Country: United States
Language: English
Source: NLM (National Library of Medicine)
FELBAMATE (UNII: X72RBB02N8) (FELBAMATE - UNII:X72RBB02N8)
Amneal Pharmaceuticals LLC
FELBAMATE
FELBAMATE 600 mg in 5 mL
ORAL
PRESCRIPTION DRUG
Felbamate oral suspension is not indicated as a first line antiepileptic treatment (see Warnings ). Felbamate oral suspension is 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 oral suspension 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 oral suspension 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. 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 Oral Suspension, USP, 600 mg/5 mL , is a pink-colored bubble gum flavored suspension; available in 8 oz bottles (NDC 65162-686-88) and 16 oz bottles (NDC 65162-686-90). Shake suspension well before using. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container. Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 02-2017-03
Abbreviated New Drug Application
Amneal Pharmaceuticals LLC ---------- MEDICATION GUIDE Felbamate (fel-BAM-ate) Oral Suspension, USP Read this Medication Guide before you start taking felbamate oral suspension 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 oral suspension? Do not stop taking felbamate oral suspension without first talking to your healthcare provider. Stopping felbamate oral suspension suddenly can cause serious problems. Felbamate oral suspension can cause serious side effects, including: 1. Felbamate oral suspension 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 oral suspension 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 Read the complete document
FELBAMATE- FELBAMATE SUSPENSION AMNEAL PHARMACEUTICALS LLC ---------- FELBAMATE ORAL SUSPENSION, USP 600 MG/5 ML RX ONLY 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 ACKNOWLEDGMENT FORM). 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 AV Read the complete document