Lanthanum Carbonate

LANTHANUM CARBONATE- lanthanum carbonate tablet, chewable
Prasco Laboratories

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 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.

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 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, LANTHANUM CARBONATE 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.

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.

3 DOSAGE FORMS AND STRENGTHS

LANTHANUM CARBONATE Chewable Tablets: 500 mg, 750 mg, and 1000 mg.

4 CONTRAINDICATIONS

Contraindicated in bowel obstruction, including ileus and fecal impaction.

5 WARNINGS AND PRECAUTIONS

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 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 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.

6 ADVERSE REACTIONS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

Overall, the safety profile of LANTHANUM CARBONATE has been studied in over 5200 subjects in completed clinical trials. The most common adverse reactions for LANTHANUM CARBONATE were gastrointestinal events, such as nausea, vomiting, and abdominal pain and they generally abated over time with continued dosing.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In double-blind, placebo-controlled studies where a total of 180 and 95 ESRD patients were randomized to LANTHANUM CARBONATE chewable tablet and placebo, respectively, for 4-6 weeks of treatment, the most common reactions that were more frequent (≥5% difference) in the LANTHANUM CARBONATE group were nausea, vomiting, and abdominal pain (Table 1).

Table 1. Adverse Reactions * That Were More Common on LANTHANUM CARBONATE in Placebo-Controlled, Double-Blind Studies With Treatment Periods of 4-6 Weeks
LANTHANUM CARBONATE%(N=180) Placebo%(N=95)
*
expressed as the event rate for each term
Nausea 11 5
Vomiting 9 4
Abdominal pain 5 0

In an open-label long-term 2 year extension study in 93 patients who had transitioned from other studies, resulting in a total of up to 6 years treatment, mean baseline values and changes in transaminases were similar to those observed in the earlier comparative studies, with little change during treatment.

The safety of LANTHANUM CARBONATE was studied in two long-term, open-labeled clinical trials, which included 1215 patients treated with LANTHANUM CARBONATE and 944 with alternative therapy. Fourteen percent (14%) of LANTHANUM CARBONATE treated patients discontinued treatment due to adverse events. Gastrointestinal adverse reactions, such as nausea, diarrhea and vomiting were the most common types of event leading to discontinuation.

In pooled active comparator controlled clinical trials, hypocalcemia was noted with an incidence of approximately 5% in both lanthanum and active comparator groups. A nonclinical study and a phase 1 study have shown reduced absorption of calcium in the intestine with lanthanum carbonate treatment.

In a crossover study in 72 healthy individuals comparing LANTHANUM CARBONATE chewable tablets to LANTHANUM CARBONATE oral powder, gastrointestinal adverse reactions such as nausea, diarrhea and vomiting were more common for the oral powder formulation (18%) than for the chewable tablets (7%).

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of LANTHANUM CARBONATE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: constipation, intestinal perforation, intestinal obstruction, ileus, subileus, dyspepsia, allergic skin reactions, hypophosphatemia, and tooth injury while chewing the tablet.

7 DRUG INTERACTIONS

Lanthanum in LANTHANUM CARBONATE has the potential to bind to drugs with anionic (e.g., carboxyl, carbonyl and hydroxyl) groups. LANTHANUM CARBONATE may decrease the bioavailability of tetracyclines or fluoroquinolones via this mechanism.

There are no empirical data on avoiding drug interactions between LANTHANUM CARBONATE and most concomitant oral drugs. 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. The duration of separation depends upon the absorption characteristics of the medication concomitantly administered, such as the time to reach peak systemic levels and whether the drug is an immediate release or an extended release product. Consider monitoring clinical responses or blood levels of concomitant medications that have a narrow therapeutic range.

7.1 Drugs Binding to Antacids

There is a potential for LANTHANUM CARBONATE to interact with compounds which bind to cationic antacids (i.e., aluminum-, magnesium-, or calcium-based). Therefore, do not administer such compounds within 2 hours of dosing with LANTHANUM CARBONATE. Examples of relevant classes of compounds where antacids have been demonstrated to reduce bioavailability include antibiotics (such as quinolones, ampicillin and tetracyclines), thyroid hormones, ACE-inhibitors, statin lipid regulators and anti-malarials.

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