50 (775 60 50mg)
Riluzole Tablet, Film Coated
Product Images NDC 42291-775
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Product Visual Gallery
This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Riluzole (NDC 42291-775). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Avkare, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.
Chemical-structure-riluzole (Spl Image 1 Structure)
Figure1 (Spl Image 2 Figure 1)
Figure2 (Spl Image 3 Figure 2)
This is a statistical report showing the Kaplan-Meler Survival Curves for a placebo group (N=242) and a group taking Riluzole 50 mg twice daily (N=236). The figure shows the survival probability over time. The other numbers (2 15 18 2) do not provide enough context to determine their meaning.*
Table1 (Table1)
This is a comparison of adverse effects experienced by patients taking Riluzole Tablets 50 mg twice daily versus those taking a placebo. The study included 320 participants who took the placebo and 313 who took Riluzole. The table lists the percentage of patients experiencing different symptoms, such as asthenia, nausea, decreased lung function, hypertension, abdominal pain, dizziness, dry mouth, insomnia, pruritus, tachycardia, flatulence, increased cough, peripheral edema, urinary tract infection, circumoral paresthesia, somnolence, vertigo, and eczema.*
Table2 (Table2)
Table 2 displays pharmacokinetic parameters of Riluzole. The oral bioavailability is approximately 60%, and it shows linearity in a dose range of 25 mg to 100 mg every 12 hours. The food effect shows an AUC of 20% and Cmax of 45% (high fat meal). Plasma Protein Binding is 96% and mainly to albumin and lipoproteins. Elimination half-life is about 12 hours, which has high interindividual variability potentially accountable to variability of CYP1A2. The primary metabolic pathway is through oxidation of CYP1A2 and glucuronidation through UGT-HP4. Approximately 80% is eliminated through urine, and at least 88% is fraction metabolized. Finally, some metabolites may be pharmacologically active even though the clinical implications are not known.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
