Tablet Manufacturer/Distributor: Square Pharmaceuticals Ltd. Generic Name: Levetiracetam 500 mg/5 ml Syrup
IracetTM (Levetiracetam) is indicated as an adjunctive therapy for: Partial Onset Seizures Myoclonic Seizures In Patients with Juvenile Myoclonic Epilepsy Primary Generalized Tonic-Clonic Seizures IracetTM (Levetiracetam) injection is an alternative for adult patients (16 years and older) when oral administration is temporarily not feasible.
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Levetiracetam is indicated as an adjunctive therapy for:
Partial Onset Seizures
Myoclonic Seizures In Patients with Juvenile Myoclonic Epilepsy
Primary Generalized Tonic-Clonic Seizures
Levetiracetam injection is an alternative for adult patients (16 years and older) when oral administration is temporarily not feasible.
Pharmacology
IracetTM (Levetiracetam) The exact mechanism of action is unknown but does not involve inhibitory and excitatory neurotransmission. Stereo-selective binding of Levetiracetam was confined to synaptic plasma membranes in the central nervous system with no binding occurring in peripheral tissue.
Dosage
Grown-ups and teenagers from 16 a long time of age: The suggested beginning dosage is 250 mg twice day by day which ought to be expanded to an beginning restorative measurements of 500 mg twice day by day after two weeks. The measurements can be encourage expanded by 250 mg twice every day each two weeks depending upon the clinical reaction. The greatest dosage is 1500 mg twice every day.
Grown-ups (≥18 years) and youths (12 to 17 a long time) weighing 50 kg or more: The beginning restorative dosage is 500 mg twice every day. This dosage can be begun on the primary day of treatment. Depending upon the clinical reaction and tolerability, the day by day measurements can be expanded up to 1,500 mg twice every day. Dosage changes can be made in 500 mg twice every day increments or diminish each two to four weeks.
Pediatric populace: The tablet detailing isn't adjusted for utilize in newborn children and children beneath the age of 6 a long time. Verbal arrangement is the favored detailing for utilize in this populace. In expansion, the accessible dosage qualities of the tablets are not suitable for starting treatment in children weighing less than 25 kg, for patients incapable to swallow tablets or for the organization of measurements underneath 250 mg. In all of the over cases, verbal arrangement ought to be utilized.
Monotherapy: The security and adequacy of levetiracetam in children and young people underneath 16 a long time as monotherapy treatment have not been built up.
Add-on treatment: Verbal arrangement is the favored definition for utilize in newborn children and children beneath the age of 6 a long time. For children 6 a long time and over, verbal arrangement ought to be utilized for measurements beneath 250 mg, for measurements not in products of 250 mg when dosing proposal isn't achievable by taking different tablets and for patients incapable to swallow tablets. The least compelling dosage ought to be utilized. The beginning measurements for a child or pre-adult of 25 kg ought to be 250 mg twice every day with a most extreme dosage of 750 mg twice day by day. Dosing for children 50 kg or more prominent is the same as in adults.
Add-on treatment: For newborn children matured from 1 month to less than 6 months: The verbal arrangement is the detailing to utilize in infants.
Administration
The flm-coated tablets must be taken orally, gulped with a sufcient amount of fluid and may be taken with or without nourishment. The day by day dosage is managed in two similarly isolated doses.
Interaction
Antiepileptic restorative items: Pre-marketing information from clinical thinks about conducted in grown-ups show that levetiracetam did not impact the serum concentrations of existing antiepileptic therapeutic items (phenytoin, carbamazepine, valproic corrosive, phenobarbital, lamotrigine, gabapentin and primidone) which these antiepileptic therapeutic items did not impact the pharmacokinetics of levetiracetam.
Methotrexate: Concomitant organization of levetiracetam and methotrexate has been detailed to diminish methotrexate clearance, coming about in increased/prolonged blood methotrexate concentration to possibly poisonous levels. Blood methotrexate and levetiracetam levels ought to be carefully checked in patients treated concomitantly with the two drugs.
Probenecid: Probenecid (500 mg four times every day), a renal tubular discharge blocking specialist, has been appeared to hinder the renal clearance of the essential metabolite but not of levetiracetam. By the by, the concentration of this metabolite remains low.
Diuretics: There have been separated reports of diminished levetiracetam viability when the osmotic purgative macrogol has been concomitantly managed with verbal levetiracetam. In this manner, macrogol ought to not be taken orally for one hour some time recently and for one hour after taking levetiracetam.
Food and liquor: The degree of assimilation of levetiracetam was not modified by nourishment, but the rate of assimilation was somewhat diminished. No information on the interaction of levetiracetam with liquor are available.
Side Effects
Most common unfavorable responses (frequency ≥ 5% more than fake treatment) include:
Adult patients: drowsiness, asthenia, contamination and dizziness
Pediatric patients: weariness, hostility, nasal clog, diminished craving, and irritability
Pregnancy & Lactation
Pregnancy: Pregnancy category C.
Lactation: No data on the use of Levetiracetam in breast-feeding women are available. Data from animals indicate that Levetiracetam is secreted into milk. Therefore Levetiracetam is contraindicated during breast-feeding.
Precautions & Warnings
Severe allergic reactions, abnormal thoughts; dark urine; decreased coordination; extreme dizziness, drowsiness, tiredness, or weakness; fever, chills, or persistent sore throat; hallucinations; memory loss; mouth sores; muscle or neck pain; new or worsening mental problem; mood or behavior changes; new or worsening seizures; pain, itching or redness at the injection site; suicidal thoughts or attempts; unusual bruising or bleeding; vision changes; yellowing of the skin or eyes.
Therapeutic Class
Adjunct anti-epileptic drugs
Storage Conditions
Store in a cool and dry place, protected from light and moisture. Keep out of the reach of children.
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