Felbamate — uses, dosing, side effects & the brands that sell it · pharmaranks
Felbamate: uses, dosing, side effects & brands
Felbamate is an anti-epileptic agent sold in the U.S. under 2 brand and generic names, for seizures, complex partial epilepsy and lennox gastaut syndrome. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
By the pharmaranks editorial team·Reviewed against the FDA (openFDA label, NDC Directory & Enforcement) sources·How we research
Key facts
Drug class
Anti-Epileptic Agent
Treats
Seizures, Complex Partial Epilepsy and Lennox Gastaut Syndrome
From the FDA label for Felbatol (application NDA020189). Other felbamate products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Felbatol ® (felbamate) has been studied as monotherapy and adjunctive therapy in adults and as adjunctive therapy in children with seizures associated with Lennox-Gastaut syndrome. As Felbatol ® is added to or substituted for existing AEDs, it is strongly recommended to reduce the dosage of those AEDs in the range of 20–33% to minimize side effects (see Drug Interactions subsection). Dosage Adjustment in the Renally Impaired Felbamate should be used with caution in patients with renal dysfunction. In the renally impaired, starting and maintenance doses should be reduced by one-half (see CLINICAL PHARMACOLOGY/Pharmacokinetics and PRECAUTIONS ). Adjunctive therapy with medications which affect felbamate plasma concentrations, especially AEDs, may warrant further reductions in felbamate daily doses in patients with renal dysfunction. Adults (14 years of age and over) The majority of patients received 3600 mg/day in clinical trials evaluating its use as both monotherapy and adjunctive therapy. Monotherapy: (Initial therapy) Felbatol ® (felbamate) has not been systematically evaluated as initial monotherapy. Initiate Felbatol ® (felbamate) at 1200 mg/day in divided doses three or four times daily. The prescriber is advised to titrate previously untreated patients under close clinical supervision, increasing the dosage in 600-mg increments every 2 weeks to 2400 mg/day based on…
Felbamate side effects
To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The most common adverse reactions seen in association with Felbatol ® (felbamate) in adults during monotherapy are anorexia, vomiting, insomnia, nausea, and headache. The most common adverse reactions seen in association with Felbatol ® in adults during adjunctive therapy are anorexia, vomiting, insomnia, nausea, dizziness, somnolence, and headache. The most common adverse reactions seen in association with Felbatol ® in children during adjunctive therapy are anorexia, vomiting, insomnia, headache, and somnolence. The dropout rate because of adverse experiences or intercurrent illnesses among adult felbamate patients was 12 percent (120/977). The dropout rate because of adverse experiences or intercurrent illnesses among pediatric felbamate patients was six percent (22/357). In adults, the body systems associated with causing these withdrawals in order of frequency were: digestive (4.3%), psychological (2.2%), whole body (1.7%), neurological (1.5%), and dermatological (1.5%). In children, the body systems associated with causing these withdrawals in order of frequency were: digestive (1.7%), neurological (1.4%), dermatological (1.4%), psychological (1.1%), and whole body (1.0%). In adults, specific events with an incidence of 1% or…
Every felbamate product we track (2)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Felbamate pill imprints
Imprint
Strength
Colour
Shape
Maker
FEL;400;TARO
400 mg
white
oval
—
FEL;600;TARO
600 mg
yellow
oval
—
ANI;731
600 mg
yellow
capsule
—
ANI;730
400 mg
yellow
capsule
—
ANI;730
400 mg
yellow
capsule
—
10;53
400 mg
Frequently asked questions
What is felbamate?
Felbatol ® (felbamate) is an antiepileptic available as 400 mg and 600 mg tablets and as a 600 mg/5 mL suspension for oral administration. Its chemical name is 2-phenyl-1,3-propanediol dicarbamate. Felbamate is a white to off-white crystalline powder with a characteristic odor. It is very slightly soluble in water, slightly soluble in ethanol, sparingly soluble in methanol, and freely soluble in dimethyl sulfoxide. The molecular weight is 238.24; felbamate’s molecular formula is C 11 H 14 N 2 O 4 ; its structural formula is: The inactive ingredients for Felbatol ® (felbamate) Tablets 400 mg and 600 mg are starch, microcrystalline cellulose, croscarmellose sodium, lactose, magnesium stearate, FD&C Yellow No. 6, D&C Yellow No. 10, and FD&C Red No. 40 (600 mg tablets only). The inactive ingredients for Felbatol ® (felbamate) Oral Suspension 600 mg/5 mL are sorbitol, glycerin, microcrystalline cellulose, carboxymethylcellulose sodium, simethicone, polysorbate 80, methylparaben, saccharin sodium, propylparaben, FD&C Yellow No. 6, FD&C Red No. 40, flavorings, and purified water. Felbamate Structural Formula
What kind of drug is felbamate?
The FDA classifies felbamate as an anti-epileptic agent. Anti-epileptic (anticonvulsant) drugs calm the abnormal, excessive electrical activity that triggers seizures. They do this by stabilizing overactive sodium or calcium channels in nerve cells, boosting the brain's natural calming chemical GABA, or dampening excitatory signals, which makes nerves less likely to fire uncontrollably. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take felbamate with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run felbamate against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is felbamate sold under?
We track 2 felbamate-containing products in the U.S.: Felbamate and Felbatol. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Who shouldn’t take felbamate
Felbatol ® is contraindicated in patients with known hypersensitivity to Felbatol ® , its ingredients, or known sensitivity to other carbamates. It should not be used in patients with a history of any blood dyscrasia or hepatic dysfunction.
Felbamate drug interactions
The drug interaction data described in this section were obtained from controlled clinical trials and studies involving otherwise healthy adults with epilepsy. Use in Conjunction with Other Antiepileptic Drugs (see DOSAGE AND ADMINISTRATION ) The addition of Felbatol ® to antiepileptic drugs (AEDs) affects the steady-state plasma concentrations of AEDs. The net effect of these interactions is summarized in Table 2: Table 2 Steady-State Plasma Concentrations of Felbatol When Coadministered With Other AEDs AED Coadministered AED Concentration Felbatol ® Concentration Phenytoin ↑ ↓ Valproate ↑ ↔ No significant effect. Carbamazepine (CBZ) Not administered, but an active metabolite of carbamazepine. CBZ epoxide ↓ ↑ ↓ Phenobarbital ↑ ↓ Specific Effects of Felbatol® on Other Antiepileptic Drugs Phenytoin Felbatol ® causes an increase in steady-state phenytoin plasma concentrations. In 10 otherwise healthy subjects with epilepsy ingesting phenytoin, the steady-state trough (C min ) phenytoin plasma concentration was 17±5 micrograms/mL. The steady-state C min increased to 21±5 micrograms/mL when 1200 mg/day of felbamate was coadministered. Increasing the felbamate dose to 1800 mg/day in six of these subjects increased the steady-state phenytoin C min to 25±7 micrograms/mL. In order to maintain phenytoin levels, limit adverse experiences, and achieve the felbamate dose…
Across the brands we track, felbamate is currently marketed as suspension and tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic felbamate?
Yes. Our catalog lists 1 generic felbamate product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.