrigine, the active ingredient in SUBVENITE. 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 significa…
Adverse Reactions
6 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 . The following serious adverse reactions are described in more detail elsewhere in the labeling: Serious Skin Rashes [see Boxed Warning and Warnings and Precautions ( 5.1 )] Hemophagocytic Lymphohistiocytosis [see Warnings and Precautions ( 5.2 )] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions ( 5.3 )] Cardiac Rhythm and Conduction Abnormalities [see Warnings and Precautions ( 5.4 )] Blood Dyscrasias [see Warnings and Precautions…
Frequently Asked Questions
What is SUBVENITE used for?
SUBVENITE contains LAMOTRIGINE. It is a kit taken as directed. Consult your doctor for specific uses.
Is SUBVENITE a controlled substance?
SUBVENITE is not classified as a controlled substance by the DEA.
What is the generic name for SUBVENITE?
The generic name for SUBVENITE is LAMOTRIGINE. There are 12 other brand versions of LAMOTRIGINE.
What is the NDC code for SUBVENITE ?
The NDC (National Drug Code) for SUBVENITE is 69102-300, listed by OWP Pharmaceuticals, Inc..