Consumer medicine information

1. Why am I being treated with Hospira Levetiracetam concentrate for IV infusion?

Hospira Levetiracetam concentrate for IV infusion contains the active ingredient levetiracetam. Hospira Levetiracetam concentrate for IV infusion is used to control epilepsy.
For more information, see Section 1. Why am I being treated with Hospira Levetiracetam concentrate for IV infusion? in the full CMI.

2. What should I know before treatment with Hospira Levetiracetam concentrate for IV infusion?

Do not start treatment if you have ever had an allergic reaction to Hospira Levetiracetam concentrate for IV infusion or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before treatment with Hospira Levetiracetam concentrate for IV infusion? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Hospira Levetiracetam concentrate for IV infusion and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How is Hospira Levetiracetam concentrate for IV infusion given?

Your doctor will decide how much Hospira Levetiracetam concentrate for IV infusion you will receive. This depends on your age, your condition and whether or not you are taking any other medicines.More instructions can be found in Section 4. How is Hospira Levetiracetam concentrate for IV infusion given? in the full CMI.

5. What should I know during treatment with Hospira Levetiracetam concentrate for IV infusion?

6. Are there any side effects?

Common side effects include dizziness, feeling weak, headache, common cold, stomach complaints, feeling tired, drowsy or sleepy, difficulty walking and trouble with balance. Serious side effects include changes in behaviour, thinking or mood (e.g. thoughts of harming yourself), upper respiratory tract infections, weight loss, muscle pain and dark red or brown urine or decreased urination, more frequent or more severe seizures, high fever, fast heartbeat and muscle stiffness, fainting and allergic type reactions. Do not be alarmed by this list. You may not experience any of them.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Levetiracetam.

2 Qualitative and Quantitative Composition

Hospira Levetiracetam concentrate for IV infusion contains 500 mg of levetiracetam in 5 mL.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Concentrated injection for intravenous infusion.
Hospira Levetiracetam concentrate for IV infusion is a clear, colourless and sterile aqueous solution.

4 Clinical Particulars

4.9 Overdose

Symptoms. The highest known dose of levetiracetam received in the clinical development program was 6000 mg/day. Other than drowsiness, there were no adverse events in the few known cases of overdose in clinical trials. Cases of somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma were observed with levetiracetam overdoses in post-marketing use.
Management of overdose. There is no specific antidote for levetiracetam. Treatment for an overdose will be symptomatic and may include haemodialysis. The dialyser extraction efficiency is 60% for levetiracetam and 74% for the major metabolite (ucb L057).
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Levetiracetam was negative in gene mutation assays (bacterial, Chinese hamster ovary/ HGPRT locus) and in assays for chromosomal damage in vitro and in vivo (Chinese hamster ovary cells, mouse micronucleus assay). The hydrolysis product and major human metabolite ucb L057 were not mutagenic in bacterial reverse mutation assays or the in vitro mouse lymphoma assay.
Carcinogenicity. There was no evidence of carcinogenicity following administration of levetiracetam in the diet to rats or orally to mice for 104 weeks, associated with respective systemic exposures (plasma AUC) up to 4-fold and 8-fold that in humans at the maximal recommended clinical dose of 3000 mg/day.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Levetiracetam 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 g/100 mL), soluble 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.
Chemical name: (S)-α-ethyl-2- oxo-1-pyrrolidineacetamide.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSLEVETI.gif Molecular formula: C₈H₁₄N₂O₂.
Molecular weight: 170.2.
CAS number. 102767-28-2.

7 Medicine Schedule (Poisons Standard)

Schedule 4 (Prescription Only Medicine).

Summary Table of Changes

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