Products

Sycocetam Tablets

Levetiracetam
 

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Active ingredient

Levetiracetam 500 mg
 

Indications

• Sycocetam is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. 
• Sycocetam is indicated as adjunctive therapy:
- In the treatment of partial onset seizures with or without secondary generalisation in adults and children from 1 month 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 generalised tonic-clonic seizures in adults and adolescents from 6 years of age with Idiopathic Generalised Epilepsy.

Dosage and Administration

Simple titration for monotherapy in adults:

 

Starting dose and first two weeks

Increase/decrease after two weeks

Maximum recommended dose

Tablets

(500 mg/scored tablets

250 mg b.d.

250 mg b.d.

1500 b.d

Simple titration for adjunctive therapy in adults:

 

Therapeutic starting dose

Increase/decrease two- four weeks

Maximum recommended dose

Tablets

(500 mg/scored tablets

500 mg b.d.

500 mg b.d.

1500 b.d

Contraindication

Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients.

Side effects

  • The most commonly reported adverse reactions were somnolence, asthenia and dizziness.
  • In the pooled safety analysis, there was no clear dose-response relationship but incidence and severity of the central nervous system related adverse reactions decreased over time.

Drug Interaction

No clinically significant drug-drug interacting up to date.

Pregnancy and Lactation

Pregnancy:
• There are no adequate data available from the use of levetiracetam in pregnant women. Studies in animals have shown reproductive toxicity.
• The potential risk for human is unknown.
Lactation:
• Levetiracetam is excreted in human breast milk. Therefore, breast-feeding 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.

Warning and Precaution

• Renal insufficiency
The administration of Sycocetam to patients with renal impairment may require dose adjustment.
• Hepatic insufficiency
In patients with severely impaired hepatic function, assessment of renal function is recommended before dose selection.

Package and Storage

  • Package: Pack of 10 film coated tablets.
  • Storage: Store at temperature not exceeding 30°C in a dry place.
    Keep out of reach of children.

Mother Company

Manufactured by Marcyrl