Spritam

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include the following:

• drowsiness
• agitation
• aggression
• decreased consciousness or loss of consciousness (coma)
• difficulty breathing

• Keppra^®
• Keppra^® XR
• Spritam^®

Avoid drinking alcohol. It can increase some of the side effects of levetiracetam and may also increase the risk of seizures.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Other drugs may interact with levetiracetam, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Levetiracetam is usually taken once every 12 to 24 hours. Take the medicine at the same time each day. You may take levetiracetam with or without food.

If a child is using this medicine, tell your doctor if the child has any changes in weight. Levetiracetam doses are based on weight in children, and any changes may affect your child's dose.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

To take the Spritam dissolvable tablet:

• Keep the tablet in its blister pack until you are ready to take it. Open the package and peel back the foil. Do not push a tablet through the foil or you may damage the tablet.
• Use dry hands to remove the tablet and place it on your tongue. Then take a sip of liquid and hold it in your mouth.
• Do not swallow the tablet whole. Allow it to dissolve in your mouth with the sip of liquid.
• Swallow only after the tablet has completely dissolved, which should take less than 30 seconds.

Use levetiracetam regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Do not stop using levetiracetam suddenly, even if you feel fine. Stopping suddenly may cause increased seizures. Follow your doctor's instructions about tapering your dose.

Seizures are often treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

Wear a medical alert tag or carry an ID card stating that you take levetiracetam. Any medical care provider who treats you should know that you take seizure medication.

While using levetiracetam, your kidney function may need to be tested often.

Store at room temperature away from moisture, heat, and light.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include extreme drowsiness, agitation, aggression, shallow breathing, weakness, or fainting.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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

Call your doctor 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

How can I 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.
• Call your doctor between visits as needed, especially if you are worried about symptoms.

Do not stop Spritam without first talking to your doctor.

• Stopping Spritam suddenly can cause serious problems. Stopping a seizure medicine suddenly can cause seizures that will not stop (status epilepticus).
• Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

Call your healthcare provider right away if you have any of these symptoms:

• mood and behavior changes such as aggression, agitation, anger, anxiety, apathy, mood swings, depression, hostility, and irritability. A few people may get psychotic symptoms such as hallucinations (seeing or hearing things that are really not there), delusions (false or strange thoughts or beliefs) and unusual behavior.
• extreme sleepiness, tiredness, and weakness
• problems with muscle coordination (problems walking and moving)
• a skin rash. Serious skin rashes can happen after you start taking Spritam. There is no way to tell if a mild rash will become a serious reaction.

Spritam may make you drowsy or dizzy. Do not drive a car or operate machinery until you know how Spritam will affect you.

Before taking Spritam, tell your doctor about all of your medical conditions, including if you:

• have or have had depression, mood problems or suicidal thoughts or behavior
• have kidney problems
• are pregnant or planning to become pregnant. It is not known if Spritam will harm your unborn baby. 
• are breastfeeding. Spritam can pass into your milk and may harm your baby. 

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Do not start a new medicine without first talking with your doctor.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist each time you get a new medicine.

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

It is not known if Spritam will harm your unborn baby. You and your doctor will have to decide if you should take Spritam while you are pregnant.

If you become pregnant while taking Spritam, talk to your doctor 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 these registries is to collect information about the safety of Spritam and other antiepileptic medicine during pregnancy.

Avoid drinking alcohol. It can increase some of the side effects of levetiracetam and may also increase the risk of seizures.

Levetiracetam may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, panic attacks, trouble sleeping, or if you feel agitated, hostile, irritable, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• unusual changes in mood or behavior (unusual risk-taking behavior, being irritable or talkative);

• confusion, hallucinations, loss of balance or coordination;

• extreme drowsiness, feeling very weak or tired;

• bruising, severe tingling, numbness, pain, muscle weakness;

• problems with walking or movement;

• the first sign of any skin rash, no matter how mild;

• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling; or

• signs of infection--fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing.

Common side effects may include:

• dizziness, drowsiness;

• feeling tired;

• weakness;

• feeling aggressive or irritable;

• loss of appetite;

• stuffy nose; or

• infection.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Spritam (levetiracetam) is an antiepileptic drug available as 250 mg, 500 mg, 750 mg, and 1000 mg round, white to off-white, spearmint-flavored tablets for oral suspension.

The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing AEDs. It has the following structural formula:

Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent).

Spritam tablets for oral suspension contain 250 mg, 500 mg, 750 mg, or 1000 mg levetiracetam. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, glycerin, mannitol, microcrystalline cellulose, polysorbate 20, povidone, sucralose, butylated hydroxyanisole, and natural and artificial spearmint flavor.

Spritam tablets for oral suspension are unitary porous structures produced by a three-dimensional printing process that binds the powders without compression.

Spritam tablets for oral suspension disintegrate in a mean time of 11 seconds (ranging from 2 to 27 seconds) in the mouth, when taken with a sip of liquid, to produce small particles that may be swallowed.

How Supplied

Spritam (levetiracetam) tablet(s) for oral suspension are supplied in child-resistant blisters as follows:

250 mg: round, white to off‑white, spearmint‑flavored tablets, marked with "" on one side, 60 tablets per carton containing 6 blisters per card x 10 cards (NDC 43485-101-60)

500 mg: round, white to off‑white, spearmint‑flavored tablets, marked with "" on one side, 60 tablets per carton containing 6 blisters per card x 10 cards (NDC 43485-102-60)

750 mg: round, white to off‑white, spearmint‑flavored tablets, marked with "" on one side, 60 tablets per carton containing 6 blisters per card x 10 cards (NDC 43485-103-60)

1000 mg: round, white to off‑white, spearmint‑flavored tablets, marked with "" on one side, 60 tablets per carton containing 6 blisters per card x 10 cards (NDC 43485-104-60)

Storage

Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].