(lee ve tye ra' se tam)
P : Caution when used during pregnancy
L : Caution when used during lactation
|| See TERMINOLOGY & ABBREVIATIONS ||
|Indication(s) & Dosage||
Monotherapy for partial seizures with or without secondary generalisation
Monotherapy for partial seizures with or without secondary generalisation
Renal impairment: Suitable total daily dose (given as 2 divided doses) based on CrCl.
Reconstitution: Add 100 ml of suitable diluent to vial. Suitable diluents include sodium chloride (0.9%) injection; lactated Ringer's injection and dextrose 5% injection.
|Administration||May be taken with or without food. Oral soln may be taken directly or diluted in a glass of water.
|Special Precautions||Renal and hepatic impairment; pregnancy, lactation; patients undergoing haemodialysis. If psychotic symptoms (eg hallucination) and behavioural symptoms (eg agitation, anxiety) occur, reduce dosage. Abrupt withdrawal may result in increased seizure frequency. May impair ability to drive or operate machinery during initial therapy.|
|Adverse Drug Reaction(s)||Somnolence, asthenia, dizziness, vertigo, depression, emotional instability, hostility, nervousness, ataxia, tremor, amnesia, headache, nausea, dyspepsia, diarrhoea, anorexia, rash, diplopia.|
|Pregnancy Category (FDA)||Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.|
|Storage||Intravenous: Once reconstituted store at 15-30Â°C and use within 24 hr.|
|Pharmacology||Anticonvulsant used in the treatment of partial seizures. The precise mechanism of anticonvulsant effect is unknown.
Onset: 1 hr
Absorption: Rapidly and almost completely absorbed from GI tract.
Distribution: Not significantly protein bound (<10%). Distributed in breast milk.
Metabolism: Not extensively metabolised (24% into inactive metabolite); primarily by enzymatic hydrolysis.
Excretion: Excreted in the urine as both unchanged drug (66%) and metabolites. Plasma half life of 6-8 hr.
|ATC Classification||N03AX14 - levetiracetam; Belongs to the class of other antiepileptics. Used in the management of epilepsy.|
|Brand Name||Manufacturer/Marketer||Composition||Dosage Form||Pack Size & Price|
|CITAZAR||ACI Ltd.||Levetiracetam INN 250mg & 500mg||Tablet (film-coated)||250mg x20's, 500mg x10's: 301.20 & 250.90 MRP|
|ELETAM||Unimed & Unihealth Manufacturers Ltd.||Levetiracetam INN 250mg & 500mg||Tablet (film-coated)||20's each: 240.00 & 480.00 MRP|
|ELETAM Solution||Unimed & Unihealth Manufacturers Ltd.||Levetiracetam INN 100mg/ml||Oral Solution||100ml: 400.00 MRP|
|ERATA 250||Sandoz/Novartis||Levetiracetam INN 250mg||Film Coated Tablet||3x10's, MRP 483.00|
|ERATA 500||Sandoz/Novartis||Levetiracetam INN 500mg||Film Coated Tablet||3x10's, MRP 906.00|
|IRACET 250||Square Pharmaceuticals Ltd.||Levetiracetam 250mg||Tablet||2x10's: 320.00 MRP|
|IRACET 500||Square Pharmaceuticals Ltd.||Levetiracetam 500mg||Tablet||1x10's: 300.00 MRP|
|IRACET INJ||Square Pharmaceuticals Ltd.||Levetiracetam 500mg/5 ml||Injection||3x2's: 240.78 MRP|
|IRACET Injection||Square Pharmaceuticals Ltd.||Levetiracetam USP 500mg/ 5ml||Injection||6's: 240.00 MRP|
|IRACET O-SOLN||Square Pharmaceuticals Ltd.||Levetiracetam 500mg/5 ml||Oral Solution||50 ml: 200.61 MRP|
Why is Levetiracetam prescribed?
Levetiracetam is used in combination with other medications to treat certain types of seizures in people with epilepsy. Levetiracetam is in a class of medications called anticonvulsants. It works by decreasing abnormal excitement in the brain.
How should Levetiracetam be used?
Levetiracetam comes as a solution (liquid) and a tablet to take by mouth. It is usually taken twice a day, once in the morning and once at night, with or without food. Try to take levetiracetam at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor to explain any part you do not understand. Take levetiracetam exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow the tablets whole; do not split, chew, or crush them.
If you are taking the oral solution, do not use a household spoon to measure your dose. You might not get the right amount of medication. Ask your doctor to recommend a medicine dropper, spoon, cup, or syringe and to show you how to use it to measure your medication.
Your doctor may start you on a low dose of levetiracetam and gradually increase your dose, not more often than once every 2 weeks.
Levetiracetam controls epilepsy but does not cure it. Continue to take levetiracetam even if you feel well. Do not stop taking levetiracetam without talking to your doctor, even if you experience side effects such as unusual changes in behavior or mood. If you suddenly stop taking levetiracetam, your seizures may become worse. Your doctor will probably decrease your dose gradually.
Your doctor will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with levetiracetam and each time you refill your prescription. Read the information carefully and ask your doctor if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs) or the manufacturer's website to obtain the Medication Guide.
Other uses for Levetiracetam
Levetiracetam may be prescribed for other uses; ask your doctor for more information.
What special precautions to follow?
Before taking levetiracetam,
- inform your doctor if you are allergic to levetiracetam or any other medications.
- inform your doctor what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- inform your doctor if you have or have ever had kidney disease.
- inform your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking levetiracetam, call your doctor. Do not breast-feed while you are taking levetiracetam.
- you should know that levetiracetam may make you dizzy or drowsy. Do not drive a car or operate machinery until you know how Levetiracetam affects you.
- you should know that your mental health may change in unexpected ways and you may become suicidal (thinking about harming or killing yourself or planning or trying to do so) while you are taking levetiracetam for the treatment of epilepsy, mental illness, or other conditions. A small number of adults and children 5 years of age and older (about 1 in 500 people) who took anticonvulsants such as levetiracetam to treat various conditions during clinical studies became suicidal during their treatment. Some of these people developed suicidal thoughts and behavior as early as one week after they started taking the medication. There is a risk that you may experience changes in your mental health if you take an anticonvulsant medication such as levetiracetam, but there may also be a risk that you will experience changes in your mental health if your condition is not treated. You and your doctor will decide whether the risks of taking an anticonvulsant medication are greater than the risks of not taking the medication. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: panic attacks; agitation or restlessness; new or worsening irritability, anxiety, or depression; acting on dangerous impulses; difficulty falling or staying asleep; aggressive, angry, or violent behavior; mania (frenzied, abnormally excited mood); talking or thinking about wanting to hurt yourself or end your life; withdrawing from friends and family; preoccupation with death and dying; giving away prized possessions; or any other unusual changes in behavior or mood. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.
What special dietary instructions to follow?
Unless your doctor informs you otherwise, continue your normal diet.
What to do if I forget a dose?
If it has only been a few hours since the time you were scheduled to take the dose, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can Levetiracetam cause?
Levetiracetam may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
agitation or hostility
numbness, burning, or tingling in the hands or feet
loss of appetite
changes in skin color
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:
hallucinating (hearing voices or seeing visions that do not exist)
thoughts of killing yourself
seizures that are worse or different than the seizures you had before
fever, sore throat, and other signs of infection
swelling of the face
Levetiracetam may cause other side effects. Call your doctor if you have any unusual problems while taking Levetiracetam.
What to know about storage and disposal of Levetiracetam?
Keep Levetiracetam in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose, consult your doctor. If the victim has collapsed or is not breathing, consult local medical emergency services.
Symptoms of overdose may include:
decreased consciousness or loss of consciousness
What other information to know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to Levetiracetam.
Do not let anyone else use your medication. If you still have symptoms and need further treatment, consult your doctor.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Ref: U.S. National Library of Medicine.
This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.