Antiomal Tablets / Film-coated

Levetiracetam
500mg
TAHA PHARMA
Pack size 30's (10's Blister x 3)
Dispensing mode POM
Source TUNISIA
AgentGULF INTERGLOBAL MEDICAL EQUIPMENT LLC
Retail Price 58.00 AED

Available as:

250mg - Tablets / Film-coated

Indications

Antiomal Tablets / Film-coated is used for: Partial seizures

Adult Dose

Oral Adjunct in seizures Adult: For partial seizures w/ or w/o secondary generalisation; myoclonic seizures (w/ juvenile myoclonic epilepsy); primary generalised tonic-clonic seizures (w/ idiopathic generalised epilepsy): Initially, 500 mg bid on the 1st day. Adjust dose in increments or decrements of 500 mg bid at 2-4 wk intervals. Max: 1,500 mg bid. Monotherapy for partial seizures with or without secondary generalisation Adult: Recommended starting dose is 250 mg bid, increased to an initial therapeutic dose of 500 mg bid after 2 wk. May further increase by 250 mg bid every 2 wk depending upon response. Max: 1,500 mg bid. Intravenous Adjunct in seizures Adult: For partial seizures w/ or w/o secondary generalisation; myoclonic seizures (w/ juvenile myoclonic epilepsy); primary generalised tonic-clonic seizures (w/ idiopathic generalised epilepsy): Initially, 500 mg bid on the 1st day. Adjust dose in increments or decrements of 500 mg bid at 2-4 wk intervals. Admin by infusion over 15 min. Max: 1,500 mg bid. Max duration: 4 days. Monotherapy for partial seizures with or without secondary generalisation Adult: Recommended starting dose is 250 mg bid, increased to an initial therapeutic dose of 500 mg bid after 2 wk. May further increase by 250 mg bid every 2 wk depending upon response. Admin by infusion over 15 min. Max: 1,500 mg bid. Max duration: 4 days. Hepatic impairment: Severe: Reduce dose by 50%.

Child Dose

Oral Adjunct in seizures Child: 1 to <6 mth Initially, 14 mg/kg daily, may adjust in increments of 14 mg/kg at 2-wk intervals. Max: 42 mg/kg daily; >6 mth <50 kg: Initially, 20 mg/kg daily, may adjust in increments of 20 mg/kg at 2-wk intervals. Max: 60 mg/kg daily. Intravenous Adjunct in seizures Child: 1 to <6 mth Initially, 14 mg/kg daily, may adjust in increments of 14 mg/kg at 2-wk intervals. Max: 42 mg/kg daily; >6 mth <50 kg: Initially, 20 mg/kg daily, may adjust in increments of 20 mg/kg at 2-wk intervals. Max: 60 mg/kg daily. To be given via infusion over 15 min.

Renal Dose

Renal impairment: ESRD patients undergoing dialysis: Loading dose of 750 mg, followed by 500-1,000 mg once daily; supplemental dose of 250-500 mg after dialysis. CrCl (ml/min) Dosage Recommendation <30 250-500 mg bid. 30-49 250-750 mg bid. 50-79 500-1,000 mg bid.

Administration

May be taken with or without food. Oral soln may be taken directly or diluted in a glass of water.

Contra Indications

Hypersensitivity.

Precautions

Renal and hepatic impairment; pregnancy, lactation; patients undergoing haemodialysis. If psychotic symptoms (eg hallucination) and behavioural symptoms (eg agitation, anxiety) occur, reduce dosage. Abrupt withdrawal may result in increased seizure frequency. May impair ability to drive or operate machinery during initial therapy. Lactation: Excreted in breast milk; not recommended

Pregnancy-Lactation

Pregnancy There are no adequate and well-controlled studies in pregnant women; prolonged experience in pregnant women has not identified a drug-associated risk of major birth defects or miscarriage, based on published literature, which includes data from pregnancy registries, and reflects experience over two decades In animal studies, levetiracetam produced evidence of developmental toxicity, including teratogenic effects, at doses similar to or greater than human therapeutic doses Use during pregnancy only if the potential benefit justifies the potential risk to the fetus Drug blood levels may decrease during pregnancy; physiological changes during pregnancy may affect drug concentration; decrease in drug plasma concentrations has been observed during pregnancy; this decrease is more pronounced during third trimester; dose adjustments may be necessary to maintain clinical response Lactation Drug is excreted in human milk; there are no data on effects of drug on breastfed infant, or on milk production Unknown if distributed in human breast milk Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

Interactions

Enzyme-inducing antiepiletic drugs.

Adverse Effects

Side effects of Levetiracetam : >10% Asthenia (11-15%), Headache (14-19%), Infection (11-15%), Increased blood pressure (17% in children < 4 years), Somnolence (11-15%), Drowsiness (2-23%), Fatigue (10-11%), Anorexia (3-13%), Weakness (9-15%), Nasopharyngitis (7-15%), Cough (2-11%) 1-10% Viral infection (2%), Asthma (2%), Dizziness (5-9%), Nervousness (2-10%), Amnesia (2%), Anxiety (2-3%), Ataxia (3%), Depression (2-5%), Hostility (10%), Paresthesia (2%), Sinusitis (2%), Diplopia (2%), Amblyopia (2%), Conjunctivitis (2-3%), Albuminuria (4%) <1% Abnormal hepatic function tests, Dyskinesia, Eczema, Neutropenia, Decreased hematocrit, Leukopenia, Suicidal tendencies, Hepatitis, Pancreatitis, Bone marrow suppression, Epidermal necrolysis

Mechanism of Action

Anticonvulsant used in the treatment of partial seizures. The precise mechanism of anticonvulsant effect is unknown.

Note

Antiomal 500mg Tablets / Film-coated manufactured by TAHA PHARMA. Its generic name is Levetiracetam. Antiomal is availble in United Arab Emirates. Farmaco UAE drug index information on Antiomal Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.

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