LANTHANUM CARBONATE

Absorption and Distribution - Following single- or multiple- dose oral administration of lanthanum carbonate to healthy subjects, the concentration of lanthanum in plasma was very low (bioavailability <0.002%). Following oral administration in patients, the mean lanthanum C max was 1.0 ng/mL. During long-term administration (52 weeks) in patients with ESRD , the mean lanthanum concentration in plasma was approximately 0.6 ng/mL. There was a minimal increase in plasma lanthanum concentrations wit...

The effectiveness of lanthanum carbonate chewable tablets in reducing serum phosphorus in patients with ESRD was demonstrated in one short-term, placebo-controlled, double-blind dose-ranging study; two placebo-controlled randomized withdrawal studies; and two long-term, active-controlled, open-label studies in patients undergoing either hemodialysis or peritoneal dialysis. 14.1 Double-Blind Placebo-Controlled Studies One -hundred and forty-four patients with chronic renal failure undergoing hemodialysis and with elevated phosphate levels were randomized to double-blind treatment at a fixed dos...

The following adverse reactions are discussed in greater detail in other sections of the labeling: Gastrointestinal Adverse Effects [see Warnings and Precautions (5.1) ] In controlled trials, the most common adverse reactions that were more frequent (≥ 5% difference vs. placebo) in lanthanum carbonate were nausea, vomiting, and abdominal pain. ( 6.1 ) The following adverse reactions have been identified during post-approval use of lanthanum carbonate: constipation, dyspepsia, allergic skin react...

Contraindicated in patients with: hypersensitivity to Lanthanum carbonate or to any ingredient in the formulation. bowel obstruction, including ileus and fecal impaction. Hypersensitivity to Lanthanum carbonate or to any ingredient in the formulation. ( 4 ) Bowel obstruction, ileus, and fecal impaction. ( 4 )

Serious cases of gastrointestinal obstruction, ileus, subileus, gastrointestinal perforation, and fecal impaction. Risks include altered gastrointestinal anatomy, hypomotility disorders, and concomitant medications. Advise patients to chew or crush the tablet completely. ( 5.1 ) Lanthanum carbonate has radio-opaque properties and, therefore, may give the appearance typical of an imaging agent during abdominal X-ray procedures. ( 5.2 ) 5.1 Gastrointestinal Adverse Effects Serious cases of gastroi...

7 DRUG INTERACTIONS There is a potential for lanthanum carbonate to interact with compounds that bind to cationic antacids (i.e., aluminum-, magnesium-, or calcium-based); therefore, do not take such compounds within 2 hours of dosing with lanthanum carbonate chewable tablets. ( 7.1 ) Oral quinolone antibiotics must be taken at least 1 hour before or 4 hours after lanthanum carbonate chewable tabl...