Source: Pharmaceutical Benefits Scheme (AU) Revision Year: 2022 Publisher: Dr. Reddys Laboratories (Australia) Pty Ltd, Suite 3.03, Level 3, 390 St Kilda Road, MELBOURNE, VIC, AUSTRALIA Phone: 1800 733 397
Levetiracetam.
| Pharmaceutical Form |
|---|
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Levecetam 250 levetiracetam 250 mg are blue coloured, oval shaped, film-coated tablets debossed with breakline separating ‘250’ and ‘MG’ on one side and ‘1014’ on other side. Levecetam 500 levetiracetam 500 mg are yellow coloured, oval shaped, film-coated tablets debossed with breakline separating ‘500’ and ‘MG’ on one side and ‘1015’ on other side. Levecetam 1000 levetiracetam 1000 mg are white to off white, oval shaped, film-coated tablets debossed with breakline separating ‘1000’ and ‘MG’ on one side and ‘1017’ on other side. |
The active ingredient in Levecetam 250, 500, 1000/tablets is levetiracetam 250 mg, 500 mg or 1000 mg.
For the full list of excipients, see Section 6.1 List of excipients.
Levetiracetam is a pure enantiomer. It is a white to off white powder with a faint odour and a bitter taste. It is very soluble in water (104 g/100 mL). It is freely soluble in chloroform (65.3 mg/100 mL) and in methanol (53.6 g/100mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane.
Chemical name: (S)-a-ethyl-2-oxo-1-pyrrolidineacetamide.
Chemical structure:
CAS number: 102767-28-2
Molecular Formula: C8H14N2O2.
Molecular weight: 170.2
| Active Ingredient | Description | |
|---|---|---|
| Levetiracetam |
Levetiracetam, is a pyrrolidone derivative, chemically unrelated to existing antiepileptic active substances. Levetiracetam induces seizure protection in a broad range of animal models of partial and primary generalised seizures without having a pro-convulsant effect. The primary metabolite is inactive. |
| List of Excipients |
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All strengths of tablet also contains the following excipients: maize starch, povidone, purified talc, colloidal anhydrous silica, sodium starch glycollate type A, silicon dioxide and magnesium stearate. 250 mg tablet coating: hypromellose, titanium dioxide, macrogol 400, indigo carmine CI73015. 500 mg tablet coating: hypromellose, titanium dioxide, macrogol 400 and iron oxide yellow CI77492. 1000 mg tablet coating: hypromellose, macrogol 400 and titanium dioxide |
Levecetam 250, 500, 1000 tablets come in 3 different strengths in packs of 60 tablets packed in PVC/PVDC/Al of blister pack.
Dr. Reddy’s Laboratories (Australia) Pty Ltd, Suite 3.03, Level 3, 390 St Kilda Road, MELBOURNE, VIC, AUSTRALIA
Phone: 1800 733 397
Date of first approval: 29 April 2010
| Drug | Countries | |
|---|---|---|
| LEVECETAM | Australia, Ecuador |
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