Overview
11 DESCRIPTION Lanthanum carbonate chewable tablets contains lanthanum carbonate with molecular formula La 2 (CO3) 3 and molecular weight 457.8 (anhydrous mass). Lanthanum carbonate is described as white to almost-white powder. Lanthanum carbonate is practically insoluble in water and is insoluble in organic solvents; it dissolves in dilute mineral acids with effervescence.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Lanthanum carbonate is a phosphate binder that reduces absorption of phosphate by forming insoluble lanthanum phosphate complexes that pass through the GI tract unabsorbed. Both serum phosphate and calcium phosphate product are reduced as a consequence of the reduced dietary phosphate absorption. 12.2 Pharmacodynamics In vitro studies have shown that lanthanum binds phosphate in the physiologically relevant pH range of 3 to 7. In simulated gastric fluid, lanthanum binds approximately 97% of the available phosphate at pH 3-5 and 67% at pH 7, when lanthanum is present in a two-fold molar excess to phosphate. Bile acids have not been shown to affect the phosphate binding affinity of lanthanum.
Indications
- 1 INDICATIONS AND USAGE Lanthanum carbonate chewable tablets are 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 chewable tablets are phosphate binder indicated to reduce serum phosphate in patients with end- stage renal disease (ESRD). ( 1 )
Common Doses
- 500 mg
- 000 mg
- 6.0 mg
- 750 mg
Dosage
2 DOSAGE AND ADMINISTRATION Divide the total daily dose of lanthanum carbonate chewable tablets and take with or immediately after meals. The recommended initial total daily dose of lanthanum carbonate chewable tablets 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 chewable Tablets has the potential to bind other orally administered drugs: consider separating the administration of other oral medications [ see Drug...
Contraindications
- 4 CONTRAINDICATIONS 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 )
Side Effects
- 6 ADVERSE REACTIONS 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 reactions, and tooth injury while chewing the tablet. ( 6.
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 chewable tablets. ( 7.1 ) Oral quinolone antibiotics must be taken at least 1 hour before or 4 hours after lanthanum carbonate chewable tablets. ( 7.2 ) Do not take thyroid hormone replacement therapy within 2 hours of dosing with lanthanum carbonate chewable tablets.