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Sedatives

Levetstad 500

Packaging:

Blister of 10 tablets. Box of 3 blisters.

Blister of 10 tablets. Box of 6 blisters.

Blister of 10 tablets. Box of 10 blisters.

Composition:

Each film-coated tablet contains:

Levetiracetam               500 mg

Excipients q.s               1 tablet

Shelf – Life:

36 months from date of manufacturing.

  • Indications
  • Contraindications
  • Adverse reactions
  • Dosage and administration

Monotherapy

  • In the treatment of partial onset seizures with or without secondary generalization in patients from 16 years of age with newly diagnosed epilepsy.

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.

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

Pregnancy and Lactation:

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.

Very common

  • Infections and infestations: Nasopharyngitis.
  • Nervous system: Somnolence, headache.

Common

  • Metabolism and nutrition: Anorexia.
  • Psychiatric: Depression, hostility/ aggression, anxiety, insomnia, nervousness/ irritability.
  • Nervous system: Convulsion, balance disorder, dizziness, lethargy, tremor.
  • Ear and labyrinth: Vertigo.
  • Respiratory, thoracic and mediastinal: Cough.
  • Gastrointestinal: Abdominal pain, diarrhoea, dyspepsia, vomiting, nausea.
  • Skin and subcutaneous tissue: Rash.
  • General and administration site conditions: Asthenia/fatigue.

Uncommon

  • Blood and lymphatic system: Thrombocytopenia, leukopenia.
  • Metabolism and nutrition: Weight decreased or weight increase.
  • Psychiatric: Suicide attempt, suicidal ideation, psychotic disorder, abnormal behavior, hallucination, anger, confusional state, panic attack affect lability/mood swings, agitation.
  • Nervous system: Amnesia, memory impairment, coordination abnormal/ ataxia, paraesthesia, disturbance in attention.
  • Eye: Diplopia, vision blurred.
  • Hepatobiliary: Liver function test abnormal.
  • Skin and subcutaneous tissue: Alopecia, eczema, pruritus.
  • Musculoskeletal and connective tissue: Muscular weakness, myalgia.
  • Injury, poisoning and procedural complications: Injury.

Rare

  • Infections and infestations: Infection.
  • Blood and lymphatic system: Pancytopenia neutropenia.
  • Psychiatric: Completed suicide, personality disorder, thinking abnormal.
  • Nervous system: Choreoathetosis, dyskinesia, hyperkinesia.
  • Gastrointestinal: Pancreatitis.
  • Hepatobiliary: Hepatic failure, hepatitis.
  • Skin and subcutaneous tissue: Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiform.

Administration

  • Levetstad 500 must be taken orally, swallowed with a sufficient quantity of water and may be taken with or without food.

Dosage

Monotherapy

- Patients from 16 years of age:

  • 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

- 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 1500 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

Creatinine clearance (ml/min)

Dosage (mg)

Intervals (hours)

> 80

500 - 1500

12

50 - 79

500 - 1000

12

30 - 49

250 -750

12

< 30

250 - 500

12

End-stage renal disease –

Patients using dialysis

500 - 1000

24*

*Following dialysis, a 250 to 500 mg supplemental dose 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.

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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