LEVEBRAIN
(Levetiracetam)




COMPOSITION

A film coated tablet contains:

Active substance: levetiracetam 250 mg, 500 mg or 1000 mg.

Excipients: silica colloidal anhydrous, talc, povidone K30, partially pregelatinised maize starch, magnesium stearate.

Film coating composition:

Levebrain 250 mg: Opadry® II Blue 85F20400 (polyvinyl alcohol partially hydrolyzed, macrogol, titanium dioxide, talc, indigo carmine aluminum lake).

Levebrain 500 mg: Opadry® II Yellow 85F220095 (polyvinyl alcohol partially hydrolyzed, macrogol, titanium dioxide, talc, iron oxide yellow, tartrazine aluminum lake, sunset yellow FCF aluminum lake).

Levebrain 1000 mg: Opadry® II White 85F18422 (polyvinyl alcohol partially hydrolyzed, macrogol, titanium dioxide, talc).

THERAPEUTIC INDICATIONS

As monotherapy (first choice drug) for treatment of:

- partial seizures with or without secondary generalization in adults and adolescents over 16 years with again diagnosed epilepsy.

As a part of complex therapy for treatment of:

- partial seizures with or without secondary generalization in adults and children over 6 years, suffered from epilepsy;

- myoclonic seizures in adults and adolescents over 12 years, suffered from juvenile myoclonic epilepsy;

- primary-generalized convulsive (tonic-clonic) seizures in adults and adolescents over 12 years, suffered from idiopathic generalized epilepsy.

CONTRAINDICATIONS

- hypersensitivity to the levetiracetam or other pyrrolidone derivatives or to any of the excipients.

ADVERSE EFFECTS

Side effects frequencies are defined as: very common (≥ 1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000).

Nervous system disorders: very common - somnolence, headache; common - convulsion, balance disorder, dizziness, lethargy, tremor; uncommon - amnesia, memory impairment, coordination abnormal/ataxia, paraesthesia, disturbance in attention; rare - choreoathetosis, dyskinesia, hyperkinesia.

Psychiatric disorders : common - depression, hostility/aggression, anxiety, insomnia, nervousness/irritability; uncommon - suicide attempt and suicidal intent, confusional state, hallucination, anger, emotional lability, moodiness; rare - completed suicide, personality disorder, thinking abnormal.

Gastrointestinal disorders : common - abdominal pain, diarrhoea, dyspepsia, vomiting, nausea; uncommon – changes in liver function test; rare - pancreatitis, hepatic failure, hepatitis.

Metabolism and nutrition disorders: common - anorexia; uncommon - weight increase.

Eye disorders : uncommon - diplopia, accomodation disorder.

Respitory disorders : common - cough intensification.

Skin disorders : common - rash; uncommon - alopecia, eczema, pruritus; rare - toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema.

Changes in laboratory parameters: uncommon - thrombocytopenia, leukopenia; rare - pancytopenia, neutropenia.

Other: very common - nasopharyngitis; commom - vertigo, asthenia, fatique; uncommon - muscular weakness, myalgia, injury; rare - infections.

DOSAGE AND ADMINISTRATION

Levebrain is taken by mouth without regard to food washing down with enough water. Daily dose is halved in equal doses.

As monotherapy:

Adults and adolescents over 16 years, treatment shall be initiated with daily dose of 500 mg, divided for two administrations (by 250 mg 2 times a day). In 2 weeks dose may be increased to initial therapeutic dose of 1000 mg (by 500 mg 2 times a day). Maximum daily dose is 3000 mg (by 1500 mg 2 times a day).

As a part of complex therapy:

In adults and adolescents (12-16 years) with body weight over 50 kg, treatment shall be initiated from the daily dose of 1000 mg, divided for 2 administration (by 500 mg 2 times a day). Dependent on clinical reaction and tolerance of the drug, daily dose may be increased to maximal dose of 3000 mg (by 1500 mg 2 times a day). Dose change to 500 mg 2 times a day may be performed by every 2-4 weeks.

In children over 6 years and adolescents (12-16 years) with body weight under 50 kg

Physician shall indicate the drug in the most suitable pharmaceutical form and dosage in dependence on patients’ body weight and necessary therapeutical dose.

In children with body weight of 20 kg or less, or children under 6 years, it is recommended to initiate treatment with drug administration in the form of oral solution.

Treatment shall be initiated from the daily dose of 20 mg/kg of body weight, divided for 2 administrations (by 10 mg/kg of body weight 2 times a day). Dose change by 20 mg/kg of body weight may be performed every 2 weeks to achieving recommended daily dose of 60 mg/kg of body weight (by 30 mg/kg of body weight 2 times a day). When intolerance of recommended daily dose occurs, its decrease is possible. Minimal effective dose shall be taken.

In children with body weight over 50 kg, a dosage is performed in accordance with the schedule provided for adults.

As levetiracetam is renally excreted, dose shall be adjusted in correspondence with creatinine clearance (CC), when indicating the drug to the patients with renal insufficiency and elderly patients.

Renal insuffiency

CC (ml/min/1 .73 m2)

Dosage regimen

Normal

> 80

500 - 1500 mg 2 times a day

Latent

50-79

500 - 1000 mg 2 times a day

Compensated

30-49

250 - 750 mg 2 times a day

Intermittent

< 30

250 - 500 mg 2 times a day

End-stage

(patients on dialysis*)

-

500 - 1000 mg once a day**

* Loading dose of 750 mg is recommended in the first day of treatment.

** Additional dose of 250-500 mg is recommended following dialysis.

Dose adjustment for levetiracetam in children with renal insufficiency shall be performed with taking into account the degree of renal insufficiency.

Dosage regimen for children and adolescents with body weight under 50 kg and with impaired renal function:


Renal insufficiency

CC (ml/min/1 .73 m2)

Dosage regimen

Normal

> 80

10 - 30 mg/kg 2 times a day

Latent

50-79

10 - 20 mg/kg 2 times a day

Compensated

30-49

5 - 15 mg/kg 2 times a day

Intermittent

< 30

5 - 10 mg/kg 2 times a day

End-stage

(patients on dialysis)

-

10 - 20 mg/kg once a day (*) (**)

* Loading dose of 15 mg/kg is recommended in the first day of treatment.

** Additional dose of 5-10 mg/kg is recommended following dialysis.

There is no need to adjust dosage regimen in patients with mild to moderate liver dysfunction. In patients with decompensated liver dysfunction and renal insufficiency, CC decrease level may not adequately reflect the degree of renal insufficiency. In such cases, with CC of < 60 ml/min/1.73 м2, decrease of daily dose by 50% is recommended.

DRUG INTERACTIONS

Drug is not interacted with antiepileptic drugs (phenytoin, carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin and primidone).

As in adults, there is no evidence of clinically significant drug interactions in pediatric patients, receiving approximately 60 mg/kg/day of levetiracetam.

Levetiracetam in daily dose of 1000 mg does not change pharmacokinetics of oral contraceptives (ethinyl estradiol and levonogestrel). Levetiracetam in daily dose of 2000 mg does not change pharmacokinetics of digoxin and warfarin. Digoxin, oral contraceptives and warfarin does not affect pharmacokinetics of levetiracetam.

Concurrent use of topiramate increases the possibility of anorexia occurrence.

Absorption completeness of levetiracetam is not affected by food intake with slight decrease of absorption rate.

There is no data regarding interaction of levetiracetam with alcohol.

SPECIAL INDICATIONS

Care shall be taken when indicating drug to the elderly patients (over 65 years), with hepatic disorders in decompensation stage, with renal insufficiency.

Patients with renal disorders and decompensated hepatic disorders are advised to test renal function before treatment initiation. With impaired renal function, dose adjustment may be needed.

If there is the need to discontinue drug administration, the discontinuation is recommended to be performed gradually. In adults and adolescents with body weight over 50 kg, single dose is decreased by 500 mg every 2-4 weeks. In children and adolescents with body weight under 50 kg, dose decrease shall not exceed 10 mg/kg of body weight 2 times a day for every 2 weeks.

Concurrent antiepileptic agents (during the period of patient transfer to levetiracetam) shall preferably be discontinued gradually. Data available on the use of drug in children does not indicate negative effect on development and puberty. However, remote effects on children learning ability, intelligence, growth, functions of endocrine glands, sexual development and fertility remain unknown.

Due to available reports on suicide cases, suicidal intent and suicidal attempts during treatment with levetiracetam, patients shall be warned about necessity to inform attending doctor immediately about any symptoms of depression or suicidal intent.

PREGNANCY AND LACTATION

Drug shall not be indicated during pregnancy (unless extreme necessity), as there is no adequate and well-controlled clinical trials investigating safety of levetiracetam use in pregnant women. Levetiracetam is excreted in human breast milk, therefore, during treatment breast-feeding is not recommended.

MANUFACTURED FORM AND PACKAGE

Film coated tablets.

10 tablets in a blister.

3 or 5 blisters with the enclosed leaflet in a carton box.

Alimentary Tract and Metabolism

All Products
Choludexan
Cocarnit
Coledan
D-Calcin
Dialin
Doprokin
Doprokin-S
Duskonal
Emfetal
Gold Ray
Kercavit
Lacidofil
Listora
Medulac
Metacartin
Panivit
Polijen
Reytoil
Silarsil
Simalgel
Sunovit
Ulsepan
Yodofol

Home      |      Site Map      |      Terms of Use      |      Privacy Policy

2015 WORLD MEDICINE. All Rights Reserved.