Share on Facebook
Share on Twitter
Share on LinkedIn
Share by Email
Print
Aptiom Generic Name & Formulations
Legal Class
Rx
General Description
Eslicarbazepine acetate 200mg+, 400mg, 600mg+, 800mg+; (+) scored tabs.
Pharmacological Class
Dibenzazepine.
How Supplied
Tabs 200mg, 400mg—30; 600mg—60, 90; 800mg—30, 90
Manufacturer
Generic Availability
NO
Aptiom Indications
Indications
Monotherapy or adjunctive treatment of partial-onset seizures.
Aptiom Dosage and Administration
Adult
Initially 400mg once daily; for some patients, may initiate at 800mg once daily if need for seizure reduction outweighs an increased risk of adverse reactions. Increase dose in weekly increments of 400–600mg, based on response and tolerability, to maintenance dose of 800–1600mg once daily. Patients on monotherapy: consider 800mg once daily if 1200mg/day not tolerated. Patients on adjunctive therapy: consider 1600mg/day if 1200mg/day is inadequate. Moderate and severe renal impairment (CrCl <50mL/min): reduce doses by 50%.
Children
<4yrs: not established. Give once daily. Dose increase should be based on response and tolerability, no more than once per week. 4–17yrs (11–21kg): initial and max titration increment: 200mg/day; maintenance: up to 400–600mg/day; (22–31kg): initial and max titration increment: 300mg/day; maintenance: up to 500–800mg/day; (32–38kg): initial and max titration increment: 300mg/day; maintenance: up to 600–900mg/day; (>38kg): initial and max titration increment: 400mg/day; maintenance: up to 800–1200mg/day. Moderate and severe renal impairment (CrCl <50mL/min): reduce doses by 50%.
Aptiom Contraindications
Contraindications
Hypersensitivity to oxcarbazepine.
Aptiom Boxed Warnings
Not Applicable
Aptiom Warnings/Precautions
Warnings/Precautions
Increased risk of suicidal thinking or behavior; monitor for clinical worsening or unusual changes. Discontinue if serious dermatologic reactions or DRESS/multiorgan hypersensitivity, anaphylaxis, angioedema occurs. Measure serum sodium and chloride levels during therapy and esp. if hyponatremia symptoms develop. Monitor for neurological adverse reactions (esp. in elderly). Monitor LFTs at baseline; discontinue if jaundice or evidence of significant liver injury occurs. Severe hepatic impairment: not recommended. Avoid abrupt cessation. Pregnancy. Nursing mothers.
Aptiom Pharmacokinetics
See Literature
Aptiom Interactions
Interactions
Avoid adjunctive therapy with oxcarbazepine. Antagonized by carbamazepine, phenobarbital, phenytoin, and primidone; monitor and adjust dose. May potentiate phenytoin, clobazam, omeprazole. May antagonize simvastatin, lovastatin. May decrease effectiveness of oral contraceptives; use additional non-hormonal forms. May affect thyroid function tests. Caution with other drugs known to decrease serum sodium. Monitor INR when given with warfarin.
Aptiom Adverse Reactions
Adverse Reactions
Dizziness, somnolence, nausea, headache, diplopia, vomiting, fatigue, vertigo, ataxia, blurred vision, tremor; hyponatremia, liver injury; rare: serious skin reactions (eg, SJS, TEN), DRESS/multiorgan hypersensitivity, anaphylaxis, angioedema, blood dyscrasias (discontinue if occur).
Aptiom Clinical Trials
See Literature
Aptiom Note
Notes
To enroll in the North American Antiepileptic Drug Pregnancy Registry call (888) 233-2334.
Aptiom Patient Counseling
See Literature
Images
