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Sedatives

Levetstad 500

 

Pack size:

Box of 3 blisters x 10 film-coated tablets.

 

Composition:

Each film-coated tablet contains levetiracetam 500 mg.

 

Shelf-life:

36 months from date of manufacturing.

Store in a well-closed container, in a dry place. Do not store above 30oC.

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

Monotherapy

  • In the treatment of partial onset seizures with or without secondary generalization in patients from 16 years of age with newly diagnosed epilepsy.
    The recommended starting dose is 250 mg twice daily which should be increased to an initial therapeutic dose of 500 mg twice daily after 2 weeks. The dose can be further increased by 250 mg twice daily every 2 weeks depending upon the clinical response. The maximum dose is 1500 mg twice daily.

Adjunctive therapy

  • In the treatment of partial onset seizures with or without secondary generalization in adults, children from 12 years of age with epilepsy.
  • In the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy.
  • In the treatment of primary generalized tonic-clonic seizures in adults and children from 12 years of age with idiopathic generalized epilepsy.
    Adults (≥ 18 years) and adolescents (12 - 17 years) weighing 50 kg or more: The initial therapeutic dose is 500 mg twice daily. Depending upon the clinical response and tolerability, the daily  dose can be increased up to 1 500 mg twice daily. Dose changes can be made in 500 mg twice daily increases every 2 to 4 weeks.
    Elderly (65 years and older) and patients with renal impairment: The daily dose must be individualized according to renal function

    *Following dialysis, a 250 to 500 mg supplementaldose is recommended.
    Patients with hepatic impairment:
    No dose adjustment is needed in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, the creatinine clearance may underestimate the renal insufficiency. Therefore a 50% reduction of the daily maintenance dose is recommended when the creatinine clearance is < 70 ml/min/1.73 m2 .


Or as prescribed by physicians.

 

  • Hypersensitivity to levetiracetam, other pyrrolidone derivatives or any of the excipients.

     

Very common

  • Nasopharyngitis.
  • Somnolence, headache.

Common

  • Anorexia.
  • Depression, hostility/ aggression, anxiety, insomnia, nervousness/ irritability.
  • Convulsion, balance disorder, dizziness, lethargy, tremor.
  • Vertigo.
  • Cough.
  • Abdominal pain, diarrhoea, dyspepsia, vomiting, nausea.
  • Rash.
  • Asthenia/fatigue.

Uncommon

  • Thrombocytopenia, leukopenia.
  • Weight decreased or weight increase.
  • Suicide attempt, suicidal ideation, psychotic disorder, abnormal behavior, hallucination, anger, confusional state, panic attack affect lability/mood swings, agitation.
  • Amnesia, memory impairment, coordination abnormal/ ataxia, paraesthesia, disturbance in attention.
  • Diplopia, vision blurred.
  • Liver function test abnormal.
  • Alopecia, eczema, pruritus.
  • Muscular weakness, myalgia.
  • Injury.

Rare

  • Infection.
  • Pancytopenia neutropenia.
  • Completed suicide, personality disorder, thinking abnormal.
  • Choreoathetosis, dyskinesia, hyperkinesia.
  • Pancreatitis.
  • Hepatic failure, hepatitis.
  • Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiform.

     

  • Discontinuance of levetiracetam: Because of the possibility of increased seizure frequency, anticonvulsant drugs, including levetiracetam, should not be discontinued suddenly. Oral levetiracetam should be withdrawn gradually by reducing the dosage by 1 g daily at 2-week intervals.
  • Renal insufficiency: The administration of levetiracetam to patients with renal impairment may require dose adjustment.
  • Suicide: Suicide, suicide attempt, suicide ideation and behavior have been reported in patients treated with antiepileptic agents.
  • Pregnancy: There are no adequate and well-controlled studies in pregnant women. In animal studies, levetiracetam produced evidence of developmental toxicity. Therefore, levetiracetam should be used during pregnancy only if the potential benefits justify the potential risk to the fetus.
  • Lactation: Levetiracetam is excreted in breast milk. Because of the potential serious adverse reactions in nursing infants from levetiracetam, a decision should be made whether to discontinue the drug or discontinue nursing, taking account into the importance of the drug to the mother.
  • Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed. Due to possible different individual sensitivity, some patients might experience somnolence or other central nervous system related symptoms, especially at the beginning of treatment or following a dose increase. Therefore, caution is recommended in those patients when performing skilled tasks, e.g. driving vehicles or operating machinery. Patients are advised not to drive or use machines until it is established that their ability to perform such activities is not affected.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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