Primidone (Mysoline) Side Effects, Dosage, and Uses

  • Pharmacy Author:
    Omudhome Ogbru, PharmD

    Dr. Ogbru received his Doctorate in Pharmacy from the University of the Pacific School of Pharmacy in 1995. He completed a Pharmacy Practice Residency at the University of Arizona/University Medical Center in 1996. He was a Professor of Pharmacy Practice and a Regional Clerkship Coordinator for the University of the Pacific School of Pharmacy from 1996-99.

  • Medical Editor: Jay W. Marks, MD
    Jay W. Marks, MD

    Jay W. Marks, MD

    Jay W. Marks, MD, is a board-certified internist and gastroenterologist. He graduated from Yale University School of Medicine and trained in internal medicine and gastroenterology at UCLA/Cedars-Sinai Medical Center in Los Angeles.

What is primidone (Mysoline)? How does it work (mechanism of action)?

Primidone, brand name Mysoline, is an oral anticonvulsant (anti-seizure) medication used for treating several types of seizures. Its exact mechanism of action is not known. Primidone is converted into phenobarbital and phenylethylmalonamide (PEMA) in the body. Primidone, phenobarbital, and PEMA all have anticonvulsant activity. In addition to its anticonvulsant activity, PEMA increases the anticonvulsant activity of phenobarbital. The FDA approved primidone in March, 1954.

What are the uses for primidone?

Primidone is used alone or with other medications for treating grand mal, psychomotor, or focal epileptic seizures. It may be effective for grand mal seizures that are not responsive to other anticonvulsants. Primidone should not be used by patients with porphyria and people who are allergic to phenobarbital. It also is used for treating partial seizures and essential tremor.

What are the side effects of primidone?

Common side effects of primidone include:

Possible serious side effects of primidone include:

Seizure medications increase the risk of suicidal thoughts or behavior. Patients treated with seizure medications should be observed for the emergence or worsening of depression, suicidal thoughts or behavior, and unusual changes in mood or behavior.

Suddenly stopping medications for seizures may cause seizures.

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What is the dosage for primidone?

To treat psychomotor, focal, or grand mal seizures

  • Patients 8 years of age or older should be treated with the following regimen:
  • Days 1 to 3: 100 to 125 mg at bedtime.
  • Days 4 to 6: 100 to 125 mg twice daily.
  • Days 7 to 9: 100 to 125 mg three times daily.
  • Day 10 to maintenance: 250 mg three or four times daily.
  • The maximum dose is 2 g daily.
  • It takes several weeks before the antiseizure effects of primidone are seen.

To treat partial seizures

  • The initial dose is 125 mg at bedtime. Increase the dose by 125 mg every 3 days to 250 mg every 12 hours if needed. The maximum dose is 500 mg daily.

Which drugs or supplements interact with primidone?

Primidone may decrease blood levels and the effect of several drugs by increasing the activity of liver enzymes that breakdown these drugs. Examples of drugs affected by Primidone include naloxegol (Movantik), roflumilast (Daliresp), lurasidone (Latuda), and many others.

Is primidone safe to take if I am pregnant or breastfeeding?

Primidone has not been adequately evaluated in pregnant women. Some other seizure medications have been associated with birth defects. Primidone is excreted in human milk and may cause adverse effects in the infant.

What else should I know about primidone?

Primidone is available as 50 mg and 250 mg tablets.

Keep this drug stored at room temperature, 20 C - 25 C (68 F - 77 F).

Primidone is available in generic form. You need a prescription from your doctor to obtain this drug.

Reference: FDA Prescribing Information

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Summary

Primidone, brand name Mysoline, is an anti-seizure medication that is used alone or in combination with other drugs to treat certain types of seizures. Seizures treated with primidone include:


Researchers do not knew exactly how primidone works in the body. Antiepileptic drugs (AEDs), for example, primidone (Mysoline), increase the risk of suicidal thoughts in patients taking antiepileptic drugs regardless of why your doctor has prescribed them to you.

The most common side effects are vertigo and poor coordination and unsteadiness). Less frequent side effects include:
Rare side effects include:
  • Granulocytopenia
  • Agranulocytosis
  • Red cell hypoplasia and aplasia

If persistent or severe side effects persist, the drug may need to be withdrawn. Researchers do not know the risks of taking primidone during pregnancy or while breastfeeding. Pregnant women with epilepsy who are taking anticonvulsant drugs have an increased risk of having a child with birth defects. Primidone is secreted in breast milk, but there are no tests to determine how much of the drug is secreted. Therefore, doctors do not recommend taking primidone if you are breastfeeding.

REFERENCE: Primidone FDA Prescribing Information.

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Reviewed on 8/22/2017
References
Reference: FDA Prescribing Information

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