Keppra XR 500 extended release film coated tablet

Keppra XR (Ucb), manufactured drug form of Levetiracetam, 500mg/tablet levetiracetam extended release film coated tablet, NDC 50474-598

Available in:

NDC Product ID:

  • 50474-598

Manufacturer:

Manufactured drug form

Manufactured form of:

Generic drug:

  • No

Label date:

  • Oct 15, 2009

Label link:

Label sections:

Section name Section URI Prominent warning Highlight text Section LOINC code
  • Recent Major Changes Section
  • No
  • 43683-2
  • 1 Indications And Usage
  • No
  • KEPPRA XR is an antiepileptic drug indicated for adjunctive therapy in the treatment of partial onset seizures in patients ≥16 years of age with epilepsy (1)
  • 34067-9
  • 2 Dosage And Administration
  • No
  • Treatment should be initiated with a dose of 1000 mg once daily. The daily dosage may be adjusted in increments of 1000 mg every 2 weeks to a maximum recommended daily dose of 3000 mg (2) . See full prescribing information for use in patients with impaired renal function (2.1) .
  • 34068-7
  • 3 Dosage Forms And Strengths
  • No
  • 500 mg white, film-coated extended-release tablet (3) 750 mg white, film-coated extended-release tablet (3)
  • 43678-2
  • 4 Contraindications
  • No
  • None (4)
  • 34070-3
  • 5 Warnings And Precautions
  • No
  • Suicidal Behavior and Ideation. (5.1) Neuropsychiatric Adverse Reactions: KEPPRA XR causes somnolence, dizziness, and behavioral abnormalities. The adverse reactions that may be seen in patients receiving KEPPRA XR tablets are expected to be similar to those seen in patients receiving immediate-release KEPPRA tablets. (5.2) In controlled trials of immediate-release KEPPRA tablets in patients experiencing partial onset seizures, immediate-release KEPPRA causes somnolence and fatigue, coordination difficulties, and behavioral abnormalities (e.g., psychotic symptoms, suicidal ideation, and other abnormalities). (5.2) Withdrawal Seizures: KEPPRA XR must be gradually withdrawn. (5.3)
  • 43685-7
  • 6 Adverse Reactions
  • No
  • Most common adverse reactions (difference in incidence rate is ≥5% between KEPPRA XR-treated patients and placebo-treated patients and occurred more frequently in KEPPRA XR-treated patients) include: somnolence and irritability (6.1) . To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at 866-822-0068 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
  • 34084-4
  • 7 Drug Interactions
  • No
  • 34073-7
  • 8 Use In Specific Populations
  • No
  • To enroll in the UCB AED Pregnancy Registry call 888-537-7734 (toll free). To enroll in the North American Antiepileptic Drug Pregnancy Registry call (888) 233-2334 (toll free). (8.1) A dose adjustment is recommended for patients with impaired renal function, based on the patient's estimated creatinine clearance (8.6) .
  • 43684-0
  • 9 Drug Abuse And Dependence
  • No
  • 42227-9
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Discontinued:

  • No

Marketing start date:

  • Sep 24, 2008

Patents:

Patent expiry date:

  • Sep 17, 2028

FDA application number:

  • NDA022285

Color:

Shape:

Size:

  • 19 mm (0.75 in )

Scoring:

  • 1

Imprint:

  • UCB;500XR

Therapeutic equivalents:

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