Primidone 50 mg/1
Primidone · TABLET · NorthStar Rx LLC
Primidone is a prescription tablet taken by mouth that belongs to a class of medications called anti-epileptic agents, used to help control seizures. It comes in a 50 mg strength and works by reducing abnormal electrical activity in the brain.
Key Facts
- Brand Name
- Primidone
- Generic Name
- Primidone
- NDC Code (Product)
72603-609- Manufacturer
- NorthStar Rx LLC
- Strength
- 50 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA214896
- Drug Class
- Anti-epileptic Agent [EPC]
- Marketing Start
- 05/01/2025
Recall History
Amerisource Health Services LLC
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Golden State Medical Supply Inc.
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Golden State Medical Supply Inc.
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Amerisource Health Services LLC
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Lannett Company Inc.
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Primidone, used alone or concomitantly with other anticonvulsants, is indicated in the control of grand mal, psychomotor, and focal epileptic seizures. It may control grand mal seizures refractory to other anticonvulsant therapy.
Dosage & Administration
DOSAGE AND ADMINISTRATION Usual Dosage Patients 8 years of age and older who have received no previous treatment may be started on primidone according to the following regimen using either 50 mg or scored 250 mg primidone tablets: Days 1 to 3: 100 to 125 mg at bedtime Days 4 to 6: 100 to 125 mg twice a day Days 7 to 9: 100 to 125 mg three times a day Day 10 to maintenance: 250 mg three times a day For most adults and children 8 years of age and over, the usual maintenance dosage is three to four 250 mg primidone tablets in divided doses (250 mg t.i.d. or q.i.d.). If required, an increase to five or six 250 mg tablets daily may be made but daily doses should not exceed 500 mg q.i.d. Dosage should be individualized to provide maximum benefit. In some cases, serum blood level determinations of primidone may be necessary for optimal dosage adjustment. The clinically effective serum level for primidone is between 5 to 12 µg/mL. INITIAL: ADULTS AND CHILDREN OVER 8 KEY: •=50 mg tablet; ●=250 mg tablet Day 1 2 3 4 5 6 AM •• •• •• NOON PM •• •• •• •• •• •• DAY 7 8 9 10 11 12 AM •• •• •• ● Adjust to Maintenance NOON •• •• •• ● PM •• •• •• ● Patients Already Receiving Other Anticonvulsants Pr…
Warnings
WARNINGS The abrupt withdrawal of antiepileptic medication may precipitate status epilepticus. The therapeutic efficacy of a dosage regimen takes several weeks before it can be assessed. Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including primidone, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for …
Contraindications
CONTRAINDICATIONS Primidone is contraindicated in: 1) patients with porphyria and 2) patients who are hypersensitive to phenobarbital (see ACTIONS ).
Adverse Reactions
ADVERSE REACTIONS The most frequently occurring early side effects are ataxia and vertigo. These tend to disappear with continued therapy, or with reduction of initial dosage. Occasionally, the following have been reported: nausea, anorexia, vomiting, fatigue, hyperirritability, emotional disturbances, sexual impotency, diplopia, nystagmus, drowsiness and morbilliform skin eruptions. Granulocytopenia, agranulocytosis, and red-cell hypoplasia and aplasia, have been reported rarely. These and, occasionally, other persistent or severe side effects may necessitate withdrawal of the drug. Megaloblastic anemia may occur as a rare idiosyncrasy to primidone and to other anticonvulsants. The anemia responds to folic acid without necessity of discontinuing medication. To report SUSPECTED ADVERSE REACTIONS, contact Oxford Pharmaceuticals, LLC at 1-844-508-1455, 8:00 AM to 4.30 PM ET, Monday – Friday or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is Primidone used for?
Primidone is a prescription tablet taken by mouth that belongs to a class of medications called anti-epileptic agents, used to help control seizures. It comes in a 50 mg strength and works by reducing abnormal electrical activity in the brain.
Is Primidone a controlled substance?
Primidone is not classified as a controlled substance by the DEA.
What is the generic name for Primidone?
The generic name for Primidone is Primidone. There are 1 other brand versions of Primidone.
What is the NDC code for Primidone 50 mg/1?
The NDC (National Drug Code) for Primidone 50 mg/1 is 72603-609, listed by NorthStar Rx LLC.