Zonegran capsules 50mg, No. 28
Expiration Date: 05/2027
Russian Pharmacy name:
Зонегран капсулы 50мг, №28
monotherapy in patients with partial epileptic seizures with or without secondary generalization, with newly diagnosed epilepsy;
as part of additional therapy in adults, adolescents and children from 6 years of age with partial epileptic seizures with or without secondary generalization.
Inside, washed down with water, regardless of the meal.
Adult patients
ZonegranЃ can be prescribed for adults as monotherapy, and as an adjunct to an already prescribed treatment. The dose of the drug is selected based on the therapeutic effect. The recommended dose escalation regimen and the amount of maintenance doses are shown in Table 1. Some patients, in particular those who do not take drugs that induce cytochrome CYP3A4, may respond to lower doses.
Table 1
Recommended dose escalation and maintenance dose in adults
Treatment regimen | Dose selection | Maintenance dose | ||
Monotherapy | Week 1-2 | Week 3-4 | Week 5-6 | |
adults with newly diagnosed epilepsy | 100 mg / day (single dose) | 200 mg / day (single dose) | 300 mg / day (single dose) | 300 mg / day (single dose). If higher doses are required: Increase by 100 mg at 2-week intervals to the maximum recommended dose of 500 mg |
Complementary therapy | Week 1 | Week 2 | Week 3-5 | from 300 to 500 mg / day (once or in 2 doses) |
| - patients taking drugs that induce the isoenzyme CYP3A4; | 50 mg / day (in 2 divided doses) | 100 mg / day (2 divided doses) | 100 mg increase at weekly intervals | |
| - patients not taking drugs that induce the isoenzyme CYP3A4 or patients with renal or hepatic impairment | Week 1-2 | Week 3-4 | Week 5-10 | 300 to 500 mg / day (once or in 2 divided doses), some patients may respond to lower doses |
| 50 mg / day (in 2 divided doses) | 100 mg / day (2 divided doses) | an increase of no more than 100 mg at 2-week intervals |
Cancellation
Cancellation of the drug ZonegranЃ is carried out gradually by reducing the dose by 100 mg per week while adjusting the dose of other jointly taken AEDs (if necessary, see 'Special instructions').
Teenagers and children from 6 years old
ZonegranЃ can be prescribed to children from 6 years of age as an adjunct to an already prescribed treatment. The dose of the drug is selected taking into account the clinical effect. The recommended dose escalation regimen and the amount of maintenance doses are shown in Table 2. Some patients, in particular those who do not take drugs that induce the isoenzyme CYP3A4, may respond to lower doses.
The attention of children and their parents or carers should be drawn to special instructions for the patient on measures to prevent heatstroke (see 'Special instructions').
table 2
Recommended dose escalation regimen and maintenance doses in children from 6 years of age
| Treatment regimen | Dose selection | Maintenance dose | ||
| Complementary therapy | Week 1 | Week 2-8 | Patients weighing 20 to 55 kg * | Patients weighing more than 55 kg |
| - patients taking drugs that induce the isoenzyme CYP3A4; | 1 mg / kg / day (once) | an increase of 1 mg / kg at weekly intervals | from 6 to 8 mg / kg / day (once) | from 300 to 500 mg / day (once) |
| - patients not taking drugs that induce the isoenzyme CYP3A4 | Week 1-2 | Week 3 and beyond | from 6 to 8 mg / kg / day (once) | from 300 to 500 mg / day (once) |
| 1 mg / kg / day (once) | an increase of 1 mg / kg at 2-week intervals |
* To ensure that the maintenance dose is maintained, it is necessary to control the child's body weight and change the dose as body weight changes until reaching 55 kg. The dosage regimen is 6Ц8 mg / kg / day up to a maximum daily dose of 500 mg.
The safety and efficacy of ZonegranЃ in children under 6 years of age or in children weighing less than 20 kg have not been established.
In clinical studies, limited data have been obtained in patients weighing less than 20 kg. In this regard, in children aged 6 years and older with a body weight of less than 20 kg, caution should be exercised during treatment.
Cancellation
Cancellation of the drug Zonegran is carried out gradually by reducing the dose by 2 mg / kg / week (in accordance with the recommendations given in table 3).
Table 3
Recommended dose reduction regimen for children from 6 years of age
| Body mass | Dose reduction at weekly intervals by *: |
| 20-28 kg | from 25 to 50 mg / day |
| 29-41 kg | from 50 to 75 mg / day |
| 42Ц55 kg | 100 mg / day |
| more than 55 kg | 100 mg / day |
* with a single dose.
Use in elderly patients
Care must be taken when prescribing the drug due to the limited experience available. The safety profile of the drug should be taken into account (see 'Side Effects').
Use in patients with renal impairment. Care must be taken when treating patients with renal insufficiency due to limited clinical experience - a slower dose adjustment may be required. Since zonisamide and its metabolites are excreted by the kidneys, it should be discontinued in patients with acute renal failure or clinically significant hypercreatininemia.
In patients with renal insufficiency, the renal clearance of single doses of zonisamide is directly proportional to Cl creatinine. AUC of zonisamide is increased by 35% in patients with severe renal insufficiency (Cl creatinine <20 ml / min).
Use in patients with hepatic impairment
The use of the drug in patients with hepatic impairment has not been studied. Use in patients with severe hepatic impairment is not recommended. Care must be taken when treating patients with mild to moderate hepatic impairment - a slower dose adjustment may be required.
| Capsules | 1 caps. |
| active substance: | |
| zonisamide | 25 mg |
| 50 mg | |
| 100 mg | |
| excipients (25/50/100 mg): hydrogenated vegetable oil - 0.75 / 1.5 / 3 mg; MCC - 49.06 / 98.12 / 196.25 mg; sodium lauryl sulfate - 0.19 / 0.38 / 0.75 mg | |
| capsule shell: gelatin - 36.895 / 46.575 / 74.239 mg; titanium dioxide (E171) - 1.105 / 1.353 / 1.613 mg; iron dye black oxide (E172) - - / 0.072 / - mg; dye 'Red charming' (E129) - - / - / 0.147 mg; dye 'Sunset Sun' yellow (E110) - - / - / 0.002 mg; ink 1014 Tekprint SW-9008 *: shellac - 36-40.5 / 36-40.5 / 36-40.5 mcg; propylene glycol - 4.5-10.5 / 4.5-10.5 / 4.5-10.5 mcg; potassium hydrochloride - 0.075-0.15 / 0.075-0.15 / 0.075-0.15 mcg; iron dye black oxide (E172) - 36-42 / 36-42 / 36-42 mcg | |
| * theoretical amounts based on the total amount of paint - 0.15 mg. |
hypersensitivity to the active substance, any of the excipients or to sulfonamides;
patients with severe hepatic impairment (there is insufficient data on the safety and efficacy of the drug for this category of patients);
pregnancy and the period of breastfeeding (there is not enough data on the safety of the drug for this category of patients (see 'Use during pregnancy and breastfeeding');
children under 6 years of age (there is not enough data on the safety and efficacy of the drug for this category of patients).
simultaneous use in children with carbonic anhydrase inhibitors such as topiramate and acetazolamide.
Carefully
elderly patients (care must be taken when prescribing the drug due to the limited experience available;
patients with renal insufficiency (due to limited clinical experience, a slower selection of the dose of the drug may be required - see 'Dosage and Administration');
patients with a high risk of developing nephrolithiasis (see 'Special instructions');
patients with hepatic insufficiency of mild to moderate severity (due to limited clinical experience, a slower selection of the dose of the drug may be required - 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 anticholinergic action;
starting treatment, canceling it or changing the dose of zonisamide while using it with P-glycoprotein substrates (for example, digoxin, quinidine);
patients weighing <20 kg (limited clinical experience).