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









Special PopulationsRenal ImpairmentDOSAGE AND ADMINISTRATIONAdult Patients with Impaired Renal Function


PRECAUTIONS, Drug Interactions













PRECAUTIONSDOSAGE AND ADMINISTRATION



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






**




**Levetiracetam





INDICATIONS & USAGE





LEVETIRACETAM CONTRAINDICATIONS



WARNINGS

Suicidal Behavior and Ideation










Neuropsychiatric Adverse Events


Adults







Pediatric Patients














Withdrawal Seizures


PRECAUTIONS

Hematologic Abnormalities


Adults



Pediatric Patients





Hepatic Abnormalities


INFORMATION FOR PATIENTS







LABORATORY TESTS



DRUG INTERACTIONS






Phenytoin


Valproate



Effect Of AEDs In Pediatric Patients



Oral Contraceptives


Digoxin


Warfarin


Probenecid


CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY








PREGNANCY











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















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

CLINICAL STUDIES











Myoclonic Seizures In Patients 12 Years Of Age And Older With Juvenile Myoclonic Epilepsy

Primary Generalized Tonic-Clonic Seizures





Adult Patients With Impaired Renal Function









HOW SUPPLIED






























STORAGE AND HANDLING




SPL MEDGUIDE

Rx Only

What is the most important information I should know about levetiracetam?
Like other antiepileptic drugs, levetiracetam 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 without first talking to a healthcare provider.
  • ●     Stopping levetiracetam 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?

  • ●     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.


  • ●     250 mg levetiracetam tablets, USP are blue colored, oval shaped, film-coated tablets debossed with breakline separating250'andMG'on one side and1014'on other side.
  • ●     500 mg levetiracetam tablets, USP are yellow colored, oval shaped, film-coated tablets debossed with breakline separating500'andMG'on one side and1015'on other side.
  • ●     750 mg levetiracetam tablets, USP are orange colored, oval shaped, film-coated tablets debossed with breakline separating750'andMG'on one side and1016'on other side.
  • ●     1000 mg levetiracetam tablets, USP are white to off white, oval shaped, film-coated tablets debossed with breakline separating1000'andMG'on one side and1017'on other side.
What should I tell my healthcare provider before starting levetiracetam?

  • ●     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 will harm your unborn baby. You and your healthcare provider will have to decide if you should take levetiracetam while you are pregnant. If you become pregnant while taking levetiracetam, 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. The purpose of this registry is to collect information about the safety of levetiracetam and other antiepileptic medicine during pregnancy.
  • ●     are breast feeding. Levetiracetam can pass into your milk and may harm your baby. You and your healthcare provider should discuss whether you should take levetiracetam or breast-feed; you should not do both.


How should I take levetiracetam?

  • ●     Your healthcare provider will tell you how much levetiracetam to take and when to take it. Levetiracetam is usually taken twice a day. Take levetiracetam 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 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, 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, call your local Poison Control Center or go to the nearest emergency room right away.
What should I avoid while taking levetiracetam?

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


  • ●     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?

  • ●     Store levetiracetam at room temperature, 59to 86(15to 30away from heat and light.
  •      Keep levetiracetam and all medicines out of the reach of children.



What are the ingredients of levetiracetam?
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:49349-630(NDC:13668-014)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LEVETIRACETAM LEVETIRACETAM 250 mg

Inactive Ingredients

Ingredient Name Strength
FD&C BLUE NO. 2
HYPROMELLOSES
MAGNESIUM STEARATE
talc
titanium dioxide
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE K30
polyethylene glycol 400
STARCH, CORN
SILICON DIOXIDE

Product Characteristics

Color Size Imprint Code Shape
blue 13 mm 250;MG;1014 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-630-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078858 2011-12-07


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