Sevelamer Carbonate Tablet, Film Coated
Product Images NDC 85898-101

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Sevelamer Carbonate (NDC 85898-101). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

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

FDA Label Image

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Sevelamer Carbonate 800 mg film-coated tablet for oral use, labeled with 'x1' on one side. The image shows a single oblong, white tablet with no additional markings. This product is marketed by Marp Pharma.*

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Figure1 (Figure 1)

Chemical structure of Sevelamer Carbonate showing polymeric units with amine and cross-linking groups, including annotations for primary amine group counts (a and b), cross-linking group number (c), and extended polymer network (m).*

FDA Label Image

Figure2 (Figure 2)

A forest plot showing change in serum phosphorus levels (mg/dL) from baseline to week 2 by subgroup for a study involving Sevelamer Carbonate versus placebo. Subgroups include screening body surface area, baseline serum phosphorus level, age, and dialysis status. The plot displays least squares mean differences with confidence intervals for each subgroup, indicating variability in treatment effect across categories.*

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Figure3 (Figure 3)

A line graph showing the percentage of patients attaining a phosphorus reduction from baseline (mg/dL) at least as great as the value on the X-axis. The Y-axis represents the percentage of patients with reduction ≥ X, ranging from 0 to 100%, while the X-axis displays reduction in serum phosphorus (mg/dL) from -4 to 8, indicating worsened increase to improved reduction. Two data lines are labeled: Active Control and Sevelamer Hydrochloride, depicting comparative phosphorus reduction outcomes.*

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Figure4 (Figure 4)

A line graph depicting mean phosphorus change from baseline over 52 weeks for patients treated with Sevelamer Hydrochloride and an Active-Control. The x-axis shows study weeks from 0 to 52, and the y-axis shows phosphorus change from baseline ranging from -5 to 2. Two lines represent the treatment groups, illustrating phosphorus reduction trends during the study period.*

FDA Label Image

Sevelamer Label Image (Mp Sel 270 Label 1.1)

Label for Sevelamer Carbonate Tablets 800 mg film-coated oral tablets. The label indicates a package of 270 tablets, manufactured for MarpPharma, Boerne, Texas, and by Haimen Pharma Inc., Jiangsu, China. The label includes storage instructions, inactive ingredients, and a barcode.*

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Table 2 (Table 2)

A data table titled 'Recommended Starting Dosage and Titration Increment Based on Pediatric Patient's Body Surface Area (m²)', showing starting doses per meal/snack and titration instructions for different BSA ranges. It includes dosage guidance for BSA from ≥0.75 to <1.2 m² and for BSA ≥1.2 m².*

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Table 3 (Table 3)

A data table comparing starting doses for dialysis patients switching from Calcium Acetate 667 mg tablets to Sevelamer Carbonate tablets. The table lists dosage conversions with number of Calcium Acetate tablets per meal in one column and equivalent Sevelamer Carbonate doses in grams in the adjacent column.*

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Table 5 (Table 5)

Table titled 'Sevelamer Drug Interactions' outlining oral drugs with no pharmacokinetic interaction when administered with sevelamer, including Digoxin, Enalapril, Iron, Metoprolol, and Warfarin. It also lists drugs requiring dosing separation from sevelamer carbonate tablets, specifically Ciprofloxacin and Mycophenolate mofetil, with dosing recommendations for timing intervals relative to sevelamer intake.*

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Table 6 (Table 6)

Table displaying mean serum phosphorus levels (mg/dL) at baseline and endpoint for Sevelamer Hydrochloride and Active Control groups, including baseline values, endpoint values, change from baseline, and 95% confidence intervals with statistical significance noted.*

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Table7 (Table 7)

A data table comparing mean serum phosphorus (mg/dL) and calcium-phosphorus ion product values at baseline and changes at endpoint after treatment. The table includes two groups: Sevelamer HCl (N=94) and Active Control (N=98), showing baseline and change-from-baseline values for phosphorus and calcium x phosphorus ion product.*

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Table (Table)

A data table titled 'Starting Dose for Adult Dialysis Patients Not Taking a Phosphate Binder' showing serum phosphorus levels in mg/dL and corresponding Sevelamer Carbonate dosing. It includes dose recommendations based on serum phosphorus ranges, specifying different daily doses of Sevelamer Carbonate taken three times daily with meals.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.