FELBAMATE suspension

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 600 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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 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

Product summary:

Felbamate Oral Suspension USP, 600 mg/5 mL, is a pink-colored, cherry flavored suspension; available in: 8 fl oz bottles (NDC 51672-4172-1) and 16 fl oz bottles (NDC 51672-4172-9). 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.

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)
Oral Suspension, USP
Read this Medication Guide before you start taking felbamate oral
suspension, 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
oral suspension, USP?
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 increa

Summary of Product characteristics

FELBAMATE- FELBAMATE SUSPENSION
TARO PHARMACEUTICALS U.S.A., INC.
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FELBAMATE
ORAL SUSPENSION USP
600 MG/5 ML
RX ONLY
BEFORE PRESCRIBING FELBAMATE ORAL SUSPENSION USP, THE PHYSICIAN SHOULD
BE THOROUGHLY FAMILIAR
WITH THE DETAILS OF THIS PRESCRIBING INFORMATION.
FELBAMATE ORAL SUSPENSION, 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 ORAL SUSPENSION, USP IS ASSOCIATED WITH A MARKED
INCREASE IN THE INCIDENCE OF APLASTIC ANEMIA. ACCORDINGLY, FELBAMATE
ORAL SUSPENSION 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 ORAL
SUSPENSION 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 ORAL SUSPENSION, IT SHOULD BE
BORNE IN MIND THAT THE CLINICAL MANIFESTATION OF APLASTIC ANEMIA MAY
NOT BE SEEN UNTIL AFTER A PATIENT HAS BEEN