Aptiom

Aptiom is a prescription medication used to treat partial onset seizures (a seizure that only affects part of the brain) in patients 4 years and older.

Aptiom belongs to a group of drugs called anticonvulsants. While the precise way Aptiom works is not known, it is thought to work by decreasing increased excitement in the brain.

This medication comes in tablet form and is taken once a day, with or without food. Aptiom tablet can be taken whole or crushed.

Common side effects include sleepiness, and nausea. Aptiom can cause dizziness, slower motor skills, and slower thinking. Do not drive or operate heavy machinery until you know how Aptiom affects you.

Aptiom is a prescription medication used to treat partial onset seizures (a seizure that only affects part of the brain) in patients 4 years and older.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Sunovion Pharmaceuticals Inc.

Serious side effects have been reported with Aptiom. See the “Aptiom Precautions” section.

Common side effects of Aptiom include the following:

• dizziness
• sleepiness
• nausea
• headache
• double vision
• vomiting
• feeling tired
• blurred vision
• shakiness
• coordination issues 

This is not a complete list of Aptiom side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• other antiepileptic drugs such as carbamazepine (Tegretol, Carbatrol, Epitol), phenobarbital, phenytoin (Dilantain, Phenytek), and primidone (Mysoline)
• oral contraceptives or birth control
• medications that use the enzyme CYP3A4 such as budesonide (Entocort), cyclosporine (Neoral, Gengraf, Sandimmune), darifenacin (Enablex), dihydroergotamine (Migranal), fentanyl (Abstral, Fentora, Onsolis, Actiq), pimozide (Orap), quinidine (Cardioquin, Duraquin, Quinact), sirolimus (Rapamune), tacrolimus (Prograf), terfenadine (Seldane), fluticasone (Flovent HFA, Flonase), eletriptan (Relpax), lovastatin (Mevacor), quetiapine (Seroquel), sildenafil (Viagra, Revatio), and simvastatin (Zocor)
• medications that use the enzyme CYP2C19 such as phenytoin (Dilantain, Phenytek), clobazam (Onfi), and omeprazole (Prilosec)

This is not a complete list of Aptiom drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Aptiom including the following:

• suicidal thought or actions. Tell your healthcare provider if you have a change or worsening of mood, including thoughts about suicide, attempt of suicide, depression, anxiety, agitation, panic attacks, trouble sleeping, increase in activity or talking, or unusual changes in behavior or mood.
• hypersensitivity (severe allergic reaction). Tell your healthcare provider about any signs or symptoms of hypersensitivity, including chest pain, swelling of the face or mouth, difficulty breathing or swallowing, or rash.
• low sodium in the blood. Tell your healthcare provider if you have any signs or symptoms of low sodium, including nausea, lack of energy, irritability, confusion, muscle weakness, or more frequent or worse seizure.
• nervous system problems. Tell your healthcare provider if you have any signs of symptoms of nervous system problems, including dizziness, issues with coordination or walking, feeling tired, issues with concentration, or vision problems.
• a decline in liver function. Tell your healthcare provider about any signs or symptoms of liver damage, including loss of appetite, loss of weight, nausea or vomiting, feeling tired, stomach pain, dark urine, light-colored stools, yellowing of the skin or whites of the eyes, fever, or rash.
• severe skin and mouth reactions. Tell your doctor or get medical help right away if you get any of these symptoms at anytime during your treatment, including blisters, peeling skin, rash, or painful sores or ulcers on your skin, lips or in your mouth
• withdrawal symptoms when Aptiom is stopped suddenly.
• some abnormal laboratory tests for thyroid. Tell your healthcare provider you are taking Aptiom when getting lab tests done.

Aptiom can cause dizziness, slower motor skills, or slower thinking. Do not drive or operate heavy machinery until you know how Aptiom affects you.

Do not take Aptiom if you are allergic to Aptiom, to any of its ingredients, or oxcarbazepine

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Privigen, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Aptiom, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Aptiom or to any of its ingredients
• have or have had any suicidal thoughts or actions, depression, or mood problems
• have liver problems
• have kidney problems
• have blood problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Aptiom has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Aptiom, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Take Aptiom exactly as prescribed.

Aptiom comes in tablet form and is taken once daily. Take with or without food. Aptiom tablets can be taken whole or crushed.

Do not stop taking Aptiom suddenly with talking to your healthcare provider.

If you miss a dose, talk to your healthcare provider.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your age

The recommended starting dose of Aptiom for the treatment of partial onset seizures is 400 mg once daily. After one week, it is recommended to increase the dose to 800 mg once daily. The maximum recommended dose is 1200 mg once daily.

If you take too much Aptiom, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Aptiom at 68^oF to 77^oF (20^oC to 25^oC)
• Keep all medications out of reach from children