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APTIOM
Seizure disorders
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Drug Name:

APTIOM Rx

Generic Name and Formulations:
Eslicarbazepine acetate 200mg+, 400mg, 600mg+, 800mg+; (+) scored tabs.

Company:
Sunovion

Therapeutic Use:

Indications for APTIOM:

Monotherapy or adjunctive treatment of partial-onset seizures.

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%.

Contraindications:

Hypersensitivity to oxcarbazepine.

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.

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.

Pharmacological Class:

Dibenzazepine.

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).

Note:

To enroll in the North American Antiepileptic Drug Pregnancy Registry call (888) 233-2334.

Generic Availability:

NO

How Supplied:

Tabs 200mg, 400mg—30; 600mg—60, 90; 800mg—30, 90

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