Levetiracetam

The US label lists levetiracetam as add-on (adjunctive) therapy for three kinds of seizures in people with epilepsy. Add-on means it is given alongside other seizure medicines.

The first is partial-onset seizures, in adults and children aged 4 years and older. The second is myoclonic seizures in people 12 years and older with juvenile myoclonic epilepsy. The third is primary generalized tonic-clonic seizures in people 6 years and older with idiopathic generalized epilepsy.

The label we reviewed does not describe other uses. Your doctor decides if it is right for you.

• Partial-onset seizures (4 years and older), add-on therapy
• Myoclonic seizures in juvenile myoclonic epilepsy (12 years and older)
• Primary generalized tonic-clonic seizures (6 years and older)

The label says the exact way levetiracetam controls seizures is not known.

In animal tests it did not block single seizures from electrical or chemical stimulation, but it protected against seizures that spread from a starting point.

The US label says to take it by mouth twice a day, with or without food. Tablets should be swallowed whole and not chewed or crushed.

For adults and teenagers 16 years and older with partial-onset seizures, the label describes starting at 500 mg twice daily. The dose may be raised by 500 mg twice daily every 2 weeks, up to 1500 mg twice daily. The same pattern is described for myoclonic and generalized tonic-clonic seizures.

Doses for younger children are based on body weight and are worked out by a doctor. The label says dose must be adjusted in people with reduced kidney function.

The label states that levetiracetam must be withdrawn gradually, so do not change or stop it on your own. Indian pack labels may differ from the US label, and your prescriber's instruction always comes first.

• Twice daily, with or without food
• Swallow tablets whole
• Dose is adjusted for kidney function
• Withdraw only gradually and under medical advice

The label lists no contraindication, but it carries several warnings. Behavioural problems, psychotic symptoms and suicidal thoughts have been seen, so mood changes should be reported.

Sleepiness and tiredness may affect driving or machinery. The label tells patients not to drive until they know how it affects them.

Stopping suddenly can cause withdrawal seizures. People with kidney problems need dose adjustment, and the label notes that older adults are more likely to have reduced kidney function.

The label says there are no adequate studies in pregnant women, and animal studies showed harm to the foetus, so it should be used only if the potential benefit justifies the risk. Blood levels can fall during pregnancy. It passes into breast milk, so a decision on breastfeeding is made with the doctor.

• Report mood, behaviour or sleep changes
• Do not drive until you know how it affects you
• Do not stop suddenly; ask your doctor or pharmacist
• Kidney disease: dose adjustment is needed
• Pregnancy and breastfeeding: discuss with your doctor
• Children: watch for irritability and aggression

• The label reports no significant pharmacokinetic interactions with liver enzymes, transporters or other medicines tested.
• Even so, sedating medicines and alcohol can add to drowsiness.
• Tell your doctor and pharmacist about everything you take.

No match in this label text. Ask your pharmacist about any medicine you take.

The label notes drowsiness in known overdoses, with agitation, aggression, lowered consciousness, slowed breathing and coma seen after marketing. Dialysis removes about half in 4 hours.

An overdose is an emergency and needs medical help at once.

The label we reviewed says to store tablets at 20 to 25 degrees Celsius, in a tight, light-resistant container with a child-resistant closure.

Check your own pack, since Indian products may differ.

We did not find levetiracetam in the Drugs Rules schedule lists we checked, so we cannot state its prescription status from our sources. Ask your pharmacist or doctor.

It is on the National List of Essential Medicines 2022 as 750 mg tablets, 750 mg modified-release tablets, an oral liquid of 100 mg/mL and a 100 mg/mL injection (page 65). NPPA lists ceiling prices for scheduled formulations, shown below.

The Jan Aushadhi list we checked includes levetiracetam tablets, extended-release tablets, oral solution and injections. We found no mention of levetiracetam in the banned-combination list we checked.

• Schedule: not found in the lists we checked
• NLEM 2022: listed
• NPPA price ceiling: listed
• Jan Aushadhi: listed

The NPPA list we checked (as on 30.09.2020) shows Rs 5.83 per 250 mg tablet, Rs 11.79 per 500 mg tablet and Rs 18.13 per 750 mg tablet. The 750 mg extended-release tablet is Rs 17.34, the oral liquid is Rs 3.64 per mL and the injection is Rs 21.75 per mL.

This list may have been revised, so check the date on your pack. The Jan Aushadhi list includes several levetiracetam products. Check the pack and seller; we do not show a brand price.