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Primidone ( INN, BAN, USP ) is an anticonvulsant of the barbiturate class. It is a structural analog of phenobarbital and related to barbiturate-derivative anticonvulsants. The active metabolites, phenobarbital, p -hydroxyphenobarbital, and phenylethylmalonamide, are also anticonvulsants. Primidone was once a mainstay anticonvulsant in the treatment of partial and generalized seizures and was the treatment of choice for secondarily generalized seizures originating in the temporal lobes, especially when combined with phenytoin, but by the early 1980s, carbamazepine had surpassed it in popularity due to the latter’s lower incidence of sedation. As time passed and more and more anticonvulsants came on the market, primidone was pushed further and further away from its former place of prominence, and major Western pharmaceutical corporations became less and less interested in manufacturing and selling it. It has largely fallen into disuse in the developed world as more and more anticonvulsants entered the market, and it has been withdrawn from various markets around the world.
1 Medical uses
1.2 Essential tremor
1.3 Long QT syndrome
1.4 Psychiatric disorders
2 Adverse effects
4 Mechanism of action
7 Available forms
9 Further reading
10 External links
Licensed for generalized tonic-clonic and complex partial seizures in the United Kingdom.
Open-label case series have suggested that primidone is effective in the treatment of epilepsy.
Primidone is considered to be a first-line therapy for essential tremor along with propranolol. In terms of tremor amplitude reduction, it is just as effective as propranolol, reducing it by 50%. Both drugs are well studied for this condition, unlike other therapies, and are recommended for initial treatment. 25 mg/day (low-dose therapy) is just as good as 75 mg/day (high-dose therapy).
Primidone is not the only anticonvulsant used for essential tremor; the others include topiramate (Topamax) and gabapentin (Neurontin). Other pharmacological agents include alprazolam (Xanax), clonazepam (Klonopin), atenolol, sotalol, nadolol, clozapine, nimodipine, and botilinum toxin A. Many of these drugs were less effective (according to Table 1), but a few were not. Only propranolol has been compared to primidone in a clinical trial.
Long QT syndrome
A case report, published in the December 1986 issue of Zhonghua Xin Xue Guan Bing Za Zhi, describes four cases, men, women, adults and adolescents, who were put on primidone for LQTS.
In 1965, Monroe and Wise reported using primidone along with a phenothiazine derivative antipsychotic and chlordiazepoxide in treatment-resistant psychosis.
In March 1993, S.G. Hayes of the University of Southern California School of Medicine reported that nine out of twenty-seven people (33%) with either treatment-resistant depression or treatment-resistant bipolar disorder had a permanent positive response to primidone. It should be noted that a plurality of subjects were also given methylphenobarbital in addition to or instead of primidone.
Five months later, Brown, Stone, and Rathbone published a case report titled, “Primidone and rapid cycling affective disorders” describing a 62-year-old woman who had rapid-cycling bipolar disorder starting in 1978. Lithium treatment was started two years later, but it only eliminated the manic swings, leaving her depressions unaffected. Between 1980 and 1989, the patient had six to ten episodes a year, each lasting between eleven and twenty-four days that left her with little energy, made tasks seem more arduous than they actually were, a smaller appetite, a tendency to sleep too much, anxious, and weepy. No antidepressant eliminated all her symptoms. At the age of fifty-eight, she was started on 125 mg/day of primidone for hand tremor. Her depression, which was resistant to all the antidepressants she tried, gradually remitted during primidone therapy; the expected depressive episode lasted three days instead of 13-17. Eight weeks later, she had an episode lasting twenty-eight days. Her last two episodes were nineteen weeks apart, lasting twenty-five and twenty-seven days, respectively. It was during the final episode, in the middle of 1990, that her dose of primidone was stabilized at 500 mg/day. She had been free of depression for two and a half years before the case report was written up.
In 1999, Drs. Linda C. Schaffer, Charles B. Schaffer, and J. Caretto conducted a follow-up study on those earlier reports, as no one else had done so in the six years following their publication, and found it to be roughly as (permanently) effective for refractory bipolar disorder as Hayes had reported it to be (31% vs. Hayes’s 33%). All subjects with a permanent and complete treatment response were either Bipolar I or Bipolar NOS. In this study, unlike the 1993 case report, primidone affected manic symptoms—especially insomnia, anxiety, and racing thoughts—and only on manic symptoms.
Unlike carbamazepine, there are few case reports mentioning the use of primidone in the treatment of trigeminal neuralgia. The first, published in the October 10, 1957 issue of Gazette Médicale de France, has no abstract.
Two trials of primidone for athetosis have been published. In one, small doses of primidone successfully treated eighteen out of thirty-one children. In a subsequent pilot trial in which children who experienced improvement were switched to placebo, the results were much more disappointing, with the two subjects who experienced subjective improvement also experiencing this on placebo.
Primidone has been used in cerebral palsy. In 1953, Plum and Sparup found that out of thirty-three patients, twenty had a favorable or moderate response. Thorn reported in 1962 that sixteen patients responded favorably to both primidone and chlordiazepoxide and four to only primidone. Nine patients responded only to chlordiazepoxide and four responded to neither drug. The best results were obtained in athetosis and rigidity.
Primidone has veterinary uses, including the prevention of aggressive behavior and cannibalism in gilt pigs, and treatment of nervous disorders in dogs and other animals.
This article needs more medical references for verification or relies too heavily on primary sources. Please review the contents of the article and add the appropriate references if you can. Unsourced or poorly sourced material may be challenged and removed. (February 2018)
Primidone can cause drowsiness, listlessness, ataxia, visual disturbances, nystagmus, headache, and dizziness. These side effects are the most common, occurring in more than 1% of users.
Dupuytren’s contracture of the fourth digit (ring finger).
Dupuytren’s contracture, a disease of the fasciae in the palm and fingers that permanently bends the fingers (usually the little and ring fingers) toward the palm, was first noted to be highly prevalent in epileptic people in 1941 by a Dr. Lund, fourteen years before primidone was on the market. Lund also noted that it was equally prevalent in individuals with idiopathic and symptomatic epilepsy and that the severity of the epilepsy did not matter. However, only one quarter of the women were affected vs. half of the men.
Primidone has other cardiovascular effects in beyond shortening the QT interval. Both it and phenobarbital are associated with elevated serum levels (both fasting and six hours after methionine loading) of homocysteine, an amino acid derived from methionine. This is almost certainly related to the low folate levels reported in primidone users. Elevated levels of homocysteine have been linked to coronary heart disease. In 1985, both drugs were also reported to increase serum levels of high density lipoprotein (HDL) cholesterol, total cholesterol, and apolipoproteins A and B.
It was first reported to exacerbate hepatic porphyria in 1975. In 1981, it was shown that phenobarbital, one of primidone’s metabolites, only induced a significant porphyrin at high concentrations in vitro.
Less than 1% of primidone users will experience a rash. Compared to carbamazepine, lamotrigine, and phenytoin, this is very low. The rate is comparable to that of felbamate, vigabatrin, and topiramate.
Radiograph of a rickets sufferer
Primidone, along with phenytoin and phenobarbital, is one of the anticonvulsants most heavily associated with bone diseases such as osteoporosis, osteopenia (which can precede osteoporosis), osteomalacia and fractures.
Anticonvulsants affect the bones in many ways. They cause hypophosphatemia, hypocalcemia, low Vitamin D levels, and increased parathyroid hormone. Anticonvulsants also contribute to the increased rate of fractures by causing somnolence, ataxia, and tremor which would cause gait disturbance, further increasing the risk of fractures on top of the increase due to seizures and the restrictions on activity placed on epileptic people.Increased fracture rate has also been reported for carbamazepine, valproate and clonazepam. The risk of fractures is higher for people taking enzyme-inducing anticonvulsants than for people taking non-enzyme-inducing anticonvulsants.
Granulocytopenia, agranulocytosis, and red-cell hypoplasia and aplasia, and megaloblastic anemia are rarely associated with the use of primidone.
This antagonistic effect is not due to the inhibition of dihydrofolate reductase, the enzyme responsible for the reduction of dihydrofolic acid to tetrahydrofolic acid, but rather to defective folate metabolism.
In addition to increasing the risk of megaloblastic anemia, primidone, like other older anticonvulsants also increases the risk of neural tube defects,
Additionally, a coagulation defect resembling Vitamin K deficiency has been observed in newborns of mothers taking primidone.
Primidone, like phenobarbital and the benzodiazepines, can also cause sedation in the newborn and also withdrawal within the first few days of life; phenobarbital is the most likely out of all of them to do that.
In May 2005, Dr. M. Lopez-Gomez’s team reported an association between the use of primidone and depression in epilepsy patients; this same study reported that inadequate seizure control, posttraumatic epilepsy, and polytherapy were also risk factors. Polytherapy was also associated with poor seizure control. Out of all of the risk factors, usage of primidone and inadequate seizure control were the greatest; with ORs of 4.089 and 3.084, respectively. They had been looking for factors associated with depression in epilepsy patients.
Primidone is one of the anticonvulsants associated with anticonvulsant hypersensitivity syndrome, others being carbamazepine, phenytoin, and phenobarbital. This syndrome consists of fever, rash, peripheral leukocytosis, lymphadenopathy, and occasionally hepatic necrosis.
Hyperammonemic encephalopathy was reported by Katano Hiroyuki of the Nagoya City Higashi General Hospital in early 2002 in a patient who had been stable on primidone monotherapy for five years before undergoing surgery for astrocytoma, a type of brain tumor. Additionally, her phenobarbital levels were inexplicably elevated post-surgery. This is much more common with the valproates than with any of the barbiturates.
The most common symptoms of primidone overdose are coma with loss of deep tendon reflexes and, during the recovery period, if the patient survives, disorientation, dysarthria, nystagmus, and ataxia,
In the Netherlands alone, there were thirty-four cases of suspected primidone poisoning between 1978 and 1982. Out of these, Primidone poisoning was much less common than phenobarbital poisoning. Twenty-seven of those adult cases were reported to the Dutch National Poison Control Center. Out of these, one person taking it with phenytoin and phenobarbital died, twelve became drowsy and four were comatose.
Treatments for primidone overdose have included hemoperfusion with forced diuresis,
In the three adults who are reported to have succumbed, the doses were 20–30 g.
Taking primidone with monoamine oxidase inhibitors (MAOIs) such as isocarboxazid (Marplan), phenelzine (Nardil), procarbazine (Matulane), selegiline (Eldepryl), tranylcypromine (Parnate) or within two weeks of stopping any one of them may potentiate the effects of primidone or change one’s seizure patterns.
Like many anticonvulsants, primidone interacts with other anticonvulsants. Clobazam decreases clearance of primidone,
Mesuximide increases plasma levels of phenobarbital in primidone users,
Primidone and the other enzyme-inducing anticonvulsants can cut the half-life of antipyrine roughly in half (6.2 ± 1.9 h vs. 11.2 ± 4.2 h), and increases the clearance rate by almost 70%. Phenobarbital reduces the half-life to 4.8 ± 1.3 and increases the clearance by almost 109%.
Mechanism of action
The exact mechanism of primidone’s anticonvulsant action is still unknown after over fifty years.
The effect of primidone in essential tremor is not mediated by PEMA.
The major metabolite, phenobarbital, is also a potent anticonvulsant in its own right and likely contributes to primidone’s effects in many forms of epilepsy. According to Brenner’s Pharmacology textbook, Primidone also increases GABA-mediated chloride flux: thereby hyperpolarizing the membrane potential.
Primidone converts to phenobarbital and PEMA;
Primidone, carbamazepine, phenobarbital and phenytoin are among the most potent hepatic enzyme inducing drugs in existence. This enzyme induction occurs at therapeutic doses. In fact, people taking these drugs have displayed the highest degree of hepatic enzyme induction on record.
The rate of metabolism of primidone into phenobarbital was inversely related to age; the highest rates were in the oldest patients (the maximum age being 55). The clinical significance is unknown.
The percentage of primidone converted to phenobarbital has been estimated to be 5% in dogs and 15% in humans. Work done twelve years later found that the serum phenobarbital 0.111 mg/100 mL for every mg/kg of primidone ingested. Authors publishing a year earlier estimated that 24.5% of primidone was metabolized to phenobarbital. However, the patient reported by Kappy and Buckley would have had a serum level of 44.4 mg/100 mL instead of 8.5 mg/100 mL if this were true for individuals who have ingested large dose. The patient reported by Morley and Wynne would have had serum barbiturate levels of 50 mg/100 mL, which would have been fatal.
Primidone’s effectiveness for epilepsy was first demonstrated in 1949 by Yule Bogue.
The first report associating it with megaloblastic anemia came in 1954 from Drs. Chalmers and Boheimer.
In Europe, up until 1963, it was not uncommon to prescribe primidone and phenobarbital in combination, often with a stimulant. They were believed to be the most useful for seizures occurring upon awakening, while phenytoin was the most useful for nocturnal seizures. Primidone and phenobarbital were prescribed in combination with phenytoin in diffuse epilepsies. They were third and fourth line-agents, respectively, in the treatment of partial seizures. By 1963, carbamazepine was marketed in most of Europe. It soon became clear that its efficacy in generalized tonic-clonic seizures was the same as phenytoin, that its ability to control partial seizures was superior, along with its tolerability. Sodium valproate was approved in France in 1967. Because the doses were so low (200–400 mg/day), it was viewed as a moderately effective anticonvulsant whose best quality was its nonsedating nature. In spite of the availability of carbamazepine and valproate, physicians practicing in Mediterranean countries still preferred phenobarbital. Other medications were seen as not usually necessary. Phenytoin was to be used as adjunctive therapy only.
In 1968, a Dr. Meadow encountered six babies with cleft lip and palate in addition to other congenital abnormalities whose mothers had been taking anticonvulsants. Meadow wrote a letter in The Lancet asking for cases of cleft lip and palate in babies whose mothers had taken anticonvulsants. That same year, Milunsky, Graef, and Gaynor reported cases of cleft lip and palate associated with attempted abortion with methotrexate and aminopterin, which are folic acid antagonists.
Carbamazepine was approved in the United States for the treatment of adult epilepsy in 1974. Its lack of sedating properties relative to phenobarbital and lack of somatic effects relative to phenytoin generated much interest.
By 1980, primidone was seen as not worth mentioning as an option for childhood temporal lobe epilepsy by doctors in the United Kingdom.
In 1990, primidone, along with phenobarbital, was a second-line agent in partial epilepsy with or without secondarily generalized tonic-clonic seizures and was one of four agents (the others being carbamazepine, phenytoin and phenobarbital) that was used along with ethosuximide or a benzodiazepine for any absence or myoclonic seizures when valproate failed to control tonic-clonics (at least in the United States).
By 1994, primidone was no longer one of the most widely used anticonvulsants. Phenytoin was still regarded as the drug of choice for partial seizures due to its long half-life and low cost; but for children, carbamazepine was seen as the best one due to phenytoin’s effects on physical appearance.
By the year 2000, primidone was something that was prescribed in the event that the patient had tried all other anticonvulsants and was not a candidate for surgery in the United States.
Primidone is available as a 250 mg/5mL suspension, and in the form of 50 mg, 125 mg, and 250 mg tablets. It is also available in a chewable tablet formulation in Canada.
It is marketed as several different brands including Mysoline (Canada, )
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