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
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use SEVELAMER HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SEVELAMER HYDROCHLORIDE ...
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Table of ContentsTable of Contents
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1 INDICATIONS AND USAGESevelamer 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 ...
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2 DOSAGE AND ADMINISTRATIONPatients 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 ...
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3 DOSAGE FORMS AND STRENGTHS800 mg Tablets: White to off-white, oval shaped film coated tablet, debossed with "NAV" on one side and debossed with "110" on other side.
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4 CONTRAINDICATIONSSevelamer hydrochloride tablets are contraindicated in patients with bowel obstruction. Sevelamer hydrochloride tablets are contraindicated in patients with known hypersensitivity to sevelamer ...
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5 WARNINGS AND PRECAUTIONS5.1 Gastrointestinal Adverse Events - Patients with dysphagia, swallowing disorders, severe gastrointestinal (GI) motility disorders, including severe constipation, or major GI tract surgery ...
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6 ADVERSE REACTIONS6.1 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 ...
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7 DRUG INTERACTIONSThere 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 ...
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8 USE IN SPECIFIC POPULATIONS8.1 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 ...
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10 OVERDOSAGESevelamer 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 ...
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11 DESCRIPTIONThe active ingredient in sevelamer hydrochloride tablets is sevelamer hydrochloride, a polymeric amine that binds phosphate and is meant for oral administration. Sevelamer hydrochloride is ...
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12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action - Sevelamer hydrochloride tablets contain sevelamer hydrochloride, a non-absorbed binding crosslinked polymer. It contains multiple amines separated by one carbon from ...
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13 NONCLINICAL TOXICOLOGY13.1 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 ...
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14 CLINICAL STUDIESThe 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 ...
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16 HOW SUPPLIED/STORAGE AND HANDLINGSevelamer 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 ...
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17 PATIENT COUNSELING INFORMATIONAdvise 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 ...
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