Levetiracetam Tablet, Film Coated
Product Images NDC 87234-0035

Product Visual Gallery

This gallery contains 22 technical images submitted to the FDA as part of the official labeling for Levetiracetam (NDC 87234-0035). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Injecta Medcial Llc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

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Table 3 (Table 3)

This text shows Adverse Reactions in Pooled Placebo-Controlled, Adjunctive Studies in Adults Experiencing Partial-Onset Seizures. It includes the percentages of various adverse reactions experienced by individuals taking Levetiracetam (N=769) compared to Placebo (N=439). Some of the reported adverse reactions and their percentages are Asthenia (15% vs. 9%), Somnolence (15% vs. 8%), and Headache (14% vs. 13%), among others. This data provides valuable information on the potential side effects associated with the use of Levetiracetam in adult patients with partial-onset seizures.*

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Chemical Formula (Chemical Formula Lev)

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Responder Rate (≥50% Reduction From Baseline) In Study 1 (Figure 1 Lev)

This is a comparison of responder rates (>50% reduction from baseline) in Study 1 among patients taking Placebo, Levetiracetam 1000 mg/day, and Levetiracetam 3000 mg/day. The study includes 95 patients in the Placebo group, 97 in the Levetiracetam 1000 mg/day group, and 101 in the Levetiracetam 3000 mg/day group.*

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Responder Rate ( ≥ 50% Reduction From Baseline) In Study 2: Period A (Figure 2 Lev)

This text provides a comparison of responder rates (>50% reduction from baseline) in Study 2 for three different groups: Placebo, Levetiracetam 1000 mg/day, and Levetiracetam 2000 mg/day. The percentages of patients who experienced the reduction in seizures are given for each group.*

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Responder Rate (≥ 50% Reduction From Baseline) In Study 3 (Figure 3 Lev)

This text shows a graph presenting the Responder Rate (>50% Reduction from Baseline) in Study 3 comparing Placebo (N=104) against Levetiracetam 3000 mg/day (N=180). The Responder Rate for Levetiracetam was 39.4% compared to 14.4% for Placebo. The graph provides a visual representation of the percentage of patients who responded to treatment for the specified conditions.*

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Responder Rate (≥ 50% Reduction From Baseline) In Study 4 (Figure 4 Lev)

This text provides information on the Responder Rate (>50% Reduction from Baseline) in Study 4. It shows the percentage of patients with a reduction in seizures. The comparison is between a placebo group (N=97) and a group taking Levetiracetam (N=101), with the latter being statistically significant in terms of efficacy.*

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Responder Rate For All Patients Ages 1 Month To < 4 Years (≥ 50% Reduction From Baseline) In Study 5 (Figure 5 Lev)

This text provides details on the Responder Rate for patients aged 1 Month to < 4 Years in Study 5. The graph shows percentages for both the Placebo group (N=51) and the Levetiracetam group (N=58) with a specific mention of statistical significance versus placebo.*

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Label (Levetiracetam 500 Label)

This is a description of a medication package containing Levetiracetam, which is a drug used to treat seizures. The package includes 100 tablets with a strength of 500mg each. The usual dosage instructions and storage conditions are also provided. The medication is distributed by Injocta Medical LLC and manufactured by Northstar RX LLC. The package includes a disclaimer about not using the medication if the blister is torn or broken.*

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Table 4 (Table 4 Lev)

This table provides information on adverse reactions that led to discontinuation or dose reduction in placebo-controlled studies involving adult patients with partial-onset seizures. The percentages of patients experiencing somnolence were 4% for those taking Levetiracetam and 2% for those on Placebo. For dizziness, the percentages were 1% and 0%, respectively.*

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Dosing Adjustment Regimen For Adult Patients With Renal Impairment (Table 1)

This is a dosing adjustment regimen for adult patients with renal impairment based on creatinine clearance levels. It provides dosage recommendations for patients with normal, mild, moderate, and severe impairment, as well as end-stage renal disease (ESRD) patients undergoing dialysis. The dosages range from 250 to 1,500 mg, with dosing frequency varying from every 12 to 24 hours.*

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Reduction In Mean Over Placebo In Weekly Frequency Of Partial-onset Seizures In Study 1 (Table 10 Lev)

This table shows the reduction in the mean frequency of partial-onset seizures in Study 1 for two different dosages of Levetiracetam (1000 mg/day and 3000 mg/day) compared to a placebo. Levetiracetam at both dosages demonstrated a reduction in the frequency of seizures over the placebo, with a 26.1% reduction for the 1000 mg/day dosage and a 30.1% reduction for the 3000 mg/day dosage.*

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Reduction In Mean Over Placebo In Weekly Frequency Of Partial-onset Seizures In Study 2: Period A (Table 11 Lev)

This text provides information on the reduction in the mean over placebo in the weekly frequency of partial-onset seizures in Study 2. It shows the comparison between Placebo and Levetiracetam dosages of 1000 mg/day and 2000 mg/day, with a percentage reduction in partial seizure frequency over placebo.*

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Reduction In Mean Over Placebo In Weekly Frequency Of Partial-onset Seizures In Study 3 (Table 12 Lev)

This text provides information on the reduction in the mean frequency of partial-onset seizures in Study 3 when comparing a placebo group of 104 individuals to the group receiving 3000 mg/day of Levetiracetam with 180 participants. The data shows a 23.0% reduction in partial seizure frequency compared to the placebo group.*

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Reduction In Mean Over Placebo In Weekly Frequency Of Partial-onset Seizures In Study 4 (Table 13 Lev)

This excerpt provides data on the reduction in the mean weekly frequency of partial-onset seizures in Study 4 for both the placebo and Levetiracetam groups. The table shows that Levetiracetam resulted in a percent reduction of 26.8% when compared to placebo in terms of partial seizure frequency.*

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Responder Rate (≥50% Reduction From Baseline) In Myoclonic Seizure Days Per Week For Patients With Jme In Study 6 (Table 14 Lev)

This information presents the Responder Rate (>50% Reduction from Baseline) in Myoclonic Seizure Days per Week for Patients with Juvenile Myoclonic Epilepsy (JME) in Study 6. The results show that the group treated with Levetiracetam had a responder rate of 60.4%, which was statistically significant compared to the placebo group's rate of 23.7%. This indicates that Levetiracetam may be an effective treatment for reducing myoclonic seizures in patients with JME.*

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Median Percent Reduction From Baseline In Pgtc Seizure Frequency Per Week In Study 7 (Table 15 Lev)

This text provides data on the median percent reduction in primary generalized tonic-clonic (PGTC) seizure frequency per week in Study 7, comparing the effects of a placebo group (N=84) and a group treated with levetiracetam (N=78). The results show a significant reduction in seizure frequency with levetiracetam compared to the placebo. Additionally, information is given on the responder rate (>50% reduction from baseline) for PGTC seizure frequency per week, revealing a higher percentage of patients achieving significant seizure reduction with levetiracetam (72.2%) compared to placebo (45.2%). This data is presented in Figure 6, demonstrating the effectiveness of levetiracetam in reducing PGTC seizure frequency.*

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Risk By Indication For Antiepileptic Drugs In The Pooled Analysis (Table 2)

This text provides a table showing the risk by indication for Antiepileptic Drugs in a Pooled Analysis. The table includes information on different indications such as Epilepsy, Psychiatric disorders, and Others. It presents the incidence of events per 1000 patients for both placebo and drug-treated patients, with relative risk analysis. The table can be used to evaluate the risk differences between the placebo and drug groups for various indications.*

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Table 5 (Table 5 Lev)

This table shows the adverse reactions observed in pediatric patients aged 4 to 16 years experiencing partial-onset seizures during pooled placebo-controlled, adjunctive studies. Common adverse reactions include headache, nasopharyngitis, vomiting, somnolence, and fatigue. Other reactions such as aggression, cough, and nasal congestion were also reported. Adverse reactions like irritability, insomnia, and depression were observed with lower frequency.*

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Table 6 (Table 6 Lev)

This excerpt provides data on adverse reactions in a placebo-controlled adjunctive study conducted on pediatric patients aged 1 month to less than 4 years experiencing partial-onset seizures. The table shows the percentage of pediatric patients experiencing somnolence and irritability when treated with Levetiracetam compared to a placebo. Somnolence was reported in 13% of patients on Levetiracetam compared to 2% on placebo, while 17% of patients on Levetiracetam experienced irritability compared to 0% on placebo.*

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Table 7 (Table 7 Lev)

This is a table showing adverse reactions in a placebo-controlled, adjunctive study in patients 12 years of age and older with myoclonic seizures. It compares the occurrence of different adverse reactions between the Levetiracetam group (N=60) and the Placebo group (N=60). Some of the adverse reactions listed include somnolence, neck pain, depression, influenza, and vertigo. The percentages show the incidence of each adverse reaction in each group.*

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Table 8 (Table 8 Lev)

This table shows the adverse reactions that led to discontinuation or dose reduction in a placebo-controlled study involving patients with Juvenile Myoclonic Epilepsy. Some of the adverse reactions include anxiety, depressed mood, depression, diplopia, hypersomnia, insomnia, irritability, nervousness, and somnolence. Levetiracetam showed varying percentages of these reactions compared to the placebo group.*

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Table 9 (Table 9 Levs)

This text provides a table showing the adverse reactions seen in a placebo-controlled adjunctive study involving patients 4 years of age and older with PGTC seizures. The data shows the percentages of patients experiencing various adverse reactions for both the Levetiracetam group (N=79) and the Placebo group (N=84). Adverse reactions include Nasopharyngitis, Fatigue, Diarrhea, Irritability, and Mood swings.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.