Products

Sycocetam Oral Solution

Levetiracetam
 

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Active ingredient

Levetiracetam 100 mg/ml
 

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

Oral solution(100mg/ml)

2.5 ml b.d

2.5 ml b.d

15 ml b.d

Simple dosing for adiunctive therapy in children and infants > or = 1 month old:

Therapeutic starting dose

Increase/decrease 2-4 weeks

Maximum recommended dose

1 month to < 6 months:

7 mg/kg b.d.

7 mg/kg b.d.

(14mg/kg b.d)

21 mg/kg b.d.

6 months to < 4 years:

10 mg/kg b.d.

10 mg/kg

(20 mg/kg b.d.)

25 mg/kg b.d

4 years to < 16 years

10 mg/kg b.d

10 mg/kg

(20mg/kg b.d.)

30 mg/kg b.d.

Simple dosing for adjunctive therapy in adults:

 

Therapeutic Starting dose

Increase/decrease two-four weeks

Maximum recommended dose

Oral solution(100mg/ml)

5 ml b.d

5 ml b.d

15 ml 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

Up till now no clinically significant drug-drug interacting.

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: Carton Box Containing glass bottle of 120 ml , measuring cup, graduated Syringe & insert leaflet.
  • Storage: Store at temperature not exceeding 30°C, Due to sensitivity to light, store in the original container.
    Keep out of the reach and sight of children.

Mother Company

Manufactured by Marcyrl