FELBAMATE tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Marlex Pharmaceuticals Inc

INN (שם בינלאומי):

FELBAMATE

הרכב:

FELBAMATE 400 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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 acknowledgment, felbamate tablets, USP 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 are contraindicated in patients with known hypersensitivity to felbamate, USP, its ingredients, or known sensitivity to other carbamates. It should not be used in patients with a history

leaflet_short:

Felbamate Tablets, USP, 400 mg , are yellow, oval shaped, biconvex tablets, with a bisect on one side and “AN 734” on the other side. They are available as follows: Bottles of 90 count: NDC 10135-601-90 Felbamate Tablets, USP, 600 mg, are peach, oval shaped, biconvex tablets, with a bisect on one side and “AN 735” on the other side. They are available as follows: Bottles of 90 count: NDC 10135-602-90 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tight container. To report SUSPECTED ADVERSE REACTIONS, c ontact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured for: Marlex Pharmaceuticals, Inc. New Castle, DE 19720 Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE 19720 Rev. 08/15

מצב אישור:

Abbreviated New Drug Application

עלון מידע

Marlex Pharmaceuticals Inc
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MEDICATION GUIDE
Felbamate Tablets
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 talking (mania)
•
other unusual changes in behavior or mood
How can I watch for early symptoms of suicidal thoughts and actions?
•
Pay

מאפייני מוצר

FELBAMATE- FELBAMATE TABLET
MARLEX PHARMACEUTICALS INC
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FELBAMATE TABLETS
FELBAMATE- FELBAMATE TABLET
MARLEX PHARMACEUTICALS, INC. OF NEW CASTLE, DE.
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FELBAMATE TABLETS
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
APLASTICANEMIA 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 RANGED FROM 5 TO 30 WEEKS). HOWEVER, THE INJURY TO
BONE MARROW STEM CELLS THAT IS HELD TO BE ULTIMATELY RESPONSIBLE
FOR THE ANEMIA MAY OCCUR WEEKS TO MONTHS EARLIER. ACCORDINGLY,
PATIENTS WHO ARE DISCONTINUED FROM FELBAMATE REMAIN AT RISK FOR
DEVELOPING ANEMIA FOR A VARIABLE, AN