By Peter Haeberli, J.D.
Reviewed by Marcia Wyman, Drug Information Pharmacist
Last Update: August 13, 2024
Mysoline (Primidone) is an anti-epileptic drug, also called an anticonvulsant, used to treat people with generalized tonic-clonic seizures, complex partial seizures, partial epileptic seizures. The medication can be used alone or together with other drugs.
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- Indications
- Dosage and instructions for use
- Overdose
- Contraindications
- Side Effects
- Drug Interactions
- Special Precautions
- Storage
Product info
Indications
Mysoline is used in the following cases:
- treatment of generalized tonic-clonic and partial seizures (mono or polytherapy);
- akinetic attacks, tonic and myoclonic cramps;
- Jacksonian and partial epilepsy;
- psychomotor epilepsy and large convulsive seizures.
Dosage and instructions for use
The drug is taken orally after a meal.
Adults: The initial daily intake is 0.125 g per day (in 1-2 doses), then every 3 days the daily dose is increased by 0.25 g per day – until the desired effect is achieved. The maximum daily intake for adults is 2 g, a single-dose is 0.75 g.
Children are recommended a dosage of 0.125 g to 0.5 g per day (depending on the age are prescribed from).
Overdose
With an overdose of primidone, a person may have the following symptoms:
- nausea and ataxia;
- suppression of the functions of the central nervous system (loss of consciousness, respiratory depression, and coma).
Often, crystalluria is manifested, which in turn is the main diagnostic symptom of an overdose of primidone. To eliminate all of the above symptoms, it is necessary to conduct symptomatic therapy in the form of gastric lavage and intake of activated charcoal.
Contraindications
Mysoline is contraindicated in the following cases:
- Hypersensitivity to the drug;
- impaired liver or kidney function;
- diseases of the hematopoiesis system;
- pregnancy and lactation.
The therapy should be carried out with caution in children and the elderly (the risk of paradoxical and motor excitement).
Side Effects
The medication can cause side effects. Consult your doctor if you have any of these symptoms:
- excessive fatigue,
- dizziness,
- complexity with coordination,
- nausea,
- vomiting,
- loss of appetite,
- double vision,
- uncontrolled eye movements,
- decreased sexual ability.
Some side effects can be severe. If you experience a rash, tell your doctor.
The drug can cause other side effects. Tell your doctor if you have any unusual problems while using it. Improper use of this drug increases the risk of serious side effects. Carefully follow the dosage instructions.
Drug Interactions
- Glucocorticoids, mineralocorticoids, indirect anticoagulants, tricyclic antidepressants, doxycycline, levothyroxine sodium, metronidazole, chloramphenicol, cyclosporine, estrogen-containing contraceptives, corticotropin, digitalis glycosides, vitamin D – decrease in their concentration and efficiency due to induction of liver enzymes by primidone;
- Alcohol and other drugs that depress the central nervous system – intensify the oppressive effect, may cause hepatotoxicity;
- Calcium folinate, phenylbutazone, carbamazepine – weakening of the primidone effect;
- MAO inhibitors (including selegiline, procarbazine, furazolidone) – an extension of the action of primidone due to inhibition of the biotransformation of phenobarbital;
- Valproic acid – an increase in the concentration and toxicity of primidone, a decrease in the concentration of valproic acid due to an increase in its metabolism with the formation of toxic metabolites;
- Other antiepileptic drugs – a decrease in effectiveness, a change in the nature of seizures; it may be necessary to determine plasma concentrations;
- Oral contraceptives – a decrease in their effectiveness; during the treatment, it is necessary to additionally use barrier methods of contraception;
- Paracetamol – a decrease in efficacy due to induction of liver enzymes by primidone;
- Amphetamines – a slowed absorption of primidone from the intestine;
- Halothane, methoxyflurane – the risk of hepatitis and nephrotoxicity.
Special Precautions
- Tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking Mysoline, consult your doctor. In case you are forced to resort to surgery, including dental surgery, tell the doctor or dentist that you are taking this medicine;
- There is a risk that you may experience changes in mental health when taking this medication. Immediately notify your doctor if you experience any of the following symptoms: panic attacks; agitation or anxiety; irritability, anxiety, depression; difficulties with falling asleep or sleeping; aggressive behavior; mania; conversations or thoughts about suicide, death and dying; any other unusual changes in behavior or mood;
- Generic Mysoline can be used as a component of complex anticonvulsant therapy. Cancellation and replacement of the drug are carried out gradually.
- The drug reduces the reaction when driving a car, working with mechanisms;
- In case of megaloblastic anemia, stop taking the preparation and begin treatment with folic acid and/or vitamin B12;
- With prolonged use, it is possible to develop drug dependence.
Storage
Keep the drug in a container tightly closed, out of the reach of children. Store at room temperature, away from excess heat and moisture (not in the bathroom). Do not freeze. Expose of medications that are expired or no longer needed.
About the Author
Peter Haeberli, J.D., joined Merck after its acquisition of Sirna Therapeutics in 2006, where he was Director of Intellectual Property and played a key role in developing the company’s IP portfolio. He originally joined Sirna’s predecessor, Ribozyme Pharmaceuticals, as a research chemist in 1993 before transitioning to the legal department in 1999, eventually taking on increasing responsibilities through the company’s restructuring and relaunch in 2003. Prior to his work at Ribozyme, he was a chemist at Ciba-Geigy Corp. Mr. Haeberli holds a B.A. in Molecular, Cellular, and Developmental Biology from the University of Colorado, Boulder, and a J.D. from the University of Denver. He is licensed to practice law in California and Colorado, and is admitted before the U.S. Patent and Trademark Office.
Disclaimer: The information presented is for informational purposes only and should not be considered as medical advice. It is essential to consult a qualified healthcare provider before making any healthcare or medication decisions. This content is not a substitute for professional medical advice, diagnosis, or treatment.