FELBAMATE tablet FELBAMATE suspension

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Wallace Pharmaceuticals Inc.

INN (Jina la Kimataifa):

FELBAMATE

Tungo:

FELBAMATE 400 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Felbamate 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 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 hepatic dysfunction. Abuse potent

Bidhaa muhtasari:

Felbamate Tablets, USP, 400 mg, are yellow, scored, capsule-shaped tablets, debossed WP 0320 on one side and plain on the other; available in bottles of 100 (NDC 51525-0430-1). Felbamate Tablets, USP, 600 mg, are peach-colored, scored, capsule-shaped tablets, debossed WP 0321 on one side and plain on the other; available in bottles of 100 (NDC 51525-0431-1). Felbamate Oral Suspension, USP, 600 mg/5 mL, is peach-colored; available in 8 oz bottles (NDC51525-0442-8) and 32 oz bottles (NDC51525-0442-3). Shake suspension well before using. Store at controlled room temperature 20°-25°C (68°-77°F). Dispense in tight container. To report SUSPECTED ADVERSE REACTIONS, contact Wallace Pharmaceuticals Inc. at 1-800-352-4047 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured for: Wallace Pharmaceuticals Inc. Somerset, NJ 08873-4120 U.S.A. IN-0321-03/140906-0218 Rev. 2/2018 SOV-IN-0321-03/500490-01 Rev. 2/2018

Idhini hali ya:

New Drug Application Authorized Generic

Taarifa za kipeperushi

FELBAMATE- FELBAMATE TABLET
FELBAMATE- FELBAMATE SUSPENSION
Wallace Pharmaceuticals Inc.
----------
MEDICATION GUIDE
FELBAMATE Tablets and Oral Suspension
IS-0321-02 Rev. 2/2018
SOV-IS-0321-02 Rev. 2/2018
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 talkin

Tabia za bidhaa

FELBAMATE- FELBAMATE TABLET
FELBAMATE- FELBAMATE SUSPENSION
WALLACE PHARMACEUTICALS INC.
----------
FELBAMATE
TABLETS 400 MG AND 600 MG, ORAL SUSPENSION 600 MG/5 ML
IN-0321-03/140906-0218 REV. 2/2018
SOV-IN-0321-03/500490-01 REV. 2/2018
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 FELBAMATEWITHOUT 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