Normeg (levetiracetam) coated tablets 250 mg. №30

Description

Normeg composition
The main active ingredient of the drug is levetiracetam.
The auxiliary substances are: colloidal anhydrous silicon dioxide, povidone, sodium croscarmellose, sodium stearyl sulfate, magnesium stearate, hypromellose, macrogol, titanium dioxide, talc, etc.

Release form
It is produced in the form of tablets, 250 mg of the main active ingredient – levetiracetam.

Pharmacological properties
This Normeg drug belongs to the group of antiepileptic drugs based on levetiracetam.
The main active ingredient, levetiracetam, is a pyrrolidone derivative, which has a different chemical structure from other drugs used in the treatment of epilepsy.
Levetiracetam does not alter the basic characteristics of nerve cells and neurotransmission.
The main active ingredient is able to protect the body of epilepsy sufferers from the occurrence of convulsive seizures, which was studied in laboratory studies used on a wide range of both partial and primary generalized seizures in animals. At the same time, it does not show a pro-convulsive effect.
The main metabolite is inactive. The substance levetiracetam itself has a high degree of solubility and penetration.
The effectiveness of this drug has been confirmed in both focal and generalized epileptic seizures (with epileptiform manifestations and with / photoparoxysmal reactions).

Indications
This drug Normeg is used to treat epilepsy.
As monotherapy, as a drug of first choice, it is prescribed for partial seizures of epilepsy with secondary generalization (or without it) in adults and at the age of 16 and older, in whom epilepsy was diagnosed for the first time.
As an additional therapy, it is prescribed for:

• partial seizures with secondary generalization (or without it) in adults and children over 6 years of age with epilepsy;
• myoclonic seizures in adults and adolescents from 12 years old, patients with juvenile myoclonic epilepsy;
• primary generalized convulsive (tonic-clonic) seizures in adults and adolescents over 12 years old, patients with idiopathic generalized epilepsy.

Contraindications
Not applicable if the patient has hypersensitivity (allergy) to one of the components that make up the drug.

Children
It is used in pediatrics for children from 50 kg.

Application during pregnancy and lactation
It is not used to treat pregnant women (except in cases of absolute necessity).
If there is a need to take this drug, then lactation (breastfeeding) should be suspended during treatment.

Method of administration and dosage
Normeg is taken with a liquid, regardless of food intake (although absorption is somewhat faster with food). Usually, the daily dosage is divided into 2 doses, in equal shares.
When monotherapy in adults and adolescents take:

• at the beginning of therapy – 250 mg 2 times a day (daily dose – 500 mg of levetiracetam);
• after 2 weeks of treatment, the dose is increased to 500 mg 2 times a day (daily dose – 1000 mg of levetiracetam);
• subsequently, but not earlier than 2 weeks later, the dose can be increased by another 250 mg per day.

The maximum daily dose is 3000 mg of levetiracetam per day.
When used as an additional therapy in children from 6 years old with a weight of 50 kg, the dose of the drug is calculated at the rate of 10 mg of levetiracetam per 1 kg of body weight. The dose is taken 2 times a day. The dose is increased by no more than 10 mg per 1 kg of body weight in 2 weeks.
With body weight, a single dosage is calculated:

• from 25 kg – 100 mg of levetiracetam per 1 kg of body weight per day;
• from 50 kg, at the age of 12-17 years – 500 mg 2 times a day;
• the maximum dose per day is 1500 mg 2 times a day.

The dosage may be increased by 500 mg every 2-4 weeks.

Overdose
An overdose of the drug can cause:

• drowsiness;
• excitation;
• aggression;
• respiratory depression;
• oppression of consciousness;
• coma.

In this case, treatment of symptoms, gastric lavage, and intake of enterosorbents is recommended.
The use of hemodialysis is recommended.

Side effects
Therapy with this drug can cause side reactions in the form of:

• nasopharyngitis, infections;
• thrombocytopenia, leukopenia, neutropenia, pancytopenia, agranulocytosis;
• anorexia, weight gain or decrease, hyponatremia;
• depression, hostility / aggressiveness, anxiety, insomnia, nervousness, suicidal thoughts, hallucinations, anger, confusion, panic attacks;
• drowsiness, imbalance, dizziness, lethargy, tremor, amnesia, memory impairment, ataxia, coordination disorders, paresthesia, hyperkinesia, dyskinesia;
• diplopia, blurred vision;
• vertigo, cough;
• diarrhea, dyspepsia, nausea, vomiting, pancreatitis;
• hepatitis, liver failure;
• rash, eczema, pruritus, alopecia, erythema multiforme;
• myalgia, muscle weakness;
• asthenia, fatigue.

Storage conditions and periods
The shelf life of the drug is no more than 3 years from the production date indicated on the package.
Does not require special storage conditions.