Felbamate Tablets, USP

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Zydus Pharmaceuticals (USA) Inc.

INN (Kansainvälinen yleisnimi):

FELBAMATE

Koostumus:

FELBAMATE 400 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Felbamate tablets, USP are not indicated as a first line antiepileptic treatment (see Warnings ). Felbamate tablets, USP are 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 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 history of any blood dyscrasia or hepa

Tuoteyhteenveto:

Felbamate Tablets USP, 400 mg are off-white to pale yellow colored, capsule shaped biconvex tablets, debossed with "10" and "53" separated by breakline on one side and plain on other and are supplied as: NDC 70710-1053-3 in bottles of 30 tablets NDC 70710-1053-9 in bottles of 90 tablets NDC 70710-1053-1 in bottles of 100 tablets NDC 70710-1053-5 in bottles of 500 tablets NDC 70710-1053-4 in cartons of 100 tablets (10 x 10 unit-dose) Felbamate Tablets USP, 600 mg are light pink to pink colored, capsule shaped biconvex tablets debossed with "10" and "54" separated by breakline on one side and plain on other and are supplied as: NDC 70710-1054-3 in bottles of 30 tablets NDC 70710-1054-9 in bottles of 90 tablets NDC 70710-1054-1 in bottles of 100 tablets NDC 70710-1054-8 in bottles of 180 tablets NDC 70710-1054-5 in bottles of 500 tablets NDC 70710-1054-4 in cartons of 100 tablets (10 x 10 unit-dose) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tight container. Manufactured by: Cadila Healthcare Limited Matoda, Ahmedabad, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 Rev.: 06/17

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

FELBAMATE- FELBAMATE TABLET
ZYDUS PHARMACEUTICALS (USA) INC.
----------
FELBAMATE TABLETS, USP
BEFORE PRESCRIBING FELBAMATE TABLETS, 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 ACKNOWLEDGEMENT 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 RA