Primidone (Mysoline) – Side Effects, Interactions, Uses, Dosage, Warnings

uses

What is Primidone (Mysoline) used for?

• Epilepsy
• Seizures

warnings

What is the most important information I should know about Primidone (Mysoline)?

You should not use this medicine if you are allergic to primidone or phenobarbital, or if you have:

• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system).

Tell your doctor if you have ever had:

• depression;
• a mood disorder; or
• suicidal thoughts or actions.

Some people have thoughts about suicide while taking primidone. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Do not start or stop taking seizure medication during pregnancy without your doctor’s advice. Having a seizure during pregnancy could harm both mother and baby. Tell your doctor right away if you become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of primidone on the baby. Be sure to tell the doctor who delivers your baby about your primidone use. Both you and the baby may need to receive medications to prevent excessive bleeding during delivery and just after birth.

Stop breast-feeding if you notice unusual drowsiness in the nursing baby. Talk with your doctor about how best to feed your baby while taking primidone.

User Reviews & Rating

Overall rating for Primidone (Mysoline)

2.4

out of  5

Side Effects

Easy to Use

Effectiveness

Read Primidone (Mysoline) Reviews

Side Effects

What are the side effects of Primidone (Mysoline)?

Get emergency medical help if you have signs of an allergic reaction: hives, mouth sores, skin rash with blistering and peeling; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• unusual thoughts or behavior;
• loss of balance or coordination;
• fever, chills, sore throat;
• easy bruising or bleeding; or
• pale skin, unusual tiredness.

Common side effects may include:

• dizziness, drowsiness, spinning sensation;
• problems with balance or muscle movement;
• nausea, vomiting, loss of appetite;
• feeling tired or irritable;
• blurred vision;
• rash; or
• impotence, sexual problems.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Pregnancy & Breastfeeding

Can I take Primidone (Mysoline) if I’m pregnant or breastfeeding?

Do not start or stop taking seizure medication during pregnancy without your doctor’s advice. Having a seizure during pregnancy could harm both mother and baby. Tell your doctor right away if you become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of primidone on the baby. Be sure to tell the doctor who delivers your baby about your primidone use. Both you and the baby may need to receive medications to prevent excessive bleeding during delivery and just after birth.

Stop breast-feeding if you notice unusual drowsiness in the nursing baby. Talk with your doctor about how best to feed your baby while taking primidone.

Interactions

What drugs and food should I avoid while taking Primidone (Mysoline)?

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Drinking alcohol with this medicine can increase side effects.

Dosage Guidelines & Tips

How to take Primidone (Mysoline)?

Use Primidone (Mysoline) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

What should I do if I missed a dose of Primidone (Mysoline)?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Overdose Signs

What happens if I overdose on Primidone (Mysoline)?

If you think you or someone else may have overdosed on: Primidone (Mysoline),  call your doctor or the Poison Control center

(800) 222-1222

If someone collapses or isn’t breathing after taking Primidone (Mysoline), call 911

911

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Primidone | Epilepsy Foundation

How to take and store [node:title]?

Swallow each tablet whole. Don’t bite or chew it.

Mysoline can be taken either with food or without food, but it’s important to be consistent day in and day out. People who usually take Mysoline with food should try to do that all the time, because it affects the way the medicine is used by the body.

Be careful if the doctor writes a new prescription using a different kind of pill. For example, if you’ve been using 50-mg tablets and the new prescription is for 250-mg tablets, be careful to use the correct number. Don’t automatically continue to use the same number of pills as before.

Store Mysoline tablets at room temperature, away from light and moisture and out of the reach of children.

What if I forget?

A forgotten dose should be taken right away. If it is almost time for the next dose, just use one dose, not a double dose, and call the doctor’s office for more advice.

Do your best to follow the doctor’s directions. If you forget doses often, it may be a good idea to get a special pillbox or watch with an alarm to remind you.

Taking the right amount of seizure medicine on time every single day is the most important step in preventing seizures!

How does [node:title] affect the brain?

How does the body digest [node:title]?

How well does the [node:title] work?

Although not prescribed very often by doctors, Mysoline (primidone) can be effective in treating seizures. When Mysoline is consumed it is metabolized (processed by the body) into phenobarbital and phenoethylmelanamide, both of which have antiepileptic effects. Therefore, taking Mysoline gives you the effectiveness of phenobarbital plus additional protection. A patient whose seizures have not been controlled by phenobarbital may have better results from Mysoline.

The most important study of Mysoline (primidone) looked at 622 adults who had partial seizures or secondarily generalized tonic-clonic seizures. Each person was treated with one of four medications. The four were primidone, phenobarbital, carbamazepine (Tegretol or Carbatrol), and phenytoin (Dilantin, Phenytek). Overall, the patients who took primidone were more likely to stop taking it because of intolerable side effects than those who took the other medicines. After the first month, however, there was hardly any difference in this regard between the primidone and the carbamazepine or phenytoin.

The patients in this study who had tonic-clonic seizures achieved similar control from all four medications. Of those in this group who took primidone for a year, 63% were seizure-free. Patients were more likely to continue to take carbamazepine (Tegretol, Carbatrol) than the other medications when considering both seizure control and side effects, but Mysoline can be very effective for partial seizures.

A similar study in children—which also included Depakote (valproate)—focused on the rate of side effects. Only 8% of the children who were given Mysoline had to stop taking it because of side effects. Phenobarbital, which can be an excellent medication, often is avoided in children because of the possibility of mental slowing. By using Mysoline alone, children can enjoy many of the same benefits while avoiding this problem because the amount of phenobarbital produced by breaking down the Mysoline is low.

Mysoline is most often used as add-on therapy in adults whose seizures are not well controlled by other medications. It is frequently paired with carbamazepine (Tegretol or Carbatrol) or phenytoin (Dilantin, Phenytek).

It is important to remember that no single combination of antiepileptic medications is perfect for everyone. Sometimes, a series of combinations must be tried before finding what is best for the individual patient.

What are the most common side effects of [node:title]?

While many people who take Mysoline (primidone) don’t report any side effects there are those who do. The most common complaints amongst those who do are:

• unsteadiness
• the feeling that the surroundings are spinning (vertigo)
• irregular eye movements
• nausea
• vomiting
• blurred or double vision
• drowsiness
• depression

The problems are mild to moderate and usually disappear with time or when the dose is reduced.

Some other side effects mentioned even less often are:

• loss of appetite
• irritability
• acne or other skin lesions
• sexual impotency
• decreased sexual desire
• blood abnormalities
• frozen shoulder

If these problems do not go away within several days, or are really bothersome, call the doctor. Sometimes the doctor can help with these side effects by changing the prescription:

• reducing the overall amount of Mysoline
• changing the amount taken at certain times, such as taking a greater proportion of the Mysoline at bedtime to reduce daytime sleepiness
• prescribing smaller doses, to be taken more often

No one should stop taking Mysoline or change the amount they take or when they take it without their doctor’s guidance.

People who have just started taking Mysoline (or who have just started taking a larger amount) should be careful during activities that might be dangerous, until they know whether they are having any side effects.

Be sure to read about the more serious side effects so you will be aware of symptoms that might indicate the beginning of a serious reaction to Mysoline. These serious problems are very rare but everyone who takes this medicine should at least be aware of them.

What are the most serious side effects of [node:title]?

Most people who take Mysoline (primidone) have no side effects or mild side effects that go away with no lasting harm, but a very small number of people have serious reactions. Here’s a list of symptoms that may be the start of one of these problems. If you notice any of these symptoms, call your doctor right away:

• An allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives)
• Fever, swollen glands, sore throat, or sores in the mouth (could mean a blood problem)
• Red or purple point-like rash or blistering or peeling skin lesions
• Easy bruising, paleness, weakness, or fatigue
• Worsening of seizures

It’s not unusual for Mysoline to make people feel sleepy or uncoordinated. If you’ve just started taking Mysoline or have just increased your dosage (especially if you tend to be sensitive to medications), be careful when doing things that could be dangerous (such as driving or using sharp objects) until you know how it will affect you.

People who are taking Mysoline should avoid drinking alcohol because this combination can cause deep sedation or sleepiness.

A complete list of all reactions to Mysoline can be found in the package insert, but it is important to remember that most people who take it have none of these serious problems.

On July 10, 2008, an advisory panel was convened by the Food and Drug Administration (FDA) to review data that the FDA had previously collected from drug studies showing an association between many of the antiepileptic drugs (AEDs) and suicidal ideation and behavior, which together are called suicidality. According to the FDA’s Alert, among the patients with epilepsy in these drug studies, 1 out of 1000 people taking the placebo (inactive substance) showed suicidality compared to approximately 3. 5 out of 1000 people who took an AED. The FDA advisory panel voted to accept the FDA’s data at its meeting on July 10.

• Taking antiepileptic medicines may increase the risk of having suicidal thoughts or actions;
• Do not make any changes to the medication regimen without first talking with the responsible healthcare professional;
• Pay close attention to any day-to-day changes in mood, behavior and actions. These changes can happen very quickly so it is important to be mindful of any sudden differences.
• Be aware of common warning signs that might be a signal for risk of suicide. Some of these are:
  • Talking or thinking about wanting to hurt yourself or end your life
  • Withdrawing from friends and family
  • Becoming depressed or having your depression get worse
  • Becoming preoccupied with death and dying
  • Giving away prized possessions

We again urge patients and families to contact their doctor before stopping an epilepsy medication because this may possibly lead to seizures and worsening of mood.

What else is [node:title] used for?

Often doctors find that medicines are useful for more than one purpose. It is legal to prescribe medicines for “off-label uses” even though the U.S. Food and Drug Administration (FDA) has not formally approved such use. Besides epilepsy, one off-label use of Mysoline is the treatment of tremors—specifically, essential tremor (ET), the most common movement disorder.

Who should not take [node:title]?

People who have had a condition called porphyria should not take Mysoline (primidone). Furthermore,those who are sensitive to phenobarbital are advised to avoid it, because the body produces phenobarbital when it processes Mysoline.

Women who are pregnant or may become pregnant, and those who are breast-feeding should be cautious about using Mysoline. The manufacturer suggests that breast-feeding be discontinued if the baby is unusually sleepy. Other seizure medicines may be a better choice for pregnant women and nursing mothers.

Can [node:title] be taken with other medicines?

What are the effects of [node:title] on Children?

If a woman takes [node:title] during pregnancy will it hurt the baby?

What are the effects of [node:title] on Seniors

What are the dose ranges for [node:title]?

Since Mysoline must be introduced gradually, the doctor will start by giving the patient a low dose. Here is an example of a typical schedule for building up to the desired level of Mysoline for an older child or adult:

Days 1 to 3: 100 to 125 mg at bedtime
Days 4 to 6: 100 to 125 mg each morning and evening
Days 7 to 9: 100 to 125 mg morning, noon, and night
Days 10 and later: 250 mg morning, noon, and night

Patients aged 8 or older usually take one 250-mg Mysoline tablet three or four times a day to maintain control of their seizures. Some people need to take more tablets, but the total dose should not exceed 2000 mg per day.

For children under 8 years of age, the usual dose for controlling seizures is 125 to 250 mg three times daily. The doctor may calculate the dose according to the child’s weight, based on 10 to 25 mg of Mysoline per day for each kilogram (about 2.2 pounds) of the child’s weight. Here is an example of a schedule that may be used to start a young child on Mysoline:

Days 1 to 3: 50 mg at bedtime
Days 4 to 6: 50 mg morning and evening.
Days 7 to 9: 100 mg morning and evening
Days 10 and later: 125 mg three times a day to 250 mg three times a day

Be sure to use only the amount that the doctor prescribes. If you think you’ve taken one or two extra tablets, call your doctor for advice. For a larger overdose, call your local poison control center or emergency room right away.

No one should stop taking Mysoline or change the amount they take without talking to the doctor first. Stopping any seizure medicine all at once can cause a serious condition called status epilepticus.

Read the package insert of [node:title]

In the United States, companies that manufacture medicines are required to publish certain kinds of information about each product. This document is commonly known as a “package insert” because it is usually included with each package of the medicine.

You can also read these documents (also called “prescribing information”) online. The U.S. package insert for Mysoline (primidone) is found at:

• http://www.valeant.com/Portals/46/Pdf/PI/Mysoline-Sept,12.pdf

Some of the information may differ in other countries.

To learn how to read and understand a package insert, see How to read a package insert.

Read About [node:title] studies

Misolin – instructions for use, doses, side effects, reviews of the drug:

Description of the drug Misolin (tablets, 250 mg) is based on the official instructions, approved by the manufacturer in 1996

Approval date: 07/31/1996

Contents

• Active substance
• ATX
• Pharmacological group
• Nosological classification (ICD-10)
• Composition and form of release
• pharmachologic effect
• Indications
• Contraindications
• Dosage and administration
• Side effects
• Storage conditions
• Best before date
• Reviews

Active ingredient

Primidone* (Primidone*)

ATX

N03AA03 Primidone

Pharmacological group

Antiepileptic drugs

Nosological classification (ICD-10)

ICD-10 code list

Composition and formulation in vials 250 ml.

Pharmacological action

Pharmacological action –

anticonvulsant .

Indications

Epilepsy (grand seizures, focal seizures, myoclonic convulsions and akinetic seizures, psychomotor epilepsy).

Contraindications

Hypersensitivity, acute intermittent porphyria.

Dosage and administration

Information for healthcare professionals only.
Are you a healthcare professional?

By mouth: start with 125 mg once, in the evening; increase every three days by 125 mg to 500 mg daily, then increase every three days by 250 mg for adults and 125 mg for children up to 9years before reaching the optimal effect; maximum daily doses: for adults 1.5 g, for children 1 g. , megaloblastic anemia, rash, systemic lupus erythematosus.

Storage conditions

In a dry place, at room temperature.

Keep out of reach of children.

Expiry date

5 years.

Do not use after the expiry date which is stated on the pack.

Date updated: 11/21/2018

Mysoline (primidone) Side effects, pictures, uses, dosage, overdose in RxList

• Generic name: primidone
• Brand name: Mysoline

9 0041

• Images and side effects
• How to take
• Avoid

Information for Mysoline patients, including side effects

Brand names: Mysoline

Generic name: primidone

• What is primidone (myzolin)?
• What are the possible side effects of primidone (myzolin)?
• What is the most important information I should know about primidone (myzolin)?
• What should I discuss with my doctor before taking primidone (myzolin)?
• How can I take primidone (Mizolin)?
• What happens if I miss a dose of (Mysoline)?
• What happens if I overdose (Mysoline)?
• What should I avoid while taking primidone (myzolin)?
• What other drugs will affect primidone (mizolin)?
• Where can I get more information (Mysoline)?

What is Primidone (Mizolin)?

Primidone is an anticonvulsant medicine used to control seizures.

Primidone may also be used for purposes not listed in this medication guide.

What are the possible side effects of primidone (myzolin)?

Get emergency medical help if you have signs of an allergic reaction : hives, mouth ulcers, skin rash with blistering and peeling; labored breathing; swelling of the face, lips, tongue, or throat.

Tell your doctor about any new or worsening symptoms. eg: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts of suicide or harming yourself.

Call your doctor right away if you have:

• unusual thoughts or behavior;
• loss of balance or coordination;
• fever, chills, sore throat;
• slight bruising or bleeding; or
• pale skin, unusual tiredness.

Common side effects may include:

• dizziness, drowsiness, feeling of whirling;
• problems with balance or muscle movement;
• nausea, vomiting, loss of appetite;
• feeling tired or irritable;
• blurred vision;
• rash; or
• impotence, sexual problems.

This is not a complete list of side effects and they may occur. Ask your doctor about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

What is the most important information I should know about primidone (myzolin)?

Some people have suicidal thoughts while taking primidone. Be alert for changes in your mood or symptoms. Tell your doctor about any new or worsening symptoms. .

Do not stop using primidone suddenly even if you feel well. A sudden stop can cause increased seizures.

Information for Mysoline patients, including how I should take

What should I discuss with my doctor before taking primidone (Mysoline)?

You should not use this medicine if you are allergic to primidone or phenobarbital, or if you have:

• porphyria (a genetic enzymatic disease that causes symptoms affecting the skin or nervous system).

Tell your doctor if you have ever had:

• depression;
• mood disorder; or
• suicidal thoughts or actions.

Some people have suicidal thoughts while taking primidone. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Do not start or stop taking anticonvulsants during pregnancy without your doctor’s advice. Seizures during pregnancy can harm both mother and baby. Tell your doctor right away if you become pregnant.

If you are pregnant, your name may be entered on a pregnancy register to track the effects of primidone on your baby. Be sure to tell the delivery doctor about your use of primidone. Both you and your baby may need medication to prevent excessive bleeding during labor and immediately after birth.

Stop breastfeeding if you notice unusual sleepiness in a nursing baby. Talk to your doctor about how best to feed your baby while taking primidone.

How do I take primidone (Mizolin)?

Follow all directions on your prescription label and read any medication guides or instructions. Your doctor may change your dose from time to time. Use the medicine exactly as directed.

If you are switching to primidone from another anticonvulsant drug, you may only need to start primidone at bedtime. Follow your doctor’s instructions.

Do not stop using primidone suddenly even if you feel well. A sudden stop can cause increased seizures. Follow your doctor’s instructions for dose reduction.

It may take several weeks before you get the full benefit of taking primidone. Your doctor will determine how long you will be treated with this medicine.

If you take this medicine for a long time, you may need frequent medical tests.

Store primidone at room temperature away from moisture, light and heat.

does loratadine contain pseudoephedrine?

In an emergency, carry or carry a medical ID to let others know that you are taking anticonvulsants.

Mysoline patient information, including missed dose

What happens if I miss a dose (Mysoline)?

Take your medicine as soon as possible, but skip the missed dose if it is almost time for your next dose. Do not take two doses at a time.

What happens if I overdose (Mysoline)?

Seek emergency medical attention or call the Poison Helpline at 1-800-222-1222.

What should I avoid while taking primidone (myzolin)?

Avoid driving or hazardous activities until you know how this medicine will affect you. Your reactions may be impaired.

Drinking alcohol with this medicine may increase the side effects.

What other drugs will affect primidone (mizolin)?

The use of primidone with other drugs that cause drowsiness may worsen this effect. Ask your doctor before taking opioids, sleeping pills, muscle relaxers, or medications for anxiety or seizures.

Other drugs may affect primidone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medications and any medications you start or stop using.

Where can I get more information (Mysoline)?

Your pharmacist can provide more information about primidone.

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Remember, keep this and all other medicines out of the reach of children, never give your medicines to others, and use this medicine only as directed. Every effort has been made to ensure that the information provided by Cerner Multum, Inc. is accurate, current and complete. (“Multum”), but no guarantees are given in this regard. The information contained herein about the drug may vary over time. Multum’s information has been collected for use by clinicians and consumers in the United States, and therefore Multum does not warrant that use outside of the United States is appropriate unless specifically stated otherwise. Multum Medication Information does not make recommendations about medications, diagnose patients, or recommend therapy. Multum Drug Information is an information resource designed to assist licensed practitioners in caring for their patients and/or serving consumers who view this service as an addition to, and not a substitute for, the experience, skills, knowledge, and judgment of practitioners.