Levebrain Solution
(Levetiracetam)




COMPOSITION

1 mL solution contains:

Active substance: levetiracetam 100 mg.

Excipients: glycerol, propyl parahydroxybenzoate, methyl parahydroxybenzoate, ammonium glycyrrhizate, citric acid monohydrate, sodium citrate, acesulfame potassium, maltitol, grapefruit flavour, purified water.

THERAPEUTIC INDICATIONS

The drug is indicated as monotherapy (first choice drug) in the treatment of the following:

- partial-onset seizures with or without secondary generalisation in adults and adolescents older than 16 years of age with newly diagnosed epilepsy.

The drug is indicated as combined therapy in the treatment of the following:

- partial-onset seizures with or without secondary generalisation in adults or children from 1 month of age with epilepsy;

- myoclonic seizures in adults and adolescents older than 12 years of age with juvenile myoclonic epilepsy;

- primary generalised seizures (tonic-clonic) in adults and adolescents older than 12 years of age with idiopathic generalised epilepsy.

CONTRAINDICATIONS

- hypersensitivity to levetiracetam or other pyrrolidone derivatives, or to any of the drug excipients;

- intolerance to fructose.

ADVERSE EFFECTS

The used side effects frequency parameters presented below are classified in the following way: very frequently (from ≥ 1/10), frequently (from ≥ 1/100 to < 1/10), infrequently (from ≥ 1/1000 to < 1/100), rarely (from ≥ 1/10000 to < 1/1000).

Nervous system disorders: very frequently – somnolence, headache; frequently - convulsions, balance disorder, dizziness, atony, tremor; infrequently - amnesia, memory impairment, impaired coordination/ ataxia, paresthesia, impaired attention; rarely - choreoathetosis, dyskinesia, hyperkinesia.

Psychiatric disorders: frequently – depression, hostility/ aggression, anxiety, insomnia, nervousness/irritability; infrequently – suicide attempt and suicidal intents, confused consciousness, hallucinations, anger, emotional lability, moodiness; rarely – completed suicide, personality disorder, thinking abnormal.

Gastrointestinal disorders: frequently – abdominal pain, diarrhoea, dyspepsia, vomiting, nausea; infrequently – changes in liver function tests; rarely – pancreatitis, hepatic failure, hepatitis.

Metabolism and nutrition disorders: frequently – anorexia; infrequently – weight increase.

Eye disorders: infrequently – diplopia, accommodation disorder.

Respiratory disorders: frequently - increased cough.

Skin disorders: frequently - rash; infrequently – alopecia, eczema, pruritus; rarely – toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema.

Changes in laboratory values: infrequently – thrombocytopenia, leukopenia; rarely – pancytopenia, neutropenia.

Others: very frequently – nasopharyngitis; frequently – vertigo, asthenia, fatigue; infrequently – muscle weakness, mialgia, traumas; rarely – infections.

DOSAGE AND ADMINISTRATION

Levebrain is for oral administration, without regard to food.

The daily dose is divided into two equal doses.

The dosing is performed using a 1-mL graduated injector (100 mg levetiracetam) or a 5-mL graduated injector (500 mg levetiracetam) or 10-mL graduated injector (1000 mg levetiracetam). The metered dose is diluted with 200 mL water.

Infants aged from 1 to 6 months are prescribed Levebrain oral solution in a 150-mL bottle with a 1-mL graduated injector graduated every 0.05 mL, which corresponds to 5 mg levetiracetam.

Infants and young children aged from 6 months to less than 4 years are prescribed Levebrain oral solution in a 150-mL bottle with a 5-mL graduated injector graduated every 0.1 mL, which corresponds to 10 mg levetiracetam.

Children aged from 4 years and older, adolescents and adults are prescribed Levebrain oral solution in a 300-mL bottle with a 10-mL graduated injector graduated every 0.25 mL, which corresponds to 25 mg levetiracetam.

Monotherapy

For adults and adolescents older than 16 years, the treatment should be started with a daily dose of 500 mg given in two divided doses (250 mg twice a day). The dose can be increased to initial therapeutic dose of 100 mg (500 mg twice daily) after two weeks. The dose can be further increased by 250 mg twice daily every two weeks depending upon the clinical response. The maximum daily dose is 3,000 mg (1,500 mg twice a day).

The safety and efficacy of Levebrain administration as monotherapy in children and adolescents under the age of 16 years have not been established.

Combined therapy

For adults and adolescents (up to 16 years old) weighing 50 kg or more, the treatment should be started with a daily dose of 1000 mg given in 2 divided doses (500 mg twice a day). Depending upon the clinical response and the drug tolerability, the daily dose can be increased up to maximum dose of 3,000 mg (1,500 mg twice daily). Dose changes by 500 mg twice daily can be made every two to four weeks.

For children aged from 4 to 11 years and adolescents (younger than 16 years old) weighing less than 50 kg (this dosage form is preferable for children younger than 6 years old), the treatment should be started with a daily dose of 20 mg/kg body weight given in 2 divided doses (10 mg/kg body weight twice daily). The dosage may be adjusted in increments of 20 mg/kg body weight every 2 weeks to a recommended daily dose of 60 mg/kg body weight (30 mg/kg body weight twice a day). The recommended daily dose can be decreased in case of its intolerance. The lowest effective dose should be administered. The physician should prescribe the drug in the most appropriate pharmaceutical form and dosage, depending on the patient body weight and the required therapeutic dose. For children weighing 20 kg or less, the treatment is recommended to start with oral solution.

For children weighing more than 50 kg, dosing is carried out according to the scheme described for adults.

Dosage regimen for infants from 6 months of age and older, children and adolescents:

Weight, kg

Starting dose

10 mg/kg twice daily

Maximum dose

30 mg/kg twice daily

6

60 mg (0.6 mL) twice daily

180 mg (1.8 mL) twice daily

10

100 mg (1 mL) twice daily

300 mg (3 mL) twice daily

15

150 mg (1.5 mL) twice daily

450 mg (4.5 mL) twice daily

20

200 mg (2 mL) twice daily

600 mg (6 mL) twice daily

25

250 mg (2.5 mL) twice daily

750 mg (7.5 mL) twice daily

From 50*

500 mg (5 mL) twice daily

1,500 mg (15 mL) twice daily

* Dose for children and adolescents weighing 50 kg or more is the same as for adults.

For children aged from 1 to 6 months , the treatment should be started with initial therapeutic dose of 7 mg/kg twice daily. Depending upon the clinical response and the drug tolerability, the dose can be increased to 21 mg/kg twice daily. Dose changes should not exceed increases or decreases of 7 mg/kg twice daily every two weeks. The lowest effective dose should be used.

Weight, kg

Starting dose

7 mg/kg twice daily

Maximum dose

21 mg/kg twice daily

4

28 mg (0.3 mL) twice daily

84 mg (0.85 mL) twice daily

5

35 mg (0.35 mL) twice daily

105 mg (1.05 mL) twice daily

7

49 mg (0.5 mL) twice daily

147 mg (1.5 mL) twice daily

Since levetiracetam is excreted by the kidneys, a dose for patients with renal impairment and for the elderly should be adjusted depending on the amount of creatinine clearance (CC).

Renal impairment

CC (mL/ min /1 . 73 m 2 )

D osage regimen

Normal

> 80

500 mg to 1500 mg twice daily

Latent

50-79

500 mg to 1000 mg twice daily

Compensated

30-49

250 mg to 750 mg twice daily

Intermittent

< 30

250 mg to 500 mg twice daily

End-stage disease

(patients undergoing dialysis*)

500 mg to 1000 mg once daily**

* A 750 mg loading dose is recommended on the first day of treatment with levetiracetam.

** Following dialysis, a 250 to 500 mg supplemental dose is recommended.

For children with renal impairment , levetiracetam dose needs to be adjusted based on the renal function severity.

Dosage regimen for infants, children and adolescents weighing less than 50 kg and with impaired renal function:

Renal impairment

CC (mL/ min /1 . 73 m 2 )

D osage regimen*

Infants aged 1 to 6 months

Infants aged 6 to 23 months, children and adolescents weighing less than 50 kg

Normal

> 80

7 to 21 mg/kg

(0.07 to 0.21 mL/kg)

twice daily

10 to 30 mg/kg

(0.10 to 0,30 mL/kg)

twice daily

Latent

50-79

7 to 14 mg/kg

(0.07 to 0.14 mL/kg)

twice daily

10 to 20 mg/kg

(0.10 to 0.20 mL/kg)

twice daily

Compensated

30-49

3.5 to 10.5 mg/kg

(0.035 to 0.105 mL/kg)

twice daily

5 to 15 mg/kg

(0.05 to 0.15 mL/kg)

twice daily

Intermittent

< 30

3.5 to 7 mg/kg

(0.035 to 0.07 mL/kg)

twice daily

От 5 до 10 mg/kg

(от 0,05 до 0,10 mL/kg)

twice daily

End-stage disease

(patients undergoing dialysis)

7 to 14 mg/kg

(0.07 to 0.14 mL/kg)

once daily (**) (****)

10 to 20 mg/kg

(0.10 to 0.20 mL/kg)

once daily (***) (*****)

* The drug should be used in doses under 250 mg.

** A 10.5 mg/kg (0.105 mL/kg) loading dose is recommended on the first day of treatment with levetiracetam.

*** A 15 mg/kg (0.15 mL/kg) loading dose is recommended on the first day of treatment with levetiracetam.

**** Following dialysis, a 3.5 to 7 mg/kg (0.035 to 0.07 mL/kg) supplemental dose is recommended.

***** Following dialysis, a 5 to 10 mg/kg (0.05 to 0.10 mL/kg) supplemental dose is recommended.

No dose adjustment is needed in patients with mild to moderate hepatic impairment. In patients with decompensated liver dysfunction and renal failure, decreased creatinine clearance level may not fully reflect the severity of renal failure. Therefore, a 50 % reduction of daily dose is recommended when the creatinine clearance is < 60 mL/min/1.73 m2.

SPECIAL INDICATIONS

The drug is prescribed with caution in elderly patients (over 65 years old) with decompensated liver disease, renal insufficiency.

Patients with renal disease and decompensated liver disease are recommended to perform renal function tests before the treatment. Dosage adjustment may be required if kidney function is impaired.

If the drug has to be discontinued it is recommended to withdraw it gradually. In adults and adolescents weighing more than 50 kg: a single dose is decreased by 500 mg every two to four weeks. In children and adolescents weighting less than 50 kg: a dose decrease should not exceed 10 mg/kg body weight twice daily every two weeks.

Concomitant antiepileptic drugs (during switch to levetiracetam) are recommended to be discontinued gradually. Available data on the drug administration in children do not show any negative impact on their development and sexual maturity. However, long-term effects of the treatment on children's ability to learn, their intellectual development, growth, endocrine function, sexual development and fertility remain unknown.

Taking into account available reports of suicide, suicidal intents and suicide attempts during levetiracetam treatment, patients should be warned of the necessity to inform immediately their doctor about any symptoms of depression or suicidal intents.

PREGNANCY AND LACTATION

The drug should not be administered during pregnancy (except in cases of extreme necessity), since no adequate and strictly controlled clinical studies on levetiracetam safety in pregnant have been performed.

Levetiracetam is excreted in human breast milk. Therefore, breast-feeding is not recommended during the treatment.

MANUFACTURED FORM AND PACKAGE

Oral solution in a 150 ml amber glass bottle with a white child proof cap. 1 bottle with a 1 ml graduated injector together with the enclosed leaflet in a carton box.

Oral solution in a 150 ml amber glass bottle with a white child proof cap. 1 bottle with a 5 ml graduated injector together with the enclosed leaflet in a carton box.

Oral solution in a 300 ml amber glass bottle with a white child proof cap. 1 bottle with a 10 ml graduated injector together with the enclosed leaflet in a carton box.

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