Felbamate
Generic Name: felbamate
Brand Names:
Felbamate
DESCRIPTION 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 white to off-white powder. It is freely soluble in dimethyl sulfoxide, sparingly soluble in methanol, slightly soluble in acetonitrile and very slightly soluble in water.
Overview
DESCRIPTION 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 white to off-white powder. It is freely soluble in dimethyl sulfoxide, sparingly soluble in methanol, slightly soluble in acetonitrile and very slightly soluble in water.
Uses
INDICATIONS AND USAGE Felbamate tablets, USP are not indicated as a first line antiepileptic treatment (see Warnings ). Felbamate tablets, USP 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.
Dosage
DOSAGE AND ADMINISTRATION 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 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 ).
Side Effects
ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Viona Pharmaceuticals Inc. at 1-888-304-5011 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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).
Interactions
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 felbamate to antiepileptic drugs (AEDs) affects the steady-state plasma concentrations of AEDs. The net effect of these interactions is summarized in Table 2: Table 2Steady-State Plasma Concentrations of Felbamate When Coadministered With Other AEDs * Not administered but an active metabolite of Carbamazepine. ** No significant effect. AED Coadministered AED Concentration Felbamate Concentartion Phenytoin ↑ ↓ Valproate ↑ ↔ ** Carbamazepine (CBZ) *CBZ epoxide ↓ ↑ ↓ Phenobarbital ↑ ↓
Warnings
WARNING: 1. APLASTIC ANEMIA THE USE OF FELBAMATE IS ASSOCIATED WITH A MARKED INCREASE IN THE INCIDENCE OF APLASTIC ANEMIA. ACCORDINGLY, FELBAMATE SHOULD ONLY BE USED IN PATIENTS WHOSE EPILEPSY IS SO SEVERE THAT THE RISK OF APLASTIC ANEMIA IS DEEMED ACCEPTABLE IN LIGHT OF THE BENEFITS CONFERRED BY ITS USE (SEE INDICATIONS ). ORDINARILY, A PATIENT SHOULD NOT BE PLACED ON AND/OR CONTINUED ON FELBAMATE WITHOUT CONSIDERATION OF APPROPRIATE EXPERT HEMATOLOGIC CONSULTATION. WARNINGS See Boxed Warning regarding aplastic anemia and hepatic failure. Antiepileptic drugs should not be suddenly discontinued because of the possibility of increasing seizure frequency. Suicidal Behavior and Ideation Antiepileptic drugs (AEDs) including felbamate, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. CONTRAINDICATIONS Felbamate is 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.
Pregnancy
Pregnancy: Pregnancy Category C . The incidence of malformations was not increased compared to control in offspring of rats or rabbits given doses up to 13.9 times (rat) and 4.2 times (rabbit) the human daily dose on a mg/kg basis, or 3 times (rat) and less than 2 times (rabbit) the human daily dose on a mg/m 2 basis. However, in rats, there was a decrease in pup weight and an increase in pup deaths during lactation. The cause for these deaths is not known. The no effect dose for rat pup mortality was 6.9 times 549 the human dose on a mg/kg basis or 1.5 times the human dose on a mg/m 2 basis.
Storage
HOW SUPPLIED Felbamate Tablets USP, 400 mg are off-white to pale yellow colored, capsule shaped biconvex tablets, debossed with "10" and "53" separated by breakline on one side and plain on other and are supplied as: NDC 72578-056-06 in bottles of 30 tablets with child-resistant closures NDC 72578-056-16 in bottles of 90 tablets with child-resistant closures NDC 72578-056-01 in bottles of 100 tabl...
Frequently Asked Questions
What is Felbamate used for?▼
INDICATIONS AND USAGE Felbamate tablets, USP are not indicated as a first line antiepileptic treatment (see Warnings ). Felbamate tablets, USP 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.
What are the side effects of Felbamate?▼
ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Viona Pharmaceuticals Inc. at 1-888-304-5011 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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).
Can I take Felbamate during pregnancy?▼
Pregnancy: Pregnancy Category C . The incidence of malformations was not increased compared to control in offspring of rats or rabbits given doses up to 13.9 times (rat) and 4.2 times (rabbit) the human daily dose on a mg/kg basis, or 3 times (rat) and less than 2 times (rabbit) the human daily dose on a mg/m 2 basis. However, in rats, there was a decrease in pup weight and an increase in pup deaths during lactation. The cause for these deaths is not known. The no effect dose for rat pup mortality was 6.9 times 549 the human dose on a mg/kg basis or 1.5 times the human dose on a mg/m 2 basis.
What are the important warnings for Felbamate?▼
WARNING: 1. APLASTIC ANEMIA THE USE OF FELBAMATE IS ASSOCIATED WITH A MARKED INCREASE IN THE INCIDENCE OF APLASTIC ANEMIA. ACCORDINGLY, FELBAMATE SHOULD ONLY BE USED IN PATIENTS WHOSE EPILEPSY IS SO SEVERE THAT THE RISK OF APLASTIC ANEMIA IS DEEMED ACCEPTABLE IN LIGHT OF THE BENEFITS CONFERRED BY ITS USE (SEE INDICATIONS ). ORDINARILY, A PATIENT SHOULD NOT BE PLACED ON AND/OR CONTINUED ON FELBAMATE WITHOUT CONSIDERATION OF APPROPRIATE EXPERT HEMATOLOGIC CONSULTATION. WARNINGS See Boxed Warning regarding aplastic anemia and hepatic failure. Antiepileptic drugs should not be suddenly discontinued because of the possibility of increasing seizure frequency. Suicidal Behavior and Ideation Antiepileptic drugs (AEDs) including felbamate, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. CONTRAINDICATIONS Felbamate is 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.
Related Medications
Avobenzone, Octocrylene, And Oxybenzone
avobenzone, octocrylene, and oxybenzone
Purpose Sunscreen
Pyridoxal-5-phosphate
pyridoxal-5-phosphate
Dosage form: POWDER. Active ingredients: PYRIDOXAL PHOSPHATE ANHYDROUS (25 kg/25kg). Category: DRUG FOR FURTHER PROCESSING.
Cantharis, Clematis, Cubeba, Echinacea, Ranunculus Bulbosus, Sabal Ser, Staphysagria, Uva Ursi
cantharis, clematis, cubeba, echinacea, ranunculus bulbosus, sabal ser, staphysagria, uva ursi
Uses* Temporarily relieves burning sensation frequent urge to urinate painful urination inflammation
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.