were not reported.
Diluted preparation is physically compatible with lorazepam, diazepam, and valproate sodium.
Storage: Discard unused vial contents. Diluted preparation is stable for at least 4 hours when stored in polyvinyl chloride (PVC) bags at controlled room temperature between 15 to 30 degrees C (59 to 86 degrees F).
STORAGE
Generic:
- Store at controlled room temperature (between 68 and 77 degrees F)
Keppra:
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Keppra XR:
- Protect from moisture
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Roweepra :
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Spritam:
- Store at 77 degrees F; excursions permitted to 59-86 degrees F
CONTRAINDICATIONS / PRECAUTIONS
General Information
Levetiracetam is contraindicated in patients with a known hypersensitivity to the drug or any of the active ingredients in the formulations.
The abuse and dependence potential of levetiracetam has not been eva luated in human studies.
Abrupt discontinuation
Abrupt discontinuation of levetiracetam therapy should not be undertaken. Levetiracetam and other antiepileptic drugs should be withdrawn gradually to minimize the potential of increased seizure frequency.
Dialysis, renal disease, renal failure, renal impairment
The clearance of levetiracetam is reduced in patients with renal disease or renal impairment and is correlated with creatinine clearance. The dosage of levetiracetam should be reduced in patients with impaired renal function. Patients on dialysis should not receive extended-release levetiracetam for therapy; immediate-release should be used. Supplemental immediate-release doses are recommended after dialysis for those patients with renal failure who are on hemodialysis.
Pregnancy
Levetiracetam is classified as FDA pregnancy risk category C. In animal studies, there was evidence that levetiracetam produced developmental toxicity at doses similar to or greater than human therapeutic doses. There are no adequate and well-controlled studies in pregnant women. Levetiracetam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The effect of levetiracetam on labor and delivery in humans is not known. NOTE: Maternal clearance of levetiracetam is higher during pregnancy compared to baseline, especially during the third trimester (see Pharmacokinetics); if levetiracetam is continued during pregnancy, monitor seizure frequency closely. A dosage adjustment may be necessary for some patients. Physicians are advised to recommend that pregnant patients receiving levetiracetam enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry to provide information about the effects of in utero exposure to the drug. Patients must call 1-888-233-2334 to enroll in the registry. The manufacturer of Keppra, UCB, has also established a pregnancy registry that patients or healthcare providers can enroll in by calling 1-888-537-7734.
Breast-feeding
Levetiracetam is excreted in human breast milk. According to the manufacturer, because of the potential for serious adverse reactions in the nursing infant, a decision should be made whether to discontinue breast-feeding or discontinue levetiracetam. Other experts suggest that breast-feeding may be continued during levetiracetam therapy in some cases. In one small case series, foremilk samp |
