Levetiracetam description, usages, side effects, indications, overdosage, supplying and lots more!

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Levetiracetam

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

LEVETIRACETAM DESCRIPTION



Levetiracetam




CLINICAL PHARMACOLOGY

Mechanism of Action





PHARMACOKINETICS



Overview


Absorption and Distribution


Metabolism


Elimination
Special Populations, Renal ImpairmentDOSAGE AND ADMINISTRATION, Adult Patients with Impaired Renal Function)

Pharmacokinetic Interactions

PRECAUTIONS, Drug Interactions)

USE IN SPECIFIC POPULATIONS

Elderly


Pediatric Patients

PRECAUTIONS, Drug Interactions

Gender
Levetiracetam Cmax and AUC were 20% higher in women (N=11) compared to men (N=12). However, clearances adjusted for body weight were comparable.

Race
Formal pharmacokinetic studies of the effects of race have not been conducted. Cross study comparisons involving Caucasians (N=12) and Asians (N=12), however, show that pharmacokinetics of levetiracetam were comparable between the two races. Because levetiracetam is primarily renally excreted and there are no important racial differences in creatinine clearance, pharmacokinetic differences due to race are not expected.

Renal Impairment
The disposition of levetiracetam was studied in adult subjects with varying degrees of renal function. Total body clearance of levetiracetam is reduced in patients with impaired renal function by 40% in the mild group (CLcr = 50 to 80 mL/min), 50% in the moderate group (CLcr = 30 to 50 mL/min) and 60% in the severe renal impairment group (CLcr <30 mL/min). Clearance of levetiracetam is correlated with creatinine clearance.
In anuric (end stage renal disease) patients, the total body clearance decreased 70% compared to normal subjects (CLcr >80 mL/min). Approximately 50% of the pool of levetiracetam in the body is removed during a standard 4-hour hemodialysis procedure.
Dosage should be reduced in patients with impaired renal function receiving levetiracetam, and supplemental doses should be given to patients after dialysis (seePRECAUTIONSandDOSAGE AND ADMINISTRATION, Adult Patients with Impaired Renal Function).

Hepatic Impairment
In subjects with mild (Child-Pugh A) to moderate (Child-Pugh B) hepatic impairment, the pharmacokinetics of levetiracetam were unchanged. In patients with severe hepatic impairment (Child-C), total body clearance was 50% that of normal subjects, but decreased renal clearance accounted for most of the decrease. No dose adjustment is needed for patients with hepatic impairment.

CLINICAL STUDIES



Effectiveness in Partial Onset Seizures in Adults with Epilepsy


Study 1





Levetiracetam



Study2






Levetiracetam




Study3





Levetiracetam



Effectiveness in Partial Onset Seizures in Pediatric Patients With Epilepsy
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Levetiracetam



Effectiveness in Myoclonic Seizures in PatientsYears of Age with Juvenile Myoclonic Epilepsy (JME)





Effectiveness for Primary Generalized Tonic-Clonic Seizures in PatientsYears of Age






Levetiracetam






INDICATIONS & USAGE





LEVETIRACETAM CONTRAINDICATIONS




WARNINGS

Suicidal Behavior and Ideation









Neuropsychiatric Adverse Events

Partial Onset Seizures

Adults







Pediatric Patients






Myoclonic Seizures




Primary Generalized Tonic-Clonic Seizures





Withdrawal Seizures


PRECAUTIONS


Hematologic Abnormalities

Partial Onset Seizures

Adults



Pediatric Patients



Juvenile Myoclonic Epilepsy


Hepatic Abnormalities


INFORMATION FOR PATIENTS







LABORATORY TESTS



DRUG INTERACTIONS





Drug-Drug Interactions between Levetiracetam and Other Antiepileptic Drugs (AEDs)Phenytoin

Phenytoin


Valproate



Effect of AEDs in Pediatric Patients


Other Drug Interactions

Oral Contraceptives


Digoxin


Warfarin


Probenecid


CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

Carcinogenesis


Mutagenesis


Impairment of Fertility


PREGNANCY

Pregnancy Category C







Pregnancy Registries


LABOR & DELIVERY



NURSING MOTHERS



PEDIATRIC USE




GERIATRIC USE





Use in Patients with Impaired Renal Function
CLINICAL PHARMACOLOGYDOSAGE AND ADMINISTRATION, Adult Patients with Impaired Renal Function).

LEVETIRACETAM ADVERSE REACTIONS



Partial Onset Seizures







Myoclonic Seizures






Primary Generalized Tonic-Clonic Seizures






Time Course of Onset of Adverse Events for Partial Onset Seizures


Discontinuation or Dose Reduction in Well-Controlled Clinical Studies

Partial Onset Seizures





Myoclonic Seizures



Primary Generalized Tonic-Clonic Seizures



Comparison of Gender, Age and Race


Postmarketing Experience


DRUG ABUSE AND DEPENDENCE



OVERDOSAGE

Signs, Symptoms and Laboratory Findings Of Acute Overdosage in Humans


Treatment or Management of Overdose


Hemodialysis


DOSAGE & ADMINISTRATION





Partial Onset Seizures

Adults 16 Years and Older
CLINICAL STUDIES


Pediatric Patients Ages 4 to <16 Years









Myoclonic Seizures in Patients 12 Years of Age and Older with Juvenile Myoclonic Epilepsy


Primary Generalized Tonic-Clonic Seizures

Adults 16 Years and Older


Pediatric Patients Ages 6 to <16 Years


Adult Patients with Impaired Renal Function








HOW SUPPLIED






















STORAGE AND HANDLING


Pharmacist


SPL MEDGUIDE

Levetiracetam Tablets, 250 mg, 500 mg and 750 mg

What is the most important information I should know about levetiracetam tablets?
Like other antiepileptic drugs, levetiracetam tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500 people taking it.
Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
  • ●     thoughts about suicide or dying
  • ●     attempts to commit suicide
  • ●     new or worse depression
  • ●     new or worse anxiety
  • ●     feeling agitated or restless
  • ●     panic attacks
  • ●     trouble sleeping (insomnia)
  • ●     new or worse irritability
  • ●     acting aggressive, being angry, or violent
  • ●     acting on dangerous impulses
  • ●     an extreme increase in activity and talking (mania)
  • ●     other unusual changes in behavior or mood
Do not stop levetiracetam tablets without first talking to a healthcare provider.
  • ●     Stopping levetiracetam tablets suddenly can cause serious problems. Stopping a seizure medicine suddenly can cause seizures that will not stop (status epilepticus).
  • ●     Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.
How can I watch for early symptoms of suicidal thoughts and actions?
  • ●     Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
What are levetiracetam tablets?

  • ●     partial onset seizures in people 4 years of age and older with epilepsy.
  • ●     myoclonic seizures in people 12 years of age and older with juvenile myoclonic epilepsy
  • ●     primary generalized tonic-clonic seizures in people 6 years of age and older with certain types of generalized epilepsy.





What should I tell my healthcare provider before starting levetiracetam tablets?

  • ●     have or have had depression, mood problems or suicidal thoughts or behavior
  • ●     have kidney problems
  • ●     are pregnant or planning to become pregnant. It is not known if levetiracetam tablets will harm your unborn baby. You and your healthcare provider will have to decide if you should take levetiracetam tablets while you are pregnant. If you become pregnant while taking levetiracetam tablets, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334.
  • ●     are breast feeding. Levetiracetam tablets can pass into your milk and may harm your baby. You and your healthcare provider should discuss whether you should take levetiracetam tablets or breast-feed; you should not do both.


How should I take levetiracetam tablets?

  • ●     Your healthcare provider will tell you how much levetiracetam tablets to take and when to take it . Levetiracetam tablets are usually taken twice a day. Take levetiracetam tablets at the same times each day.
  • ●     Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider.
  • ●     Take levetiracetam tablets with or without food.
  • ●     Swallow the tablets whole. Do not chew or crush tablets. Ask your healthcare provider for levetiracetam oral solution if you cannot swallow tablets.
  • ●     If your healthcare provider has prescribed levetiracetam oral solution, be sure to ask your pharmacist for a medicine dropper or medicine cup to help you measure the correct amount of levetiracetam oral solution. Do not use a household teaspoon. Ask your pharmacist for instructions on how to use the measuring device the right way.
  • ●     If you miss a dose of levetiracetam tablets, take it as soon as you remember. If it is almost time for your next dose, just skip the missed dose. Take the next dose at your regular time.Do not take two doses at the same time.
  • ●     If you take too much levetiracetam tablets, call your local Poison Control Center or go to the nearest emergency room right away.
What should I avoid while taking levetiracetam tablets?

What are the possible side effects of levetiracetam tablets?
  • ●     SeeWhat is the most important information I should know about levetiracetam tablets?


  • ●     mood and behavior changes such as aggression, agitation, anger, anxiety, apathy, mood swings, depression, hostility, and irritability. A few people may get psychotic symptoms such as hallucinations (seeing or hearing things that are really not there), delusions (false or strange thoughts or beliefs) and unusual behavior.
  • ●     extreme sleepiness, tiredness, and weakness
  • ●     problems with muscle coordination (problems walking and moving)

  • ●     sleepiness
  • ●     weakness
  • ●     dizziness
  • ●     infection

  • ●     accidental injury
  • ●     irritability
  • ●     hostility



Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store levetiracetam tablets?
  • ●     Store levetiracetam tablets at 20to 25(68to 77to 30(59to 86
  • ●      Keep levetiracetam tablets and all medicines out of the reach of children.
General information about levetiracetam tablets.

What are the ingredients of levetiracetam tablets?
Levetiracetam tablet:



PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Levetiracetam

Levetiracetam

Levetiracetam

Levetiracetam TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-584(NDC:55111-182)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LEVETIRACETAM LEVETIRACETAM 500 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
MAGNESIUM STEARATE
cellulose, microcrystalline
povidone
talc
SODIUM STARCH GLYCOLATE TYPE A POTATO
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
FERRIC OXIDE YELLOW
ferric oxide red
polyethylene glycol 400
polysorbate 80
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
brown 18 mm RDY;182 BULLET

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-584-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076920 2011-10-12


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Be sure to consult your doctor before taking any medication!
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