Details About Generic Salt ::  Felbamat

Main Medicine Class:: Anticonvulsant   

(FELL-buh-MATE)
Felbatol
Class: Anticonvulsant

 

Drugs Class ::

 Action May reduce seizure spread in generalized tonic-clonic or partial seizures and may increase seizure threshold in absence seizures.

Indications for Drugs ::

 Indications Monotherapy or adjunctive therapy in treatment of partial seizures with and without generalization in epileptic adults. Adjunctive therapy in treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children.

Drug Dose ::

 Route/Dosage

Because of reports of aplastic anemia, it has been recommended to stop use of this drug unless physician decides that withdrawal would cause greater risk.

Initial Monotherapy

ADULTS & ADOLESCENTS ³ 14 YR: PO 1200 mg/day in 3 or 4 divided doses; increase in 600 mg increments q 2 wk to 2400 mg/day and then 3600 mg/day if indicated.

Conversion to Monotherapy

ADULTS & ADOLESCENTS ³ 14 YR: Initial dose: PO 1200 mg/day in 3 or 4 divided doses, reducing dose of other antiepileptic drugs by . At wk 2 increase felbamate to 2400 mg/day and at wk 3 increase to 3600 mg/day; continue to reduce dose of other antiepileptic drugs as indicated.

Adjunctive Therapy

ADULTS & ADOLESCENTS ³ 14 YR: Initial dose: PO 1200 mg/day in 3 or 4 divided doses; reduce original dose of other antiepileptic drugs by 20% to 33% for 1 wk. At wk 2 increase felbamate to 2400 mg/day and at wk 3 increase to 3600 mg/day if needed; reduce dosage of other antiepileptic drugs as clinically indicated. CHILDREN 2 to 14 YR WITH LENNOX-GASTAUT SYNDROME: PO15 mg/kg/day in 3 or 4 divided doses while reducing other antiepileptic drugs by ³ 20%. Increase felbamate by 15 mg/kg/day increments at weekly intervals up to 45 mg/kg/day; continue to reduce dosage of other antiepileptic drugs as needed.

Contraindication ::

 Contraindications Hypersensitivity to felbamate or ingredients of this product; hypersensitivity reactions to other carbamates; history of any blood dyscrasia or hepatic dysfunction.

Drug Precautions ::

 Precautions

Pregnancy: Category C. Lactation: Excreted in breast milk. Children: Safety and efficacy not established other than for adjunctive therapy of Lennox-Gastaut syndrome. Elderly patients: Use caution and start with low doses. Clinical experience is limited. Aplastic anemia: It is recommended that use of felbamate be suspended unless health care professional judges that patient’s well-being is at greater risk if drug is discontinued. Carcinogenesis: Drug may have carcinogenic potential. Discontinuation: Withdraw drug slowly to avoid increased seizure frequency. Hypersensitivity: Administer drug with caution to patients with prior hypersensitivity reactions to carbamates. Pre-existing liver failure: Eight cases of acute liver failure have occurred, including 4 deaths, in association with the use of felbamate. Evaluate patients prior to treatment initiation for evidence of pre-existing liver damage; avoid use in patients with pre-existing liver pathology. Once treatment is initiated, monitor ALT, AST, and bilirubin on a weekly basis. The drug should be withdrawn immediately in patients who develop lab findings indicating liver injury. Aplastic anemia: It is recommended that use of felbamate be suspended unless health care professional judges that patient’s well-being is at a greater risk if drug is discontinued.

PATIENT CARE CONSIDERATIONS


Drug Side Effects ::

 Adverse Reactions

CNS: Insomnia; headache; anxiety; somnolence; dizziness; nervousness; tremor; abnormal gait; depression; paresthesia; ataxia; dry mouth; stupor; thinking abnormalities; emotional lability. DERM: Acne; rash; pruritus. EENT: Diplopia; abnormal vision; miosis; otitis media; rhinitis; sinusitis; taste perversion; pharyngitis. GI: Dyspepsia; vomiting; constipation; diarrhea; nausea; anorexia; abdominal pain; hiccoughs. GU: Urinary incontinence; intramenstrual bleeding; UTI. HEMA: Aplastic anemia; purpura; leukopenia. HEPA: Increased ALT and AST; acute liver failure. RESP: Upper respiratory tract infection; coughing. OTHER: Fatigue; weight decrease; facial edema; fever; chest pain; pain; hypophosphatemia; myalgia.

Drug Mode of Action ::  

 Action May reduce seizure spread in generalized tonic-clonic or partial seizures and may increase seizure threshold in absence seizures.

Drug Interactions ::

 Interactions

Antiepileptic drugs: Felbamate may increase blood levels of phenytoin and valproic acid and decrease blood levels of carbamazepine. Phenytoin or carbamazepine may increase clearance of felbamate.

Drug Assesment ::

 Assessment/Interventions

  • Obtain patient history, including drug history and any known allergies. Note current status and frequency of seizures and use of other antiepileptic drugs, nonprescription drugs, and social drugs (alcohol).
  • Assess baseline data on patient’s weight and hematologic and hepatic functions.
  • Monitor for effectiveness; note any changes in seizure patterns and frequency.
  • If seizures occur, protect patient from injury.
  • Weigh patient weekly and record weight.
  • Monitor serum levels of felbamate and/or other antiepileptic drugs as necessary.

Drug Storage/Management ::

 Administration/Storage

  • Instruct patient to take tablet whole with full glass of water; do not crush.
  • May administer tablet with food.
  • Administer suspension if patient is unable to swallow tablets.
  • Shake suspension prior to administration.
  • Do not discontinue administration suddenly because of the possibility of increased frequency of seizures.
  • Store at room temperature in tightly closed container away from excessive heat, direct sunlight, and moisture.

Drug Notes ::

 Patient/Family Education

  • Instruct patient to drink at least 1 full glass of water with each dose.
  • Remind patient to take tablet whole; do not crush.
  • Inform patient that tablet may be taken with food.
  • Caution patient to not stop taking this medication suddenly because of possibility of increasing seizure frequency.
  • Advise patient to avoid exposure to sunlight or sunlamps and to use sunscreen or wear protective clothing to avoid photosensitivity reaction.
  • Instruct patient and family that if seizures occur, they should protect patient from injury.
  • Inform patient to report these symptoms to physician: loss of appetite, nausea, vomiting, indigestion, constipation, diarrhea, weight loss/gain, anxiety, nervousness, tremors, dizziness, depression, chest pain, fever, headache, poor coordination, drowsiness, sleeplessness, edema (fluid retention), intramenstrual bleeding (women), dry mouth, vision problems and any changes in seizure activity.
  • Advise patient that drug may cause drowsiness, dizziness, and vision problems, and to use caution while driving or performing other tasks requiring mental alertness.

Disclaimer ::

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