Keppra Oral Solution
Brand Name Choices
No generic medication is available for Keppra Oral Solution (Levetiracetam)
What Keppra Oral Solution is and what it is used for
Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy). Keppra 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.
• as an add-on to other antiepileptic medicines to treat:
• partial onset seizures with or without generalisation in 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). Keppra concentrate for solution for infusion is an alternative for patients when administration of the antiepileptic oral Keppra medicine is temporarily not feasible.
How to take Keppra Oral Solution
A doctor or a nurse will administer you Keppra as an intravenous infusion. Keppra 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 your oral administration. You can switch from the film-coated tablets or from the oral solution to the intravenous formulation or reverse directly without dose adaptation. Your total daily dose and frequency of administration remain identical. Monotherapy Dose in adults and adolescents (from 16 years of age): General dose: between 1000 mg and 3,000 mg each day. When you will first start taking Keppra, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest general dose. 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 bodyweight and 60 mg per kg bodyweight each day. Method and route of administration: Keppra 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 Keppra is provided in section 6. Duration of treatment:
• There is no experience with administration of intravenous levetiracetam for a longer period than 4 days. If you stop using Keppra: If stopping treatment, as with other antiepileptic medicines, Keppra should be discontinued gradually to avoid an increase of seizures. Should your doctor decide to stop your Keppra treatment, he/she will instruct you about the gradual withdrawal of Keppra. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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 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 user in 10 people
• somnolence (sleepiness), headache.
Common: may affect 1 to 10 users in 100 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);
• abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
• asthenia/fatigue (tiredness).
Uncommon: may affect 1 to 10 users in 1000 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 1 to 10 users in 10,000 people
• 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);
• uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity);
• liver failure, hepatitis;
• 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 (StevensJohnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis).
• rhabdomyolysis (breakdown of muscle tissue) and associated blood creatine phosphokinase increase. Prevalence is significantly higher in Japanese patients when compared to nonJapanese patients.
Reporting of side effects If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system: United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard Ireland HPRA Pharmacovigilance Earlsfort Terrace IRL
•Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: [email protected] Malta ADR Reporting The Medicines Authority Post-Licensing Directorate 203 Level 3, Rue D'Argens GŻR-1368 Gżira Website: www.medicinesauthority.gov.mt e-mail: [email protected] By reporting side effects you can help provide more information on the safety of this medicine.
How to Store Keppra Oral Solution
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. This medicine does not require any special storage conditions.
2 to 3 weeks on average
The average shipping time is 2 weeks in North America and 4 weeks internationally. We offer free shipping on all orders shipped to North America. Shipping is a flat rate of $20.00 for all other countries.
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