Generic Name
LamoTRIgine
Brand Names
Subvenite, Lamictal, Lamictal ODT
FDA approval date: January 17, 1995
Classification: Anti-epileptic Agent
Form: Tablet, Kit, Suspension
What is Subvenite (LamoTRIgine)?
Lamotrigine 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.
Approved To Treat
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Brand Information
SUBVENITE (LAMOTRIGINE)
1DESCRIPTION
SUBVENITE (lamotrigine) oral suspension, an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-
SUBVENITE oral ouspension contains 10 mg per mL lamotrigine, USP and the following inactive ingredients: carboxymethylcellulose sodium, cherry flavor, FD&C Red 40, FD&C Yellow 6,glycerin, methylparaben, polyethylene glycol, propylene glycol, purified water, saccharin sodium, silicified microcrystalline cellulose, sodium benzoate, sodium phosphate dibasic, sorbitol solution, sucralose and xanthan gum.
2PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Rash
Prior to initiation of treatment with SUBVENITE, 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
Administration
Instruct patients or caregivers that a calibrated measuring device, such as an oral dosing syringe or oral dosing cup, should be obtained from the pharmacy to accurately measure and deliver the prescribed dose of medication. A household teaspoon or tablespoon is not an adequate measuring device.
Instruct patients to shake well before each use and to discard any unused portion 90 days after first opening the bottle.
Hemophagocytic Lymphohistiocytosis
Prior to initiation of treatment with SUBVENITE, inform patients that excessive immune activation may occur with SUBVENITE and that they should report signs or symptoms such as fever, rash, or lymphadenopathy to a healthcare provider immediately
DRESS/Multiorgan Hypersensitivity Reactions, Blood Dyscrasias, and Organ Failure
Instruct patients and caregivers that a fever or rash associated with signs of other organ system involvement (e.g., lymphadenopathy, hepatic dysfunction) may be drug-related. SUBVENITE should be discontinued immediately if a serious hypersensitivity reaction is suspected Isolated organ failure or isolated blood dyscrasias without evidence of multiorgan hypersensitivity may also occur. Instruct patients to contact their healthcare providers immediately if they experience any signs or symptoms of these conditions
Cardiac Rhythm and Conduction Abnormalities
Inform patients that, due to its mechanism of action, SUBVENITE could lead to irregular or slowed heart rhythm. This risk is increased in patients with underlying cardiac disease or heart conduction problems or who are taking other medications that affect heart conduction. Patients should be made aware of and report cardiac signs or symptoms to their healthcare provider right away. Patients who develop syncope should lie down with raised legs and contact their healthcare provider
Suicidal Thinking and Behavior
Inform patients, their caregivers, and families that AEDs, including SUBVENITE, may increase the risk of suicidal thoughts and behavior. Instruct them to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts or behavior or thoughts about self-harm. Instruct them to immediately report behaviors of concern to their healthcare providers
Worsening of Seizures
Instruct patients to notify their healthcare providers if worsening of seizure control occurs
Central Nervous System Adverse Reactions
Inform patients that SUBVENITE may cause dizziness, somnolence, and other symptoms and signs of central nervous system depression. Accordingly, instruct them neither to drive a car nor to operate other complex machinery until they have gained sufficient experience on SUBVENITE to gauge whether or not it adversely affects their mental and/or motor performance.
Pregnancy and Lactation
Instruct patients to notify their healthcare providers if they become pregnant or intend to become pregnant during therapy and if they intend to breastfeed or are breastfeeding an infant.
Encourage patients to enroll in the NAAED Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of AEDs during pregnancy. To enroll, patients can call the toll-free number 1-888-233-2334 [see Use in Specific Populations (8.1)].
Inform patients who intend to breastfeed that SUBVENITE is present in breast milk and advise them to monitor their child for potential adverse effects of this drug. Discuss the benefits and risks of continuing breastfeeding.
Use of Estrogen-Containing Products, Including Oral Contraceptives
Instruct women to notify their healthcare providers if they plan to start or stop use of oral contraceptives or other female hormonal preparations (including HRT). Starting estrogen-containing products, including oral contraceptives, may significantly decrease lamotrigine plasma levels and stopping estrogen-containing oral contraceptives (including the pill-free week) may significantly increase lamotrigine plasma levels
Discontinuing SUBVENITE
Instruct patients to contact their healthcare providers before stopping SUBVENITE for any reason and to consult with their healthcare providers before resuming SUBVENITE
Inform patients that SUBVENITE may cause aseptic meningitis. Instruct them to notify their healthcare providers immediately if they develop signs and symptoms of meningitis such as headache, fever, nausea, vomiting, stiff neck, rash, abnormal sensitivity to light, myalgia, chills, confusion, or drowsiness while taking SUBVENITE.
Potential Medication Errors
To avoid a medication error of using the wrong drug or formulation, strongly advise patients to visually inspect their product to verify that it is SUBVENITE, as well as the correct formulation of lamotrigine, each time they fill their prescription
3PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 10 mg/mL
240 mL Suspension
NDC 69102-418-01
SUBVENITE
(lamotrigine) Oral Suspension, 10 mg/mL
Rx Only
Container Label
Carton Label
