Felbamate (Page 4 of 5)

DRUG ABUSE AND DEPENDENCE

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.

OVERDOSAGE

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.

DOSAGE AND ADMINISTRATION

Felbamate tablets, USP have been studied as monotherapy and adjunctive therapy in adults and as adjunctive therapy in children with seizures associated with Lennox-Gastaut syndrome. As felbamate tablets, USP are 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, USP 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, USP plasma concentrations, especially AEDs, may warrant further reductions in felbamate, USP 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 tablets, USP have not been systematically evaluated as initial monotherapy. Initiate felbamate tablets, USP 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 tablets, USP at 1200 mg/day in divided doses three or four times daily. Reduce the dosage of concomitant AEDs by one-third at initiation of felbamate tablets, USP therapy. At week 2, increase the felbamate tablets, USP dosage to 2400 mg/day while reducing the dosage of other AEDs up to an additional one-third of their original dosage. At week 3, increase the felbamate tablets, USP dosage up to 3600 mg/day and continue to reduce the dosage of other AEDs as clinically indicated.

Adjunctive Therapy: Felbamate tablets, USP should be added at 1200 mg/day in divided doses three or four times daily while reducing present AEDs by 20% in order to control plasma concentrations of concurrent phenytoin, valproic acid, phenobarbital and carbamazepine and its metabolites. Further reductions of the concomitant AEDs dosage may be necessary to minimize side effects due to drug interactions. Increase the dosage of felbamate, USP by 1200 mg/day increments at weekly intervals to 3600 mg/day. Most side effects seen during felbamate tablets, USP adjunctive therapy resolve as the dosage of concomitant AEDs is decreased.

Table 6 Dosage Table (adults)
Dosage reduction of concomitant AEDs WEEK 1 REDUCE original dose by 20% to 33%* WEEK 2 REDUCE original dose by up to an additional 1/3* WEEK 3 REDUCE as clinically indicated
Felbamate Tablet, USP Dosage 1200 mg/day Initial dose 2400 mg/day Therapeutic dosage range 3600 mg/day Therapeutic dosage range
*See Adjunctive and Conversion to Monotherapy sections.

While the above felbamate tablets, USP conversion guidelines may result in a felbamate tablets, USP 3600 mg/day dose within 3 weeks, in some patients titration to a 3600 mg/day felbamate tablets, USP dose has been achieved in as little as 3 days with appropriate adjustment of other AEDs.

Children with Lennox-Gastaut Syndrome (Ages 2 to 14 years)

Adjunctive Therapy: Felbamate tablets, USP should be added at 15 mg/kg/day in divided doses three or four times daily while reducing present AEDs by 20% in order to control plasma levels of concurrent phenytoin, valproic acid, phenobarbital, and carbamazepine and its metabolites. Further reductions of the concomitant AEDs dosage may be necessary to minimize side effects due to drug interactions. Increase the dosage of felbamate tablets, USP by 15 mg/kg/day increments at weekly intervals to 45 mg/kg/day. Most side effects seen during felbamate tablets, USP adjunctive therapy resolve as the dosage of concomitant AEDs is decreased.

HOW SUPPLIED

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.

Distributed by:
Amneal Pharmaceuticals
Bridgewater, NJ 08807

Rev. 11-2015-00

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 attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
  • Keep all follow-up visits with your healthcare provider as scheduled.

Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop felbamate without first talking to a healthcare provider.

Stopping felbamate suddenly can cause serious problems. You should talk to your health care provider before stopping. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures.

Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

What is felbamate?

Felbamate is a prescription medicine used when other treatments have failed in:

  • adults alone or with other medicines to treat:
    • partial seizures with and without generalization
  • children with other medicines to treat:
    • seizures associated with Lennox-Gastaut syndrome

Who should not take felbamate tablets?

Do not take felbamate tablets if you:

  • are allergic to felbamate, carbamates or any of the ingredients in felbamate tablets. See the end of this Medication Guide for a complete list of ingredients in felbamate tablets.
  • have or have had blood problems
  • have or have had liver problems

What should I tell my healthcare provider before taking felbamate?

Before you take felbamate, tell your healthcare provider if you:

  • have kidney problems
  • have or have had depression, mood problems, or suicidal thoughts or behavior
  • have any other medical conditions
  • are pregnant or plan to become pregnant. It is not known if felbamate can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking felbamate. You and your healthcare provider will decide if you should take felbamate while you are pregnant.
    • If you become pregnant while taking felbamate, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334.
  • are breastfeeding or plan to breastfeed. Felbamate may pass into your breast milk. You and your healthcare provider should decide if you should take felbamate while you breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.

Taking felbamate with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take felbamate?

  • Take felbamate exactly as your healthcare provider tells you. Your healthcare provider will tell you how much felbamate to take and when to take it.
  • Your healthcare provider may change your dose of felbamate. Do not change your dose of felbamate without talking to your healthcare provider.
  • Because of the risk of serious blood and liver problems, your healthcare provider may do blood tests before you start and while you take felbamate.
  • If you take too much felbamate, call your healthcare provider or local Poison Control Center right away.
  • Do not stop felbamate without first talking to your healthcare provider.

What should I avoid while taking felbamate?

  • Felbamate can cause drowsiness and dizziness. Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking felbamate, until you talk with your doctor. Taking felbamate with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.

What are the possible side effects of felbamate?

See “What is the most important information I should know about felbamate?”

Felbamate may cause serious side effects including:

The most common side effects of felbamate include:

  • weight loss
  • vomiting
  • trouble sleeping
  • nausea
  • dizziness
  • sleepiness
  • headache
  • double-vision
  • changes in the way that food tastes

These are not all the possible side effects of felbamate. For more information, ask your healthcare provider or pharmacist.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store felbamate?

  • Store felbamate at room temperature between 68°F to 77°F (20°C to 25°C).

Keep felbamate and all medicines out of the reach of children.

General information about felbamate.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use felbamate for a condition for which it was not prescribed. Do not give felbamate to other people, even if they have the same symptoms that you have. It may harm them.

What are the ingredients in felbamate tablets?

The inactive ingredients for felbamate tablets 400 mg and 600 mg are croscarmellose sodium, FD&C Yellow No. 6, D&C Yellow No. 10 and FD&C Red No. 40 (600 mg tablets only), lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch.

This Medication Guide summarizes the most important information about felbamate. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about felbamate that is written for health professionals.

For more information, go to www.amneal.com or call 1-877-835-5472.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Distributed by:
Amneal Pharmaceuticals
Bridgewater, NJ 08807

Rev. 11-2015-00

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