Levetiracetam Extended-release

Levetiracetam Extended-release

Levetiracetam Extended-release Recall

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Extended-release levetiracetam tabletis an antiepileptic drug indicated for adjunctive therapy in the treatment of partial onset seizures in patients ≥16 years of age with epilepsy

History

There is currently no drug history available for this drug.

Other Information

Levetiracetam extended-release tablet is an antiepileptic drug available as 500 mg (white) and 750 mg (yellow) extended-release tablets for oral administration.

The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:

397470a1-figure-02

Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform

(65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.)

Levetiracetam extended-release tablets, 500 mg and 750 mg contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, magnesium stearate, polyvinyl alcohol, polyethylene glycol, talc and titanium dioxide.

In addition, the 750 mg strength contains iron oxide yellow and iron oxide red.

Levetiracetam Extended-release Manufacturers


  • Anchen Pharmaceuticals, Inc.
    Levetiracetam Extended-release (Levetiracetam) Tablet, Film Coated, Extended Release [Anchen Pharmaceuticals, Inc.]
  • Golden State Medical Supply, Inc.
    Levetiracetam Extended-release (Levetiracetam) Tablet, Extended Release [Golden State Medical Supply, Inc.]

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