Zonegran capsules 25 mg, 14 pcs. (Zonysamyd)

Release form

Capsules



packaging 14 pcs

Contraindications

hypersensitivity to the active substance, for any of the excipients or to

sulfonamides, patients with severe hepatic insufficiency (there are insufficient data on the safety and efficacy of the drug for this category of patients)

pregnancy and the period of breastfeeding (there are insufficient data on the safety of the drug for this category of patients (see " pregnancy and lactation ”)

children under 6 years of age (data on the safety and effectiveness of the drug for this category of patients are insufficient).

is simultaneously used in children with carbonic anhydrase inhibitors such as topiramate and acetazolamide.

Caution

elderly patients (care must be taken when prescribing the drug due to the limited experience of

patients with renal failure (due to limited clinical experience, it may require a slower dosage selection of the drug - see “Dosage and Administration”)

patients with a high risk of developing nephrolithiasis (see "Special Instructions")

patients with mild to moderate hepatic insufficiency (due to limited clinical experience, may sweat rely on a slower selection of the dose of the drug - see "Dosage and Administration")

simultaneous use in adults with carbonic anhydrase inhibitors such as topiramate and acetazolamide (insufficient data, to exclude pharmacodynamic interaction)

simultaneous use in adults with pyrogenic drugs, including carbonic anhydrase inhibitors and drugs with the anticholinergic effect of

, start treatment, cancel it or change the dose of zonisamide while using P-glycoprotein substrates (for example, digoxin, quinidine patients) srdl body weight

Dosage and administration

Inside, with water, during meals or regardless of food intake. The dose of the drug is selected taking into account 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 drugs that induce CYP3A4 cytochrome, 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. Then the dose can be increased by 100 mg every 7 days, to the 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 CYP3A4 cytochrome.

Side effects

Infectious and parasitic diseases: urogenital infections, pneumonia

From the blood and lymphatic system: leukopenia, thrombocytopenia

Metabolic and nutritional disorders: decreased appetite, hypokalemia

Psychiatric anxiety, nervousness, anxiety, anxiety, anxiety confusion, acute psychosis, aggressiveness, suicidal thoughts, hallucinations

From the nervous system: ataxia, dizziness, decreased memory, drowsiness, bradyphrenia, arushenie attention, paraesthesia, nystagmus, speech disorder, tremor, convulsions

part of the vision: diplopia

part of the respiratory system, thorax and mediastinum: violation

breathing part of the intestine: constipation, diarrhea, dyspepsia, nausea, vomiting, abdominal pain

From the liver and biliary tract: acute cholecystitis

From the skin and subcutaneous tissue: rash, itching, ecchymosis

General disorders and disorders at the injection site: increased fatigue, fever body, irritability

Laboratory and instrumental data: decrease in bicarbonates, weight loss, increase in CPK, increase in ALT, increase in AST, impaired urinalysis.

Overdose

Symptoms: there have been cases of intentional and unintentional overdose with Zonegran® in adults and children. In some cases, an overdose was asymptomatic, especially with immediate gastric lavage. In other cases, an overdose was accompanied by the following symptoms: drowsiness, nausea, gastritis symptoms, nystagmus, myoclonus, coma, bradycardia, impaired renal function, arterial hypotension and respiratory depression. A very high concentration of zonisamide in blood plasma (100.1 μg / ml) was observed approximately 31 hours after an overdose of 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 had no complications.

Treatment: there is no specific antidote for the treatment of overdose with Zonegran®. After a suspected overdose, immediate gastric lavage is indicated against the background of conventional measures aimed at maintaining airway patency. Conduct maintenance therapy, including regular monitoring of the main indicators of the state of the body, and careful monitoring. Zonisamide has a long T1 / 2, in connection with which the symptoms of its overdose can be persistent. Studies of the treatment of overdose have not been conducted, however, it is known that hemodialysis reduces the concentration of zonisamide in plasma in patients with renal failure and can be considered as a means of treating overdose.

Storage conditions

At a temperature not exceeding 30 ° C.

Term hodnosty

3 years

Prescription terms from

pharmacies Prescription

Form of Treatment

kapsul

Eisai MANUFACTURING Limited, UK



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