Label: SEVELAMER HYDROCHLORIDE tablet, film coated

  • NDC Code(s): 70710-2058-8
  • Packager: Zydus Pharmaceuticals USA Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 5, 2025

If you are a consumer or patient please visit this version.

  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use SEVELAMER HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SEVELAMER HYDROCHLORIDE ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    Sevelamer hydrochloride tablets are indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. The safety and efficacy of sevelamer hydrochloride ...
  • 2 DOSAGE AND ADMINISTRATION
    Patients Not Taking a Phosphate Binder. The recommended starting dose of sevelamer hydrochloride tablets is 800 mg to 1600 mg orally, which can be administered as one or two 800 mg sevelamer ...
  • 3 DOSAGE FORMS AND STRENGTHS
    800 mg Tablets: White to off-white, oval shaped film coated tablet, debossed with "NAV" on one side and debossed with "110" on other side.
  • 4 CONTRAINDICATIONS
    Sevelamer hydrochloride tablets are contraindicated in patients with bowel obstruction. Sevelamer hydrochloride tablets are contraindicated in patients with known hypersensitivity to sevelamer ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Gastrointestinal Adverse Events - Patients with dysphagia, swallowing disorders, severe gastrointestinal (GI) motility disorders, including severe constipation, or major GI tract surgery ...
  • 6 ADVERSE REACTIONS
    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 ...
  • 7 DRUG INTERACTIONS
    There are no empirical data on avoiding drug interactions between sevelamer hydrochloride and most concomitant oral drugs. For oral medication where a reduction in the bioavailability of that ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Sevelamer hydrochloride is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the ...
  • 10 OVERDOSAGE
    Sevelamer hydrochloride has been given to normal healthy volunteers in doses of up to 14 g per day for eight days with no adverse effects. Sevelamer hydrochloride has been given in average doses ...
  • 11 DESCRIPTION
    The active ingredient in sevelamer hydrochloride tablets is sevelamer hydrochloride, a polymeric amine that binds phosphate and is meant for oral administration. Sevelamer hydrochloride is ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Sevelamer hydrochloride tablets contain sevelamer hydrochloride, a non-absorbed binding crosslinked polymer. It contains multiple amines separated by one carbon from ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Standard lifetime carcinogenicity bioassays were conducted in mice and rats. Rats were given sevelamer hydrochloride by diet at 0.3 ...
  • 14 CLINICAL STUDIES
    The ability of sevelamer hydrochloride to lower serum phosphorus in CKD patients on dialysis was demonstrated in six clinical trials: one double-blind placebo-controlled 2-week study (sevelamer ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Sevelamer hydrochloride tablets are supplied as white to off-white, oval shaped film-coated tablets, debossed with "NAV" on one side and debossed with "110" on other side. Sevelamer hydrochloride ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise patients to take sevelamer hydrochloride tablets with meals and adhere to their prescribed diets. Provide instructions on concomitant medications that should be dosed apart from sevelamer ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    pdp-bottle
  • INGREDIENTS AND APPEARANCE
    Product Information