Inside, regardless of food intake.
The daily dose of the drug is divided into two doses in the same dose.
Monotherapy
Adults and teens over 16 years of age
Treatment should begin with a daily dose of 500 mg divided into 2 divided doses (250 mg twice a day). After 2 weeks, the dose may be increased to the initial therapeutic dose of 1000 mg (500 mg twice a day). The maximum daily dose is 3000 mg (1500 mg twice a day).
As part of complex therapy
Adults from 18 years and adolescents (12 to 17 years) with a body weight of more than 50 kg
Treatment should begin with a daily dose of 1000 mg divided into 2 divided doses (500 mg each 2 times a day). Depending on the clinical response and the tolerability of the drug, the daily dose can be increased to a maximum of 3000 mg (1500 mg twice a day). A dose change of 500 mg 2 times a day can be carried out every 2-4 weeks.
Use in special patient groups
Patients with renal insufficiency
Because the levetiracetam is excreted from the body by the kidneys, when the drug is administered patients with renal insufficiency and elderly patients (65 years and older) The dose should be adjusted depending on the amount of creatinine clearance (CC).
Creatinine clearance (CC) for men can be calculated based on the serum creatinine concentration, according to the following formula:
CK (ml / min) = [140 - age (years)] x body weight (kg)/ 72 х КTOserum (mg / dL)
Creatinine clearance for women can be calculated by multiplying the obtained value by a factor of 0.85.
Then the QC is adjusted taking into account the body surface area (PIT) according to the following formula:
KK (ml / min / 1.73 m2) = KK (ml / min) / PPT of the facility (m2) x 1.73
| Renal insufficiency | QC (ml / min / 1.73 m2) | Dosing regimen |
| Norm | >80 | from 500 to 1500 mg twice a day |
| Lightweight | 50-79 | from 500 to 1000 mg twice a day |
| Moderate | 30-49 | from 250 to 750 mg twice a day |
| Heavy | <30 | from 250 to 500 mg twice a day |
| Terminal stage (patients on dialysis *) | | from 500 to 1000 mg 1 once a day ** |
* The first day of treatment is recommended to take a saturating dose of 750 mg;
** After dialysis, an additional 250-500 mg dose is recommended.
Children with kidney failure correction of the dose of levetiracetam should be made taking into account the degree of renal failure.
Creatinine clearance (ml / min / 1.73 m2) can be assessed based on serum creatinine (mg / dL) for adolescents, children and newborns using the following formula (Schwartz formula):
KK (ml / min / 1.73 m2) = Height (cm) x ks/ QCserum (mg / dL)
ks = 0.45 for children under 1 year;
ks = 0.55 for children under 13 and females;
ks = 0.7 for adolescent males.
Dosing for newborns, children and adolescents weighing less than 50 kg with impaired renal function
| Renal failure | QC (ml / min / 1.73 m2) | Dosing regimen |
| age from 1 to 6 months | age from 6 to 23 months, children |
| Norm | >80 | 7-21 mg / kg (0.07-0.21 ml / kg) twice daily | 10-30 mg / kg (0.10-0.30 ml / kg) twice daily |
| Lightweight | 50-79 | 7-14 mg / kg (0.07-0.14 ml / kg) twice daily | 10-20 mg / kg (0.10-0.20 ml / kg) twice daily |
| Moderate | 30-49 | 3,5-10,5 mg / kg (0,035-0,105 ml / kg) 2 times a day | 5-15 mg / kg (0.05-0.15 ml / kg) twice daily |
| Heavy | <30 | 3.5-7 mg / kg (0.035-0.07 ml / kg) twice daily | 5-10 mg / kg (0.05-0.10 ml / kg) twice daily |
| Terminal stage (patients on dialysis *) | - | 7-14 mg / kg (0.07-0.14 ml / kg) 1 time per day (1) (3) | 10-20 mg / kg (0.10-0.20 ml / kg) 1 time per day (2) (4) |
(1) - 10.5 mg / kg (0.105 ml / kg) the recommended loading dose on the first day of treatment;
(2) - 15 mg / kg (0.15 ml / kg) the recommended loading dose on the first day of treatment;
(3) - recommended maintenance dose after dialysis 3.5-7 mg / kg (0.035-0.07 ml / kg);
(4) is the recommended maintenance dose after dialysis of 5-10 mg / kg (0.05-0.10 ml / kg).
Patients with impaired hepatic function
Patients with a malfunction of the liver of mild to moderate severity are not required to adjust the dose.
In patients with severe decompensated impairment of liver function and renal insufficiency the level of decrease in the clearance of creatinine may not fully reflect the severity of renal failure. In such cases, when creatinine clearance <60 ml / min / 1.73, a daily dose reduction of 50% is recommended.
Use in children
Children aged 6 months to 23 months, children aged 2 to 11 years and adolescents from 12 to 17 years of age with a body weight of less than 50 kg
Treatment should begin with a dose of 20 mg / kg body weight divided into 2 divided doses (10 mg / kg body weight 2 times a day). Depending on the clinical response and the tolerability of the drug, the daily dose can be increased to 30 mg / kg 2 times a day. A dose change of 20 mg / kg (10 mg / kg body weight 2 times a day) of body weight can be done every 2 weeks. The minimum effective dose should be used.
Recommended dosages for children (from 6 months) and adolescents:
| Body mass | Initial dose | The maximum dose |
| | (10 mg / kg 2 times a day) | (30 mg / kg 2 times a day) |
| 6 kg * | 60 mg (0.6 ml) twice daily | 180 mg (1.8 ml) twice daily |
| 10 kg * | 100 mg (1 ml) twice daily | 300 mg (3 ml) twice daily |
| 15 kg * | 150 mg (1.5 ml) twice daily | 450 mg (4.5 ml) twice daily |
| 20 kg * | 200 mg (2 ml) twice daily | 600 mg (6 ml) twice daily |
| 25 kg * | 250 mg twice daily | 750 mg twice a day |
| from 50 kg ** | 500 mg twice a day | 1500 mg twice a day |
* For children with a body weight of 25 kg or less, it is preferable to begin treatment with the administration of a solution for ingestion of Tiraspol 100 mg / ml.
** Dosage for children and adolescents with a body weight of more than 50 kg is the same as for adults.
Children aged 1 month to 6 months
The initial treatment dose is 7 mg / kg twice a day.
Depending on the clinical efficacy and tolerability, the dose can be increased to 21 mg / kg twice a day.The dose change should not exceed plus or minus 7 mg / kg twice a day every two weeks. The minimum effective dose should be given.
Dosage recommendations for children under 6 months of age
| Body mass | The initial dose (7 mg / kg twice daily) | The maximum dose (21 mg / kg twice a day) |
| 4 kg | 28 mg (0.3 ml) twice daily | 84 mg (0.85 ml) twice daily |
| 5 kg | 35 mg (0.35 ml) twice daily | 105 mg (1.05 ml) twice daily |
| 7 kg | 49 mg (0.5 ml) twice daily | 147 mg (1.5 ml) twice daily |
Dosage of the solution is carried out with the help of the measuring syringes included in the delivery package of the preparation.
There are syringes of nominal capacity:
- 12 ml (corresponding to 1200 mg levetiracetam) and with a 0.25 ml fission rate (corresponding to 25 mg) for children 4 years and older, adolescents and adults;
- 3 ml (corresponding to 300 mg) with a fission rate of 0.1 ml (corresponding to 10 mg) for children aged 6 months to 4 years;
- 1 ml (corresponding to 100 mg) and the cost of dividing 0.05 ml (corresponding to 5 mg) for children aged 1 month to 6 months.
A metered dose of the drug is diluted in a glass of drinking water or a baby bottle.
Instructions for dosing a solution using a measuring syringe:
- Open the bottle: to do this, click on the cap and rotate it counter-clockwise (Fig.1).
- Separate the adapter from the syringe (Figure 2). Insert the syringe adapter into the neck of the vial, make sure it is well fixed, then take the syringe and place it in the adapter.
- Turn the bottle upside down (Fig. 3).
- Fill the syringe with a small amount of solution, pulling the piston down, then push the piston upward to remove air bubbles (Fig. 4a, 4b).
- Fill the syringe with the solution, pulling the piston to the division corresponding to the number of milliliters (ml) of the solution prescribed by the doctor dose (Fig. 4c).
- Turn the bottle upside down and pull the syringe out of the adapterera.
- Enter the contents of the syringe into a glass of drinking water or a baby bottle, pressing the piston against the stop (Fig. 5).
- It is necessary to drink completely all the contents of the glass (or baby bottle).
- Rinse the syringe with drinking water (Figure 6).
- Close the bottle with a screw cap.