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Fosrenol
Overview
What is Fosrenol?
FOSRENOL contains lanthanum carbonate with molecular formula La(CO) xHO (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 FOSRENOL, white to off-white, chewable tablet contains lanthanum carbonate hydrate equivalent to 500, 750, or 1000 mg of elemental lanthanum and the following inactive ingredients: colloidal silicon dioxide NF, dextrates (hydrated) NF, magnesium stearate NF.
FOSRENOL Oral Powder is a white to off-white powder containing lanthanum carbonate hydrate equivalent to 750 or 1000 mg of elemental lanthanum and the following inactive ingredients: colloidal silicon dioxide NF, dextrates (hydrated) NF, magnesium stearate NF.
What does Fosrenol look like?
What are the available doses of Fosrenol?
FOSRENOL Chewable Tablets: 500 mg, 750 mg, and 1000 mg.
FOSRENOL Oral Powder: 750 mg and 1000 mg.
What should I talk to my health care provider before I take Fosrenol?
How should I use Fosrenol?
FOSRENOL is a phosphate binder indicated to reduce serum phosphate in patients with end stage renal disease (ESRD).
Management of elevated serum phosphorus levels in end stage renal disease patients 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.
Divide the total daily dose of FOSRENOL and take with or immediately after meals. The recommended initial total daily dose of FOSRENOL is 1500 mg. Titrate the dose every 2-3 weeks until an acceptable serum phosphate level is reached. Monitor serum phosphate levels as needed during dose titration and on a regular basis thereafter.
In clinical studies of ESRD patients, FOSRENOL doses up to 4500 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.
Information for FOSRENOL Chewable Tablets
Chew or crush FOSRENOL Chewable T
ablets completely before swallowing. Do not swallow intact FOSRENOL Chewable T
ablets.
Information for FOSRENOL Oral Powder
Sprinkle FOSRENOL Oral Powder on a small quantity of applesauce or other similar food and consume immediately. Do not open until ready to use. Do not store FOSRENOL Oral Powder for future use once mixed with food. As FOSRENOL Oral Powder is insoluble, do not attempt to dissolve in liquid for administration.
Consider using the oral powder formulation in patients with poor dentition or who have difficulty chewing tablets.
What interacts with Fosrenol?
Sorry No Records found
What are the warnings of Fosrenol?
Sorry No Records found
What are the precautions of Fosrenol?
Sorry No Records found
What are the side effects of Fosrenol?
Sorry No records found
What should I look out for while using Fosrenol?
Contraindicated in bowel obstruction, including ileus and fecal impaction.
What might happen if I take too much Fosrenol?
The symptoms associated with overdose are adverse reactions such as headache, nausea and vomiting. In clinical trials in healthy adults, GI symptoms were reported with daily doses up to 6000 mg/day of lanthanum carbonate administered with food. Given the topical activity of lanthanum in the gut, and the excretion in feces of the majority of the dose, supportive therapy is recommended for overdosage. Lanthanum carbonate was not acutely toxic in animals by the oral route. No deaths and no adverse effects occurred in mice, rats or dogs after single oral doses of 2000 mg/kg (1.7, 3.4, and 11.3 times the MRHD, respectively, on a mg/m basis).
How should I store and handle Fosrenol?
Storage - Store at 25°C (77°F): excursions permitted to 15-30°C (59-86°F).[See USP controlled room temperature].Storage - Store at 25°C (77°F): excursions permitted to 15-30°C (59-86°F).[See USP controlled room temperature].Since sirolimus is not absorbed through the skin, there are no special precautions. However, if direct contact occurs with the skin or eyes, wash skin thoroughly with soap and water; rinse eyes with plain water.Do not use Sirolimus Tablets after the expiration date that is located on the blister. The expiration date refers to the last day of that month.Since sirolimus is not absorbed through the skin, there are no special precautions. However, if direct contact occurs with the skin or eyes, wash skin thoroughly with soap and water; rinse eyes with plain water.Do not use Sirolimus Tablets after the expiration date that is located on the blister. The expiration date refers to the last day of that month.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
FOSRENOL is a phosphate binder that reduces absorption of phosphate by forming insoluble lanthanum phosphate complexes that pass through the gastrointestinal (GI) tract unabsorbed. Both serum phosphate and calcium phosphate product are reduced as a consequence of the reduced dietary phosphate absorption.
Non-Clinical Toxicology
Contraindicated in bowel obstruction, including ileus and fecal impaction.Nimodipine is metabolized via the cytochrome P450 3A4 system located both in the intestinal mucosa and in the liver. Drugs that are known to either inhibit or to induce this enzyme system may therefore alter the first pass or the clearance of nimodipine.
In addition, the blood pressure lowering effects of antihypertensives could be enhanced when taken concomitantly with nimodipine.
Serious cases of gastrointestinal obstruction, ileus, subileus, gastrointestinal perforation and fecal impaction have been reported in patients taking lanthanum, some requiring surgery or hospitalization.
Risk factors for gastrointestinal obstruction and gastrointestinal perforation identified from post-marketing reports in patients taking FOSRENOL Chewable Tablets include altered 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 concomitant medications (e.g., calcium channel blockers). 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 FOSRENOL clinical studies
Advise patients who are prescribed FOSRENOL Chewable Tablets to chew the tablet completely to reduce the risk of serious adverse gastrointestinal events such as those described above.
The following adverse reactions are discussed in greater detail in other sections of the labeling:
Overall, the safety profile of FOSRENOL has been studied in over 5200 subjects in completed clinical trials. The most common adverse reactions for FOSRENOL were gastrointestinal events, such as nausea, vomiting, and abdominal pain and they generally abated over time with continued dosing.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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