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 ADMINISTRATIONAdult Patients with Impaired Renal Function
Pharmacokinetic Interactions

PRECAUTIONSDrug Interactions

USE IN SPECIFIC POPULATIONS





PRECAUTIONSDrug Interactions








PRECAUTIONSDOSAGE AND ADMINISTRATIONAdult Patients with Impaired Renal Function



CLINICAL STUDIES


Effectiveness in Partial Onset Seizures in Adults with Epilepsy

Study 1



***

Levetiracetam


Study 2




***

Levetiracetam



Study 3



**

Levetiracetam


Effectiveness in Partial Onset Seizures In Pediatric Patients with Epilepsy



**

Levetiracetam



INDICATIONS & USAGE



LEVETIRACETAM CONTRAINDICATIONS



WARNINGS

Suicidal Behavior and Ideation









Neuropsychiatric Adverse Events
Partial Onset Seizures
Adults







Pediatric Patients





Withdrawal Seizures


PRECAUTIONS

Hematologic Abnormalities
Partial Onset Seizures
Adults



Pediatric Patients


Hepatic Abnormalities


INFORMATION FOR PATIENTS







LABORATORY TESTS



DRUG INTERACTIONS




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








Other Drug Interactions









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 ADMINISTRATIONAdult Patients with Impaired Renal Function

LEVETIRACETAM ADVERSE REACTIONS


Partial Onset Seizures








Time Course of Onset of Adverse Events For Partial Onset Seizures

Discontinuation or Dose Reduction in Well-Controlled Clinical Studies
Partial Onset 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



Adults 16 Years and Older
CLINICAL STUDIES


Pediatric Patients Ages 4 to <16 Years










Adult Patients with Impaired Renal Function






**


HOW SUPPLIED





STORAGE AND HANDLING




SPL MEDGUIDE

LEVETIRACETAM TABLETS
250 mg, 500 mg and 750 mg tablets


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 is LEVETIRACETAM TABLET?

  • ●     partial onset seizures in people 4 years of age and older with 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 is 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.
  • ●     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?



  • ●     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.
You may also report side effects to Lupin Pharmaceuticals, Inc. at 1-800-399-2561.
How should I store LEVETIRACETAM TABLETS?

  • ●     Store LEVETIRACETAM TABLETS at room temperature away from heat and light.
  •      Keep LEVETIRACETAM TABLETS and all medicines out of the reach of children.
General information about LEVETIRACETAM TABLETS.


What are the ingredients of LEVETIRACETAM TABLETS?








PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Levetiracetam

Levetiracetam

Levetiracetam

Levetiracetam TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-779(NDC:68180-113)
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
CROSPOVIDONE
HYPROMELLOSES
MAGNESIUM STEARATE
povidone
polyethylene glycol
POLYVINYL ALCOHOL
talc
FERRIC OXIDE YELLOW
titanium dioxide
cellulose, microcrystalline

Product Characteristics

Color Size Imprint Code Shape
yellow 18 mm L;U;X02 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-779-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078154 2011-09-21


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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