FDA Label for Primidone
View Indications, Usage & Precautions
Primidone Product Label
The following document was submitted to the FDA by the labeler of this product Avkare. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Rx Only
Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478
Mfg. Rev. 06/11
AV Rev. 11/12 (P)
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Description
Primidone is a white crystalline, highly stable substance, M.P. 279-284° C. It is poorly soluble in water (60 mg per 100 ML at 37° C) and in most organic solvents. It possesses no acidic properties, in contrast to its barbiturate analog.
Chemical name: 5-ethyldihydro-5-phenyl-4,6 (1H, 5H)-pyrimidinedione.
Structural formula:
C12H14N2O2 M.W. 218.25
Primidone 50 mg and 250 mg tablets contain the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, methyl cellulose, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate.
Clinical Pharmacology
Primidone raises electro- or chemoshock seizure thresholds or alters seizure patterns in experimental animals. The mechanisms(s) of primidone’s antiepileptic action is not known.
Primidone per se has anticonvulsant activity as do its two metabolites, phenobarbital and phenylethylmalonamide (PEMA). In addition to its anticonvulsant activity, PEMA potentiates the anticonvulsant activity of phenobarbital in experimental animals.
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.
Contraindications
Primidone is contraindicated in:
1) patients with porphyria and
2) patients who are hypersensitive to phenobarbital
(see CLINICAL PHARMACOLOGY).
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.
Usage In Pregnancy
The effects of primidone in human pregnancy and nursing infants are unknown.
Recent reports suggest an association between the use of anticonvulsant drugs by women with epilepsy and an elevated incidence of birth defects in children born to these women. Data are more extensive with respect to diphenylhydantoin and phenobarbital, but these are also the most commonly prescribed anticonvulsants; less systematic or anecdotal reports suggest a possible similar association with the use of all known anticonvulsant drugs.
The reports suggesting an elevated incidence of birth defects in children of drug-treated epileptic women cannot be regarded as adequate to prove a definate cause-and-effect relationship. There are intrinsic methodologic problems in obtaining adequate data on drug teratogenicity in humans: the possibility also exists that other factors leading to birth defects, e.g., genetic factors or the epileptic condition itself, may be more important than drug therapy. The majority of mothers on anticonvulsant medication deliver normal infants. It is important to note that anticonvulsant drugs should not be discontinued in patients in whom the drug is administered to prevent major seizures because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life. In individual cases where the severity and frequency of the seizure disorders are such that the removal of medication does not pose a serious threat to the patient, discontinuation of the drug may be considered prior to and during pregnancy, although it cannot be said with any confidence that even minor seizures do not pose some hazard to the developing embryo or fetus.
The prescribing physician will wish to weigh these considerations in treating or counseling epileptic women of childbearing potential.
Neonatal hemorrhage, with a coagulation defect resembling vitamin K deficiency, has been described in newborns whose mothers were taking primidone and other anticonvulsants. Pregnant women under anticonvulsant therapy should receive prophylactic vitamin K therapy for one month prior to, and during, delivery.
Precautions
The total daily dosage should not exceed 2g. Since primidone therapy generally extends over prolonged periods, a complete blood count and a sequential multiple analysis-12 (SMA-12) test should be made every six months.
In Nursing Mothers
There is evidence that in mothers treated with primidone, the drug appears in the milk in substantial quantities. Since tests for the presence of primidone in biological fluids are too complex to be carried out in the average clinical laboratory, it is suggested that the presence of undue somnolence and drowsiness in nursing newborns of primidone-treated mothers be taken as an indication that nursing should be discontinued.
Please refer to the Primidone Medication Guide provided separately for more information.
Adverse Reactions
The most frequently occuring 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 erruptions. 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.
Adult 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 b.i.d.
Days 7 to 9: 100 to 125 mg t.i.d.
Day 10 to Maintenance: 250 mg t.i.d.
For most adults and children 8 years of age and over, the usual maintenance dosage is three to four 250 mg primidone tablets daily 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.
| 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 | •• | •• | •• | ● | ||
| NOON | •• | •• | •• | ● | Adjust to Maintenance | |
| PM | •• | •• | •• | ● | ||
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.
In Patients Already Receiving Other Anticonvulsants
Primidone should be started at 100 to 125 mg at bedtime and gradually increased to maintenance level as the other drug is gradually decreased. This regimen should be continued until satisfactory dosage level is achieved for the combination, or the other medication is completely withdrawn. When therapy with primidone alone is the objective, the transition from concomitant therapy should not be completed in less than two weeks.
Pediatric Dosage
For children under 8 years of age, the following regimen may be used:
Days 1 to 3: 50 mg at bedtime.
Days 4 to 6: 50 mg b.i.d.
Days 7 to 9: 100 mg b.i.d.
Day 10 to maintenance: 125 mg t.i.d. to 250 mg t.i.d.
For children under 8 years of age, the usual maintenance dosage is 125 to 250
mg three times daily or 10 to 25 mg/kg/day in divided doses.
How Supplied
Primidone Tablets USP 50 mg are supplied as white, round, flat faced tablets, debossed AN above 44 on one side and cut bisected on the other side.
Bottles of 500 NDC 42291-509-50
Primidone Tablets USP 250 mg are supplied as white, round, flat faced tablets, debossed AN bisect 545 on one side and plain on the other side.
Bottles of 500 NDC 42291-511-50
Storage And Handling
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C-30°C (59°F- 86°F). [See USP Controlled Room Temperature].
Dispense contents with a child-resistant closure (as required) and in a tight, light-resistant container as defined in the USP.
KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN.
Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478
Mfg. Rev. 04/11
AV Rev. 11/12 (P)
Spl Medguide Section
Primidone Tablets USP, 50 mg and 250 mg
Read this Medication Guide before you start taking Primidone Tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
What is the most important information I should know about primidone tablets?
Do not stop taking primidone tablets without first talking to your healthcare provider.
Stopping primidone tablets suddenly can cause serious problems.
Primidone tablets can cause serious side effects, including:
Like other antiepileptic drugs, primidone tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
Call a healthcare provider 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 healthcare provider between visits as needed, especially if you are worried about symptoms.
Do not stop primidone tablets without first talking to a healthcare provider.
• Stopping primidone tablets suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy 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.
What is primidone tablets?
Primidone tablets is a prescription medicine used alone or with other medicines to treat people with:
• generalized tonic-clonic (grand mal) seizures
• complex partial (psychomotor) seizures
• partial (focal) epileptic seizures.
Who should not take primidone tablets?
Do not take primidone tablets if you:
• have a genetic disorder called porphyria
• are allergic to phenobarbital
What should I tell my healthcare provider before taking primidone tablets?
Before you take primidone tablets, tell your healthcare provider if you:
• have or have had depression, mood problems or suicidal thoughts or behavior
• have any other medical conditions
• are pregnant or planning to become pregnant. Primidone tablets may harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking primidone tablets. You and your healthcare provider will decide if you should take primidone tablets while you are pregnant.
° If you become pregnant while taking primidone tablets, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.
• are breastfeeding or plan to breastfeed. Primidone tablets can pass into breast
milk. Talk to your healthcare provider about the best way to feed your baby if you
take primidone tablets.
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Taking primidone tablets with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your
healthcare provider.
Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist each time you get a new medicine.
How should I take primidone tablets?
Take primidone tablets exactly as prescribed. Your healthcare provider will tell you how much primidone tablets to take and when to take it.
• Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider.
• Do not stop taking primidone tablets without first talking to your healthcare provider. Stopping primidone tablets suddenly can cause serious problems.
• If you take too much primidone tablets, call your healthcare provider or local Poison Control Center right away.
What should I avoid while taking primidone tablets?
• Primidone tablets can make you sleepy or dizzy. Do not drink alcohol or take other drugs that make you sleepy or dizzy while taking primidone tablets without first discussing this with your healthcare provider. Taking primidone
tablets with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.
• Do not drive, operate heavy machinery, or do other dangerous activities until you know how primidone tablets affects you. Primidone tablets can slow your thinking and motor skills.
What are the possible side effects of primidone tablets?
See “What is the most important information I should know about primidone tablets?”.
Primidone tablets may cause other serious side effects including:
• Sleepiness that can be severe, especially when you first start taking primidone
tablets.
• Primidone tablets may rarely cause blood problems. Symptoms may include:
° fever, swollen glands, or sore throat that come and go or do not go away
° frequent infections or an infection that does not go away
° tiredness
° shortness of breath
• Primidone tablets may rarely cause allergic reactions. Symptoms may include:
° skin rash
° hives
° sores in your mouth
° blistering or peeling skin
The most common side effects of primidone tablets include:
• problems with walking and moving
• feelings of dizziness, spinning, or swaying (vertigo)
These are not all the possible side effects of primidone tablets. For more information, ask your healthcare provider or pharmacist.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store primidone tablets?
Store primidone tablets at room temperature between 68°F to 77°F (20°C to 25°C) in a tight, light-resistant container. Keep primidone tablets and all medicines out of the reach of children.
General Information about primidone tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use primidone tablets for a condition for which it was not prescribed. Do not give primidone tablets to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about primidone tablets. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about primidone tablets that is written for health professionals.
For more information, go to www.Amneal.com or call 1-877-835-5472.
What are the ingredients in primidone tablets?
Active Ingredient: primidone
Inactive ingredients: corn starch, lactose monohydrate, magnesium stearate,methyl
cellulose, microcrystalline cellulose, sodium lauryl sulfate, and sodium starch glycolate.
Principal Display Panel 50 Mg
AvKARE
NDC 42291-509-50
Primidone Tablets, USP
50 mg
500 Tablets Rx Only
Each tablet contains:
Primidone, USP...... 50 mg
Usual Dosage and Complete Prescribing Information: See accompanying literature.
Dispense contents with a child-resistant closure (as required) and in a tight, light-resistant container as defined in the USP.
Store at 20°C to 25°C (68°F-77°F); excursions permitted to 15°C - 30°C (59°F - 86°F). [See USP Controlled Room Temperature].
KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.
Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478
Mfg. Rev. 04/12 AV. Rev. 02/13 (P)
N3 42291 50950 4
Principal Display Panel 250 Mg
AvKARE
NDC 42291-511-50
Primidone Tablets, USP
250 mg
500 Tablets Rx Only
Each tablet contains:
Primidone, USP...... 250 mg
Usual Dosage and Complete Prescribing Information: See accompanying literature.
Dispense contents with a child-resistant closure (as required) and in a tight, light-resistant container as defined in the USP.
KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.
Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478
Mfg. Rev. 04/12 AV. Rev. 02/13 (P)
N3 42291 51150 7
* Please review the disclaimer below.