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Aptiom as adjunctive therapy in partial-onset seizures was established in three randomized, double-blind, placebo-controlled, multicenter trials in adult patients with epilepsy (Study 3, Study. Patient Counseling Information See FDA-approved patient labeling (Medication Guide). No effects on the immune system were observed. Pregnancy Registry Encourage patients to enroll in the North American Antiepileptic Drug Pregnancy Registry if they become pregnant. Patients with a prior anaphylactic-type reaction with either oxcarbazepine or Aptiom should not be treated with Aptiom see Contraindications ( 4 ). Advise patients and caregivers to report symptoms of low sodium such as nausea, tiredness, lack of energy, irritability, confusion, muscle weakness/spasms, or more frequent or more severe seizures see Warnings and Precautions (.5 ). Instruct patients and caregivers that Aptiom should only be taken as prescribed. Are breastfeeding or plan to breastfeed. My IBS was so bad that even my doctor was surprised at how often I had flare ups.
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Aptiom - FDA prescribing information, side effects and uses
Oxcarbazepine was not allowed as a concomitant AED. Call (8 AM8 PM, MondayFriday). Sunovion Under license from Bial principal display panel 400 MG 30 count oblong bottle NDC Tablets once daily Aptiom (eslicarbazepine acetate) Tablets 400 mg Rx Only attention dispenser: Each time Aptiom is dispensed give the patient the accompanying Medication Guide. If you have any questions regarding your eligibility or benefits, or if you wish to discontinue your participation, call Sunovion Answers for aptiom at 1-844-4aptiom ( ) 8 AM to 8 PM ET, Monday through Friday.
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Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression; any unusual changes in mood. Do not stop taking Aptiom without first talking to your healthcare provider. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated. The combination of transaminase elevations and elevated bilirubin without evidence of obstruction is generally recognized as an important predictor of severe liver injury. When you use this card, you are certifying that you have read the program rules, regulations, and terms and conditions; you have not submitted and will not submit a claim for reimbursement under any federal, state, or other governmental programs for this prescription; if you. 901716R04 medication guide Aptiom (ap tee' om) (eslicarbazepine acetate) tablets What is the most important information I should know about Aptiom?