Drug Catalog - Product Detail
LANTHANUM CARBONATE CHEW TAB 750 MG (ELEMENTAL) 15 CT X 6
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 66993-0423-85 | PRASCO LABORATORIES | 15 | 750MG | TABLET CHEWABLE |
PACKAGE FILES
Generic Name
LANTHANUM CARBONATE
Substance Name
LANTHANUM CARBONATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
NDA021468
Description
11 DESCRIPTION LANTHANUM CARBONATE contains lanthanum carbonate with molecular formula La 2 (CO 3 ) 3 xH 2 O (on average x=4-5 moles of water) 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. Each LANTHANUM CARBONATE white to off-white, chewable tablet contains lanthanum carbonate hydrate equivalent to 500, 750, or 1,000 mg of elemental lanthanum and the following inactive ingredients: colloidal silicon dioxide, dextrates (hydrated), magnesium stearate.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING LANTHANUM CARBONATE is supplied as a chewable tablet in three dosage strengths for oral administration: 500-mg tablets, 750-mg tablets, and 1,000-mg tablets. Each chewable tablet is white to off-white round, flat with a beveled edge, and debossed on one side with 'S405' above the dosage strength corresponding to the content of elemental lanthanum. 500-mg Patient Pack (2 bottles of 45 tablets, NDC 66993-422-47, per each patient pack) NDC 66993-422-85. 750-mg Patient Pack (6 bottles of 15 tablets, NDC 66993-423-53, per each patient pack) NDC 66993-423-85. 1,000-mg Patient Pack (9 bottles of 10 tablets, NDC 66993-424-75, per each patient pack) NDC 66993-424-85. Storage and Handling Store LANTHANUM CARBONATE Chewable Tablets at 25°C (77°F): excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP controlled room temperature.]
Indications & 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 )