KEPPRA 500MG TAB (TABLET)
Description: Levetiracetam (Keppra) 250 mg tablet: Each blue, oblong, debossed with code 'ucb' and '250' on one side, film coated tablet contains 250 mg levetiracetam.
Levetiracetam (Keppra) 500 mg tablet: Each yellow, oblong, debossed with code 'ucb' and '500' on one side, film coated tablet contains 500 mg levetiracetam.
Levetiracetam (Keppra) 1 g tablet: Each white, scored, oblong, debossed with code 'ucb' and '1000' on one side, film coated tablet contains 1 g of levetiracetam.
Levetiracetam (Keppra) 100 mg/mL oral solution: Each mL of clear liquid oral solution contains 100 mg of levetiracetam.
Levetiracetam (Keppra) 500 mg/5 mL concentrate solution for infusion: Each mL of clear liquid oral solution contains 100 mg of levetiracetam. The 5 mL vial contains 500 mg of levetiracetam.
Presentation / Packing: FC tab 250 mg x 60's. 500 mg x 60's. 1 g x 60's. Oral soln 100 mg/mL x 300 mL. Infusion conc (vial) 500 mg/5 mL x 5 mL x 5's.
Storage: Levetiracetam (Keppra) 250 mg, 500 mg and 1g tablet: Store at temperatures not exceeding 30°C.
Levetiracetam (Keppra) 100 mg/mL oral solution: Store below 30°C.
Levetiracetam (Keppra) 500 mg/5 mL concentrate solution for infusion: Store at temperatures not exceeding 30°C. From a microbiological point of view, the product should be used immediately after dilution. If not used immediately, in-use storage time and conditions prior to use are responsibility of the user and would normally not be longer than 24 hours at 28°C, unless dilution has taken place in controlled and validated aseptic conditions.
Contents: Levetiracetam
Indications / Uses: Monotherapy in the treatment of partial onset seizures w/ or w/o secondary generalization in adults & adolescents ≥16 yr w/ newly diagnosed epilepsy. Adjunctive therapy in the treatment of partial onset seizures w/ or w/o secondary generalization in adults, adolescents & childn ≥4 yr w/ epilepsy; myoclonic seizures in adults & adolescents ≥12 yr w/ juvenile myoclonic epilepsy & primary generalized tonic-clonic seizures in adults & childn ≥4 yr w/ idiopathic generalized epilepsy.
₱72.32
Availability:
In stock
SKU
6746
Dosage / Direction for Use: Monotherapy Adult & adolescent from 16 yr Initially 250 mg bid, increased to 500 mg bid after 2 wk. May be further increased by 250 mg bid every 2 wk. Max: 1,500 mg bid. Add-on therapy Adult (≥18 yr) & adolescent (12-17 yr) ≥50 kg Initially 500 mg bid, may be increased up to 1,500 mg bid. Dose may be increase or decrease to 500 mg bid every 2-4 wk. Childn & adolescent ≥50 kg Adult dose, 4-17 yr <50 kg Initially 10 mg/kg bid, may be increased up to 30 mg/kg bid. Dose increment/decrement should not be >10 mg/kg bid every 2 wk. Oral soln Childn ≤20 kg Initially 100 mg/mL.
Overdosage: Symptoms: Somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma were observed.
Treatment: After an acute overdose, the stomach may be emptied by induction of emesis. There is no specific antidote for levetiracetam. Treatment of an overdose will be symptomatic and may include hemodialysis. The dialyzer extraction efficiency is 60% for levetiracetam and 74% for the primary metabolite.
Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
Administration: May be taken with or without food: Oral solution: May be taken directly or diluted in a glass of water.
Contraindications: Hypersensitivity to levetiracetam or other pyrrolidone derivatives.
Special Precautions: Avoid abrupt withdrawal. Monitor for signs of depression &/or suicidal ideation & behaviors. Renal & severe hepatic impairment. Contains sunset yellow lake (tab) & methyl & propyl parahydroxybenzoate (oral soln) which may cause allergic reactions. May impair ability to drive or operate machinery. Pregnancy & lactation. Infants <1 yr w/ epilepsy. Childn <6 yr (tab), <4 yr & infants (infusion conc). Elderly. Oral soln: Rare hereditary problems of fructose intolerance (due to maltitol content) & may cause headache, stomach upset & diarrhea (due to glycerol content). Soln for infusion: Patients on controlled Na diet.
Use In Pregnancy & Lactation: Fertility: No impact on fertility was detected in animal studies. No clinical data are available, potential risk for human is unknown.
Use in Pregnancy: Levetiracetam is not recommended during pregnancy and in women of childbearing potential not using contraception unless clearly necessary.
Postmarketing data from several prospective pregnancy registries have documented outcomes in over 1000 women exposed to levetiracetam monotherapy during the first trimester of pregnancy. Overall, these data do not suggest a substantial increase in the risk for major congenital malformations, although a teratogenic risk cannot be completely excluded. Therapy with multiple antiepileptic medicinal products is associated with a higher risk of congenital malformations than monotherapy and, therefore, monotherapy should be considered. Studies in animals have shown reproductive toxicity.
Physiological changes during pregnancy may affect levetiracetam concentration. Decrease in levetiracetam plasma concentrations has been observed during pregnancy. This decrease is more pronounced during the third trimester (up to 60% of baseline concentration before pregnancy). Appropriate clinical management of pregnant women treated with levetiracetam should be ensured. Discontinuation of antiepileptic treatments may result in exacerbation of the disease which could be harmful to the mother and the foetus.
Use in Lactation: Levetiracetam is excreted in human breast milk. Therefore, breastfeeding is not recommended.
However, if levetiracetam treatment is needed during breastfeeding, the benefit/risk of the treatment should be weighed considering the importance of breastfeeding.
Side Effects / Adverse Reactions: Nasopharyngitis, somnolence, headache, anorexia, depression, hostility/aggression, anxiety, insomnia, nervousness/irritability, convulsion, balance disorder, dizziness, lethargy, tremor, vertigo, cough, abdominal pain, diarrhea, dyspepsia, vomiting, nausea, rash, asthenia/fatigue.
Interactions: Higher clearance w/ enzyme-inducing antiepileptic drugs (in childn). Slightly reduced absorption w/ food. Decreases methotrexate clearance.