FELBAMATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FELBAMATE (UNII: X72RBB02N8) (FELBAMATE - UNII:X72RBB02N8)

Available from:

Taro Pharmaceuticals U.S.A., inc.

INN (International Name):

Felbamate

Composition:

Felbamate 400 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Felbamate tablets, USP is not indicated as a first line antiepileptic treatment (see Warnings ). Felbamate 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 acknowledgement, felbamate 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 is contraindicated in patients with known hypersensitivity to felbamate tablets, 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 potential was not evaluated in human studies. 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.

Product summary:

Felbamate Tablets USP, 400 mg are white, caplet shaped, functionally scored on one side, engraved “FEL” on the left of the score line and “400” on the right. Engraved “Taro” on the other side; available in bottles of 30 (NDC 51672-4185-6), 90 (51672-4185-5) and 100 (NDC 51672-4185-1). Felbamate Tablets USP, 600 mg are yellowish, caplet shaped, functionally scored on one side, engraved “FEL” on the left of the score line and “600” on the right. Engraved “Taro” on the other side; available in bottles of 30 (NDC 51672-4186-6), 90 (51672-4186-5) and 100 (NDC 51672-4186-1). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Taro Pharmaceuticals U.S.A., inc.
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MEDICATION GUIDE
Felbamate (fel BAM ate)
Tablets, USP
Read this Medication Guide before you start taking felbamate tablets,
USP 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
tablets, USP?
Do not stop taking felbamate tablets without first talking to your
healthcare provider.
Stopping felbamate tablets suddenly can cause serious problems.
Felbamate tablets can cause serious side effects, including:
1. Felbamate tablets 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 tablets 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 b

Summary of Product characteristics

FELBAMATE- FELBAMATE TABLET
TARO PHARMACEUTICALS U.S.A., INC.
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FELBAMATE
TABLETS USP
400 MG AND 600 MG
RX ONLY
BEFORE PRESCRIBING FELBAMATE TABLETS USP, THE PHYSICIAN SHOULD BE
THOROUGHLY FAMILIAR WITH THE DETAILS OF THIS PRESCRIBING INFORMATION.
FELBAMATE TABLETS, USP 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
ACKNOWLEDGEMENT (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 PATI