Frequently asked questions about PRIMAXA ODT

Find answers to a range of topics related to PRIMAXA ODT below.

About PRIMAXA ODT

Is PRIMAXA ODT for children or adults?

PRIMAXA ODT is an antiseizure medicine designed to help children and adults with difficult-to-treat seizures. Dosing is personalized, depending on each person’s needs.

What does "ODT" stand for?

ODT stands for orally disintegrating tablet, or a tablet that quickly dissolves in the mouth without the need to chew or swallow. This new formulation of PRIMAXA is designed to melt on the tongue in 30 seconds, making it ideal for children or adults with swallowing issues.

Is PRIMAXA ODT any different than a generic version?

Unlike generic (or unbranded) medicines, which may vary, PRIMAXA ODT delivers consistent absorption of primidone, the active ingredient, with each dose.

PRIMAXA ODT for children

Is PRIMAXA ODT safe for children?

Children as young as 1 year old may be prescribed PRIMAXA ODT for difficult-to-treat seizures. Talk to your doctor to see if PRIMAXA ODT is right for your child.

I struggle to give my child their medicine because of how it tastes or because they have swallowing issues. Will it be any different with PRIMAXA ODT?

PRIMAXA ODT delivers precise, individualized dosing as prescribed by your doctor. It has a pleasant bubblegum-flavored taste and melts quickly on the tongue (within 30 seconds), making it ideal for children and people with swallowing issues.

I worry about my child taking their medicine correctly while at school, during sports, or if they’re out with friends. Is PRIMAXA ODT convenient?

Yes. There is no refrigeration, mixing, or restorage needed with PRIMAXA ODT. It is easy to carry and fits any routine at home, school, or on the go.

How much PRIMAXA ODT should my child take?

Always talk to your child’s doctor for exact dosing instructions. When first starting treatment, your child will be prescribed a lower dose, which will gradually increase as their body adjusts. The prescribed dose and schedule may be adjusted over time to meet your child’s individual needs.

Dosing information

How does PRIMAXA ODT ensure accurate dosing?

Your doctor will determine the right dose of PRIMAXA ODT for you or your child based on individual needs. The medicine comes in 4 dosing strengths, including scored tablets to make splitting easy.

Will my dose of PRIMAXA ODT need to be adjusted?

When first starting treatment, you or your child will be prescribed a low dose, which will gradually increase as the body adjusts to treatment. This will help reduce early side effects. The dose and schedule for taking PRIMAXA ODT may be adjusted over time to meet personal needs.  

How does PRIMAXA ODT personalize treatment?  

Not every person taking PRIMAXA ODT will have the same dose or the same dosing schedule. PRIMAXA ODT comes in 4 dosing strengths (50 mg, 100 mg, 125 mg, and 250 mg) to make personalized dosing easier.  

Safety and side effects

Is PRIMAXA ODT a new product?  

Primidone, the active ingredient in PRIMAXA ODT, was first approved as a treatment for epilepsy more than 70 years ago. It is a proven antiseizure medicine that is now available in a new formulation. 

What are the side effects of PRIMAXA ODT?  

The most common side effects are trouble with coordination or balance and dizziness. These effects are usually temporary and fade over time as the body gets used to PRIMAXA ODT. For more information on side effects, see the PRIMAXA ODT Medication Guide and Important Safety Information.

What should I do if I experience side effects from taking PRIMAXA ODT? 

Once you or your child are prescribed PRIMAXA ODT, be sure to pay attention to how you/they are feeling, both physically and emotionally. Write down any changes, even if they are small, and talk to your prescribing doctor right away if something feels off, especially in mood or behavior. If something feels serious, seek medical help immediately. Visit the Safety section for more information about what to watch for with PRIMAXA ODT. 

Is PRIMAXA ODT safe for people with swallowing issues?   

PRIMAXA ODT dissolves quickly on the tongue (less than 30 seconds) and does not require chewing or swallowing, making PRIMAXA ODT an ideal treatment for patients with epilepsy and swallowing issues.

Do you or your child struggle with your antiseizure medications?

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INDICATION AND IMPORTANT SAFETY INFORMATION View Full

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about Primaxa™ ODT?

Primaxa ODT is a medicine used to help control certain types of seizures. Like many seizure medications, Primaxa ODT can cause serious side effects in some people. Be sure to talk to your healthcare provider before starting this medication.

Serious warnings and precautions:

  • Suicidal thoughts or actions:
    Seizure medicines like Primaxa ODT may increase the risk of suicidal thoughts or behaviors. Call your healthcare provider right away if you or your caregiver notice new or worsening depression, mood changes, or thoughts of harming yourself.
  • Do not stop suddenly:
    Do not stop taking Primaxa ODT without talking to your healthcare provider. Suddenly stopping can cause serious problems, including more seizures or a life-threatening condition called status epilepticus.
  • Drowsiness and dizziness:
    Primaxa ODT can make you sleepy, dizzy, or cause problems with coordination. Do not drive or operate machinery until you know how Primaxa affects you.
  • Serious blood problems:
    Rare but serious blood disorders (such as anemia or low white blood cell counts) have been reported. Your healthcare provider may do regular blood tests to check for problems.
  • Birth defects and pregnancy risks:
    The effects of Primaxa ODT in pregnant women are not well known. Like many seizure medications, it may carry a risk of birth defects. If you are pregnant or planning to become pregnant, talk to your healthcare provider about the risks and benefits. Some women may need vitamin K during the last month of pregnancy.
  • Breastfeeding:
    Primidone and its byproducts can pass into breast milk. Talk to your provider about the risks if you are nursing. Watch for unusual drowsiness or feeding problems in your baby.
  • Phenylketonuria (PKU) warning:
    Primaxa ODT contains aspartame, which is a source of phenylalanine. People with PKU should speak with their doctor before using this medicine.
  • Do not take more than prescribed:
    The maximum dose of Primaxa ODT is 2 grams per day. It may take several weeks to see the full effects. Your doctor may order regular check-ups or lab work while you take this medication.

What are the possible side effects?

The most common side effects of Primaxa ODT include:

  • Sleepiness or drowsiness
  • Dizziness, vertigo, or balance problems
  • Nausea, vomiting, or loss of appetite
  • Blurred or double vision
  • Skin rash or itching
  • Feeling irritable, tired, or emotionally sensitive
  • Sexual side effects

Serious side effects that require immediate attention include:

  • Unusual bruising or bleeding
  • Fever or sore throat
  • Yellowing of the skin or eyes
  • Trouble breathing or chest pain
  • Thoughts of harming yourself

These are not all the possible side effects. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Please see full Prescribing Information for additional safety and dosing information.

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