Levectam 100 mg/ ML Syrup 120 ML

Antiseizure agent used in the treatment of focal onset seizures and generalized onset seizures, prophylaxis against craniotomy induced seizure and traumatic brain injury.

-Intravenous formulations: infuse over 15 minutes. Various rates of IV administration have been reported; doses ≤1 g (undiluted) have been administered over 2 to 5 minutes, doses ≤3 g (diluted) over 5 to 6 minutes, and doses ≤4.5 g (diluted) over 10 minutes. Do not use if solution contains particulate matter or is discolored. In case of pediatrics vials must be diluted prior to use. It is recommended to dilute the dose in 100 ml of NS, LR, or D5W. If a smaller volume is required (eg, pediatric patients), the amount of diluent should be calculated to not exceed a maximum levetiracetam concentration of 15 mg/mL of diluted solution. A 1:1 dilution of drug from vial with D5W or NS (eg, 1 g per 10 mL diluted in 10 mL of NS; total volume 20 mL) has also been safely used. Alternatively, doses up to 1 g have been safely administered undiluted. -Oral: -Administer without regard to meals. A-Oral solution: Administer with a calibrated measuring device (not a household teaspoon or tablespoon). B-Tablet: 1-Disintegrating soluble tablet for oral suspension: Place whole tablet on the tongue with dry hand, follow with a sip of water and swallow only after tablet disintegrates. Do not swallow tablets intact. Tablet disintegrates in a mean time of 11 seconds (ranging from 2 to 27 seconds) in the mouth when taken with a sip of water. Or allow whole tablet to disperse in a small volume of water (one tablespoon or enough to cover the tablet) in a cup; consume entire contents immediately; resuspend any residue by adding an additional small volume of water and swallow the full amount. 2-Immediate release: Tablets should be swallowed whole, not chewed or crushed. 3-Extended release: Only administer as whole tablet; do not crush, break, or chew.

-Fatigue, dizziness, somnolence and drowsiness, hypersensitivity reactions, hallucinations, and behavioral problems (including aggressive behavior, agitation, anger, anxiety, apathy, confusion, depersonalization, depression, emotional lability, hostility, dyskinesia, irritability, nervousness) -Increased blood pressure, vomiting, headache, nasopharyngitis, anorexia, constipation, decreased appetite, diarrhea, gastroenteritis, nausea, upper abdominal pain, bruise, eosinophilia, amnesia, anxiety, ataxia, confusion, depression, dizziness, arthralgia, joint sprain, neck pain, conjunctivitis, otalgia, cough, nasal congestion, pharyngitis, pharyngolaryngeal pain, rhinitis and sinusitis. -Pediatric dosing continue: -Tonic-clonic seizures: Children ≥6 years and adolescents <16 years: IV: Initial: 10 mg/kg/dose twice daily; increase dosage every 2 weeks by 10 mg/kg/dose twice daily based on response and tolerability to the recommended dose of 30 mg/kg/dose twice daily. Oral: Immediate release: 1-Weight-directed: Oral solution or tablets: Initial: 10 mg/kg/dose twice daily; increase dosage every 2 weeks by 10 mg/kg/dose twice daily based on response and tolerability to the recommended dose of 30 mg/kg/dose twice daily. 2-Fixed-dosing: Orally disintegrating tablets: If the patient weight is 20 to 40 kg: Initial: 250 mg twice daily; increase dosage every 2 weeks by 250 mg twice daily based on response and tolerability to the maximum recommended dose of 750 mg twice daily. If the patient weight is >40 kg: Initial: 500 mg twice daily; increase dosage every 2 weeks by 500 mg twice daily based on response and tolerability to the maximum recommended dose of 1,500 mg twice daily. While in case of adolescents ≥16 years: IV, Oral: Initial: 500 mg twice daily; increase dosage every 2 weeks by 500 mg/dose twice daily based on response and tolerability to the recommended dose of 1,500 mg twice daily.

-Should not be given to patients suffering from hypersensitivity to levetiracetam. -Use caution with renal impairment: if the Creatinine clearance is 80 to 130 mL/minute/1.73 m2: 500 mg to 1.5 g every 12 hours, if the Creatinine clearance is 50 to <80 mL/minute/1.73 m2: 500 mg to 1 g every 12 hours, if the Creatinine clearance is 30 to <50 mL/minute/1.73 m2: 250 to 750 mg every 12 hours and if the Creatinine clearance is 15 to <30 mL/minute/1.73 m2: 250 to 500 mg every 12 hours. -Antiseizure medications should not be discontinued abruptly because of the possibility of increasing seizure frequency and status epilepticus; therapy should be withdrawn gradually to minimize the potential of increased seizure frequency, unless safety concerns require a more rapid withdrawal. -In case of over dose be ready to tell or show what was taken, how much and when it happened, and seek immediate medical attention. For additional information call us on 16676. Always tell your physician your detailed medical history.

-Store at room temperature. -Pediatric dosing (continue) 2-Fixed dosing: Tablet (immediate release or for oral suspension): If the patient weight is 20 to 40 kg: Initial: 250 mg twice daily; increase dosage every 2 weeks by 250 mg twice daily based on response and tolerability to the maximum recommended dose of 750 mg twice daily, if the patient weight is >40 kg: Initial: 500 mg twice daily; increase dosage every 2 weeks by 500 mg twice daily based on response and tolerability to the maximum recommended dose of 1,500 mg twice daily. B-Extended release: Children ≥12 years and adolescents: Initial: 1,000 mg once daily; may increase dosage every 2 weeks by 1,000 mg/day based on response and tolerability to a maximum recommended dose of 3,000 mg once daily. Adolescents ≥16 years: IV: Initial: 500 mg twice daily; increase dosage every 2 weeks by 500 mg/dose twice daily based on response and tolerability to a maximum recommended dose of 1,500 mg twice daily. Oral: 1-Immediate release (tablets, oral solution, tablets for oral suspension): Initial: 500 mg twice daily; increase dosage every 2 weeks by 500 mg twice daily based on response and tolerability to the maximum recommended dose of 1,500 mg twice daily. 2-Extended release: Initial: 1,000 mg once daily; increase dosage every 2 weeks by 1,000 mg/day based on response and tolerability to a maximum recommended dose of 3,000 mg once daily.

-Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). -Apixaban: Levetiracetam may diminish the therapeutic effect of Apixaban. -Azelastine (Nasal): May enhance the CNS depressant effect of CNS Depressants. -Carbamazepine: Levetiracetam may enhance the adverse/toxic effect of carbamazepine. -Dabigatran Etexilate: Levetiracetam may diminish the therapeutic effect of Dabigatran Etexilate. -Gabapentin: Levetiracetam may enhance the CNS depressant effect of Gabapentin. -Kava Kava: May enhance the CNS depressant effect of CNS Depressants. -Lamotrigine: Levetiracetam may enhance the CNS depressant effect of lamotrigine. -Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. -Methotrexate: Levetiracetam may increase the serum concentration of Methotrexate. -Metoclopramide: May enhance the CNS depressant effect of CNS Depressants. -Olopatadine (Nasal): May enhance the CNS depressant effect of CNS Depressants. -Orlistat: May decrease the serum concentration of Antiseizure Agents. -Oxcarbazepine: May decrease the serum concentration of Levetiracetam. -Phenobarbital: Levetiracetam may enhance the CNS depressant effect of phenobarbital. -Rivaroxaban: Levetiracetam may decrease the serum concentration of rivaroxaban. -Valerian: May enhance the CNS depressant effect of CNS Depressants. -Valproate Products: Levetiracetam may enhance the CNS depressant effect of valproate products. -Zolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem.

-Levetiracetam crosses the placenta and can be detected in the newborn following delivery. An increase in the overall rate of major congenital malformations has not been observed following maternal use of levetiracetam. Available studies have not been large enough to determine if there is an increased risk of specific birth defects. -Levetiracetam is present in breast milk, the relative infant dose (RID) of levetiracetam is 7.9%, in general, breastfeeding is considered acceptable when the RID is <10%. Adverse effects, including hypotonia, sedation, vomiting, weight loss, and poor suckling have been reported in breastfed infants, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. -Ask your physician before taking any medication during pregnancy or lactation.

BIOPHARM EGYPT