FELBATOL- felbamate tablet FELBATOL- felbamate suspension

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Meda Pharmaceuticals Inc.

INN (Medzinárodný Name):

FELBAMATE

Zloženie:

FELBAMATE 400 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Felbatol® is not indicated as a first line antiepileptic treatment (see Warnings ). Felbatol® 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, Felbatol® 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. Felbatol® is contraindicated in patients with known hypersensitivity to Felbatol®, its ingredients, or known sensitivity to other carbamates. It should not be used in patients with a history of any blood dyscrasia or hepatic dysfunctio

Prehľad produktov:

Felbatol® (felbamate) Tablets, 400 mg, are yellow, scored, capsule-shaped tablets, debossed 0430 on one side and FELBATOL 400 on the other; available in bottles of 100 (NDC 0037-0430-01). Felbatol® (felbamate) Tablets, 600 mg, are peach-colored, scored, capsule-shaped tablets, debossed 0431 on one side and FELBATOL 600 on the other; available in bottles of 100 (NDC 0037-0431-01). Felbatol® (felbamate) Oral Suspension, 600 mg/5 mL, is peach-colored; available in 8 oz bottles (NDC 0037-0442-67) and 32 oz bottles (NDC 0037-0442-17). 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 Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured for: MEDA Pharmaceuticals Inc. Somerset, NJ 08873 U.S.A. FELBATOL is a registered trademark of Meda Pharmaceuticals Inc., a Mylan company © 2018 Mylan Specialty LP IN-00431-19/140907-0218 Rev. 2/2018 SOV-IN-00431-19/500489-02 Rev. 2/2018

Stav Autorizácia:

New Drug Application

Príbalový leták

FELBATOL- FELBAMATE TABLET
FELBATOL- FELBAMATE SUSPENSION
Meda Pharmaceuticals
----------
MEDICATION GUIDE
FELBATOL (Fel-ba-taal)
(felbamate)
Tablets and Oral Suspension
IS-00431-02 Rev. 2/2018
SOV-IS-00431-02 Rev. 2/2018
Read this Medication Guide before you start taking FELBATOL 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 FELBATOL?
Do not stop taking FELBATOL without first talking to your healthcare
provider.
Stopping FELBATOL suddenly can cause serious problems.
FELBATOL can cause serious side effects, including:
1. FELBATOL 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, FELBATOL 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

Súhrn charakteristických

FELBATOL- FELBAMATE TABLET
FELBATOL- FELBAMATE SUSPENSION
MEDA PHARMACEUTICALS
----------
FELBATOL® (FELBAMATE)
TABLETS 400 MG AND 600 MG, ORAL SUSPENSION 600 MG/5 ML
IN-00431-19/140907-0218 REV. 2/2018
SOV-IN-00431-19/500489-02 REV. 2/2018
BEFORE PRESCRIBING FELBATOL® (FELBAMATE), THE PHYSICIAN SHOULD BE
THOROUGHLY
FAMILIAR WITH THE DETAILS OF THIS PRESCRIBING INFORMATION.
FELBATOL® 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 FELBATOL WRITTEN
ACKNOWLEDGEMENT (SEE PATIENT/PHYSICIAN ACKNOWLEDGMENT FORM).
WARNING
1. APLASTIC ANEMIA
THE USE OF FELBATOL® (felbamate) IS ASSOCIATED WITH A MARKED INCREASE
IN THE INCIDENCE OF APLASTIC ANEMIA. ACCORDINGLY, FELBATOL® 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 FELBATOL® WITHOUT
CONSIDERATION OF APPROPRIATE EXPERT HEMATOLOGIC CONSULTATION.
AMONG FELBATOL® 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 FELBATOL® 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 FELBATOL®, IT SHOULD BE BORNE IN MIND THAT
THE CLINICAL MANIFESTATION OF APLASTIC ANEMIA MAY NOT BE