keppra xr
Pharmaranks rates Keppra XR 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Keppra XR (Levetiracetam) is a medication used to treat Partial Epilepsies, Tonic-Clonic Epilepsy, Juvenile Myoclonic Epilepsy.
Levetiracetam · by Ucb Inc
Available as a generic: Levetiracetam in Sodium Chloride
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Levetiracetam
- Form
- Tablet, extended release
- Strength
- Levetiracetam 500MG · Levetiracetam 750MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Ucb Inc
- Half-life
- about 7 hours (the label states 7 ± 1 hour in adults) (how long it stays in your system)
- What the pharmacy pays
- ~$2.34 for 30 — not your price
- FDA application
- NDA022285
What is Keppra XR?
From the FDA label:KEPPRA XR is an antiepileptic drug available as 500 mg and 750 mg (white) extended-release tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8 H 14 N 2 O 2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula: Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.) KEPPRA XR tablets contain the labeled amount of levetiracetam. Inactive ingredients: colloidal anhydrous silica, hypromellose, magnesium stearate, polyethylene glycol 6000, polyvinyl alcohol-partially hydrolyzed, titanium dioxide (E171), Macrogol/PEG3350, and talc. The imprinting ink contains shellac, FD&C Red #40, n-butyl alcohol, propylene glycol, titanium dioxide, ethanol, and methanol. The medication is combined with a drug release controlling polymer that provides a drug release at a controlled rate. The biologically inert components of the tablet may…
How to use
Initiate treatment with a dose of 1000 mg once daily; increase by 1000 mg every 2 weeks to a maximum recommended dose of 3000 mg once daily ( 2 ) See full prescribing information for use in patients with impaired renal function ( 2.1 ) 2.1 Recommended Dosing For adults and adolescent patients, the recommended dosing for monotherapy and adjunctive therapy is the same; as outlined below. Adults and Adolescents 12 Years of Age and Older Weighing 50 kg or More Initiate treatment with a dose of 1000 mg once daily. The once daily dosage may be adjusted in increments of 1000 mg every 2 weeks to a maximum recommended daily dose of 3000 mg/day once daily. Administration KEPPRA XR is administered once daily. KEPPRA XR tablets should be swallowed whole. The tablets should not be chewed, broken, or crushed. 2.2 Dosage Adjustments in Adult Patients with Renal Impairment KEPPRA XR dosing must be individualized according to the patient's renal function status. Recommended dosage adjustments for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this, an estimate of the patient's creatinine clearance (CLcr) in mL/min must first be calculated using the following formula: CLcr= [140-age (years)] × weight (kg) -------------------------------------- (× 0.85 for…
Side effects
The following adverse reactions are discussed in more details in other sections of labeling: Behavioral abnormalities and Psychotic Symptoms [see Warnings and Precautions (5.1) ] Suicidal Behavior and Ideation [see Warnings and Precautions (5.2) ] Somnolence and Fatigue [see Warnings and Precautions (5.3) ] Anaphylaxis and Angioedema [see Warnings and Precautions (5.4) ] Serious Dermatological Reactions [see Warnings and Precautions (5.5) ] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions (5.6) ] Coordination Difficulties [see Warnings and Precautions (5.7) ] Hematologic Abnormalities [see Warnings and Precautions (5.9) ] Most common adverse reactions (incidence ≥5% more than placebo) include: somnolence and irritability ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at (844) 599-CARE (2273) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. KEPPRA XR Tablets In the controlled clinical study in patients with partial-onset seizures [see Clinical Studies (14.1) ], the most common adverse reactions in…
Warnings
Important safety information
Behavioral abnormalities including psychotic symptoms, suicidal ideation, irritability, and aggressive behavior have been observed; monitor patients for psychiatric signs and symptoms ( 5.1 ) Suicidal Behavior and Ideation: Monitor patients for new or worsening depression, suicidal thoughts/behavior, and/or unusual changes in mood or behavior ( 5.2 ) Monitor for somnolence and fatigue and advise patients not to drive or operate machinery until they have gained sufficient experience on KEPPRA XR ( 5.3 ) Serious Dermatological Reactions: Discontinue KEPPRA at the first sign of rash unless clearly not drug related ( 5.5 ) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity: Discontinue if no alternative etiology ( 5.6 ) Coordination Difficulties: Monitor for ataxia, abnormal gait, and incoordination. Advise patients to not drive or operate machinery until they have gained experience on KEPPRA ( 5.7 ) Withdrawal Seizures: KEPPRA XR must be gradually withdrawn ( 5.8 ) 5.1 Behavioral Abnormalities and Psychotic Symptoms KEPPRA XR may cause behavioral abnormalities and psychotic symptoms. Patients treated with KEPPRA XR should be monitored for psychiatric signs and symptoms. Behavioral abnormalities KEPPRA XR Tablets A total of 7% of KEPPRA XR-treated patients experienced non-psychotic behavioral disorders (reported as irritability and aggression) compared to 0% of placebo-treated patients. Irritability was reported in 7% of KEPPRA XR-treated patients. Aggression was reported in 1% of KEPPRA XR-treated patients. No patient discontinued treatment or had a dose reduction as a result of these adverse reactions. The number of patients exposed to KEPPRA XR was considerably smaller than the number of patients exposed to immediate-release KEPPRA tablets in controlled trials. Therefore, certain adverse reactions observed in the immediate-release KEPPRA controlled trials will likely occur in patients receiving KEPPRA XR. Immediate-Release KEPPRA Tablets A total of 13% of adult patients and 38% of pediatric patients (4 to 16 years of age) treated with immediate-release KEPPRA experienced non-psychotic behavioral symptoms (reported as aggression, agitation, anger, anxiety, apathy, depersonalization, depression, emotional lability, hostility, hyperkinesias, irritability, nervousness, neurosis, and personality disorder), compared to 6% and 19% of adult and pediatric patients on placebo. A randomized, double-blind, placebo-controlled study was performed to assess the neurocognitive and behavioral effects of immediate-release KEPPRA tablets as adjunctive therapy in pediatric patients (4 to 16 years of age). An exploratory analysis suggested a worsening in aggressive behavior in patients treated with immediate-release KEPPRA tablets in that study [see Use in Specific Populations (8.4) ] . A total of 1.7% of adult patients treated with immediate-release KEPPRA discontinued treatment due to behavioral adverse reactions, compared to 0.2% of placebo-treated patients. The treatment dose was reduced in 0.8% of adult patients treated with immediate-release KEPPRA, compared to 0.5% of placebo-treated patients. Overall, 11% of pediatric patients treated with immediate-release KEPPRA experienced behavioral symptoms associated with discontinuation or dose reduction, compared to 6.2% of placebo-treated pediatric patients. One percent of adult patients and 2% of pediatric patients (4 to 16 years of age) treated with immediate-release KEPPRA experienced psychotic symptoms, compared to 0.2% and 2%, respectively, in adult and placebo-treated pediatric patients. In the controlled study that assessed the neurocognitive and behavioral effects of immediate-release KEPPRA in pediatric patients 4 to 16 years of age, 1.6% KEPPRA-treated patients experienced paranoia, compared to no placebo-treated patients. There were 3.1% patients treated with immediate-release KEPPRA who experienced confusional state, compared to no placebo-treated patients [see Use in Specific Populations (8.4) ] . Psychotic symptoms Immediate-Release KEPPRA tablets One percent of KEPPRA-treated adult patients experienced psychotic symptoms compared to 0.2% of placebo-treated patients. Two (0.3%) KEPPRA-treated adult patients were hospitalized and their treatment was discontinued due to psychosis. Both events, reported as psychosis, developed within the first week of treatment and resolved within 1 to 2 weeks following treatment discontinuation. There was no difference between drug and placebo-treated patients in the incidence of pediatric patients who discontinued treatment due to psychotic and non-psychotic adverse reactions. 5.2 Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including KEPPRA XR, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide. The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed. The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5-100 years) in the clinical trials analyzed. Table 2 shows absolute and relative risk by indication for all evaluated AEDs. Table 2: Risk by Indication for Antiepileptic Drugs in the Pooled Analysis Indication Placebo Patients with Events Per 1000 Patients Drug Patients with Events Per 1000 Patients Relative Risk: Incidence of Events in Drug Patients/Incidence in Placebo Patients Risk Difference: Additional Drug Patients with Events Per 1000 Patients Epilepsy 1.0 3.4 3.5 2.4 Psychiatric 5.7 8.5 1.5 2.9 Other 1.0 1.8 1.9 0.9 Total 2.4 4.3 1.8 1.9 The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications. Anyone considering prescribing KEPPRA XR or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated. 5.3 Somnolence and Fatigue KEPPRA XR may cause somnolence and fatigue. Patients should be…
Who should not take Keppra XR
KEPPRA XR is contraindicated in patients with a hypersensitivity to levetiracetam . Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.4) ] . Known hypersensitivity to levetiracetam; angioedema and anaphylaxis have occurred ( 4 , 5.4 )
Overdose — what happens if you take too much
10.1 Signs, Symptoms and Laboratory Findings of Acute Overdosage in Humans The signs and symptoms for KEPPRA XR overdose are expected to be similar to those seen with immediate-release KEPPRA tablets. The highest known dose of oral immediate-release KEPPRA received in the clinical development program was 6000 mg/day. Other than drowsiness, there were no adverse reactions in the few known cases of overdose in clinical trials. Cases of somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma were observed with immediate-release KEPPRA overdoses in postmarketing use. 10.2 Management of Overdose There is no specific antidote for overdose with KEPPRA XR. If indicated, elimination of unabsorbed drug should be attempted by emesis or gastric lavage; usual precautions should be observed to maintain airway. General supportive care of the patient is indicated including monitoring of vital signs and observation of the patient's clinical status. A Certified Poison Control Center should be contacted for up to date information on the management of overdose with KEPPRA XR. 10.3 Hemodialysis Standard hemodialysis procedures result in significant clearance of levetiracetam (approximately 50% in 4 hours) and should be considered in cases of overdose. Although hemodialysis has not been performed in the few known cases of overdose, it may be indicated by…
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
How long does Levetiracetam stay in your body?
The elimination half-life of levetiracetam is about 7 hours (the label states 7 ± 1 hour in adults) — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the plasma elimination half-life of levetiracetam itself in adults with normal organ function; the label says it is unaffected by dose or repeated dosing. Levetiracetam is not a prodrug and has no active metabolite that outlasts it — its major metabolite, ucb L057 (24% of the dose), is described by the label as inactive in animal seizure models. The drug is cleared mainly by the kidneys (66% excreted unchanged), so kidney function drives how long it lasts: in older adults (61-88 years, creatinine clearance 30-74 mL/min) total body clearance fell 38% and the half-life was 2.5 hours longer than in healthy adults. In renal impairment the label reports reduced clearance rather than a half-life number — down 40% in mild (CLcr 50-80 mL/min), 50% in moderate (30-50 mL/min), 60% in severe (<30 mL/min), and 70% in anuric end-stage renal disease; roughly 50% of the body's levetiracetam is removed by a standard 4-hour hemodialysis session. Liver impairment matters little: pharmacokinetics were unchanged in mild-to-moderate (Child-Pugh A-B) impairment, and in severe (Child-Pugh C) total body clearance was 50% of normal, mostly explained by reduced renal clearance. In children the half-life is shorter (about 5-5.3 hours). Not a drug-test detection window and not dosing guidance.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: Levetiracetam tablet, film coated — FDA label, Section 12.3 Pharmacokinetics (DailyMed).
May treat (source: NIH RxClass)
Dosage forms
Tablet, extended release
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
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Request a 90-day supply
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Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
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Frequently asked questions
- What does Keppra XR treat?
- Keppra XR (Levetiracetam) may be used to treat partial epilepsies, tonic-clonic epilepsy, juvenile myoclonic epilepsy, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Keppra XR rated?
- pharmaranks gives Keppra XR a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Keppra XR cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $2.34 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Keppra XR?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Keppra XR. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Keppra XR?
- Keppra XR is marketed by Ucb Inc. You can see Ucb Inc's full profile, rating, and other products on pharmaranks.
- Is Keppra XR a brand-name or generic drug?
- Keppra XR is a brand-name product with the active ingredient Levetiracetam. Lower-cost generic equivalents containing Levetiracetam are available — ask your pharmacist.
- Is Keppra XR available over the counter?
- No. Keppra XR is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Keppra XR come in?
- Keppra XR is currently marketed as tablet, extended release, per the FDA's National Drug Code Directory.
- Is Keppra XR FDA-registered?
- Keppra XR is on record with the U.S. FDA under application number NDA022285. You can verify this on its official FDA label.
- Has Keppra XR been recalled by the FDA?
- Keppra XR has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Keppra XR safe?
- There's no single safe-or-not verdict. pharmaranks gives Keppra XR a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Keppra XR?
- Keppra XR's side effects are taken directly from its FDA label. From the label: The following adverse reactions are discussed in more details in other sections of labeling: Behavioral abnormalities and Psychotic Symptoms [see Warnings and Precautions (5.1) ] Suicidal Behavior and Ideation [see Warnings and Precautions (5.2) ] Somnolence and Fatigue [see Warnings and Precautions… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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keppra xr
70/100