Levetiracetam Injection USP 500mg/5ml

PATIENT INFORMATION LEAFLET

Levetiracetam Injection USP 500mg/5ml

Read all of this leaflet carefully before you or your child start using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or nurse.
If you get any side effects to talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

WHAT IS IN THIS LEAFLET

What Levetiracetam Injection USP 500mg/5ml is and what it is used for
What you need to know before you are given Levetiracetam Injection USP 500mg/5ml
How Levetiracetam Injection USP 500mg/5ml is given
Possible side effects
How to store Levetiracetam Injection USP 500mg/5ml
Contents of the pack and other information

1. WHAT LEVETIRACETAM INJECTION USP 500MG/5ML IS AND WHAT IT IS USED FOR

Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Levetiracetam Injection USP 500mg/5ml is used

on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy. Epilepsy is a condition where the patients have repeated fits (seizures). Levetiracetam is used for the epilepsy form in which the fits initially affect only one side of the brain, but could thereafter extend to larger areas on both sides of the brain (partial-onset seizure with or without secondary generalisation). Levetiracetam has been given to you by your doctor to reduce the number of fits

with other antiepileptic medicines (add-on therapy) to treat:

partial-onset seizures with or without generalisation in adults, adolescents and children from 4 years of age
myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy
primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).

Levetiracetam Injection USP 500mg/5ml concentrates for solution for infusion can be used when the administration of oral levetiracetam is temporarily impossible.

2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN LEVETIRACETAM INJECTION USP 500MG/5ML

Do not use Levetiracetam Injection USP 500mg/5ml

if you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before you are given Levetiracetam Injection USP 500mg/5ml

If you suffer from kidney problems, follow your doctor’s instructions. He/she may decide if your dose should be adjusted.
If you notice any slow down in growth, or if there is unexpected puberty development in your child, please contact your doctor.
A small number of people being treated with anti-epileptics such as Levetiracetam Injection USP 500mg/5ml have had thoughts of harming or killing themselves. If you have any symptoms of depression and/or thoughts about committing suicide, please contact your doctor.

Children and adolescents

Levetiracetam Injection USP 500mg/5ml is not indicated in children and adolescents below 16 years on its own (monotherapy).

Other medicines and Levetiracetam Injection USP 500mg/5ml

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Do not take macrogol (a drug used as a laxative) for one hour before and one hour after taking levetiracetam as this may result in a reduction of its effect.

Pregnancy and breast-feeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Levetiracetam can be used during pregnancy, only if after careful assessment it is considered necessary by your doctor.

You should not stop your treatment without discussing this with your doctor.

A risk of birth defects for your unborn child cannot be completely excluded.

Breastfeeding is not recommended during treatment.

Driving and using machines

Levetiracetam Injection USP 500mg/5ml may impair your ability to drive or operate any tools or machinery, as it may make you feel sleepy. This is more likely at the beginning of treatment or after an increase in the dose. You should not drive or use machines until it is established that your ability to perform such activities is not affected.

Levetiracetam Injection USP 500mg/5ml contains sodium

One maximum single dose of Levetiracetam Injection USP 500mg/5ml concentrate contains 2.5 mmol (or 57 mg) of sodium (0.8 mmol (or 19 mg) of sodium per vial). This should be taken into consideration if you are on a controlled sodium diet.

3. HOW LEVETIRACETAM INJECTION USP 500MG/5ML IS GIVEN

A doctor or a nurse will administer you Levetiracetam Injection USP 500mg/5ml as an intravenous infusion.

Levetiracetam Injection USP 500mg/5ml must be administered twice a day, once in the morning and once in the evening, at about the same time each day.

The intravenous formulation is an alternative to an oral formulation. You can be switched from one to the other without changing dose. Your total daily dose and frequency of administration remain the same.

Monotherapy

Dose in adults and adolescents (from 16 years of age)

When you will first start taking Levetiracetam Injection USP 500mg/5ml, your doctor will prescribe a lower dose for 2 weeks before adjusting the dose as necessary.

General dose: between 1,000 mg and 3,000 mg each day.

Add-on therapy

Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more

General dose: between 1,000 mg and 3,000 mg each day.

Dose in children (4 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg

General dose: between 20 mg per kg body weight and 60 mg per kg bodyweight each day.

Method and route of administration

Levetiracetam Injection USP 500mg/5ml is for intravenous use.

The recommended dose must be diluted in at least 100 ml of a compatible diluent and infused over 15 minutes. For doctors and nurses, more detailed direction for the proper use of Levetiracetam Injection USP 500mg/5ml is provided in section 6.

Duration of treatment

There is no experience with the administration of intravenous levetiracetam for a longer period than 4 days.

If you stop using Levetiracetam Injection USP 500mg/5ml

If stopping treatment, as with other antiepileptic medicines, Levetiracetam Injection USP 500mg/5ml should be discontinued gradually to avoid an increase of seizures. Should your doctor decide to stop your Levetiracetam Injection USP 500mg/5ml treatment, he/she will instruct you about the gradual withdrawal of Levetiracetam Injection USP 500mg/5ml.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately, or go to your nearest emergency department, if you experience:

weakness, feel light-headed or dizzy or have difficulty breathing, as these may be signs of a serious allergic (anaphylactic) reaction
swelling of the face, lips, tongue and throat (Quincke?s oedema)
flu-like symptoms and a rash on the face followed by an extended rash with a high temperature increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS])
symptoms such as low urine volume, tiredness, nausea, vomiting, confusion and swelling in the legs, ankles or feet, as this may be a sign of sudden decrease of kidney function
a skin rash which may form blisters and look like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
a more severe form of rash-causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis)
signs of serious mental changes or if someone around you notices signs of confusion, somnolence (sleepiness), amnesia (loss of memory), memory impairment (forgetfulness), abnormal behaviour or other neurological signs including involuntary or uncontrolled movements. These could be symptoms of an encephalopathy.

The most frequently reported adverse reactions were nasopharyngitis, somnolence (sleepiness), headache, fatigue and dizziness. At the beginning of the treatment or at dose increase of the side effects like sleepiness, tiredness and dizziness may be more common. These effects should, however, decrease over time.

Very common: may affect more than 1 in 10 people

nasopharyngitis
somnolence (sleepiness), headache

Common: may affect up to 1 in 10 people

anorexia (loss of appetite)
depression, hostility or aggression, anxiety, insomnia, nervousness or irritability
convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary trembling)
vertigo (sensation of rotation)
cough
abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea
rash
asthenia/fatigue (tiredness)

Uncommon: may affect up to 1 in 100 people

decreased number of blood platelets, decreased number of white blood cells
weight decrease, weight increase
suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucination, anger, confusion, panic attack, emotional instability/mood swings, agitation
amnesia (loss of memory), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired coordinated movements), paraesthesia (tingling), disturbance in attention (loss of concentration)
diplopia (double vision), vision blurred
elevated/abnormal values in a liver function test
hair loss, eczema, pruritus
muscle weakness, myalgia (muscle pain)
injury

Rare: may affect up to 1 in 1,000 people

infection
decreased number of all blood cell types
severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction], Quincke?s oedema [swelling of the face, lips, tongue and throat]))
decreased blood sodium concentration
suicide, personality disorders (behavioural problems), thinking abnormal (slow thinking, unable to concentrate)
delirium
encephalopathy (see sub-section ?Tell your doctor immediately? for a detailed description of symptoms)
uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity)
pancreatitis
liver failure, hepatitis
a sudden decrease in kidney function
skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis)
rhabdomyolysis (the breakdown of muscle tissue) and associated blood creatine phosphokinase increase. Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients.
limp or difficulty walking.

Reporting of side effects

If you get any side effects to talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. `

5. HOW TO STORE LEVETIRACETAM INJECTION USP 500MG/5ML

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the vial and carton box after EXP: The expiry date refers to the last day of the month.

Do not refrigerate or freeze.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Levetiracetam Injection USP 500mg/5ml contains

Each ml of injection contains:
Levetiracetam?????????.100mg

Each 5 ml vial contains 500 mg of levetiracetam. The other ingredients are sodium acetate trihydrate, glacial acetic acid, sodium chloride, water for injection.

What Levetiracetam Injection USP 500mg/5ml looks like and contents of the pack

Levetiracetam Injection USP 500mg/5ml concentrates for solution for infusion (sterile concentrate) is a clear, colourless liquid. Levetiracetam Injection USP 500mg/5ml concentrates for solution for infusion is packed in a cardboard box containing 10 vials of 5 ml.

7. MANUFACTURED IN INDIA BY:
TAJ LIFE SCIENCES PVT. LTD.
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
Mumbai-400001
at: Ahmedabad- Gujarat, INDIA.
Ho.NO.+91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222-825)