Peganone

Peganone is a prescription medication used to treat epilepsy. Peganone belongs to a group of drugs called anticonvulsants. It works by affecting the electrical system of the brain to stop the spread of abnormal brain activity which leads to seizures.

This medication comes in tablet form. It is taken 4 to 6 times daily after meals.

Common side effects include nausea, vomiting, tiredness, and rash.

Peganone is a prescription medicine used to treat tonic-clonic (grand mal) and complex partial (psychomotor) seizures.

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

• Recordati Rare Diseases, Inc.

See "Drug Precautions" section.

Peganone may cause other rare, but serious side effects, including:

• Blood problems - symptoms may include: not feeling well, soar throat, fever, bruising easily, red or purple spots on your body, nose bleed
• Liver problems - symptoms may include: yellowing of your skin or the whites of your eyes (jaundice), dark urine, nausea or vomiting, loss of appetite, pain on the right side of your stomach, bruising easily.
• Swollen glands (enlarged lymph nodes)
• Lupus - symptoms may include: a rash on your cheeks or other parts of your body, sensitivity to the sun, new joint or muscle pains, chest pain or shortness of breath, swelling of your feet, ankles or legs.
• Serious rash - symptoms may include: skin rash, hives, sore throat, sores in your mouth, your skin blisters and peels, swelling of your face, eyes, lips, tongue, or throat.

Call your healthcare provider right away if you have any of the symptoms listed above.

The most common side effects of Peganone include:

• nausea or vomiting
• tiredness
• rash
• dizziness
• jerky eye movements
• problems with walking and balance
• double vision
• overgrowth of gum tissue

These are not all the possible side effects of Peganone. For more information, ask your healthcare provider or pharmacist.

Tell your healthcare provider if you have any side effect that bothers you or that does 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 healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Taking Peganone with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

Especially tell your healthcare provider if you take medicines that affect blood clotting such as warfarin (Coumadin, Jantoven).

Do not stop taking Peganone without first talking to your healthcare provider. Stopping Peganone suddenly can cause serious problems.

Peganone can cause serious side effects, including:

Like other antiepileptic drugs, Peganone may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you.

• thoughts about suicide or dying
• attempts to commit suicide
• new or worse depression
• new or worse anxiety
• feeling agitated or restless
• panic attacks
• trouble sleeping (insomnia)
• new or worse irritability
• acting aggressive, being angry, or violent
• acting on dangerous impulses
• an extreme increase in activity and talking (mania)
• other unusual changes in behavior or mood

Watch for early symptoms of suicidal thoughts and actions:

• Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
• Keep all follow-up visits with your healthcare provider as scheduled.

Do not take Peganone if you have:

• liver problems
• blood problems

Medicines 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 Peganone there are no specific foods that you must exclude from your diet when receiving Peganone.
 

Before you take Peganone, tell your healthcare provider if you:

• have or have had depression, mood problems, or suicidal thoughts or behavior
• have any other medical conditions
• are pregnant or breastfeeding

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

Tell your healthcare provider if you are pregnant or plan to become pregnant. Peganone may harm your unborn baby and cause birth defects. Birth defects may occur even in children born to women who are not taking any medicines and do not have other risk factors. Tell your healthcare provider right away if you become pregnant while taking Peganone. You and your healthcare provider should decide if you will take Peganone while you are pregnant.

• If you become pregnant while taking Peganone, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Peganone can pass into breast milk. You and your healthcare provider should decide if you will take Peganone or breastfeed. You should not do both. Talk to your healthcare provider about the best way to feed your baby if you take this medication.

• Take Peganone exactly as your healthcare provider tells you. Your healthcare provider will tell you how much Peganone to take.
• Your healthcare provider may change your dose. Do not change your dose of Peganone without talking to your healthcare provider.
• Do not stop taking Peganone without first talking to your healthcare provider. Stopping Peganone suddenly can cause serious problems.
• Take Peganone after eating, and space doses out evenly.
• If you take too much Peganone, call your healthcare provider or local Poison Control Center right away.

For adults, the starting daily dose of Peganone should be 1 g or less, with gradual dosage increases over a period of several days. The usual adult maintenance dose is 2 to 3 g daily. Less than 2 g daily has been found ineffective in most adults.

Peganone dosage in children depends upon the age and weight of the child. The starting dose should not exceed 750 mg daily. The usual maintenance dose in children ranges from 500 mg to 1 g daily, although occasionally 2 or (rarely) 3 g daily may be necessary.

If a patient is receiving another antiepileptic drug, it should not be discontinued when Peganone therapy is begun. The dosage of the other drug should be reduced gradually as that of Peganone is increased. Peganone may eventually replace the other drug or the optimal dosage of both antiepileptics may be established.

In tonic-clonic (grand mal) seizures, usPeganone e of the drug with phenobarbital may be beneficial.

If you take too much Peganone, call your healthcare provider or local Poison Control Center right away.

• Store at 20-25°C (68-77°F).
• Keep Peganone in a tightly closed container, and out of the light.

Keep this and all medicines out of the reach of children.