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Fosrenol (Lanthanum Carbonate Hydrate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

FOSRENOL® is indicated to reduce serum phosphate in patients with end stage renal disease.

DOSAGE AND ADMINISTRATION

The total daily dose of FOSRENOL® should be divided and taken with meals. The recommended initial total daily dose of FOSRENOL® is 750-1500 mg. The dose should be titrated every 2-3 weeks until an acceptable serum phosphate level is reached. Serum phosphate levels should be monitored as needed during dose titration and on a regular basis thereafter.

In clinical studies of ESRD patients, FOSRENOL® doses up to 3750 mg were evaluated. Most patients required a total daily dose between 1500 mg and 3000 mg to reduce plasma phosphate levels to less than 6.0 mg/dL. Doses were generally titrated in increments of 750 mg/day.

Tablets should be chewed completely before swallowing. Intact tablets should not be swallowed.

HOW SUPPLIED

FOSRENOL® is supplied as a chewable tablet in two dosage strengths for oral administration: 250 mg tablets and 500 mg tablets. Each chewable tablet is white to off-white and embossed on one side with‘S405’ and the dosage strength corresponding to the content of elemental lanthanum. The 250 mg tablets are round/convex and the 500 mg tablets are flat with a beveled edge.

250 mg supplied in bottles of 100     NDC 54092-247-01

500 mg supplied in bottles of 100     NDC 54092-249-01

Storage

Store at 25°C (77°F): excursions permitted to 15-30°C (59-86°F)

[See USP controlled room temperature]

Protect from moisture

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