FELBAMATE suspension

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

VistaPharm, Inc.

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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 acknowledgement, 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 h

Sommarju tal-prodott:

Felbamate Oral Suspension, USP 600 mg/5 mL, is a pink colored suspension available in 8 oz. bottles (NDC 66689-825-08) and 16 oz. bottles (NDC 66689-825-16). Shake suspension well before using. Store oral suspension at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Dispense in a tight container. To report SUSPECTED ADVERSE REACTIONS, contact VistaPharm, Inc., at 1-888-655-1505 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

FELBAMATE- FELBAMATE SUSPENSION
VISTAPHARM, INC.
----------
FELBAMATE ORAL SUSPENSION, USP 600 MG/5 ML
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
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 PATIENTS FOR WHOM DATA
ARE AVAILABLE HAS RANGE