Product Description.:
S405 750
chewable tablet , white , round round
Beveled edgeWhite to off-whiteFlat-faced
FOSRENOL? contains lanthanum carbonate (2:3) hydrate with molecular formula La2(CO3)3xH2O (on average x=4-5 moles of water) and molecular weight 457.8 (anhydrous mass). Lanthanum (La) is a naturally occurring rare earth element. Lanthanum carbonate is practically insoluble in water.
Each FOSRENOL?, white to off-white, chewable tablet contains lanthanum carbonate hydrate equivalent to 250 or 500 mg of elemental lanthanum and the following inactive ingredients: dextrates (hydrated) NF, colloidal silicon dioxide NF, magnesium stearate NF, and talc USP.
INDICATIONS AND USAGE
FOSRENOL? is indicated to reduce serum phosphate in patients with end stage renal disease.
CONTRAINDICATIONS
None known.
PRECAUTIONS
General:
Patients with acute peptic ulcer, ulcerative colitis, Crohn?s disease or bowel obstruction were not included in FOSRENOL? clinical studies. Caution should be used in patients with these conditions.
Diagnostic Tests:
Abdominal x-rays of patients taking lanthanum carbonate may have a radio-opaque appearance typical of an imaging agent.
Long-term Effects:
There were no differences in the rates of fracture or mortality in patients treated with FOSRENOL? compared to alternative therapy for up to 3 years. The duration of treatment exposure and time of observation in the clinical program are too short to conclude that FOSRENOL? does not affect the risk of fracture or mortality beyond 3 years.
Information for the Patient:
FOSRENOL? tablets should be taken with or immediately after meals. Tablets should be chewed completely before swallowing. Intact tablets should not be swallowed.
Notify your physician that you are taking FOSRENOL? prior to an abdominal x-ray
Drug Interactions:
FOSRENOL? is not metabolized.
Studies in healthy subjects have shown that FOSRENOL? does not adversely affect the pharmacokinetics of warfarin, digoxin or metoprolol. The absorption and pharmacokinetics of FOSRENOL? are unaffected by co-administration with citrate-containing compounds (see CLINICAL PHARMACOLOGY: In Vitro/In Vivo Drug Interactions).
An in vitro study showed no evidence that FOSRENOL? forms insoluble complexes with warfarin, digoxin, furosemide, phenytoin, metoprolol and enalapril in simulated gastric fluid. However, it is recommended that compounds known to interact with antacids should not be taken within 2 hours of dosing with FOSRENOL?.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Oral administration of lanthanum carbonate to rats for up to 104 weeks, at doses up to 1500 mg of the salt per kg/day [2.5 times the maximum recommended daily human dose (MRHD) of 5725 mg, on a mg/m2 basis, assuming a 60-kg patient] revealed no evidence of carcinogenic potential. In the mouse, oral administration of lanthanum carbonate for up to 99 weeks, at a dose of 1500 mg/kg/day (1.3 times the MRHD) was associated with an increased incidence of glandular stomach adenomas in male mice.
Lanthanum carbonate tested negative for mutagenic activity in an in vitro Ames assay using Salmonella typhimurium and Escherichia coli strains and in vitro HGPRT gene mutation and chromosomal aberration assays in Chinese hamster ovary cells. Lanthanum carbonate also tested negative in an oral mouse micronucleus assay at doses up to 2000 mg/kg (1.7 times the MRHD), and in micronucleus and unscheduled DNA synthesis assays in rats given IV lanthanum chloride at doses up to 0.1 mg/kg, a dose that produced plasma lanthanum concentrations >2000 times the peak human plasma concentration.
Lanthanum carbonate, at doses up to 2000 mg/kg/day (3.4 times the MRHD), did not affect fertility or mating performance of male or female rats.
