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SANDOZ LEVETIRACETAM is a brand name for Levetiracetam, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Sandoz Levetiracetam (levetiracetam tablets) is indicated as adjunctive therapy in the management of adult (> 18 years of age) patients with epilepsy who are not satisfactorily controlled by conventional therapy. 1.1 Pediatrics Pediatrics (< 18 years of age): Based on the data submitted and reviewed by Health Canada,…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Sandoz Levetiracetam is given orally with or without food. After oral administration, the bitter taste of levetiracetam may be experienced. 2 Recommended Dose and Dosage Adjustment Adults Treatment should be initiated at a dose of 1000 mg/day, given as twice daily dosing (500 mg bid).
Depending on clinical response and tolerability, the daily dose may be increased every two weeks by increments of 1000 mg, to a maximum recommended daily dose of 3000 mg. In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice a day dosing, were shown to be effective.
Although there was a tendency toward greater response rate with higher dose, a consistent statistically significant increase in response with increased dose has not been shown. There are limited safety data from controlled clinical trials at doses higher than 3000 Sandoz Levetiracetam Page 5 of 39 Unclassified / Non classifié mg/day (approximately 40 patients), therefore these doses are not recommended.
Patients with Impaired Renal Function Renal excretion of unchanged drug accounts for approximately 66% of administered levetiracetam dose. Consistent with this, Sandoz Levetiracetam dosage should be reduced in patients with impaired renal function (see Table 1 below).
Patients with end stage renal disease should receive supplemental doses following dialysis. To use this dosing table, an estimate of the patient’s creatinine clearance is needed. 73 m2) Dosage and Frequency Normal ≥ 80 500 to 1500 mg twice daily Mild 50 - 79 500 to 1000 mg twice daily Moderate 30 - 49 250 to 750 mg twice daily Severe* < 30 250 to 500 mg twice daily End-stage renal disease patients undergoing dialysis (1) - 500 to 1000 mg once daily (1) Following dialysis, a 250 to 500 mg supplemental dose is recommended.
* or according to best clinical judgment Patients with Impaired Hepatic Function No dose adjustment is needed in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, the creatinine clearance may underestimate the renal insufficiency.
73m2. 3 Pediatrics). Sandoz Levetiracetam Page 6 of 39 Unclassified / Non classifié Geriatrics (≥ 65 years of age) Dose selection and titration should proceed cautiously in elderly patients, as renal function decreases with age. 4 Administration The film-coated tablets must be taken orally, swallowed with liquid.
). Seizure Worsening A paradoxical reaction of worsening of seizure may be observed especially when starting treatment or at increase in dose. Lack of efficacy or seizure worsening has also been reported in patients with epilepsy associated with sodium voltage-gated channel alpha subunit 8 (SCN8A) mutations.
In the case of lack of efficacy or worsening seizures, use of Sandoz Levetiracetam should be re-evaluated. Psychiatric Suicidal Ideation and Behaviour Suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents in several indications.
All patients treated with antiepileptic drugs, irrespective of indication, should be monitored for signs of depression and/or suicidal ideation and behaviour and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
An FDA meta-analysis of randomized placebo-controlled trials, in which antiepileptic drugs were used for various indications, has shown a small increased risk of suicidal ideation and behaviour in patients treated with these drugs.
The mechanism of this risk is not known. There were 43892 patients in the placebo controlled clinical trials that were included in the meta- analysis. Approximately 75% of patients in these clinical trials were treated for indications other than epilepsy and, for the majority of non-epilepsy indications the treatment (antiepileptic drug or placebo) was administered as monotherapy.
, patients in both treatment arms were being treated with one or more antiepileptic drug). 24% for patients on placebo) is based largely on patients that received monotherapy treatment (antiepileptic drug or placebo) for non-epilepsy indications.
The study design does not allow an estimation of the risk of suicidal ideation and behaviour for patients with epilepsy that are taking antiepileptic drugs, due both to this population being the minority in the study, and the drug- placebo comparison in this population being confounded by the presence of adjunct antiepileptic drug treatment in both arms.
General As with all antiepileptic drugs, Sandoz Levetiracetam should be withdrawn gradually to minimize the potential of increased seizure frequency. Carcinogenesis and Mutagenesis See 16 NON-CLINICAL TOXICOLOGY, Carcinogenicity and 16 NON-CLINICAL TOXICOLOGY, Genotoxicity for discussion on animal data.
Cardiovascular QT Prolongation Sandoz Levetiracetam Page 8 of 39 Unclassified / Non classifié The effect of levetiracetam on the QTc interval was evaluated in a randomized, double-blind, placebo- and positive-controlled, single-dose, four-way crossover study of levetiracetam (1000 mg or 5000 mg) in 52 healthy subjects.
5 h after dosing. Rare cases of ECG QT interval prolongation have been observed during post-marketing surveillance in patients with and without a prior history of cardiac conditions. 5 Post-Market Adverse Reactions, Cardiac disorders).
, coordination difficulties). Therefore, patients are advised not to drive or operate machinery or other skilled tasks until it is established that their ability to perform such activities is not affected. Hematologic Statistically significant decreases compared to placebo were seen in total mean RBC count, mean hemoglobin, and mean hematocrit in levetiracetam -treated patients in controlled trials.
5% each. 2% of placebo patients had at least one possibly significant decrease in hematocrit (≤ 37% in males and 32% in females). 6% of treated vs. 0 x 109/L). Of the levetiracetam treated patients with a low neutrophil count, all but one rose towards or reached baseline with continued treatment.
No patient was discontinued secondary to low neutrophil counts. Cases of decreased blood cell counts (neutropenia, agranulocytosis, leucopenia, thrombocytopenia and pancytopenia) have been described in association with levetiracetam administration.
5 Post-Market Adverse Reactions, Blood and lymphatic disorders). 5 Post-Market Adverse Sandoz Levetiracetam Page 9 of 39 Unclassified / Non classifié Reactions). 2 Recommended Dose and Dosage Adjustment. Immune Hypersensitivity Reactions • Serious Dermatological Reactions Serious hypersensitivity reactions with dermatological involvement have been reported in both children and adults in association with levetiracetam use, including Stevens-Johnson syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
Sandoz Levetiracetam is contraindicated in patients who are hypersensitive to: • this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The daily dose is administered in two equally divided doses. 5 Missed Dose If the patient misses a dose by a few hours, they should be instructed to take Sandoz Levetiracetam as soon as they remember. If it is close to their next dose, they should be instructed to take their medication at the next regular time.
Patients should not take two doses at the same time.
Psychiatric Reactions and Changes in Behaviour Levetiracetam may cause behavioural abnormalities and psychotic symptoms. Behavioural adverse reactions reported with levetiracetam include affect liability, aggression, agitation, anger, Sandoz Levetiracetam Page 11 of 39 Unclassified / Non classifié anxiety, apathy, depression, hostility, irritability, personality change, paranoia and obsessive- compulsive disorder (OCD).
Closely monitor patients treated with levetiracetam for psychiatric signs and symptoms. Renal Renal excretion of unchanged drug accounts for approximately 66% of administered levetiracetam dose. 3 Pharmacokinetics, Special Populations and Conditions, Renal Insufficiency).
In patients with renal impairment Sandoz Levetiracetam dosage should be appropriately reduced. e. 2 Recommended Dose and Dosage Adjustment, Patients with Impaired Renal Function).
Reproductive Health:
Female and Male Potential • Fertility The effect of this medication on human fertility is unknown. No adverse effects on male or female fertility or reproductive performance were observed in rats at doses up to 1800 mg/kg/day (see 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology) • Teratogenic Risk There is non-clinical evidence suggesting that levetiracetam is embryotoxic and teratogenic (see 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology).
1 Pregnant Women). 1 Pregnant Women Levetiracetam Blood Levels May Decrease During Pregnancy: As with other antiepileptic drugs, physiological changes during pregnancy may affect levetiracetam concentration. There have been reports of decreased levetiracetam concentration during pregnancy.
This decrease is more pronounced during the third trimester (up to 60% of baseline concentration before pregnancy). It is recommended that clinical response should be monitored carefully in women receiving Sandoz Levetiracetam treatment during pregnancy, and determination of changes in plasma concentrations should be considered to ensure that adequate seizure control is maintained throughout pregnancy.
In the event that medication is increased during pregnancy, the dose may need to be adjusted postpartum.
Risk to the Unborn Child:
In reproductive toxicity studies in rats and rabbits, levetiracetam induced developmental toxicity at exposure levels similar to or greater than the human exposure. There was evidence of increased skeletal variations/minor anomalies, retarded growth, embryonic death, and increased pup mortality.
In the rat, fetal abnormalities occurred in the absence of overt Sandoz Levetiracetam Page 12 of 39 Unclassified / Non classifié maternal toxicity. The systemic exposure at the observed no effect level in the rabbit was about 4 to 5 times the human exposure.
There are no adequate and well-controlled studies on the use of levetiracetam in pregnant women. Levetiracetam and/or its metabolites cross the placental barrier in animal […]
Such serious skin reactions may be life-threatening, and some patients have required hospitalization with very rare reports of fatal outcome. There is no way to tell if a mild rash will become a severe skin reaction. If any of these hypersensitivity reactions are suspected, and an alternative cause cannot be established, Sandoz Levetiracetam should be discontinued.
Recurrence of the serious skin reactions following re-challenge with levetiracetam has been reported. The median time to onset for reported cases of SJS and TEN was 12 days. The reporting rate of TEN and SJS associated with levetiracetam use, which is generally accepted to be an underestimate due to underreporting, is 9 cases/million patient years.
5 to 6 cases per million-person years. g. up to 6 weeks or more after treatment initiation. Typically, although not exclusively, DRESS initially presents with fever and rash, and then with other organ system involvement that may or may not include eosinophilia, lymphadenopathy, hepatitis, nephritis, and/or myocarditis.
Because DRESS is variable in its expression, other organ system signs and symptoms not noted here may also occur. Organ involvement may be more severe than skin involvement. • Anaphylaxis and Angioedema Levetiracetam can cause anaphylaxis or angioedema after the first dose or at any time during treatment.
Signs and symptoms in cases reported in the post-marketing setting have included hypotension, hives, rash, respiratory distress, and swelling of the face, lip, mouth, eye, tongue, throat, and feet. In some reported cases, reactions were life-threatening and required emergency treatment.
If a patient develops signs or symptoms of anaphylaxis or angioedema, the patient should seek immediate medical attention. Sandoz Levetiracetam should be discontinued permanently if […]