Felbamate

Felbamate oral suspension, USP 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. …

• 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 )
• 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) felbamate has not been systematically evaluated as initial monotherapy
• Initiate 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 clinical response and thereafter to 3600 mg/day if clinically indicated
• Conversion to Monotherapy Initiate felbamate at 1200 mg/day in divided doses three or four times daily. …

The safety and effectiveness of felbamate in children other than those with Lennox-Gastaut syndrome has not been established.

No systematic studies in geriatric patients have been conducted. Clinical studies of felbamate did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. …

• Patients should be informed that the use of felbamate is associated with aplastic anemia and hepatic failure, potentially fatal conditions acutely or over a long term
• The physician should obtain written acknowledgement prior to initiation of felbamate therapy (see PATIENT/PHYSICIAN ACKNOWLEDGMENT FORM section)
• Patients should be instructed to read the Medication Guide supplied as required by law when felbamate oral suspension is dispensed
• The complete text of the Medication Guide is reprinted at the end of this document
• Aplastic anemia in the general population is relatively rare. …

• Felbamate oral suspension, USP is contraindicated in patients with known hypersensitivity to felbamate oral suspension, 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

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 2 Steady-State Plasma Concentrations of Felbamate When Coadministered With Other AEDs AED Coadministered AED Concentration Felbamate Concentration Phenytoin ↑ ↓ Valproate ↑ ↔ No significant effect. …

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 oral suspension, 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. …

To report SUSPECTED ADVERSE REACTIONS, contact Taro at 1-866-923-4914 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. …

Pregnancy Patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233-2334 (see Pregnancy section). …

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 1 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.

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.

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.

Tómala en cuanto te acuerdes, salvo que falte poco para la siguiente. En ese caso, sáltate la olvidada. Nunca tomes dos dosis a la vez para compensar. Revisa tu prospecto, porque algunos medicamentos son distintos.