IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
PRIMIDONE – ORAL
COMMON BRAND NAME(S): Mysoline
USES: This medication is used alone or with other medications to control seizures. Controlling and reducing seizures lets you do more of your normal daily activities, reduces your risk of harm when you lose consciousness, and lessens your risk for a possibly life-threatening condition of frequent, repeated seizures. Primidone belongs to a class of drugs known as barbiturate anticonvulsants. It works by controlling the abnormal electrical activity in the brain that occurs during a seizure.
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using primidone and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth with or without food, usually 3-4 times daily or as directed by your doctor. Take with food or milk if stomach upset occurs. Your doctor may direct you to start this medication at a low dose at bedtime and gradually increase your dose to prevent side effects such as drowsiness and dizziness. If you are changing from a different anticonvulsant to primidone, your doctor may direct you to continue your old medication and slowly lower the dose as you begin taking primidone. Follow your doctor’s instructions carefully.
Dosage is based on your medical condition, blood levels of primidone, use of other medications to treat seizures, and response to treatment. It may take several weeks to reach the best dose for you.
This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same times each day.
Do not stop taking this medication (and other anticonvulsant medications) without consulting your doctor. Your seizures may worsen or cause a very severe seizure that is difficult to treat (status epilepticus) when this drug is suddenly stopped.
This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as anxiety, hallucinations, twitching, trouble sleeping) may occur if you suddenly stop using this medication. Withdrawal from primidone can be severe and include seizures and (rarely) death. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.
Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.
Tell your doctor if your seizure control worsens (such as the number of seizures increases).
SIDE EFFECTS: Dizziness, drowsiness, excitation, tiredness, headache, loss of appetite, nausea, or vomiting may occur as your body adjusts to the medication. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if any of these unlikely but serious side effects occur: staggering walk/clumsiness, decreased sexual ability/interest, double vision.
A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor right away if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.
Tell your doctor right away if any of these rare but very serious side effects occur: easy bruising/bleeding, fainting, slow heartbeat, severe tiredness/weakness, pale skin, fast/slow/shallow breathing.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US –
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking primidone, tell your doctor or pharmacist if you are allergic to it; or to other barbiturates (such as phenobarbital); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain hormone problems (adrenal disease such as Addison’s disease), kidney problems, liver problems, lung disease (such as sleep apnea, chronic obstructive pulmonary disease-COPD), mental/mood disorders (such as depression, thoughts of suicide), history of alcohol/substance abuse, personal/family history of a certain blood disorder (porphyria), certain vitamin deficiencies (folic acid, vitamin K).
This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Older adults may be more sensitive to the effects of this drug, especially drowsiness and dizziness. However, this drug can often cause excitement or confusion instead of drowsiness in older adults.
Children may be more sensitive to the side effects of the drug. This drug can often cause excitement instead of drowsiness in young children.
This medication is not recommended for use during pregnancy. It may harm an unborn baby. However, since untreated seizures are a serious condition that can harm both a pregnant woman and her unborn baby, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately talk to your doctor about the benefits and risks of using this medication during pregnancy. Since birth control pills, patches, implants, and injections may not work if taken with this medication (see also Drug Interactions section), discuss reliable forms of birth control with your doctor.
This medication may lower your folic acid and vitamin K levels, increasing the risk of spinal cord defects. Therefore, check with your doctor to make sure you are taking enough folic acid and vitamin K. Infants born to mothers who have been using this medication during pregnancy may also have symptoms such as fussiness, shaking, or bleeding. Tell the doctor right away if you notice any of these symptoms in your newborn.
This medication passes into breast milk and may cause excessive sleepiness or feeding problems in the nursing infant. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.
Some products that may interact with this drug include: darunavir, felbamate, MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine), phenothiazines (such as chlorpromazine, prochlorperazine).
Other medications can affect the removal of primidone from your body, which may affect how primidone works. Examples include disulfiram, phenytoin, valproic acid, St. John’s wort, among others.
This medication can speed up the removal of other medications from your body, which may affect how they work. Examples of affected drugs include cyclosporine, doxycycline, estrogens, griseofulvin, lurasidone, metronidazole, ranolazine, voriconazole, “blood thinners” such as warfarin, corticosteroids such as prednisone, calcium channel blockers such as felodipine/nimodipine, among others.
This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.
The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also affect breathing or cause drowsiness. Therefore, tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, antihistamines (such as cetirizine, diphenhydramine), tricyclic antidepressants (such as amitriptyline), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and narcotic pain relievers (such as codeine).
Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.
Primidone is very similar to phenobarbital. Do not use medications containing phenobarbital while using primidone.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe tiredness/dizziness, inability to wake up, very slow breathing rate.
NOTES: Do not share this medication with others.
Laboratory and/or medical tests (such as primidone blood levels, blood counts, liver/kidney tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised October 2015. Copyright(c) 2015 First Databank, Inc.