A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Felbatol Indications, Dosage, Storage, Stability - Felbamate
Felbatol Indications, Dosage, Storage, Stability - Felbamate
INDICATIONS
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, informed consent, 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.
DOSAGE AND ADMINISTRATION
Felbatol® (felbamate) has been studied as monotherapy
and adjunctive therapy in adults and as adjunctive therapy in children
with seizures associated with Lennox-Gastaut syndrome. As Felbatol®
is added to or substituted for existing AEDs, it is strongly recommended
to reduce the dosage of those AEDs in the range of 20-33% to minimize
side effects (see DRUG INTERACTIONS
section).
Adults (14 years of age and over)
The majority of patients received 3600 mg/day in clinical trials evaluating
its use as both monotherapy and adjunctive therapy.
Monotherapy: (Initial therapy) Felbatol®
(felbamate) has not been systematically evaluated as initial monotherapy.
Initiate Felbatol® at 1200 mg/day in divided doses three
or four times daily. The prescriber is advised to titrate previously untreated
patients under close clinical supervision, increasing the dosage in 600-mg
increments every 2 weeks to 2400 mg/day based on clinical response and
thereafter to 3600 mg/day if clinically indicated.
Conversion to Monotherapy: Initiate Felbatol®
at 1200 mg/day in divided doses three or four times daily. Reduce the
dosage of concomitant AEDs by one-third at initiation of Felbatol®
therapy. At week 2, increase the Felbatol® dosage to 2400
mg/day while reducing the dosage of other AEDs up to an additional one-third
of their original dosage. At week 3, increase the Felbatol®
dosage up to 3600 mg/day and continue to reduce the dosage of other AEDs
as clinically indicated.
Adjunctive Therapy: Felbatol® should be
added at 1200 mg/day in divided doses three or four times daily while
reducing present AEDs by 20% in order to control plasma concentrations
of concurrent phenytoin, valproic acid, phenobarbital, and carbamazepine
and its metabolites. Further reductions of the concomitant AEDs dosage
may be necessary to minimize side effects due to drug interactions. Increase
the dosage of Felbatol® by 1200 mg/day increments at weekly
intervals to 3600 mg/day. Most side effects seen during Felbatol®
adjunctive therapy resolve as the dosage of concomitant AEDs is decreased.
| Dosage Table
(adults) |
| |
WEEK 1 |
WEEK 2 |
WEEK 3 |
| Dosage reduction of concomitant AEDs
|
REDUCE original dose by 20-33%* |
REDUCE original dose by up
to an additional 1/3* |
REDUCE as Clinically indicated |
| Felbatol®
Dosage |
1200 mg/day Initial dose |
2400 mg/day Therapeutic dosage
range |
3600 mg/day Therapeutic
dosage range |
| * See Adjunctive
and Conversion to Monotherapy sections. |
While the above Felbatol® conversion guidelines may result
in a Felbatol® 3600 mg/day dose within 3 weeks, in some
patients titration to a 3600 mg/day Felbatol® dose has
been achieved in as little as 3 days with appropriate adjustment of other
AEDs.
Children with Lennox-Gastaut Syndrome (Ages 2-14 years)
Adjunctive Therapy: Felbatol® should be
added at 15 mg/kg/day in divided doses three or four times daily while
reducing present AEDs by 20% in order to control plasma levels of concurrent
phenytoin, valproic acid, phenobarbital, and carbamazepine and its metabolites.
Further reductions of the concomitant AEDs dosage may be necessary to
minimize side effects due to drug interactions. Increase the dosage of
Felbatol® by 15 mg/kg/day increments at weekly intervals
to 45 mg/kg/day. Most side effects seen during Felbatol®
adjunctive therapy resolve as the dosage of concomitant AEDs is decreased.
HOW SUPPLIED
Felbatol® (felbamate) Tablets, 400 mg, are yellow, scored,
capsule-shaped tablets, debossed "0430" on one side and "WALLACE" on the
other; available in:
| Bottles of 100 |
NDC 0037-0430-01
|
| Unit Dose 100's |
NDC 0037-0430-11
|
Felbatol® (felbamate) Tablets, 600 mg, are peach-colored,
scored, capsule-shaped tablets, debossed "0431" on one side and "WALLACE"
on the other; available in:
| Bottles of 100 |
NDC 0037-0431-01
|
| Unit Dose 100's |
NDC 0037-0431-11
|
Felbatol® (felbamate) Oral Suspension, 600 mg/5mL, is
peach-colored; available in:
| 8 o bottles |
NDC 0037-0442-67
|
| 32 o bottles |
NDC 0037-0442-17
|
Shake suspension well before using.
Store at controlled room temperature 15°-30°C (59°-86°F). Dispense in
tight container.
CAUTION: Federal wlaw prohibits dispensing without prescription.
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