Sycocetam 100 mg/ml Oral Solution 120 ml

Sycocetam 100 mg/ml Oral Solution 120 ml

Composition:

Levetiracetam – 100 mg/ml.
Methylparahydroxybenzoate – 1.0 mg/ml.
Propylparahydroxybenzoate – 0.2 mg/ml.
Sodium acetate trihydrate – 1.0 mg/ml.
Citric acid monohydrate – 0.5 mg/ml.
Glycerol – 150 mg/ml.
Liquid maltitol – 200 mg/ml.
Flavoring (anise, grape).
Purified water – up to 1 ml.

Product Description:

An antiepileptic agent containing levetiracetam.
It has pronounced anticonvulsant activity, reducing the frequency and intensity of epileptic seizures.
The mechanism of action is associated with binding to the SV2A protein, which decreases neuronal excitability.
The solution is intended for oral administration and is supplied in 120 ml bottles.

Indications for use:

Partial (focal) seizures in adults and children from 1 month of age.
Myoclonic seizures in juvenile myoclonic epilepsy in patients from 12 years of age.
Primary generalized tonic-clonic seizures in idiopathic generalized epilepsy in patients from 6 years of age.

Method of administration and dosage:

Adults and adolescents ≥16 years:
initial dose 500 mg twice daily, increased up to 1500 mg twice daily.
Children 4–16 years: 10 mg/kg twice daily, increased up to 30 mg/kg twice daily.
Children 6 months–4 years: 10 mg/kg twice daily, increased up to 25 mg/kg twice daily.
Children 1–6 months: 7 mg/kg twice daily, increased up to 21 mg/kg twice daily.

Contraindications:

Hypersensitivity to levetiracetam or excipients.
Severe allergic reactions (angioedema, anaphylaxis).

Precautions:

Dose adjustment in renal impairment.
Caution in patients with psychiatric disorders (depression, suicidal thoughts).
Do not use household spoons for dosing, only a measuring syringe or dispenser.

Adverse reaction / Side effects:

Drowsiness, dizziness, weakness.
Behavioral disturbances, irritability, depression.
Gastrointestinal disorders (nausea, diarrhea).
Rarely – skin reactions, seizures, angioedema.

Pregnancy and lactation:

Use is possible only if the benefit outweighs the risk.
Levetiracetam passes into breast milk; breastfeeding is not recommended during therapy.

Storage conditions:

Store at a temperature not exceeding 25 °C, in the original packaging, protected from light and moisture.
Keep out of the reach of children.

Packaging:

Dark glass bottle of 120 ml, supplied with a measuring device.
Carton packaging.