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Felbamate
Overview
What is Felbamate?
Felbamate is an antiepileptic available as 400 mg and 600 mg tablets for oral administration. Its chemical name is 2-Phenyl-1,3-propanediol dicarbamate.
Felbamate, USP is a white to off-white 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 CHNO; its structural formula is:
The inactive ingredients for felbamate tablets, USP 400 mg and 600 mg are colloidal silicon dioxide, corn starch, croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose.
What does Felbamate look like?
What are the available doses of Felbamate?
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What should I talk to my health care provider before I take Felbamate?
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How should I use Felbamate?
Felbamate tablets, USP are not indicated as a first line antiepileptic treatment (see ). Felbamate tablets are recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use.
If these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgment, Felbamate tablets can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children.
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 felbamate is added to or substituted for existing AEDs, it is strongly recommended to reduce the dosage of those AEDs in the range of 20% to 33% to minimize side effects (see
subsection).
What interacts with Felbamate?
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What are the warnings of Felbamate?
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What are the precautions of Felbamate?
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What are the side effects of Felbamate?
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What should I look out for while using Felbamate?
Felbamate tablets are contraindicated in patients with known hypersensitivity to felbamate, 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.
See regarding aplastic anemia and hepatic failure. Antiepileptic drugs should not be suddenly discontinued because of the possibility of increasing seizure frequency.
What might happen if I take too much Felbamate?
Four subjects inadvertently received felbamate as adjunctive therapy in dosages ranging from 5400 to 7200 mg/day for durations between 6 and 51 days. One subject who received 5400 mg/day as monotherapy for one week reported no adverse experiences. Another subject attempted suicide by ingesting 12,000 mg of felbamate in a 12-hour period. The only adverse experiences reported were mild gastric distress and a resting heart rate of 100 bpm. No serious adverse reactions have been reported. General supportive measures should be employed if overdosage occurs. It is not known if felbamate is dialyzable.
How should I store and handle Felbamate?
Care should be exercised in handling of THALOMID. THALOMID capsules should not be opened or crushed. If powder from THALOMID contacts the skin, wash the skin immediately and thoroughly with soap and water. If THALOMID contacts the mucous membranes, flush thoroughly with water. Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published.Rx only and only able to be prescribed and dispensed under the terms of the THALOMID REMS Restricted Distribution Program.Care should be exercised in handling of THALOMID. THALOMID capsules should not be opened or crushed. If powder from THALOMID contacts the skin, wash the skin immediately and thoroughly with soap and water. If THALOMID contacts the mucous membranes, flush thoroughly with water. Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published.Rx only and only able to be prescribed and dispensed under the terms of the THALOMID REMS Restricted Distribution Program.Care should be exercised in handling of THALOMID. THALOMID capsules should not be opened or crushed. If powder from THALOMID contacts the skin, wash the skin immediately and thoroughly with soap and water. If THALOMID contacts the mucous membranes, flush thoroughly with water. Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published.Rx only and only able to be prescribed and dispensed under the terms of the THALOMID REMS Restricted Distribution Program.Felbamate Tablets, USP contain 400 mg or 600 mg of felbamate, USP. The 400 mg tablet is white to off-white, modified capsule shaped, functionally scored, debossed with on one side of the tablet and on the left of the score and on the right of the score on the other side of the tablet. They are available as follows:NDC 47781-550-01bottles of 100 tabletsThe 600 mg tablet is white to off-white, modified capsule shaped, functionally scored, debossed with on one side of the tablet and on the left of the score and on the right of the score on the other side of the tablet. They are available as follows:NDC 47781-551-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:To report SUSPECTED ADVERSE REACTIONS, contact or FDA at 1-800-FDA-1088 or . PI550-00 Rev. 10/2016Felbamate Tablets, USP contain 400 mg or 600 mg of felbamate, USP. The 400 mg tablet is white to off-white, modified capsule shaped, functionally scored, debossed with on one side of the tablet and on the left of the score and on the right of the score on the other side of the tablet. They are available as follows:NDC 47781-550-01bottles of 100 tabletsThe 600 mg tablet is white to off-white, modified capsule shaped, functionally scored, debossed with on one side of the tablet and on the left of the score and on the right of the score on the other side of the tablet. They are available as follows:NDC 47781-551-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:To report SUSPECTED ADVERSE REACTIONS, contact or FDA at 1-800-FDA-1088 or . PI550-00 Rev. 10/2016Felbamate Tablets, USP contain 400 mg or 600 mg of felbamate, USP. The 400 mg tablet is white to off-white, modified capsule shaped, functionally scored, debossed with on one side of the tablet and on the left of the score and on the right of the score on the other side of the tablet. They are available as follows:NDC 47781-550-01bottles of 100 tabletsThe 600 mg tablet is white to off-white, modified capsule shaped, functionally scored, debossed with on one side of the tablet and on the left of the score and on the right of the score on the other side of the tablet. They are available as follows:NDC 47781-551-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:To report SUSPECTED ADVERSE REACTIONS, contact or FDA at 1-800-FDA-1088 or . PI550-00 Rev. 10/2016Felbamate Tablets, USP contain 400 mg or 600 mg of felbamate, USP. The 400 mg tablet is white to off-white, modified capsule shaped, functionally scored, debossed with on one side of the tablet and on the left of the score and on the right of the score on the other side of the tablet. They are available as follows:NDC 47781-550-01bottles of 100 tabletsThe 600 mg tablet is white to off-white, modified capsule shaped, functionally scored, debossed with on one side of the tablet and on the left of the score and on the right of the score on the other side of the tablet. They are available as follows:NDC 47781-551-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:To report SUSPECTED ADVERSE REACTIONS, contact or FDA at 1-800-FDA-1088 or . PI550-00 Rev. 10/2016Felbamate Tablets, USP contain 400 mg or 600 mg of felbamate, USP. The 400 mg tablet is white to off-white, modified capsule shaped, functionally scored, debossed with on one side of the tablet and on the left of the score and on the right of the score on the other side of the tablet. They are available as follows:NDC 47781-550-01bottles of 100 tabletsThe 600 mg tablet is white to off-white, modified capsule shaped, functionally scored, debossed with on one side of the tablet and on the left of the score and on the right of the score on the other side of the tablet. They are available as follows:NDC 47781-551-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:To report SUSPECTED ADVERSE REACTIONS, contact or FDA at 1-800-FDA-1088 or . PI550-00 Rev. 10/2016Felbamate Tablets, USP contain 400 mg or 600 mg of felbamate, USP. The 400 mg tablet is white to off-white, modified capsule shaped, functionally scored, debossed with on one side of the tablet and on the left of the score and on the right of the score on the other side of the tablet. They are available as follows:NDC 47781-550-01bottles of 100 tabletsThe 600 mg tablet is white to off-white, modified capsule shaped, functionally scored, debossed with on one side of the tablet and on the left of the score and on the right of the score on the other side of the tablet. They are available as follows:NDC 47781-551-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:To report SUSPECTED ADVERSE REACTIONS, contact or FDA at 1-800-FDA-1088 or . PI550-00 Rev. 10/2016Felbamate Tablets, USP contain 400 mg or 600 mg of felbamate, USP. The 400 mg tablet is white to off-white, modified capsule shaped, functionally scored, debossed with on one side of the tablet and on the left of the score and on the right of the score on the other side of the tablet. They are available as follows:NDC 47781-550-01bottles of 100 tabletsThe 600 mg tablet is white to off-white, modified capsule shaped, functionally scored, debossed with on one side of the tablet and on the left of the score and on the right of the score on the other side of the tablet. They are available as follows:NDC 47781-551-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:To report SUSPECTED ADVERSE REACTIONS, contact or FDA at 1-800-FDA-1088 or . PI550-00 Rev. 10/2016Felbamate Tablets, USP contain 400 mg or 600 mg of felbamate, USP. The 400 mg tablet is white to off-white, modified capsule shaped, functionally scored, debossed with on one side of the tablet and on the left of the score and on the right of the score on the other side of the tablet. They are available as follows:NDC 47781-550-01bottles of 100 tabletsThe 600 mg tablet is white to off-white, modified capsule shaped, functionally scored, debossed with on one side of the tablet and on the left of the score and on the right of the score on the other side of the tablet. They are available as follows:NDC 47781-551-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:To report SUSPECTED ADVERSE REACTIONS, contact or FDA at 1-800-FDA-1088 or . PI550-00 Rev. 10/2016Felbamate Tablets, USP contain 400 mg or 600 mg of felbamate, USP. The 400 mg tablet is white to off-white, modified capsule shaped, functionally scored, debossed with on one side of the tablet and on the left of the score and on the right of the score on the other side of the tablet. They are available as follows:NDC 47781-550-01bottles of 100 tabletsThe 600 mg tablet is white to off-white, modified capsule shaped, functionally scored, debossed with on one side of the tablet and on the left of the score and on the right of the score on the other side of the tablet. They are available as follows:NDC 47781-551-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:To report SUSPECTED ADVERSE REACTIONS, contact or FDA at 1-800-FDA-1088 or . PI550-00 Rev. 10/2016Felbamate Tablets, USP contain 400 mg or 600 mg of felbamate, USP. The 400 mg tablet is white to off-white, modified capsule shaped, functionally scored, debossed with on one side of the tablet and on the left of the score and on the right of the score on the other side of the tablet. They are available as follows:NDC 47781-550-01bottles of 100 tabletsThe 600 mg tablet is white to off-white, modified capsule shaped, functionally scored, debossed with on one side of the tablet and on the left of the score and on the right of the score on the other side of the tablet. They are available as follows:NDC 47781-551-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:To report SUSPECTED ADVERSE REACTIONS, contact or FDA at 1-800-FDA-1088 or . PI550-00 Rev. 10/2016
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The mechanism by which felbamate exerts its anticonvulsant activity is unknown, but in animal test systems designed to detect anticonvulsant activity, felbamate has properties in common with other marketed anticonvulsants. Felbamate is effective in mice and rats in the maximal electroshock test, the subcutaneous pentylenetetrazol seizure test, and the subcutaneous picrotoxin seizure test. Felbamate also exhibits anticonvulsant activity against seizures induced by intracerebroventricular administration of glutamate in rats and N-methyl-D,L-aspartic acid in mice. Protection against maximal electroshock-induced seizures suggests that felbamate may reduce seizure spread, an effect possibly predictive of efficacy in generalized tonic-clonic or partial seizures. Protection against pentylenetetrazol-induced seizures suggests that felbamate may increase seizure threshold, an effect considered to be predictive of potential efficacy in absence seizures.
Receptor-binding studies indicate that felbamate has weak inhibitory effects on GABA-receptor binding, benzodiazepine receptor binding, and is devoid of activity at the MK-801 receptor binding site of the NMDA receptor-ionophore complex. However, felbamate does interact as an antagonist at the strychnine-insensitive glycine recognition site of the NMDA receptor-ionophore complex. Felbamate is not effective in protecting chick embryo retina tissue against the neurotoxic effects of the excitatory amino acid agonists NMDA, kainite, or quisqualate
The monocarbamate, p-hydroxy, and 2-hydroxy metabolites were inactive in the maximal electroshock-induced seizure test in mice. The monocarbamate and p-hydroxy metabolites had only weak (0.2 to 0.6) activity compared with felbamate in the subcutaneous pentylenetetrazol seizure test. These metabolites did not contribute significantly to the anticonvulsant action of felbamate.
Non-Clinical Toxicology
Felbamate tablets are contraindicated in patients with known hypersensitivity to felbamate, 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.See regarding aplastic anemia and hepatic failure. Antiepileptic drugs should not be suddenly discontinued because of the possibility of increasing seizure frequency.
The drug interaction data described in this section were obtained from controlled clinical trials and studies involving otherwise healthy adults with epilepsy.
A study in otherwise healthy individuals with renal dysfunction indicated that prolonged half-life and reduced clearance of felbamate are associated with diminishing renal function. Felbamate should be used with caution in patients with renal dysfunction (see ).
To report SUSPECTED ADVERSE REACTIONS, contact or FDA at 1-800-FDA-1088 or .
The most common adverse reactions seen in association with felbamate in adults during monotherapy are anorexia, vomiting, insomnia, nausea, and headache. The most common adverse reactions seen in association with felbamate in adults during adjunctive therapy are anorexia, vomiting, insomnia, nausea, dizziness, somnolence, and headache.
The most common adverse reactions seen in association with felbamate 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 6% (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%). In adults, specific events with an incidence of 1% or greater associated with causing these withdrawals, in order of frequency were: anorexia (1.6%), nausea (1.4%), rash (1.2%), and weight decrease (1.1%). In children, specific events with an incidence of 1% or greater associated with causing these withdrawals, in order of frequency was rash (1.1%).
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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