Keppra solution for oral administration 100 mg/ml 300 ml bottle 1 pc. in Moscow
Monotherapy
Adults and teenagers over 16 years of age.
Treatment should begin with a daily dose of 500 mg, divided into 2 administrations (250 mg 2 times a day). After 2 weeks, the dose can be increased to the initial therapeutic dose of 1000 mg (500 mg 2 times a day). The maximum daily dose is 3000 mg (1500 mg 2 times a day).
The following solvents can be used:
- 0.9% sodium chloride solution for injection;
- lactated Ringer's solution for injection;
- 5% dextrose solution for injection.
The solution remains chemically stable at 15–25 °C for 24 hours in PVC bags.
However, from the point of view of microbiological purity, the drug must be used immediately after dilution.
If necessary, the solution can be stored at a temperature of 2 to 8 °C for 24 hours, provided that the dilution was carried out under aseptic conditions. In this case, responsibility for microbiological cleanliness lies with the user.
The use of the drug is not allowed if the color of the solution changes or mechanical inclusions appear.
As part of complex therapy
Children from 4 to 11 years old and adolescents 12–17 years old weighing up to 50 kg.
Treatment should begin with a daily dose of 20 mg/kg, divided into 2 administrations (10 mg/kg 2 times a day). The dose can be changed by 10 mg/kg every 2 weeks until the recommended daily dose is reached - 60 mg/kg (30 mg/kg 2 times a day). If the recommended daily dose is not tolerated, it may be reduced.
There is no clinical experience with the infusion of levetiracetam for periods exceeding 4 days.
The minimum effective dose should be used.
Recommended dosages for children (from 4 years old) and adolescents (up to 17 years old)
| Body weight, kg | Initial dose: 10 mg/kg, 2 times a day | Maximum dose - 30 mg/kg, 2 times a day |
| 15 | 150 mg 2 times a day | 450 mg 2 times a day |
| 20 | 200 mg 2 times a day | 600 mg 2 times a day |
| 25 | 250 mg 2 times a day | 750 mg 2 times a day |
| from 50 | 500 mg 2 times a day | 1500 mg 2 times a day |
Adults and adolescents weighing more than 50 kg.
Treatment should begin with a daily dose of 1000 mg, divided into 2 administrations (500 mg 2 times a day). Depending on the clinical response and tolerability of the drug, the daily dose can be increased to a maximum of 3000 mg (1500 mg 2 times a day). The dose can be changed to 500 mg 2 times a day every 2–4 weeks.
The duration of the course of treatment is determined by the doctor.
Inside,
regardless of food intake. The daily dose is divided into 2 doses of the same dose.
The tablets are taken with a sufficient amount of liquid.
The tablets are not intended for children under 6 years of age due to the impossibility of selecting the correct dose.
In the case of a solution, dosing is carried out using a measuring syringe included with the drug, with a nominal capacity of 10 ml (corresponding to 1000 mg of levetiracetam) with a division value of 25 mg (corresponding to 0.25 ml). The measured dose of the drug is diluted in a glass of water (200 ml).
Dosing of the solution is carried out using measuring syringes included in the delivery package of the drug. Syringes are available with nominal capacities:
- 10 ml (corresponding to 1000 mg of levetiracetam) and with a division price of 0.25 ml (corresponding to 25 mg) for children 4 years and older, adolescents and adults;
- 3 ml (corresponds to 300 mg) with a division price of 0.1 ml (corresponds to 10 mg) for children from 6 months to 4 years;
- 1 ml (corresponds to 100 mg) and divided into 0.05 ml (corresponds to 5 mg) for children from 1 to 6 months.
A measured dose of the drug is diluted in a glass of water or a baby bottle.
Instructions for dosing the solution using a measuring syringe
1. Open the bottle: to do this, press the cap and turn it counterclockwise.
2. Insert the syringe adapter into the neck of the bottle, make sure it is well fixed, then take the syringe and place it in the adapter.
3. Turn the bottle upside down.
4. Fill the syringe with a small amount of solution by pulling the plunger down, then push the plunger up (to remove air bubbles).
5. By pulling the plunger, fill the syringe with the solution until the division corresponds to the number of ml of the solution prescribed by the doctor.
6. Turn the bottle upside down and remove the syringe from the adapter.
7. Introduce the contents of the syringe into a glass of water or a baby bottle, pressing the plunger all the way.
8. Drink the entire contents of the glass (or baby bottle).
9. Rinse the syringe with water.
10. Close the bottle with a plastic cap.
Monotherapy
Adults and teenagers over 16 years of age.
The initial daily dose is 500 mg in 2 divided doses (250 mg 2 times a day). After 2 weeks, the dose can be increased to the initial therapeutic dose of 1000 mg (500 mg 2 times a day). The maximum daily dose is 3000 mg (1500 mg 2 times a day).
As part of complex therapy
Children from 1 to 6 months.
The initial therapeutic dose is 7 mg/kg 2 times a day. Depending on clinical effectiveness and tolerability, the dose may be increased to 21 mg/kg 2 times a day. Dose changes should not exceed ±7 mg/kg 2 times a day every 2 weeks. The minimum effective dose should be prescribed.
Recommended dosages for children from 1 to 6 months
| Body weight, kg | Initial dose: 7 mg/kg 2 times a day | Maximum dose - 21 mg/kg 2 times a day |
| 4 | 28 mg (0.3 ml) 2 times a day | 84 mg (0.85 ml) 2 times a day |
| 5 | 35 mg (0.35 ml) 2 times a day | 105 mg (1.05 ml) 2 times a day |
| 7 | 49 mg (0.5 ml) 2 times a day | 147 mg (1.5 ml) 2 times a day |
Children from 6 months to 11 years and adolescents from 12 to 17 years weighing less than 50 kg.
Treatment should begin with a dose of 20 mg/kg, divided into 2 doses (10 mg/kg 2 times a day). Depending on the clinical response and tolerability of the drug, the daily dose can be increased to 30 mg/kg 2 times a day. The dose can be changed by 20 mg/kg (10 mg/kg 2 times a day) of body weight every 2 weeks. The minimum effective dose should be used.
Recommended dosages for children (from 6 months) and adolescents (up to 17 years)
| Body weight, kg | Initial dose: 10 mg/kg 2 times a day | Maximum dose - 30 mg/kg 2 times a day |
| 6* | 60 mg (0.6 ml) 2 times a day | 180 mg (1.8 ml) 2 times a day |
| 10* | 100 mg (1 ml) 2 times a day | 300 mg (3 ml) 2 times a day |
| 15* | 150 mg (1.5 ml) 2 times a day | 450 mg (4.5 ml) 2 times a day |
| 20* | 200 mg (2 ml) 2 times a day | 600 mg (6 ml) 2 times a day |
| 25 | 250 mg 2 times a day | 750 mg 2 times a day |
| from 50** | 500 mg 2 times a day | 1500 mg 2 times a day |
* For children weighing 25 kg or less, it is preferable to start treatment with Keppra®, oral solution, 100 mg/ml.
** The dosage for children and adolescents weighing more than 50 kg is the same as for adults.
Due to the lack of the required dosage, the tablets are not intended for the treatment of children weighing less than 25 kg, when a dose is prescribed less than 250 mg, as well as for patients who have difficulty swallowing them. In these cases, it is recommended to begin treatment by taking the drug in the form of an oral solution.
Adults and adolescents (from 12 to 17 years old) weighing more than 50 kg.
The initial daily dose is 1000 mg in 2 divided doses (500 mg 2 times a day). Depending on the clinical response and tolerability of the drug, the daily dose can be increased to a maximum of 3000 mg (1500 mg 2 times a day). The dose can be changed to 500 mg 2 times a day every 2–4 weeks.
Special patient groups
Renal dysfunction.
Since levetiracetam is excreted from the body by the kidneys, when prescribing the drug to patients with renal failure, the dose should be adjusted depending on the creatinine clearance.
Creatinine clearance for men can be calculated from serum creatinine concentration using the following formula:
Cl creatinine, ml/min=(140−age, years)×body weight, kg/72×Cl serum creatinine, mg/dl
Creatinine clearance for women can be calculated by multiplying the resulting value by a factor of 0.85.
Creatinine clearance is then adjusted for body surface area (BSA) using the following formula:
Cl creatinine, ml/min/1.73 m2=Cl creatinine, ml/min×1.73/BSA of object, m2
Dose adjustment for adults
| Kidney failure | Cl creatinine, ml/min/1.73 m2 | Dosage regimen |
| Absent (normal) | >80 | from 500 to 1500 mg 2 times a day |
| Lightweight | 50–79 | from 500 to 1000 mg 2 times a day |
| Moderate | 30–49 | from 250 to 750 mg 2 times a day |
| Heavy | <30 | from 250 to 500 mg 2 times a day |
| End stage (hemodialysis patients) | — | from 500 to 1000 mg 1 time per day* |
* On the first day of treatment with levetiracetam, a loading dose of 750 mg is recommended. After dialysis, an additional dose of 250–500 mg is recommended.
In children with renal failure, dose adjustment of levetiracetam should be made taking into account the degree of renal failure.
Creatinine clearance (ml/min/1.73 m2) can be estimated from serum creatinine (mg/dL) for adolescents, children and neonates using the following formula (Schwartz formula):
Cl creatinine, ml/min/1.73 m2=height, cm×ks/Cl serum creatinine, mg/dl
ks=0.45 for children under 1 year; ks=0.55 for children under 13 years of age and female adolescents; ks=0.7 for male adolescents.
Dose adjustment for newborns, children and adolescents weighing less than 50 kg
| Kidney failure | Cl creatinine, ml/min/1.73 m2 | Dosage regimen | |
| from 1 to 6 months | from 6 months | ||
| Absent (normal) | >80 | 7–21 mg/kg (0.07–0.21 ml/kg) 2 times a day | 10–30 mg/kg (0.1–0.3 ml/kg) 2 times a day |
| Lightweight | 50–79 | 7–14 mg/kg (0.07–0.14 ml/kg) 2 times a day | 10–20 mg/kg (0.1–0.2 ml/kg) once a day |
| 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) 2 times a day |
| Heavy | <30 | 3.5–7 mg/kg (0.035–0.07 ml/kg) 2 times a day | 5–10 mg/kg (0.1–0.2 ml/kg) 2 times a day |
| End stage (hemodialysis patients) | — | 7–14 mg/kg (0.07–0.14 ml/kg) 1 time per day* | 10–20 mg/kg (0.1–0.2 ml/kg) once a day** |
* On the first day of treatment with levetiracetam, a loading dose of 10.5 mg/kg (0.105 ml/kg) is recommended. After dialysis, an additional dose of 3.5–7 mg/kg (0.035–0.07 ml/kg) is recommended.
**On the first day of treatment with levetiracetam, a loading dose of 15 mg/kg (0.15 ml/kg) is recommended. After dialysis, an additional dose of 5–10 mg/kg (0.05–0.1 ml/kg) is recommended.
Liver dysfunction.
Patients with mild to moderate liver dysfunction do not require dosage adjustment. In patients with decompensated liver function and renal failure, the decrease in creatinine clearance may not fully reflect the severity of renal failure. In such cases, with creatinine clearance <60 ml/min/1.73 m2, it is recommended to reduce the daily dose by 50%.
Keppra, 1 piece, 300 ml, 100 mg/ml, oral solution
IV
drip, in the form of infusion, for 15 minutes.
The transition from oral to intravenous use and back can be carried out while maintaining the dose and frequency of administration.
One bottle of concentrate for solution for infusion contains 500 mg of levetiracetam (100 mg/ml).
The daily dose is divided into two injections of the same dose.
Before use, the concentrate must be diluted with a solvent of at least 100 ml.
Instructions for dosing the solution
| Dose, mg | Volume of the drug | Solvent volume, ml | Infusion time, min | Administration frequency, once a day | Daily dose, mg/day |
| 250 | 2.5 ml (half ampoule 5 ml) | 100 | 15 | 2 | 500 |
| 500 | 5 ml (1 ampoule of 5 ml) | 100 | 15 | 2 | 1000 |
| 1000 | 10 ml (2 ampoules of 5 ml) | 100 | 15 | 2 | 2000 |
| 1500 | 15 ml (3 ampoules of 5 ml) | 100 | 15 | 2 | 3000 |
The following solvents can be used:
— 0.9% sodium chloride solution for injection;
— lactated Ringer's solution for injection;
— 5% dextrose solution for injection.
The solution remains chemically stable at 15–25 °C for 24 hours in PVC bags.
However, from the point of view of microbiological purity, the drug must be used immediately after dilution.
If necessary, the solution can be stored at a temperature of 2 to 8 °C for 24 hours, provided that the dilution was carried out under aseptic conditions. In this case, responsibility for microbiological cleanliness lies with the user.
The use of the drug is not allowed if the color of the solution changes or mechanical inclusions appear.
Monotherapy
Adults and teenagers over 16 years of age.
Treatment should begin with a daily dose of 500 mg, divided into 2 administrations (250 mg 2 times a day). After 2 weeks, the dose can be increased to the initial therapeutic dose of 1000 mg (500 mg 2 times a day). The maximum daily dose is 3000 mg (1500 mg 2 times a day).
As part of complex therapy
Children from 4 to 11 years old and adolescents 12–17 years old weighing up to 50 kg.
Treatment should begin with a daily dose of 20 mg/kg, divided into 2 administrations (10 mg/kg 2 times a day). The dose can be changed by 10 mg/kg every 2 weeks until the recommended daily dose is reached - 60 mg/kg (30 mg/kg 2 times a day). If the recommended daily dose is not tolerated, it may be reduced.
There is no clinical experience with the infusion of levetiracetam for periods exceeding 4 days.
The minimum effective dose should be used.
Recommended dosages for children (from 4 years old) and adolescents (up to 17 years old)
| Body weight, kg | Initial dose: 10 mg/kg, 2 times a day | Maximum dose - 30 mg/kg, 2 times a day |
| 15 | 150 mg 2 times a day | 450 mg 2 times a day |
| 20 | 200 mg 2 times a day | 600 mg 2 times a day |
| 25 | 250 mg 2 times a day | 750 mg 2 times a day |
| from 50 | 500 mg 2 times a day | 1500 mg 2 times a day |
Adults and adolescents weighing more than 50 kg.
Treatment should begin with a daily dose of 1000 mg, divided into 2 administrations (500 mg 2 times a day). Depending on the clinical response and tolerability of the drug, the daily dose can be increased to a maximum of 3000 mg (1500 mg 2 times a day). The dose can be changed to 500 mg 2 times a day every 2–4 weeks.
The duration of the course of treatment is determined by the doctor.
Inside,
regardless of food intake. The daily dose is divided into 2 doses of the same dose.
The tablets are taken with a sufficient amount of liquid.
The tablets are not intended for children under 6 years of age due to the impossibility of selecting the correct dose.
In the case of a solution, dosing is carried out using a measuring syringe included with the drug, with a nominal capacity of 10 ml (corresponding to 1000 mg of levetiracetam) with a division value of 25 mg (corresponding to 0.25 ml). The measured dose of the drug is diluted in a glass of water (200 ml).
Dosing of the solution is carried out using measuring syringes included in the delivery package of the drug. Syringes are available with nominal capacities:
- 10 ml (corresponding to 1000 mg of levetiracetam) and with a division price of 0.25 ml (corresponding to 25 mg) for children 4 years and older, adolescents and adults;
- 3 ml (corresponds to 300 mg) with a division price of 0.1 ml (corresponds to 10 mg) for children from 6 months to 4 years;
- 1 ml (corresponds to 100 mg) and divided into 0.05 ml (corresponds to 5 mg) for children from 1 to 6 months.
A measured dose of the drug is diluted in a glass of water or a baby bottle.
Instructions for dosing the solution using a measuring syringe
1. Open the bottle: to do this, press the cap and turn it counterclockwise.
2. Insert the syringe adapter into the neck of the bottle, make sure it is well fixed, then take the syringe and place it in the adapter.
3. Turn the bottle upside down.
4. Fill the syringe with a small amount of solution by pulling the plunger down, then push the plunger up (to remove air bubbles).
5. By pulling the plunger, fill the syringe with the solution until the division corresponds to the number of ml of the solution prescribed by the doctor.
6. Turn the bottle upside down and remove the syringe from the adapter.
7. Introduce the contents of the syringe into a glass of water or a baby bottle, pressing the plunger all the way.
8. Drink the entire contents of the glass (or baby bottle).
9. Rinse the syringe with water.
10. Close the bottle with a plastic cap.
Monotherapy
Adults and teenagers over 16 years of age.
The initial daily dose is 500 mg in 2 divided doses (250 mg 2 times a day). After 2 weeks, the dose can be increased to the initial therapeutic dose of 1000 mg (500 mg 2 times a day). The maximum daily dose is 3000 mg (1500 mg 2 times a day).
As part of complex therapy
Children from 1 to 6 months.
The initial therapeutic dose is 7 mg/kg 2 times a day. Depending on clinical effectiveness and tolerability, the dose may be increased to 21 mg/kg 2 times a day. Dose changes should not exceed ±7 mg/kg 2 times a day every 2 weeks. The minimum effective dose should be prescribed.
Recommended dosages for children from 1 to 6 months
| Body weight, kg | Initial dose: 7 mg/kg 2 times a day | Maximum dose - 21 mg/kg 2 times a day |
| 4 | 28 mg (0.3 ml) 2 times a day | 84 mg (0.85 ml) 2 times a day |
| 5 | 35 mg (0.35 ml) 2 times a day | 105 mg (1.05 ml) 2 times a day |
| 7 | 49 mg (0.5 ml) 2 times a day | 147 mg (1.5 ml) 2 times a day |
Children from 6 months to 11 years and adolescents from 12 to 17 years weighing less than 50 kg.
Treatment should begin with a dose of 20 mg/kg, divided into 2 doses (10 mg/kg 2 times a day). Depending on the clinical response and tolerability of the drug, the daily dose can be increased to 30 mg/kg 2 times a day. The dose can be changed by 20 mg/kg (10 mg/kg 2 times a day) of body weight every 2 weeks. The minimum effective dose should be used.
Recommended dosages for children (from 6 months) and adolescents (up to 17 years)
| Body weight, kg | Initial dose: 10 mg/kg 2 times a day | Maximum dose - 30 mg/kg 2 times a day |
| 6* | 60 mg (0.6 ml) 2 times a day | 180 mg (1.8 ml) 2 times a day |
| 10* | 100 mg (1 ml) 2 times a day | 300 mg (3 ml) 2 times a day |
| 15* | 150 mg (1.5 ml) 2 times a day | 450 mg (4.5 ml) 2 times a day |
| 20* | 200 mg (2 ml) 2 times a day | 600 mg (6 ml) 2 times a day |
| 25 | 250 mg 2 times a day | 750 mg 2 times a day |
| from 50** | 500 mg 2 times a day | 1500 mg 2 times a day |
* For children weighing 25 kg or less, it is preferable to start treatment with Keppra®, oral solution, 100 mg/ml.
** The dosage for children and adolescents weighing more than 50 kg is the same as for adults.
Due to the lack of the required dosage, the tablets are not intended for the treatment of children weighing less than 25 kg, when a dose is prescribed less than 250 mg, as well as for patients who have difficulty swallowing them. In these cases, it is recommended to begin treatment by taking the drug in the form of an oral solution.
Adults and adolescents (from 12 to 17 years old) weighing more than 50 kg.
The initial daily dose is 1000 mg in 2 divided doses (500 mg 2 times a day). Depending on the clinical response and tolerability of the drug, the daily dose can be increased to a maximum of 3000 mg (1500 mg 2 times a day). The dose can be changed to 500 mg 2 times a day every 2–4 weeks.
Special patient groups
Renal dysfunction.
Since levetiracetam is excreted from the body by the kidneys, when prescribing the drug to patients with renal failure, the dose should be adjusted depending on the creatinine clearance.
Creatinine clearance for men can be calculated from serum creatinine concentration using the following formula:
Cl creatinine, ml/min=(140−age, years)×body weight, kg/72×Cl serum creatinine, mg/dl
Creatinine clearance for women can be calculated by multiplying the resulting value by a factor of 0.85.
Creatinine clearance is then adjusted for body surface area (BSA) using the following formula:
Cl creatinine, ml/min/1.73 m2=Cl creatinine, ml/min×1.73/BSA of object, m2
Dose adjustment for adults
| Kidney failure | Cl creatinine, ml/min/1.73 m2 | Dosage regimen |
| Absent (normal) | >80 | from 500 to 1500 mg 2 times a day |
| Lightweight | 50–79 | from 500 to 1000 mg 2 times a day |
| Moderate | 30–49 | from 250 to 750 mg 2 times a day |
| Heavy | <30 | from 250 to 500 mg 2 times a day |
| End stage (hemodialysis patients) | — | from 500 to 1000 mg 1 time per day* |
* On the first day of treatment with levetiracetam, a loading dose of 750 mg is recommended. After dialysis, an additional dose of 250–500 mg is recommended.
In children with renal failure, dose adjustment of levetiracetam should be made taking into account the degree of renal failure.
Creatinine clearance (ml/min/1.73 m2) can be estimated from serum creatinine (mg/dL) for adolescents, children and neonates using the following formula (Schwartz formula):
Cl creatinine, ml/min/1.73 m2=height, cm×ks/Cl serum creatinine, mg/dl
ks=0.45 for children under 1 year; ks=0.55 for children under 13 years of age and female adolescents; ks=0.7 for male adolescents.
Dose adjustment for newborns, children and adolescents weighing less than 50 kg
| Kidney failure | Cl creatinine, ml/min/1.73 m2 | Dosage regimen | |
| from 1 to 6 months | from 6 months | ||
| Absent (normal) | >80 | 7–21 mg/kg (0.07–0.21 ml/kg) 2 times a day | 10–30 mg/kg (0.1–0.3 ml/kg) 2 times a day |
| Lightweight | 50–79 | 7–14 mg/kg (0.07–0.14 ml/kg) 2 times a day | 10–20 mg/kg (0.1–0.2 ml/kg) once a day |
| 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) 2 times a day |
| Heavy | <30 | 3.5–7 mg/kg (0.035–0.07 ml/kg) 2 times a day | 5–10 mg/kg (0.1–0.2 ml/kg) 2 times a day |
| End stage (hemodialysis patients) | — | 7–14 mg/kg (0.07–0.14 ml/kg) 1 time per day* | 10–20 mg/kg (0.1–0.2 ml/kg) once a day** |
* On the first day of treatment with levetiracetam, a loading dose of 10.5 mg/kg (0.105 ml/kg) is recommended. After dialysis, an additional dose of 3.5–7 mg/kg (0.035–0.07 ml/kg) is recommended.
**On the first day of treatment with levetiracetam, a loading dose of 15 mg/kg (0.15 ml/kg) is recommended. After dialysis, an additional dose of 5–10 mg/kg (0.05–0.1 ml/kg) is recommended.
Liver dysfunction.
Patients with mild to moderate liver dysfunction do not require dosage adjustment. In patients with decompensated liver function and renal failure, the decrease in creatinine clearance may not fully reflect the severity of renal failure. In such cases, with creatinine clearance <60 ml/min/1.73 m2, it is recommended to reduce the daily dose by 50%.
Keppra concentrate for solution for infusion 100 mg/ml 5 ml bottle 10 pcs. in Moscow
IV
drip, in the form of infusion, for 15 minutes.
The transition from oral to intravenous use and back can be carried out while maintaining the dose and frequency of administration.
One bottle of concentrate for solution for infusion contains 500 mg of levetiracetam (100 mg/ml).
The daily dose is divided into two injections of the same dose.
Before use, the concentrate must be diluted with a solvent of at least 100 ml.
Monotherapy
Adults and teenagers over 16 years of age.
Treatment should begin with a daily dose of 500 mg, divided into 2 administrations (250 mg 2 times a day). After 2 weeks, the dose can be increased to the initial therapeutic dose of 1000 mg (500 mg 2 times a day). The maximum daily dose is 3000 mg (1500 mg 2 times a day).
The following solvents can be used:
- 0.9% sodium chloride solution for injection;
- lactated Ringer's solution for injection;
- 5% dextrose solution for injection.
The solution remains chemically stable at 15–25 °C for 24 hours in PVC bags.
However, from the point of view of microbiological purity, the drug must be used immediately after dilution.
If necessary, the solution can be stored at a temperature of 2 to 8 °C for 24 hours, provided that the dilution was carried out under aseptic conditions. In this case, responsibility for microbiological cleanliness lies with the user.
The use of the drug is not allowed if the color of the solution changes or mechanical inclusions appear.
As part of complex therapy
Children from 4 to 11 years old and adolescents 12–17 years old weighing up to 50 kg.
Treatment should begin with a daily dose of 20 mg/kg, divided into 2 administrations (10 mg/kg 2 times a day). The dose can be changed by 10 mg/kg every 2 weeks until the recommended daily dose is reached - 60 mg/kg (30 mg/kg 2 times a day). If the recommended daily dose is not tolerated, it may be reduced.
There is no clinical experience with the infusion of levetiracetam for periods exceeding 4 days.
The minimum effective dose should be used.
Recommended dosages for children (from 4 years old) and adolescents (up to 17 years old)
| Body weight, kg | Initial dose: 10 mg/kg, 2 times a day | Maximum dose - 30 mg/kg, 2 times a day |
| 15 | 150 mg 2 times a day | 450 mg 2 times a day |
| 20 | 200 mg 2 times a day | 600 mg 2 times a day |
| 25 | 250 mg 2 times a day | 750 mg 2 times a day |
| from 50 | 500 mg 2 times a day | 1500 mg 2 times a day |
Adults and adolescents weighing more than 50 kg.
Treatment should begin with a daily dose of 1000 mg, divided into 2 administrations (500 mg 2 times a day). Depending on the clinical response and tolerability of the drug, the daily dose can be increased to a maximum of 3000 mg (1500 mg 2 times a day). The dose can be changed to 500 mg 2 times a day every 2–4 weeks.
The duration of the course of treatment is determined by the doctor.
Inside,
regardless of food intake. The daily dose is divided into 2 doses of the same dose.
The tablets are taken with a sufficient amount of liquid.
The tablets are not intended for children under 6 years of age due to the impossibility of selecting the correct dose.
In the case of a solution, dosing is carried out using a measuring syringe included with the drug, with a nominal capacity of 10 ml (corresponding to 1000 mg of levetiracetam) with a division value of 25 mg (corresponding to 0.25 ml). The measured dose of the drug is diluted in a glass of water (200 ml).
Dosing of the solution is carried out using measuring syringes included in the delivery package of the drug. Syringes are available with nominal capacities:
- 10 ml (corresponding to 1000 mg of levetiracetam) and with a division price of 0.25 ml (corresponding to 25 mg) for children 4 years and older, adolescents and adults;
- 3 ml (corresponds to 300 mg) with a division price of 0.1 ml (corresponds to 10 mg) for children from 6 months to 4 years;
- 1 ml (corresponds to 100 mg) and divided into 0.05 ml (corresponds to 5 mg) for children from 1 to 6 months.
A measured dose of the drug is diluted in a glass of water or a baby bottle.
Instructions for dosing the solution using a measuring syringe
1. Open the bottle: to do this, press the cap and turn it counterclockwise.
2. Insert the syringe adapter into the neck of the bottle, make sure it is well fixed, then take the syringe and place it in the adapter.
3. Turn the bottle upside down.
4. Fill the syringe with a small amount of solution by pulling the plunger down, then push the plunger up (to remove air bubbles).
5. By pulling the plunger, fill the syringe with the solution until the division corresponds to the number of ml of the solution prescribed by the doctor.
6. Turn the bottle upside down and remove the syringe from the adapter.
7. Introduce the contents of the syringe into a glass of water or a baby bottle, pressing the plunger all the way.
8. Drink the entire contents of the glass (or baby bottle).
9. Rinse the syringe with water.
10. Close the bottle with a plastic cap.
Monotherapy
Adults and teenagers over 16 years of age.
The initial daily dose is 500 mg in 2 divided doses (250 mg 2 times a day). After 2 weeks, the dose can be increased to the initial therapeutic dose of 1000 mg (500 mg 2 times a day). The maximum daily dose is 3000 mg (1500 mg 2 times a day).
As part of complex therapy
Children from 1 to 6 months.
The initial therapeutic dose is 7 mg/kg 2 times a day. Depending on clinical effectiveness and tolerability, the dose may be increased to 21 mg/kg 2 times a day. Dose changes should not exceed ±7 mg/kg 2 times a day every 2 weeks. The minimum effective dose should be prescribed.
Recommended dosages for children from 1 to 6 months
| Body weight, kg | Initial dose: 7 mg/kg 2 times a day | Maximum dose - 21 mg/kg 2 times a day |
| 4 | 28 mg (0.3 ml) 2 times a day | 84 mg (0.85 ml) 2 times a day |
| 5 | 35 mg (0.35 ml) 2 times a day | 105 mg (1.05 ml) 2 times a day |
| 7 | 49 mg (0.5 ml) 2 times a day | 147 mg (1.5 ml) 2 times a day |
Children from 6 months to 11 years and adolescents from 12 to 17 years weighing less than 50 kg.
Treatment should begin with a dose of 20 mg/kg, divided into 2 doses (10 mg/kg 2 times a day). Depending on the clinical response and tolerability of the drug, the daily dose can be increased to 30 mg/kg 2 times a day. The dose can be changed by 20 mg/kg (10 mg/kg 2 times a day) of body weight every 2 weeks. The minimum effective dose should be used.
Recommended dosages for children (from 6 months) and adolescents (up to 17 years)
| Body weight, kg | Initial dose: 10 mg/kg 2 times a day | Maximum dose - 30 mg/kg 2 times a day |
| 6* | 60 mg (0.6 ml) 2 times a day | 180 mg (1.8 ml) 2 times a day |
| 10* | 100 mg (1 ml) 2 times a day | 300 mg (3 ml) 2 times a day |
| 15* | 150 mg (1.5 ml) 2 times a day | 450 mg (4.5 ml) 2 times a day |
| 20* | 200 mg (2 ml) 2 times a day | 600 mg (6 ml) 2 times a day |
| 25 | 250 mg 2 times a day | 750 mg 2 times a day |
| from 50** | 500 mg 2 times a day | 1500 mg 2 times a day |
* For children weighing 25 kg or less, it is preferable to start treatment with Keppra®, oral solution, 100 mg/ml.
** The dosage for children and adolescents weighing more than 50 kg is the same as for adults.
Due to the lack of the required dosage, the tablets are not intended for the treatment of children weighing less than 25 kg, when a dose is prescribed less than 250 mg, as well as for patients who have difficulty swallowing them. In these cases, it is recommended to begin treatment by taking the drug in the form of an oral solution.
Adults and adolescents (from 12 to 17 years old) weighing more than 50 kg.
The initial daily dose is 1000 mg in 2 divided doses (500 mg 2 times a day). Depending on the clinical response and tolerability of the drug, the daily dose can be increased to a maximum of 3000 mg (1500 mg 2 times a day). The dose can be changed to 500 mg 2 times a day every 2–4 weeks.
Special patient groups
Renal dysfunction.
Since levetiracetam is excreted from the body by the kidneys, when prescribing the drug to patients with renal failure, the dose should be adjusted depending on the creatinine clearance.
Creatinine clearance for men can be calculated from serum creatinine concentration using the following formula:
Cl creatinine, ml/min=(140−age, years)×body weight, kg/72×Cl serum creatinine, mg/dl
Creatinine clearance for women can be calculated by multiplying the resulting value by a factor of 0.85.
Creatinine clearance is then adjusted for body surface area (BSA) using the following formula:
Cl creatinine, ml/min/1.73 m2=Cl creatinine, ml/min×1.73/BSA of object, m2
Dose adjustment for adults
| Kidney failure | Cl creatinine, ml/min/1.73 m2 | Dosage regimen |
| Absent (normal) | >80 | from 500 to 1500 mg 2 times a day |
| Lightweight | 50–79 | from 500 to 1000 mg 2 times a day |
| Moderate | 30–49 | from 250 to 750 mg 2 times a day |
| Heavy | <30 | from 250 to 500 mg 2 times a day |
| End stage (hemodialysis patients) | — | from 500 to 1000 mg 1 time per day* |
* On the first day of treatment with levetiracetam, a loading dose of 750 mg is recommended. After dialysis, an additional dose of 250–500 mg is recommended.
In children with renal failure, dose adjustment of levetiracetam should be made taking into account the degree of renal failure.
Creatinine clearance (ml/min/1.73 m2) can be estimated from serum creatinine (mg/dL) for adolescents, children and neonates using the following formula (Schwartz formula):
Cl creatinine, ml/min/1.73 m2=height, cm×ks/Cl serum creatinine, mg/dl
ks=0.45 for children under 1 year; ks=0.55 for children under 13 years of age and female adolescents; ks=0.7 for male adolescents.
Dose adjustment for newborns, children and adolescents weighing less than 50 kg
| Kidney failure | Cl creatinine, ml/min/1.73 m2 | Dosage regimen | |
| from 1 to 6 months | from 6 months | ||
| Absent (normal) | >80 | 7–21 mg/kg (0.07–0.21 ml/kg) 2 times a day | 10–30 mg/kg (0.1–0.3 ml/kg) 2 times a day |
| Lightweight | 50–79 | 7–14 mg/kg (0.07–0.14 ml/kg) 2 times a day | 10–20 mg/kg (0.1–0.2 ml/kg) once a day |
| 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) 2 times a day |
| Heavy | <30 | 3.5–7 mg/kg (0.035–0.07 ml/kg) 2 times a day | 5–10 mg/kg (0.1–0.2 ml/kg) 2 times a day |
| End stage (hemodialysis patients) | — | 7–14 mg/kg (0.07–0.14 ml/kg) 1 time per day* | 10–20 mg/kg (0.1–0.2 ml/kg) once a day** |
* On the first day of treatment with levetiracetam, a loading dose of 10.5 mg/kg (0.105 ml/kg) is recommended. After dialysis, an additional dose of 3.5–7 mg/kg (0.035–0.07 ml/kg) is recommended.
**On the first day of treatment with levetiracetam, a loading dose of 15 mg/kg (0.15 ml/kg) is recommended. After dialysis, an additional dose of 5–10 mg/kg (0.05–0.1 ml/kg) is recommended.
Liver dysfunction.
Patients with mild to moderate liver dysfunction do not require dosage adjustment. In patients with decompensated liver function and renal failure, the decrease in creatinine clearance may not fully reflect the severity of renal failure. In such cases, with creatinine clearance <60 ml/min/1.73 m2, it is recommended to reduce the daily dose by 50%.
