Lanthanum carbonate

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE LANTHANUM CARBONATE is a phosphate binder indicated to reduce serum phosphate in patients with end-stage renal disease (ESRD). Management of elevated serum phosphorus levels in patients with ESRD usually includes all of the following: reduction in dietary intake of phosphate, removal of phosphate by dialysis, and reduction of intestinal phosphate absorption with phosphate binders. LANTHANUM CARBONATE is a phosphate binder indicated to reduce serum phosphate in patients with end-stage renal disease (ESRD). ( 1 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION Divide the total daily dose of LANTHANUM CARBONATE and take with or immediately after meals. The recommended initial total daily dose of LANTHANUM CARBONATE is 1,500 mg. Titrate the dose every 2 to 3 weeks until an acceptable serum phosphate level is reached. Monitor serum phosphate levels as needed during dose titration and on a regular basis thereafter. LANTHANUM CARBONATE has the potential to bind other orally administered drugs; consider separating the administration of other oral medications [see Drug Interactions (7) ] . In clinical studies of patients with ESRD, LANTHANUM CARBONATE doses up to 4,500 mg were evaluated. Most patients required a total daily dose between 1,500 mg and 3,000 mg to reduce plasma phosphate levels to less than 6.0 mg/dL. Doses were generally titrated in increments of 750 mg/day. Chew or crush LANTHANUM CARBONATE completely before swallowing. Do not swallow intact LANTHANUM CARBONATE Chewable Tablets. Consider using the oral powder formulation in patients with poor dentition or who have difficulty chewing tablets. The recommended initial total daily dose of LANTHANUM CARBONATE is 1,500 mg in divided doses. Titrate every 2 to 3 weeks based on serum phosphate level. ( 2 ) Take LANTHANUM CARBONATE with or immediately after meals. ( 2 ) Chew or crush tablet completely before swallowing. ( 2 ) Warnings and cautions 5 WARNINGS AND PRECAUTIONS 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 gastrointestinal obstruction, ileus, subileus, gastrointestinal perforation, and fecal impaction have been reported in patients taking lanthanum, some requiring surgery or hospitalization. Consider discontinuing LANTHANUM CARBONATE in patients without another explanation for severe gastrointestinal symptoms. Risk factors for gastrointestinal obstruction and gastrointestinal perforation identified from post-marketing reports in patients taking LANTHANUM CARBONATE Chewable Tablets include abnormal gastrointestinal anatomy (e.g., diverticular disease, peritonitis, history of gastrointestinal surgery, gastrointestinal cancer, gastrointestinal ulceration), hypomotility disorders (e.g., constipation, ileus, subileus, diabetic gastroparesis), and the use of medications known to potentiate these effects. Some cases were reported in patients with no history of gastrointestinal disease. Patients with acute peptic ulcer, ulcerative colitis, Crohn's disease, or bowel obstruction were not included in LANTHANUM CARBONATE clinical studies [see Contraindications (4) ] . Advise patients who are prescribed LANTHANUM CARBONATE Chewable Tablets to chew the tablet completely and not to swallow them whole. Serious gastrointestinal complications have been reported in association with unchewed or incompletely chewed tablets [see Adverse Reactions ( 6.2 )] . 5.2 Diagnostic Tests LANTHANUM CARBONATE has radio-opaque properties and therefore may give the appearance typical of an imaging agent during abdominal X-ray procedures. Postmarketing reports of product residue have been reported during endoscopic imaging. Drug interactions 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. ( 7.1 ) Oral quinolone antibiotics must be taken at least 1 hour before or 4 hours after LANTHANUM CARBONATE. ( 7.2 ) Do not take thyroid hormone replacement therapy within 2 hours of dosing with LANTHANUM CARBONATE. Monitoring of TSH levels is recommended in patients receiving both medicinal agents. ( 7.3 ) For oral medications where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy, consider separation of the timing of the administration of the two drugs. ( 7.4 ) 7.1 Drugs Binding to Antacids There is a potential for LANTHAN