11 DESCRIPTION Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white to off-white) 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 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 USP is a white to off-white, crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104 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 tablets USP contain the labeled amount of levetiracetam. Inactive ingredients: corn starch, colloidal silicon dioxide, povidone, talc, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and purified water. In addition 250 mg contains FD&C Blue #2/indigo carmine aluminum lake, 500 mg contains iron oxide yellow, and 750 mg contains FD&C Yellow #6/sunset yellow FCF aluminum lake, FD&C Blue #2/indigo carmine aluminum lake, and iron oxide red. Meets USP dissolution test 2. Chemical Structure
⚠️ Warnings
See Table 1 for the recommended preparation and administration of Desitrend concentrate for solution for infusion to achieve a total daily dose of 500 mg, 1,000 mg, 2,000 mg, or 3,000 mg in two divided doses.
Table 1. Preparation and administration of levetiracetam concentrate for solution for infusion
Dose
Withdrawal Volume
Volume of Diluent
Infusion Time
Frequency of Administration
Total Daily Dose
250 mg
2.5 ml (half 5 ml ampoule)
100 ml
15 minutes
Twice daily
500 mg/day
500 mg
5 ml (one 5 ml ampoule)
100 ml
15 minutes
Twice daily
1,000 mg/day
1,000 mg
10 ml (two 5 ml ampoules)
100 ml
15 minutes
Twice daily
2,000 mg/day
1,500 mg
15 ml (three 5 ml ampoules)
100 ml
15 minutes
Twice daily
3,000 mg/day
This medicinal product is for single use only, any unused solution should be discarded.
Desitrend concentrate for solution for infusion was found to be physically compatible and chemically stable for at least 24 hours when mixed with the following diluents and stored in PVC bags at controlled room temperature 15 – 25 °C:
Diluents
• Sodium chloride 9 mg/ml (0.9%) solution for injection
• Lactated Ringer's solution for injection
• Glucose 50 mg/ml (5%) solution for injection
Medicinal product with particulate matter or discolouration should not be used.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
