levetiracetam in sodium chloride
Pharmaranks rates Levetiracetam in Sodium Chloride 3.4/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Levetiracetam in Sodium Chloride (Levetiracetam) is a medication used to treat Partial Epilepsies, Tonic-Clonic Epilepsy, Juvenile Myoclonic Epilepsy.
Levetiracetam · by B Braun Medical
Generic of Keppra
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
- Injectable
- Strength
- Levetiracetam 1.5GM/100ML (15MG/ML) · Levetiracetam 1GM/100ML (10MG/ML) · Levetiracetam 500MG/100ML (5MG/ML)
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- B Braun Medical
- 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
- ANDA209705
What is Levetiracetam in Sodium Chloride?
From the FDA label:Levetiracetam in Sodium Chloride Injection is an antiepileptic drug available as a clear, colorless, sterile solution for intravenous 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.) Levetiracetam in Sodium Chloride Injection is a clear, colorless, sterile solution that is available in a single-dose dual port container. This container closure is not made with natural rubber latex, PVC or DEHP. 500 mg/100 mL: One 100 mL fill container contains 500 mg of levetiracetam (5 mg/mL), water for injection, 820 mg sodium chloride, 5.5 mg of glacial acetic acid and buffered at approximately pH 5.5 with glacial acetic acid and 164 mg sodium acetate trihydrate. 1,000 mg /100 mL : One 100 mL fill container contains 1,000 mg of…
How to use
For intravenous infusion only ( 2.1 ) Do not dilute prior to its use ( 2.1 ) Administer dose-specific container intravenously over 15-minutes ( 2.1 ) Initial Exposure to Levetiracetam Partial-Onset Seizures: Initial dose is 500 mg twice daily. Increase by 500 mg twice daily every 2 weeks to a maximum recommended dose of 1,500 mg twice daily (2.2). Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy: Initial dose is 500 mg twice daily. Increase by 500 mg twice daily every 2 weeks to the recommended dose of 1,500 mg twice daily (2.2). Primary Generalized Tonic-Clonic Seizures: Initial dose is 500 mg twice daily. Increase by 500 mg twice daily every 2 weeks to the recommended dose of 1,500 mg twice daily (2.2). Switching from or to oral Levetiracetam: The total daily dosage/frequency of levetiracetam injection should be equivalent to those of oral levetiracetam (2.3, 2.4). Renal Impairment: Dose adjustment necessary based on creatinine clearance ( 2.5 ). 2.1 General Information – Administration Levetiracetam in Sodium Chloride Injection is for intravenous infusion only. It is available in the following concentrations: three single-dose 100 mL fill containers, each containing a different total dosage of levetiracetam (500 mg [5 mg/mL], 1,000 mg [10 mg/mL], or 1,500 mg [15 mg/mL]). A single-dose container should be administered intravenously over a 15-minute IV infusion…
Side effects
The following serious adverse reactions are discussed in more details in other sections of labeling: Psychiatric Reactions [see Warnings and Precautions (5.1) ] Somnolence and Fatigue [see Warnings and Precautions (5.2) ] Anaphylaxis and Angioedema [see Warnings and Precautions (5.3) ] Serious Dermatological Reactions [see Warnings and Precautions (5.4) ] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions (5.5) ] Coordination Difficulties [see Warnings and Precautions (5.6) ] Withdrawal Seizures [see Warnings and Precautions (5.7) ] Hematologic Abnormalities [see Warnings and Precautions (5.8) ] Seizure Control During Pregnancy [see Warnings and Precautions (5.9) ] Most common adverse reactions (incidence in levetiracetam-treated patients is greater than or equal to 5% more than in placebo-treated patients) include: somnolence, asthenia, infection, and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact B. Braun Medical Inc . at 1-800-854-6851 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. The adverse…
Warnings
Important safety information
Psychiatric Reactions: Behavioral abnormalities including psychotic symptoms, suicidal ideation, irritability, and aggressive behavior have been observed. Monitor patients for psychiatric signs and symptoms. ( 5.1 ) Somnolence and Fatigue: Monitor patients for these symptoms and advise patients not to drive or operate machinery until they have gained sufficient experience on levetiracetam. ( 5.2 ) Serious Dermatological Reactions: Discontinue Levetiracetam at the first sign of rash unless clearly not drug related. ( 5.4 ) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity: Discontinue if no alternative etiology. ( 5.5 ) Coordination Difficulties: Monitor for ataxia, abnormal gait, and incoordination. ( 5.6 ) Withdrawal Seizures: Levetiracetam must be gradually withdrawn. ( 5.7 ) 5.1 Psychiatric Reactions In some patients levetiracetam causes behavioral abnormalities. The incidences of behavioral abnormalities in the myoclonic and primary generalized tonic-clonic seizure studies were comparable to those of the adult partial-onset seizure studies. A total of 13.3% of adult levetiracetam-treated patients compared to 6.2% of placebo patients experienced non-psychotic behavioral symptoms (reported as aggression, agitation, anger, anxiety, apathy, depersonalization, depression, emotional lability, hostility, irritability, and nervousness). A total of 1.7% of adult levetiracetam-treated patients discontinued treatment due to behavioral adverse events, compared to 0.2% of placebo patients. The treatment dose was reduced in 0.8% of adult levetiracetam-treated patients and in 0.5% of placebo patients. One percent of adult levetiracetam-treated patients experienced psychotic symptoms compared to 0.2% of placebo patients. Two (0.3%) adult levetiracetam-treated 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. The above psychiatric signs and symptoms should be monitored. 5.2 Somnolence and Fatigue In some patients, levetiracetam causes somnolence and fatigue. The incidences of somnolence and fatigue provided below are from controlled adult partial-onset seizure studies. In general, the incidences of somnolence and fatigue in the myoclonic and primary generalized tonic-clonic studies were comparable to those of the adult partial-onset seizure studies. In controlled trials of adult patients with epilepsy experiencing partial-onset seizures, 14.8% of levetiracetam-treated patients reported somnolence, compared to 8.4% of placebo patients. There was no clear dose response up to 3,000 mg/day. In a study where there was no titration, about 45% of patients receiving 4,000 mg/day reported somnolence. The somnolence was considered serious in 0.3% of the treated patients, compared to 0% in the placebo group. About 3% of levetiracetam-treated patients discontinued treatment due to somnolence, compared to 0.7% of placebo patients. In 1.4% of treated patients and in 0.9% of placebo patients the dose was reduced, while 0.3% of the treated patients were hospitalized due to somnolence. In controlled trials of adult patients with epilepsy experiencing partial-onset seizures, 14.7% of levetiracetam-treated patients reported asthenia, compared to 9.1% of placebo patients. Treatment was discontinued due to asthenia in 0.8% of treated patients as compared to 0.5% of placebo patients. In 0.5% of treated patients and in 0.2% of placebo patients the dose was reduced due to asthenia. Somnolence and asthenia occurred most frequently within the first 4 weeks of treatment. Patients should be monitored for these signs and symptoms and advised not to drive or operate machinery until they have gained sufficient experience on levetiracetam to gauge whether it adversely affects their ability to drive or operate machinery. 5.3 Anaphylaxis and Angioedema Levetiracetam can cause anaphylaxis or angioedema after the first dose or at any time during treatment. Signs and symptoms in cases reported in the postmarketing setting with levetiracetam have included hypotension, hives, rash, respiratory distress, and swelling of the face, lip, mouth, eye, tongue, throat, and feet. In some reported cases, reactions were life-threatening and required emergency treatment. If a patient develops signs or symptoms of anaphylaxis or angioedema, levetiracetam should be discontinued and the patient should seek immediate medical attention. Levetiracetam should be discontinued permanently if a clear alternative etiology for the reaction cannot be established [see Contraindications (4) ]. 5.4 Serious Dermatological Reactions Serious dermatological reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in patients treated with levetiracetam. The median time of onset is reported to be 14 to 17 days, but cases have been reported at least four months after initiation of treatment. Recurrence of the serious skin reactions following rechallenge with levetiracetam has also been reported. Levetiracetam should be discontinued at the first sign of a rash, unless the rash is clearly not drug-related. If signs or symptoms suggest SJS/TEN, use of this drug should not be resumed and alternative therapy should be considered. 5.5 Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan hypersensitivity, has been reported in patients taking antiepileptic drugs, including levetiracetam. These events can be fatal or life-threatening, particularly if diagnosis and treatment do not occur as early as possible. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling, in association with other organ system involvement, such as hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis, sometimes resembling an acute viral infection. Eosinophilia is often present. Because this disorder is variable in its expression, other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately. Levetiracetam should be discontinued if an alternative etiology for the signs or symptoms cannot be established [see Contraindications (4 )]. 5.6 Coordination Difficulties Coordination difficulties were only observed in the adult partial-onset seizure studies. A total of 3.4% of adult levetiracetam-treated patients experienced coordination difficulties, (reported as either ataxia, abnormal gait, or incoordination) compared to 1.6% of placebo patients. A total of 0.4% of patients in controlled trials discontinued levetiracetam treatment due to ataxia, compared to 0% of placebo patients. In 0.7% of treated patients and in 0.2% of placebo patients the dose was reduced due to coordination difficulties, while one of the treated patients was hospitalized due to worsening of pre-existing ataxia. These events occurred most frequently within the first 4 weeks of treatment. Patients should be monitored for these signs and symptoms and advised not to drive or operate machinery until they have gained sufficient experience on levetiracetam to gauge whether it adversely affects their ability to drive or operate machinery. 5.7 Withdrawal Seizures As with most antiepileptic drugs, levetiracetam should be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus. But if withdrawal is needed because of a serious adverse reaction, rapid discontinuation can be considered. 5.8 Hematologic Abnormalities Levetiracetam can cause hematologic abnormalities. Hematologic…
Who should not take Levetiracetam in Sodium Chloride
Levetiracetam in Sodium Chloride Injection is contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.3) ]. Known hypersensitivity to levetiracetam; angioedema and anaphylaxis have occurred. ( 4 )
Overdose — what happens if you take too much
10.1 Signs, Symptoms and Laboratory Findings of Acute Overdosage in Humans The highest known dose of oral levetiracetam received in the clinical development program was 6,000 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 levetiracetam overdoses in postmarketing use. 10.2 Management of Overdose There is no specific antidote for overdose with levetiracetam. 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 levetiracetam. 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 the patient's clinical state or in patients with significant renal impairment.
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.
Interactions
In vitro data on metabolic interactions indicate that levetiracetam is unlikely to produce, or be subject to, pharmacokinetic interactions. Levetiracetam and its major metabolite, at concentrations well above C max levels achieved within the therapeutic dose range, are neither inhibitors of nor high affinity substrates for human liver cytochrome P450 isoforms, epoxide hydrolase or UDP-glucuronidation enzymes. In addition, levetiracetam does not affect the in vitro glucuronidation of valproic acid. Potential pharmacokinetic interactions of or with levetiracetam were assessed in clinical pharmacokinetic studies (phenytoin, valproate, warfarin, digoxin, oral contraceptive, probenecid) and through pharmacokinetic screening in the placebo-controlled clinical studies in epilepsy patients. Phenytoin Levetiracetam (3,000 mg daily) had no effect on the pharmacokinetic disposition of phenytoin in patients with refractory epilepsy. Pharmacokinetics of levetiracetam were also not affected by phenytoin. Valproate Levetiracetam (1,500 mg twice daily) did not alter the pharmacokinetics of valproate in healthy volunteers. Valproate 500 mg twice daily did not modify the rate or extent of levetiracetam absorption or its plasma clearance or urinary excretion. There also was no effect on exposure to and the excretion of the primary metabolite, ucb L057. Other Antiepileptic Drugs Potential drug interactions between levetiracetam and other AEDs (carbamazepine, gabapentin, lamotrigine, phenobarbital, phenytoin, primidone and valproate) were also assessed by evaluating the serum concentrations of levetiracetam and these AEDs during placebo-controlled clinical studies. These data indicate that levetiracetam does not influence the plasma concentration of other AEDs and that these AEDs do not influence the pharmacokinetics of levetiracetam. Oral Contraceptives Levetiracetam (500 mg twice daily) did not influence the pharmacokinetics of an oral contraceptive containing 0.03 mg ethinyl estradiol and 0.15 mg levonorgestrel, or of the luteinizing hormone and progesterone levels, indicating that impairment of contraceptive efficacy is unlikely. Coadministration of this oral contraceptive did not influence the pharmacokinetics of levetiracetam. Digoxin Levetiracetam (1,000 mg twice daily) did not influence the pharmacokinetics and pharmacodynamics (ECG) of digoxin given as a 0.25 mg dose every day. Coadministration of digoxin did not influence the pharmacokinetics of levetiracetam. Warfarin Levetiracetam (1,000 mg twice daily) did not influence the pharmacokinetics of R and S warfarin. Prothrombin time was not affected by levetiracetam. Coadministration of warfarin did not affect the pharmacokinetics of levetiracetam. Probenecid Probenecid, a renal tubular secretion blocking agent, administered at a dose of 500 mg four times a day, did not change the pharmacokinetics of levetiracetam 1,000 mg twice daily. C ss max of the metabolite, ucb L057, was approximately doubled in the presence of probenecid while the fraction of drug excreted unchanged in the urine remained the same. Renal clearance of ucb L057 in the presence of probenecid decreased 60%, probably related to competitive inhibition of tubular secretion of ucb L057. The effect of levetiracetam on probenecid was not studied.
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
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- What does Levetiracetam in Sodium Chloride treat?
- Levetiracetam in Sodium Chloride (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 Levetiracetam in Sodium Chloride rated?
- pharmaranks gives Levetiracetam in Sodium Chloride a composite score of 3.4 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 Levetiracetam in Sodium Chloride 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 Levetiracetam in Sodium Chloride?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Levetiracetam in Sodium Chloride. To pay less, Levetiracetam in Sodium Chloride is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Levetiracetam in Sodium Chloride?
- Levetiracetam in Sodium Chloride is marketed by B Braun Medical. You can see B Braun Medical's full profile, rating, and other products on pharmaranks.
- Is Levetiracetam in Sodium Chloride a brand-name or generic drug?
- Levetiracetam in Sodium Chloride is a generic medication; its active ingredient is Levetiracetam. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Levetiracetam in Sodium Chloride available over the counter?
- No. Levetiracetam in Sodium Chloride 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 Levetiracetam in Sodium Chloride come in?
- Levetiracetam in Sodium Chloride is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Levetiracetam in Sodium Chloride FDA-registered?
- Levetiracetam in Sodium Chloride is on record with the U.S. FDA under application number ANDA209705. You can verify this on its official FDA label.
- Has Levetiracetam in Sodium Chloride been recalled by the FDA?
- Levetiracetam in Sodium Chloride 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 Levetiracetam in Sodium Chloride safe?
- There's no single safe-or-not verdict. pharmaranks gives Levetiracetam in Sodium Chloride a recall-safety score of 68/100, 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 Levetiracetam in Sodium Chloride?
- Levetiracetam in Sodium Chloride's side effects are taken directly from its FDA label. From the label: The following serious adverse reactions are discussed in more details in other sections of labeling: Psychiatric Reactions [see Warnings and Precautions (5.1) ] Somnolence and Fatigue [see Warnings and Precautions (5.2) ] Anaphylaxis and Angioedema [see Warnings and Precautions (5.3) ] Serious Derma… 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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levetiracetam in sodium chloride
68/100