Levit IV Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Storage Patient Counseling Information MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Levetiracetam

Indications/Uses

Adjunctive therapy, as alternative when oral administration of levetiracetam is temporarily not feasible, in treatment of partial onset seizures in adults & childn ≥1 mth w/ epilepsy; myoclonic seizures in adults & adolescents ≥12 yr w/ juvenile myoclonic epilepsy; primary generalized tonic-clonic seizures in adults & childn ≥6 yr w/ idiopathic generalized epilepsy.

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Dosage/Direction for Use

Partial onset seizure Adult ≥16 yr Initially 500 mg bid, may be increased by 500 mg bid every 2 wk to 1,500 mg bid. Ped patient 4 yr-<16 yr Initially 10 mg/kg bid, increased by 10 mg/kg bid every 2 wk to 30 mg/kg bid, 6 mth-<4 yr Initially 10 mg/kg bid, increased by 10 mg/kg bid every 2 wk to 25 mg/kg bid, 1 mth-<6 mth Initially 7 mg/kg bid, increased by 7 mg/kg bid every 2 wk to 21 mg/kg bid. Myoclonic seizure Adult & ped patient ≥12 yr w/ juvenile myoclonic epilepsy Initially 500 mg bid, increased by 500 mg bid every 2 wk to 1,500 mg bid. Primary generalized tonic-clonic seizure Adult ≥16 yr Initially 500 mg bid, increased by 500 mg bid every 2 wk to 1,500 mg bid. Ped patient 6 yr-<16 yr Initially 10 mg/kg bid, increased by 10 mg/kg bid every 2 wk to 30 mg/kg bid. Dose adjustment Adult w/ mild renal impairment (CrCl 50-80 mL/min/1.73 m²) 500-1,000 mg every 12 hr, moderate (CrCl 30-50 mL/min/1.73 m²) 250-750 mg every 12 hr, severe (CrCl <30 mL/min/1.73 m²) 250-500 mg every 12 hr, ESRD patient using dialysis 500-1,000 mg every 24 hr. Supplemental dose of 250-500 mg is recommended following dialysis.

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Overdosage

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Contraindications

Hypersensitivity.

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Special Precautions

Discontinue use if patient develops signs or symptoms of anaphylaxis or angioedema or serious dermatological reactions eg, SJS/TEN. Risk of hematologic abnormalities including decreased RBC, Hb, & hematocrit, & increased eosinophil count. Gradually w/draw treatment when discontinuing. Monitor patients for psychiatric signs & symptoms. May cause somnolence, fatigue & coordination difficulties which may affect ability to drive or operate machinery. Patients w/ renal impairment. Physiological changes during pregnancy may gradually decrease plasma levels throughout pregnancy (more pronounced during 3rd trimester). Potential for serious adverse reactions in nursing infants; discontinue nursing during treatment or discontinue the drug. Monitor patients 1 mth-<4 yr of age for increases in diastolic BP. Elderly ≥65 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Adult: Somnolence, asthenia, infection, & dizziness. Ped patient: Fatigue, aggression, nasal congestion, decreased appetite, & irritability.

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Drug Interactions

Doubled C_max,ss & decreased renal clearance of the metabolite w/ probenecid.

Storage

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Description

View Levit IV description for details of the chemical structure and excipients (inactive components).

Action

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MIMS Class

Anticonvulsants

ATC Classification

N03AX14 - levetiracetam ; Belongs to the class of other antiepileptics.

Regulatory Classification

Patient Counseling Information

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Presentation/Packing

Form

Levit IV soln for inj 100 mg/mL

Packing/Price

5 mL x 1's

Levit IV

levetiracetam

Manufacturer:

Aspiro Pharma

Distributor:

InnoGen Pharmaceuticals