Country: United States
Language: English
Source: NLM (National Library of Medicine)
FELBAMATE (UNII: X72RBB02N8) (FELBAMATE - UNII:X72RBB02N8)
Amneal Pharmaceuticals LLC
FELBAMATE
FELBAMATE 400 mg
ORAL
PRESCRIPTION DRUG
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. If these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgment, felbamate tablets, USP 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 tablets, USP are contraindicated in patients with known hypersensitivity to felbamate, USP, 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. Abuse: Abuse potential was not evaluated in human studies. Dependence: Rats administered felbamate orally at doses 8.3 times the recommended human dose 6 days each week for 5 consecutive weeks demonstrated no signs of physical dependence as measured by weight loss following drug withdrawal on day 7 of each week.
Felbamate Tablets, USP, 400 mg , are yellow, oval shaped, biconvex tablets, with a bisect on one side and “AN 734” on the other side. They are available as follows: Bottles of 30 count: NDC 65162-734-03 Bottles of 90 count: NDC 65162-734-09 Bottles of 270 count: NDC 65162-734-27 Bottles of 500 count: NDC 65162-734-50 Felbamate Tablets, USP, 600 mg , are peach, oval shaped, biconvex tablets, with a bisect on one side and “AN 735” on the other side. They are available as follows: Bottles of 30 count: NDC 65162-735-03 Bottles of 90 count: NDC 65162-735-09 Bottles of 180 count: NDC 65162-735-18 Bottles of 270 count: NDC 65162-735-27 Bottles of 500 count: NDC 65162-735-50 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tight container. To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Abbreviated New Drug Application
Amneal Pharmaceuticals LLC ---------- MEDICATION GUIDE Felbamate Tablets Read this Medication Guide before you start taking felbamate and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. What is the most important information I should know about felbamate? Do not stop taking felbamate without first talking to your healthcare provider. Stopping felbamate suddenly can cause serious problems. Felbamate can cause serious side effects, including: 1. Felbamate may cause serious blood problems that may be life-threatening. Call your healthcare provider right away if you have any of the following symptoms: • Fever, sore throat or other infections that come and go or do not go away • Frequent infections or an infection that does not go away • Easy bruising • Red or purple spots on your body • Bleeding gums or nose bleeds • Severe fatigue or weakness 2. Liver problems that may be life-threatening. Call your healthcare provider right away if you have any of these symptoms: • yellowing of your skin or the whites of your eyes (jaundice) • dark urine • nausea or vomiting • loss of appetite • pain on the right side of your stomach (abdomen) 3. Like other antiepileptic drugs, felbamate may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: • thoughts about suicide or dying • attempts to commit suicide • new or worse depression • new or worse anxiety • feeling agitated or restless • panic attacks • trouble sleeping (insomnia) • new or worse irritability • acting aggressive, being angry, or violent • acting on dangerous impulses • an extreme increase in activity and talking (mania) • other unusual changes in behavior or mood How can I watch for early symptoms of suicidal thoughts and actions? • Pay Read the complete document
FELBAMATE- FELBAMATE TABLET AMNEAL PHARMACEUTICALS LLC ---------- FELBAMATE TABLETS, USP 400 MG AND 600 MG BEFORE PRESCRIBING FELBAMATE, THE PHYSICIAN SHOULD BE THOROUGHLY FAMILIAR WITH THE DETAILS OF THIS PRESCRIBING INFORMATION. FELBAMATE SHOULD NOT BE USED BY PATIENTS UNTIL THERE HAS BEEN A COMPLETE DISCUSSION OF THE RISKS AND THE PATIENT, PARENT, OR GUARDIAN HAS BEEN PROVIDED THE FELBAMATE WRITTEN ACKNOWLEDGMENT (SEE PATIENT/PHYSICIAN ACKNOWLEDGMENTFORM). 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. AMONG FELBAMATE TREATED PATIENTS, APLASTIC ANEMIA (PANCYTOPENIA IN THE PRESENCE OF A BONE MARROW LARGELY DEPLETED OF HEMATOPOIETIC PRECURSORS) OCCURS AT AN INCIDENCE THAT MAY BE MORE THAN A 100 FOLD GREATER THAN THAT SEEN IN THE UNTREATED POPULATION (I.E., 2 TO 5 PER MILLION PERSONS PER YEAR). THE RISK OF DEATH IN PATIENTS WITH APLASTIC ANEMIA GENERALLY VARIES AS A FUNCTION OF ITS SEVERITY AND ETIOLOGY; CURRENT ESTIMATES OF THE OVERALL CASE FATALITY RATE ARE IN THE RANGE OF 20 TO 30%, BUT RATES AS HIGH AS 70% HAVE BEEN REPORTED IN THE PAST. THERE ARE TOO FEW FELBAMATE ASSOCIATED CASES, AND TOO LITTLE KNOWN ABOUT THEM TO PROVIDE A RELIABLE ESTIMATE OF THE SYNDROME'S INCIDENCE OR ITS CASE FATALITY RATE OR TO IDENTIFY THE FACTORS, IF ANY, THAT MIGHT CONCEIVABLY BE USED TO PREDICT WHO IS AT GREATER OR LESSER RISK. IN MANAGING PATIENTS ON FELBAMATE, IT SHOULD BE BORNE IN MIND THAT THE CLINICAL MANIFESTATION OF APLASTIC ANEMIA MAY NOT BE SEEN UNTIL AFTER A PATIENT HAS BEEN ON FELBAMATE FOR SEVERAL MONTHS (E.G., ONSET OF APLASTIC ANEMIA AMONG FELBAMATE EXPOSED PATIENTS FOR WHOM DATA ARE AVAILABLE HAS RAN Read the complete document