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Indications
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
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.
IracetTM (Levetiracetam) injection is an alternative for adult patients (16 years and older) when oral administration is temporarily not feasible.
Dosage & Administration
IracetTM (Levetiracetam) can be initiated with either intravenous or oral administration.
For tablet and oral solution
Treatment should initiate with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg.
Interaction
Medications that are antiepileptic:
Pre-marketing data from adult clinical studies show that levetiracetam had no effect on the serum concentrations of existing antiepileptic medicines (phenytoin, carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin, and primidone), and that these medicines had no effect on the pharmacokinetics of levetiracetam.
Probenecid, a renal tubular secretion inhibiting drug, has been found to decrease renal clearance of the main metabolite but not of levetiracetam (500 mg four times day). Nonetheless, this metabolite's concentration remains modest.
Methotrexate: It has been reported that taking levetiracetam and methotrexate together reduces methotrexate clearance, resulting in higher/longer blood methotrexate concentrations that are potentially hazardous. The levels of methotrexate and levetiracetam in the blood should be closely monitored in patients who are taking both medicines at the same time.
When the osmotic laxative macrogol is taken concurrently with oral levetiracetam, there have been rare instances of reduced levetiracetam effectiveness. As a result, one hour before and one hour after taking levetiracetam, macrogol should not be taken orally.
Food and alcohol had no effect on the amount of levetiracetam absorption, although the pace of absorption was somewhat slowed. There is no information on how levetiracetam interacts with alcohol.
Contraindications
Hypersensitivity to the active ingredient, other pyrrolidone derivatives, or any excipient.
Side Effects
The following are the most frequent adverse events (incidence 5% higher than placebo):
Somnolence, asthenia, illness, and dizziness in adults
Fatigue, aggressiveness, nasal congestion, reduced appetite, and irritability are common in children.
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
Anti-epileptic medications used in addition
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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