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Zonegran - antiepileptic.
Monotherapy in patients with partial epileptic seizures with secondary generalization or without, with newly diagnosed epilepsy; in the composition of additional therapy in adults, adolescents and children from 6 years of age with partial epileptic seizures with secondary generalization or without.
Excipients: vegetable oil, hydrogenated - 3 mg, microcrystalline cellulose - 196.25 mg, sodium lauryl sulfate - 0.75 mg.
The composition of the capsular shell: gelatin - 74.239 mg, titanium dioxide (E171) - 1.613 mg, dye red charming (E129) - 0.147 mg, dye sunny sunset yellow (E110) - 0.002 mg, ink 1014 Techprint SW-9008 * (shellac - 36.0 -40.5 mcg, propylene glycol - 4.5-10.5 mcg, potassium hydrochloride - 0.075-0.150 mcg), iron dye black oxide (E172) - 36.0-42.0 mcg).
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Dosage and Administration
Inside, drinking water, while eating or regardless of the meal. The dose of the drug is selected based on the therapeutic effect. As shown by clinical studies, a daily dose of 300-500 mg is effective, although some patients, in particular those who do not take cytochrome CYP3A4 inducing drugs, may respond to lower doses.
The initial dose is 50 mg divided into two doses. After one week of taking the daily dose can be increased to 100 mg per day. The dose can then be increased by 100 mg every 7 days, up to a maximum recommended dose of 500 mg per day. Subsequently, during treatment, you can switch to a single dose of the drug every day.
The use of two-week intervals should be considered for patients with hepatic or renal failure, as well as patients not taking drugs that induce cytochrome CYP3A4.
Infectious and parasitic diseases: urogenital infections, pneumonia;
- elderly patients (care must be taken when prescribing the drug due to the limited experience available;
- patients with renal failure (due to limited clinical experience, a slower dose selection may be required - see “Dosage and administration”);
- patients with a high risk of nephrolithiasis (see "Special Instructions");
- patients with mild to moderate hepatic insufficiency (due to limited clinical experience, a slower dose selection may be required - see "Dosage and administration");
- simultaneous use in adults with carbonic anhydrase inhibitors, such as topiramate and acetazolamide (not enough data to exclude pharmacodynamic interaction);
- simultaneous use in adults with pyrogenic drugs, including carbonic anhydrase inhibitors and drugs with anticholinergic action;
- initiation of treatment, its cancellation or change in the dose of zonisamide with simultaneous use of P-glycoprotein (for example, digoxin, quinidine) with substrates;
- weight patients
With drug therapy Zonegran® The development of severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, has been reported.
The abolition of the drug Zonegran is recommended.® in patients who have skin rashes and which cannot be explained by other causes. All patients with the appearance of lesions on the skin while taking the drug Zonegran® must be carefully monitored, especially patients with the simultaneous administration of other antiepileptic drugs that themselves can cause skin rashes.
The abolition of the drug Zonegran® produced by gradually reducing the dose in order to avoid the occurrence of epileptic seizures. Not enough data on the abolition of concurrently used antiepileptic drugs after achieving seizure control when using the drug Zonegran® in the framework of adjuvant therapy for the transition to monotherapy with the drug Zonegran®. Therefore, the abolition of concomitant antiepileptic treatment should be carried out with caution.
Reactions associated with the presence of sulfonamide group
Zoneran® contains a sulfonamide group. Serious adverse reactions of the immune system associated with taking drugs that contain the sulfonamide group include the appearance of a skin rash and other allergic reactions, as well as the development of severe hematological disorders, including aplastic anemia, in very rare cases, leading to death.
The development of cases of agranulocytosis, thrombocytopenia, leukopenia, aplastic pancytopenia anemia and leukocytosis has been reported.Information to assess the possible relationship of these phenomena with the magnitude of the dose of the drug Zonegran® and the duration of treatment is not enough.
Suicidal thinking and behavior
The development of suicidal thinking and behavior is possible in patients taking antiepileptic drugs for a number of indications. A meta-analysis of randomized, placebo-controlled studies of antiepileptic drugs also showed an increased risk of suicidal thoughts and behavior.
The mechanism of this phenomenon is unknown, the available data do not exclude the possibility of an increased risk of the formation of suicidal behavior even while taking the drug Zonegran®.
Patients should be monitored for suicidal thoughts and behaviors, and appropriate treatment should be provided. Patients (and those caring for them) should be advised to seek medical help if suicidal thoughts and behaviors appear.
Some patients, especially those with a predisposition to nephrolithiasis, may have an increased risk of kidney stones and the appearance of signs and symptoms such as renal colic, kidney pain or side pain.
Nephrolithiasis can lead to chronic kidney damage. Risk factors for nephrolithiasis include previous kidney stone formation, as well as a family history of nephrolithiasis and hypercalciuria. None of these risk factors is a reliable sign that predicts the formation of kidney stones during treatment with zonisamide. In addition, the risk may be increased in patients taking other drugs that provoke the development of urolithiasis. Increased fluid intake and forced diuresis helps reduce the risk of stone formation, incl. and in patients with a predisposition for this.
The formation of hyperchloremic metabolic acidosis without anionic rupture (reduction of bicarbonate levels in the absence of chronic gas alkalosis) is associated with therapy with the drug Zonegran®. The development of metabolic acidosis is due to the loss of bicarbonates in the kidneys due to the inhibitory effect of zonisamide on carbonic anhydrase, and possibly at any stage of treatment, although it is more often noted in the early stages of treatment. Similar irregularities were noted both during the placebo-controlled clinical trials and in the post-marketing period. A decrease in the level of bicarbonates is usually expressed only slightly (the average value is about 3.5 mEq / L with a daily dose of 300 mg in adults); in rare cases, patients may experience a more significant decrease. Conditions or treatments that predispose to the development of acidosis (for example, kidney disease, severe respiratory disorders, status epilepticus, diarrhea, surgical interventions, a diet that promotes the formation of ketone bodies, a number of drugs) can enhance the effect of zonisamide on bicarbonate levels.
The risk and severity of metabolic acidosis increase in young patients. In the event of signs or symptoms of metabolic acidosis, it is recommended to evaluate the content of bicarbonate in serum. If the developed metabolic acidosis does not pass, the possibility of reducing the dose or completely discontinuing the use of the drug Zonegran should be considered.® (with a gradual decrease in dose), because possible development of osteopenia. If it is decided to continue therapy in the presence of persistent acidosis, the possibility of using alkaloids should be considered.
It is necessary to exercise caution when prescribing simultaneously with carbonic anhydrase inhibitors (for example, topiramate and acetazolamide), since insufficient data to exclude pharmacodynamic interaction (see. "Interaction").
Cases of decreased sweating and fever have been recorded mainly in patients under 18 years of age. In some cases, heat stroke occurred, requiring inpatient treatment. Most cases occurred under conditions of high ambient temperature. Patients and / or their caregivers should be warned about the need to maintain adequate hydration of the body and avoid exposure to elevated temperatures. Care must be taken when prescribing the drug Zonegran® simultaneously with drugs that promote overheating of the body, including carbonic anhydrase inhibitors and holinoblokatory.
With the development of patients with signs of pancreatitis while taking the drug Zonegran®monitoring of pancreatic lipase and amylase levels is necessary. In the case of confirmed pancreatitis in the absence of other obvious reasons, the abolition of the drug Zonegran is recommended.® and the appointment of appropriate treatment.
With the development of patients taking Zonegran®, severe muscle pain and / or weakness, especially with fever, requires an assessment of the content of muscle damage markers, including the level of CPK and aldolase. If they are elevated, in the absence of other obvious causes, such as an injury or a major epileptic seizure, it is recommended that the drug be canceled.® and the appointment of appropriate treatment.
Women with preserved childbearing potential
Women with preserved childbearing potential should use reliable methods of contraception during treatment with the drug Zonegran® and for 1 month after its cancellation (see. "Use during pregnancy and lactation").
Zoneran® can cause weight loss, so during the treatment of patients with low body weight or while reducing it, you must assign nutritional supplements and enhanced nutrition. With a marked decrease in body weight, the possibility of drug withdrawal should be considered.®. Reduced body weight in children may be more pronounced.
The above precautions apply to children and adolescents. The following are safety precautions for which special attention should be paid.
Heatstroke and dehydration
Prevention of overheating and dehydration in children. Zoneran® may cause a decrease in sweating and lead to overheating, and in the absence of appropriate assistance, the child may experience brain damage and death. Children are at high risk, especially in hot weather.
If the child is taking the drug Zonerag®: overheating should be avoided, especially in hot weather; considerable physical exertion should be avoided, especially in hot weather; should increase water consumption; The following drugs should not be used: carbonic anhydrase inhibitors (such as topiramate and acetazolamide) and anticholinergics (such as clomipramine, hydroxyzine, diphenhydramine, haloperidol, imipramine, and oxybutynin).
If any of the following symptoms occur, you should immediately seek medical help: feeling a strong heat from the skin with little sweating or in the absence of it, or when a child becomes confused, have muscle spasms, or if the heart rate increases or the child is breathing. It is necessary to place the child in a cool shaded place; wet the baby’s skin with water to cool it; Give your child a drink of cool water.
Reported cases of decreased sweating and fever, mainly in children. In some cases, there was a heat stroke that required hospitalization. In some cases, a heat stroke with a fatal outcome has been reported. In most cases, the phenomenon occurred during warm weather.The patient and caregivers should be warned about the possible severity of heat stroke, situations where it may occur, as well as measures to be taken if any signs or symptoms appear. Patients or caregivers should be warned about the need to consume a sufficient amount of fluid and avoid excessive physical exertion, depending on the patient's condition. In case of signs and symptoms of dehydration, oligohydrosis or fever, you should consider withdrawing the drug Zonegran®.
Drug Zonegran® should not be used in children who receive other drugs at the same time, in which patients are prone to the occurrence of disorders associated with exposure to excessive heat; these include carbonic anhydrase inhibitors and anticholinergic drugs.
Cases of weight loss that have led to a deterioration of the general condition and the cessation of the use of an anti-epileptic drug, which are fatal, have been described. Use of the drug Zoneran® not recommended in children with underweight or in children with poor appetite.
The frequency of weight loss is the same in different age groups, however, given the possible seriousness of weight loss in children, in this group of patients it is necessary to control body weight. When delaying weight gain in a patient, on the basis of physical development cards, it is recommended to review the diet or increase the amount of food intake, otherwise you should stop using the drug Zonegran®.
In clinical studies, limited data were obtained from patients with a body weight less than 20 kg. In this regard, the treatment of children aged 6 years and older with a body weight less than 20 kg should be careful. The effect of prolonged low body weight on growth and development in children is unknown.
The risk of acidosis associated with the use of zonisamide in children and adolescents may be higher and more severe. In this group of patients, appropriate monitoring and control of serum bicarbonate levels should be carried out. The long-term effect of low bicarbonate levels on growth and development is unknown.
Drug Zonegran® It should not be used in children with other carbonic anhydrase inhibitors, such as topiramate or acetazolamide.
Children have reported kidney stones. Some patients, especially those with a predisposition to nephrolithiasis, may have an increased risk of kidney stones and associated signs and symptoms, such as renal colic, kidney pain or side pain. Urolithiasis can lead to chronic kidney damage. Risk factors for urolithiasis include previous kidney stones and a hereditary predisposition to nephrolithiasis and hypercalciuria. None of these risk factors is a reliable sign that predicts the formation of kidney stones during treatment with zonisamide.
Increased fluid intake and forced diuresis can reduce the risk of kidney stones, especially in people with risk factors. At the discretion of the doctor can be carried out ultrasound of the kidneys. In case of detection of kidney stones, the drug Zonegran®should cancel.
In children and adolescents, an increase in liver function and biliary tract, such as ALT, AST, GGT and bilirubin, was observed, but no obvious patterns for values exceeding VGN were found.
However, in case of suspected occurrence of adverse events on the part of the liver, it is necessary to evaluate liver function and decide on the abolition of the drug Zonegran®.
Impaired cognitive function in patients with epilepsy is associated with the underlying disease and / or with the use of AED.
In a placebo-controlled study using zonisamide in children and adolescents, the proportion of patients with impaired cognitive function was quantitatively higher in the zonisamide group compared with the placebo group.
The composition of the drug Zoneran® At a dosage of 100 mg, the dusts “Sunset Yellow” (E110) and “Red Charming” (E129), which can cause allergic reactions, are included.
Influence on the ability to drive and work with mechanisms. Special studies of the effect of the drug on the ability to drive and work with mechanisms were not conducted. Zoneran® may cause (especially at the beginning of therapy or with an increase in dose) drowsiness and difficulty concentrating, and therefore, during the period of treatment, care must be taken when engaging in activities that require increased concentration and psychomotor reactions.
Symptoms: there were cases of deliberate and unintentional overdose of the drug Zonegran® in adults and children. In some cases, overdose was asymptomatic, especially with immediate gastric lavage. In other cases, overdose was accompanied by the following symptoms: drowsiness, nausea, gastritis symptoms, nystagmus, myoclonus, coma, bradycardia, impaired renal function, hypotension and respiratory depression. A very high plasma concentration of zonisamide (100.1 μg / ml) was observed approximately 31 hours after an overdose of the drug Zonegran® and clonazepam. A patient with an overdose of these drugs developed coma and respiratory depression. However, after 5 days he regained consciousness, and he did not have any complications.
Treatment: specific antidote for the treatment of overdose with the drug Zonegran® does not exist. After a presumptive overdose, immediate gastric lavage is indicated against the background of conventional measures aimed at maintaining airway patency. Conduct supportive therapy, including regular monitoring of key indicators of the state of the body, and careful observation. Zonisamide has a long T1/2In this connection, the symptoms of his overdose may be persistent. Studies of overdose treatment have not been conducted, however, it is known that hemodialysis reduces the concentration of zonisamide in the blood plasma of patients with renal insufficiency and can be considered as a treatment for overdose.
- Brand name: Zonegran
- Active ingredient: Zonisamide
- Dosage form: Capsules size No. 1, with a red lid and a white case, a company logo and the name of the drug with a black ink applied with a black ink, and a digital indication of the dosage “ZONEGRAN 100”, the contents of the capsules are white and white powder with a yellowish tint, free from visible inclusions.
- Manufacturer: Eisai Manufactured Limited
- Country of Origin: Great Britain
- Monitoring of zonisamide in human breast milk and maternal plasma by solid-phase extraction HPLC method
- A novel hypothesized clinical implication of zonisamide for autism
- Simultaneous determination of lamotrigine, zonisamide, and carbamazepine in human plasma by high-performance liquid chromatography
- ChemInform Abstract: Research and Development of Zonisamide, a New Type of Antiepileptic Drug
- Preclinical abuse potential assessment of the anticonvulsant zonisamide
- A double-blind placebo-controlled trial of zonisamide (zonegran) in the treatment of essential tremor
- Restless legs syndrome induced by zonisamide
- Zonisamide in patients with essential tremor and Parkinson's disease
- Zonisamide for essential tremor: An evaluator-blinded study
- A pilot open-label trial of zonisamide in Unverricht-Lundborg disease
- Simple and sensitive assay of zonisamide in human serum by high-performance liquid chromatography using a solid-phase extraction technique
- Carbamazepine pharmacokinetics are not affected by zonisamide: in vitro mechanistic study and in vivo clinical study in epileptic patients
- Zonisamide for absence seizures
- Zonisamide at clinically relevant concentrations inhibits field EPSP but not presynaptic fiber volley in rat frontal cortex
- Effects of zonisamide on neurotransmitter exocytosis associated with ryanodine receptors
- Efficacy and safety of adjunctive zonisamide therapy for refractory partial seizures
- Serotonin but not zonisamide inhibits theophylline-induced epileptiform activity in guinea pig hippocampal CA3 neurons
- Antiepileptic activity of zonisamide on hippocampal CA3 neurons does not depend on carbonic anhydrase inhibition
- Antiepileptic activity of zonisamide on hippocampal CA3 neurons does not depend on carbonic anhydrase inhibition
- Zonisamide in children and young adults with refractory epilepsy: An open label, multicenter Italian study
- Zonisamide block of cloned human T-type voltage-gated calcium channels
- Topiramate and zonisamide prevent paradoxical intoxication induced by carbamazepine and phenytoin
- Urolithiasis on the ketogenic diet with concurrent topiramate or zonisamide therapy
- Blockade of sustained repetitive action potentials in cultured spinal cord neurons by zonisamide (AD 810, CI 912), a novel anticonvulsant