SPL Set ID: d2de9565-0c0b-4957-bafa-1a286103709e

Levetiracetam in Sodium Chloride Injection is an antiepileptic drug available as a clear, colorless, sterile solution for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8 H 14 N 2 O 2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: 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 grams per 100 mL). It is freely soluble in chloroform (65.3 grams per 100 mL) and in methanol (53.6 grams per 100 mL), soluble in ethanol (16.5 grams per 100 mL), sparingly soluble in acetonitrile (5.7 grams per 100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as grams per 100 mL solvent.) Levetiracetam in Sodium Chloride Injection is a clear, colorless, sterile solution that is available in a single-dose dual port bag with an aluminum overwrap. The container closure is not made with natural rubber latex. 500 mg per 100 mL: One 100 mL bag contains 500 mg of levetiracetam (5 mg per mL), water for injection, 820 mg sodium chloride, 5.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,000 mg per 100 mL: One 100 mL bag contains 1,000 mg of levetiracetam (10 mg per mL), water for injection, 750 mg sodium chloride, 6.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,500 mg per 100 mL: One 100 mL bag contains 1,500 mg of levetiracetam (15 mg per mL), water for injection, 540 mg sodium chloride, 7.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. Figure