felbamate

Adult Dosing

Adjunctive treatment in seizure disorder

Start 1200 mg/day PO divided tid-qid. Initially decrease dose of other antiepileptic medications by 20%-30%
Titrate: Increase in increments of 1200mg/day q7 days. Max: 3600 mg/day.

Monotherapy in seizure disorder

Start 1200 mg/day PO divided tid-qid.
Titrate: May be increased by 600 mg/day at 2-wk intervals up to a total of 3600 mg. Max: 3600 mg/day

Conversion to Monotherapy in seizure disorder

Start 1200 mg/day PO divided tid-qid. Initially decrease dose of other antiepileptic medications by 20%-30%
At week two, increase felbamate to 2400 mg/day divided tid-qid.
At week three, increase felbamate to 3600 mg/day divided tid-qid.

Pediatric Dosing

Adjunctive treatment in seizure disorder

14 yrs: Start 1200 mg/day PO divided tid-qid. Initially decrease dose of other antiepileptic medications by 20%-30%
Titrate: Increase in increments of 1200mg/day q7 days. Max: 3600 mg/day.

Monotherapy in seizure disorder

14 yrs: Start 1200 mg/day PO divided tid-qid. Initially decrease dose of other antiepileptic medications by 20%-30%
Titrate: May be increased by 600 mg/day at 2-wk intervals up to a total of 3600 mg. Max:3600 mg/day

Conversion to Monotherapy in seizure disorder

14 yrs: Start 1200 mg/day PO divided tid-qid. Initially decrease dose of other antiepileptic medications by 20%-30%
At week two, increase felbamate to 2400 mg/day divided tid-qid.
At week three, increase felbamate to 3600 mg/day divided tid-qid.

Adjunctive therapy in children with Lennox-Gestault Syndrome

2-14 yrs: Start 15 mg/kg/day PO divided tid-qid. Initially decrease dose of other antiepileptic medications by 20%
Titrate: Increase in increments of 15 mg/kg/day q7 days to 45 mg/kg/day. Max:45 mg/kg/day or 3600 mg/day.

[Outline]

Adult Dosing
Pediatric Dosing

Indications ⬆ ⬇

First line and combination therapy for epilepsy and seizure disorders
Treatment of Lennox-Gastaut syndrome in children

Contraindications ⬆ ⬇

Hypersensitivity to any of the ingredients of the product
Hypersensitivity to carisoprodol
Hypersensitivity to meprobamate
History of any blood dyscrasia or hepatic dysfunction

Black Box Warnings ⬆ ⬇

Therapy with this drug is associated with a marked increase in the incidence of aplastic anemia. Use only 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. Avoid using this therapy or avoid continuous use in patients without consideration of appropriate expert hematologic consultation
In treated patients, aplastic anemia (pancytopenia in the presence of a bone marrow largely depleted of hematopoietic precursors) occured at an incidence that may be more than a 100 fold > that seen in the untreated population. Risk of death in patients with aplastic anemia varies as a function of its severity and etiology; estimation of the overall case fatality rate are in the range of 20-30%, but rates as high as 70% has occurred
Onset of aplastic anemia in felbamate treated patients has not occurred until several weeks. Injury to bone marrow stem cells that is ultimately responsible for the anemia have occurred weeks to months earlier. Accordingly, patients in whom therapy is discontinued remain at risk for developing anemia for a variable, and unknown, period afterwards
It is unsafe for assumption that a patient without signs of hematologic abnormality for long periods of time is without risk. Unknown whether or not the dose or concomitant use of antiepileptic drugs affects the incidence of aplastic anemia
Aplastic anemia develops without premonitory clinical or laboratory signs. Routine blood testing cannot be used reliably to reduce the incidence of aplastic anemia. Allows detection of the hematologic changes. Discontinue therapy on evidence of bone marrow depression
Acute liver failure has been reported on postmarketing. Death or liver transplantation has occurred usually within 5 weeks of the onset of signs and symptoms of liver failure. Onset of severe hepatic dysfunction was followed by liver failure within 3 weeks after initiation of therapy. Some reports described dark urine and nonspecific prodromal symptoms (e.g., anorexia, malaise, and gastrointestinal symptoms)
Whether or not the risk of developing hepatic failure changes with duration of exposure or concomitant use of other antiepileptic drugs affects the incidence of hepatic failure is unknown
Initiate therapy only in individuals without active liver disease and with normal baseline serum transaminases. Unproven that periodic serum transaminase testing will prevent serious injury. Early detection of drug induced hepatic injury along with immediate withdrawal of the suspect drug enhances the likelihood for recovery
Monitoring serum transaminase levels at baseline and periodically thereafter
Discontinue therapy if either serum AST or serum ALT levels increases 2x ULN or if clinical signs and symptoms suggest liver failure
Increased risk for liver injury exists in patients who developed evidence of hepatocellular injury while treated with this drug and on reintroduction of therapy if at all it was withdrawn due to any reason. Avoid considering such patients for retreatment

Dosing Adjustment ⬆ ⬇

Renal Dose Adjustment

Renal impairment: Decrease initial and maintenance dose by 50%

Hepatic Dose Adjustment

Hepatic impairment: Contraindicated

Warnings/Precautions ⬆ ⬇

See Supplemental Patient Information

Avoid abrupt withdrawal as possibility of increasing seizure exists
Felbamate is associated with morbidity and mortality and increases risk of suicidal thoughts or behavior. Monitor patients for the emergence or worsening of depression, suicidal thoughts or behavior
Perform CBC before therapy and frequently during therapy, and for a significant period of time after discontinuation therapy

Cautions: Use cautiously in:

Renal impairment
History of depression

Supplemental Patient Information

Inform patients, their caregivers, and families about the increased risk of suicidal thoughts and behavior. Advise them about the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior or the emergence of suicidal thoughts, behavior, or thoughts about self-harm; also advise them to immediately report to healthcare providers

Interactions ⬆ ⬇

Felbatol interacts with :

Contraceptives, Oral

Pregnancy/Breast Feeding ⬆ ⬇

Pregnancy Category:C

Breastfeeding: Unsafe; No information is available on the use of felbamate during breastfeeding, and as it can cause potentially fatal hematologic and hepatic toxicities, authors recommend that breastfeeding not be undertaken during maternal felbamate therapy until more safety data are available. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 2 February 2011). Effect on nursing is unknown.

Adverse Reactions ⬆ ⬇

HEMA: Aplastic anemia
GI Hepatic failure, anorexia, vomiting, nausea, dyspepsia, constipation, taste changes, abdominal pain
CNS: Insomnia, headache, dizziness, somnolence, fatigue, nervousness, tremor, depression, anxiety, ataxia
PSYCHIATRIC: Suicidality
EENT: Otitis media, diplopia
RESP: URTI, Rhinitis
DERM: Acne, rash
METABOLIC: Hypophosphatemia
GU: Intramenstrual bleeding, UTI

Clinical Pharmacology ⬆ ⬇

Anticonvulsant; precise mechanism of action unknown; acts by raising seizure threshold and prevents seizure spread
Well absorbed
Partially metabolized by liver; CYP450: 2C19
Excreted in urine (40-50% unchanged
Half-life: 20-23 hrs

Brands and Availability ⬆ ⬇

US Trade Name(s)

Felbatol

US Availability

felbamate (generic)

TABS: 400, 600 mg
SUSP: 600 mg/5 mL

Felbatol

TABS: 400, 600 mg
SUSP: 600 mg/5 mL

Canadian Trade Name(s)

Canadian Availability

UK Trade Name(s)

UK Availability

Australian Trade Name(s)

Australian Availability

[Outline]

Classification ⬆ ⬇

Neurologic

Anticonvulsants
Carbamate Anticonvulsants

Pricing ⬆ ⬇

Pricing data from www.DrugStore.com in U.S.A.

Felbatol 400 MG TABS [Bottle] (MEDA PHARMACEUTICALS)
90 mg = $447.01
100 mg = $494.99
Felbatol 600 MG TABS [Bottle] (MEDA PHARMACEUTICALS)
90 mg = $519.01
270 mg = $1532.94
Felbatol 600 MG/5ML SUSP [Bottle] (MEDA PHARMACEUTICALS)
237 5ml = $590.01
711 5ml = $1741.97

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Pill ⬆

Drug Name: Felbatol 400 MG Oral Tablet

Ingredient(s): Felbamate

Imprint: 0430

Color(s): Yellow

Shape: Capsule

Size (mm): 16.00

Score: 2

Inactive Ingredient(s): N/A

Drug Label Author:
Meda Pharmaceuticals Inc.

DEA Schedule:
Non-Scheduled

Drug Name: Felbatol 600 MG Oral Tablet