Getting started with PRIMAXA ODT

When first starting treatment, you will be prescribed a lower dose that will gradually increase so your body can adjust. This will help reduce early side effects.

PRIMAXA ODT is an orally dissolving tablet that works quickly. It easily melts on the tongue in less than 30 seconds without water or food required.

Tablets shown are not actual size.

The daily dose should not exceed 2 g (500 mg 4 times a day).

How to take PRIMAXA ODT

Work with your prescribing doctor to determine exact dosing for you or your child. The dose and schedule may be adjusted over time to meet individual needs. For more information, see the Medication Guide

Do not change the dose without first speaking to your doctor

Do not stop
PRIMAXA ODT suddently, as this may cause serious problems

If you think you or your child has taken too much contact their doctor or Poison Control Center

For Caregivers

Helping your child take PRIMAXA ODT at the same time(s) every day can help lessen the chance of forgotten doses. As a seizure medication that doesn’t require water or food, PRIMAXA ODT is designed to be easy and convenient to fit into your child’s routine.

Did you know?

The active ingredient in PRIMAXA ODT has been used to treat epilepsy for decades. PRIMAXA ODT is simply a new formulation (an orally dissolving tablet) designed to help you manage treatment.

INDICATION AND IMPORTANT SAFETY INFORMATION View Full

WARNING: RISK OF SUICIDAL THOUGHTS AND BEHAVIORS; ABRUPT WITHDRAWAL; CNS DEPRESSION; HEMATOLOGIC ABNORMALITIES; USE IN PREGNANCY AND LACTATION; PHENYLKETONURIA; AND MAXIMUM DOSAGE LIMITATIONS

Suicidal Thoughts and Behaviors

Antiepileptic drugs (AEDs), including PrimaxaTM ODT (primidone orally disintegrating tablets), may increase the risk of suicidal thoughts or behavior. This risk is class-wide and applies to all AEDs, regardless of indication. Monitor all patients for new or worsening depression, suicidal ideation, or unusual changes in mood or behavior. Inform patients, caregivers, and families to be alert for these symptoms and to report them immediately.

Abrupt Withdrawal

Abrupt discontinuation of Primaxa ODT may result in increased seizure frequency or status epilepticus. Withdrawal should be done gradually under close medical supervision to minimize risk.

Central Nervous System Depression

Primaxa ODT can cause dose-dependent CNS depression. The most frequently reported side effects include sedation, dizziness, ataxia, vertigo, nausea, and visual disturbances. Caution patients against performing activities requiring mental alertness, such as driving or operating machinery, until they understand how the medication affects them.

Hematologic Abnormalities

Serious blood disorders have been reported with Primaxa ODT, including agranulocytosis, aplastic anemia, and red cell aplasia. Periodic complete blood counts are recommended during prolonged therapy. Megaloblastic anemia may also occur as a rare idiosyncratic reaction and typically responds to folic acid supplementation without discontinuing therapy.

Use in Pregnancy

The effects of primidone in human pregnancy are not well established. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. AEDs have been associated with an increased incidence of birth defects. Neonatal bleeding resembling vitamin K deficiency has been reported; consider vitamin K1 supplementation during the last month of pregnancy.

Use in Lactation

Primidone and its metabolites are excreted into breast milk in substantial quantities. Monitor nursing infants for signs of sedation or feeding difficulties. Discontinue breastfeeding if adverse effects are observed.

Phenylketonuria Warning

Primaxa ODT contains aspartame, a source of phenylalanine. Use with caution in patients with phenylketonuria.

Maximum Dosage Limitation

The total daily dose of Primaxa ODT should not exceed 2 grams. Therapeutic effects may take several weeks to be fully realized. Patients on long-term treatment should undergo periodic monitoring, including bloodwork and metabolic panels (e.g., SMA-12) every 6 months.

Adverse Reactions

The most common side effects include nausea, anorexia, vomiting, fatigue, hyperirritability, emotional disturbances, sexual dysfunction, diplopia, nystagmus, drowsiness, and morbilliform skin eruptions. Early side effects such as ataxia and vertigo tend to resolve with continued therapy or dose reduction. Rare but serious events include dermatologic reactions and hematologic abnormalities. Most adverse events are dose-related and may subside with dosage adjustment or continued use.

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