Lanthanum carbonate 500 mg Tablet, Chewable, 1,220-count
Other active recalls for Lanthanum Carbonate (different manufacturers) — 2 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Drugs for treatment of hyperkalemia and hyperphosphatemia class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
This is a chewable tablet containing 500 mg of lanthanum carbonate, marked as a drug for further processing. Lanthanum carbonate is typically used in dialysis patients to bind phosphate in the digestive tract, helping to lower blood phosphate levels that can build up in kidney disease. The chewable tablet form allows flexible dosing during meals.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Lanthanum Carbonate — tap one for details:
Lanthanum Carbonate may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Where does this data come from?
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
-
UNII G263MI44RU
Dextrates are a carbohydrate mixture made from corn or potato starch. They work as fillers and binders in tablets and capsules to add bulk and help hold the medicine together.
-
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
-
UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
4 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Lanthanum carbonate 500 mg 66993-0422-85 | Prasco | 45 tablets | $3.262 | AB | Availability likely | — |
| Lanthanum Carbonate 500 mg 67877-0256-90 | Ascend | 45 tablets | $3.262 | AB | Availability likely | — |
| Lanthanum Carbonate 500 mg 68180-0819-42 | Lupin | 45 tablets | $3.262 | AB | Availability likely | — |
| Lanthanum carbonate 500 mg 69097-0934-98 | Cipla | 45 tablets | $3.262 | AB | Availability likely | — |
| Lanthanum carbonate 500 mg 76282-0476-90 | Exelan | 45 tablets | $3.262 | AB | Availability likely | — |
| Lanthanum carbonate 500 mgthis 00093-5938-00 | Teva | 1220 tablets | — | AB | FDA listed | — |
| Fosrenol 500 mg 54092-0252-90 | Takeda | 45 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 00093-5938-98 | 2 BOTTLE in 1 CARTON (0093-5938-98) / 45 TABLET, CHEWABLE in 1 BOTTLE (0093-5938-54) | $3.26 / ea | $293.61 | 2022-05-25 | Active |
| 00093-5938-00 You're viewing this | 1220 TABLET, CHEWABLE in 1 BOX (0093-5938-00) | — | — | — | Active |
This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓
Pack size FAQ
What quantity is in NDC 00093-5938-00?
What NDC number is used to bill for this package of Lanthanum carbonate 500 mg Tablet, Chewable?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Does this product come in other package sizes?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Lanthanum carbonate chewable tablets are 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 chewable tablets are 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 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 Interactions ( 7 )] . In clinical studies of patients with ESRD, lanthanum carbonate chewable tablets 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 chewable tablets 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 chewable tablets is 1,500 mg in divided doses.
Titrate every 2 to 3 weeks based on serum phosphate level. ( 2 ) Take lanthanum carbonate chewable tablets with or immediately after meals. ( 2 ) Chew or crush tablet completely before swallowing.
( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Lanthanum carbonate chewable tablets: 500 mg, 750 mg, and 1,000 mg. Lanthanum carbonate chewable tablets: 500 mg, 750 mg, and 1,000 mg. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Contraindicated in patients with: - hypersensitivity to lanthanum carbonate chewable tablets or to any ingredient in the formulation. - bowel obstruction, including ileus and fecal impaction. Hypersensitivity to lanthanum carbonate chewable tablets or to any ingredient in the formulation. ( 4 ) Bowel obstruction, ileus, and fecal impaction. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Serious cases of gastrointestinal obstruction, ileus, subileus, gastrointestinal perforation, and fecal impaction. Risks include altered gastrointestinal anatomy, hypomotility disorders, and concomitant medications. Advise patients to chew or crush the tablet completely.
( 5.1 ) Lanthanum carbonate chewable tablets have radio-opaque properties and, therefore, may give the appearance typical of an imaging agent during abdominal X-ray procedures. ( 5.2 )
5.1Gastrointestinal 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 chewable tablets 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 abnormal 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 chewable tablets 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 )] .
5.2Diagnostic Tests Lanthanum carbonate chewable tablets have radio-opaque properties and therefore may give the appearance typical of an imaging agent during abdominal X-ray procedures. Postmarketing reports of product residue have been reported during endoscopic imaging.
🤒 Adverse Reactions ▾
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 chewable tablets were nausea, vomiting, and abdominal pain. ( 6.1 ) The following adverse reactions have been identified during post-approval use of lanthanum carbonate chewable tablets: constipation, dyspepsia, allergic skin reactions, and tooth injury while chewing the tablet.
( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the 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. Overall, the safety profile of lanthanum carbonate chewable tablets has been studied in over 5,200 subjects in completed clinical trials. The most common adverse reactions for lanthanum carbonate chewable tablets were gastrointestinal events, such as nausea, vomiting, and abdominal pain and they generally abated over time with continued dosing.
In double-blind, placebo-controlled studies where a total of 180 and 95 patients with ESRD were randomized to lanthanum carbonate chewable tablet and placebo, respectively, for 4 to 6 weeks of treatment, the most common reactions that were more frequent (≥5% difference) in the lanthanum carbonate chewable tablet group were nausea, vomiting, and abdominal pain (Table 1). Table 1. Adverse Reactions* That Were More Common on Lanthanum Carbonate Chewable Tablets in Placebo-Controlled, Double-Blind Studies with Treatment Periods of 4 to 6 Weeks Lanthanum Carbonate Chewable Tablets % (N=180) Placebo % (N=95) Nausea 11 5 Vomiting 9 4 Abdominal pain 5 0 *Expressed as the event rate for each term 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 chewable tablets was studied in two long-term, open-label clinical trials, which included 1,215 patients treated with lanthanum carbonate chewable tablets and 944 with alternative therapy. Fourteen percent (14%) of patients treated with lanthanum carbonate chewable tablets 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%).
6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of lanthanum carbonate chewable tablets. 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. Cases of constipation, intestinal perforation, intestinal obstruction, ileus, subileus, dyspepsia, allergic skin reactions, hypophosphatemia, and tooth injury while chewing the tablet…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS There is a potential for lanthanum carbonate chewable tablets 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.
Monitoring of TSH levels is recommended in patients receiving both medicinal agents. ( 7.3 ) 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. ( 7.4)
7.1Drugs Binding to Antacids There is a potential for lanthanum carbonate chewable tablets 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 chewable tablets. 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.
7.2Quinolone Antibiotics Coadministration of lanthanum carbonate chewable tablets with quinolone antibiotics may reduce the extent of their absorption. The bioavailability of oral ciprofloxacin was decreased by approximately 50% when taken with lanthanum carbonate chewable tablets in a single-dose study in healthy volunteers. Administer oral quinolone antibiotics at least 1 hour before or 4 hours after lanthanum carbonate chewable tablets.
When oral quinolones are given for short courses, consider eliminating the doses of lanthanum carbonate chewable tablets that would normally be scheduled near the time of quinolone intake to improve quinolone absorption [ see Clinical Pharmacology (12.3) ] .
7.3Levothyroxine The bioavailability of levothyroxine was decreased by approximately 40% when taken together with lanthanum carbonate chewable tablets. Administer thyroid hormone replacement therapy at least 2 hours before or 2 hours after dosing with lanthanum carbonate chewable tablets and monitor thyroid stimulating hormone (TSH) levels [ see Clinical Pharmacology (12.3) ] .
7.4Use with Other Oral Medications There are no empirical data on avoiding drug interactions between lanthanum carbonate chewable tablets 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.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Available data from case reports with use of lanthanum carbonate chewable tablets in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of lanthanum carbonate to pregnant rats and rabbits during organogenesis at doses 3 and 2.5 times, respectively, the maximum recommended human dose (MRHD), resulted in no adverse developmental effects. In rabbits, lanthanum carbonate doses 5 times the MRHD was associated with maternal toxicity and resulted in increased post-implantation loss, reduced fetal weights, and delayed fetal ossification (see Data) .
Deposition of lanthanum into developing bone, including growth plate, was observed in juvenile animals in long-term animal studies with lanthanum carbonate [see Use in Specific Populations (8.4)] . Use a non-lanthanum containing phosphate binder in a pregnant woman. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In pregnant rats, oral administration of lanthanum carbonate at doses as high as 2,000 mg/kg/day during organogenesis resulted in no evidence of harm to the fetus.
The MRHD for lanthanum carbonate chewable tablets is 5,725 mg, representing a dose of 95.4 mg/kg, or 3,530 mg/m 2 for a 60-kg patient. The 2,000-mg/kg/day dose in the rat is equivalent to 12,000 mg/m 2 , 3 times the MRHD. In pregnant rabbits, oral administration of lanthanum carbonate at 1,500 mg/kg/day (18,000 mg/m 2 ; 5 times the daily MRHD) during organogenesis was associated with increased post-implantation loss, reduced fetal weights, and delayed fetal ossification.
No effects on the pregnant rabbits or fetuses were observed at 750 mg/kg/day (9,000 mg/m 2 ; 2.5 times the MRHD). In a pre- and postnatal development study in the rat, pregnant rats were dosed at up to 2,000 mg/kg/day (12,000 mg/m 2 /day; equivalent to 3 times the MRHD) from day 6 of pregnancy through 20 days postpartum (including lactation). At 2,000 mg/kg/day, no maternal toxicity was observed, nor were any changes seen with respect to gestational length or delivery; however, piloerection/pallor, delayed eye opening, decreased body weight, and delayed sexual development were observed in the offspring at 2,000 mg/kg/day.
At 200 and 600 mg/kg/day (equivalent to 0.3 and 1 time the MRHD, respectively), slight delays in sexual development (delayed vaginal opening) were observed in the female offspring [see Nonclinical Toxicology (13.2)] .
8.2Lactation Risk Summary There are no data on the presence of lanthanum carbonate from lanthanum carbonate chewable tablets in human milk, the effects on the breastfed infant, or the effects on milk production. Deposition of lanthanum into developing bone, including growth plate, was observed in juvenile animals in long-term animal studies with lanthanum carbonate [see Use in Specific Populations (8.4)] . Use a non-lanthanum containing phosphate binder in a lactating woman.
8.4Pediatric Use The safety and efficacy of lanthanum carbonate chewable tablets in pediatric patients have not been established. While growth abnormalities were not identified in long-term animal studies, lanthanum was deposited into developing bone, including growth plate. The consequences of such deposition in developing bone in pediatric patients are unknown; therefore, the use of lanthanum carbonate chewable tablets in this population is not recommended.
8.5Geriatric Use Of the total number of patients in clinical studies of lanthanum carbonate chewable tablets, 32% (538) were ≥65 years of age, while 9.3%…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Available data from case reports with use of lanthanum carbonate chewable tablets in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of lanthanum carbonate to pregnant rats and rabbits during organogenesis at doses 3 and 2.5 times, respectively, the maximum recommended human dose (MRHD), resulted in no adverse developmental effects. In rabbits, lanthanum carbonate doses 5 times the MRHD was associated with maternal toxicity and resulted in increased post-implantation loss, reduced fetal weights, and delayed fetal ossification (see Data) .
Deposition of lanthanum into developing bone, including growth plate, was observed in juvenile animals in long-term animal studies with lanthanum carbonate [see Use in Specific Populations (8.4)] . Use a non-lanthanum containing phosphate binder in a pregnant woman. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In pregnant rats, oral administration of lanthanum carbonate at doses as high as 2,000 mg/kg/day during organogenesis resulted in no evidence of harm to the fetus.
The MRHD for lanthanum carbonate chewable tablets is 5,725 mg, representing a dose of 95.4 mg/kg, or 3,530 mg/m 2 for a 60-kg patient. The 2,000-mg/kg/day dose in the rat is equivalent to 12,000 mg/m 2 , 3 times the MRHD. In pregnant rabbits, oral administration of lanthanum carbonate at 1,500 mg/kg/day (18,000 mg/m 2 ; 5 times the daily MRHD) during organogenesis was associated with increased post-implantation loss, reduced fetal weights, and delayed fetal ossification.
No effects on the pregnant rabbits or fetuses were observed at 750 mg/kg/day (9,000 mg/m 2 ; 2.5 times the MRHD). In a pre- and postnatal development study in the rat, pregnant rats were dosed at up to 2,000 mg/kg/day (12,000 mg/m 2 /day; equivalent to 3 times the MRHD) from day 6 of pregnancy through 20 days postpartum (including lactation). At 2,000 mg/kg/day, no maternal toxicity was observed, nor were any changes seen with respect to gestational length or delivery; however, piloerection/pallor, delayed eye opening, decreased body weight, and delayed sexual development were observed in the offspring at 2,000 mg/kg/day.
At 200 and 600 mg/kg/day (equivalent to 0.3 and 1 time the MRHD, respectively), slight delays in sexual development (delayed vaginal opening) were observed in the female offspring [see Nonclinical Toxicology (13.2)] .
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and efficacy of lanthanum carbonate chewable tablets in pediatric patients have not been established. While growth abnormalities were not identified in long-term animal studies, lanthanum was deposited into developing bone, including growth plate. The consequences of such deposition in developing bone in pediatric patients are unknown; therefore, the use of lanthanum carbonate chewable tablets in this population is not recommended.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the total number of patients in clinical studies of lanthanum carbonate chewable tablets, 32% (538) were ≥65 years of age, while 9.3% (159) were ≥75 years of age. No overall differences in safety or effectiveness were observed between patients ≥65 years of age and younger patients.
🆘 Overdosage ▾
10 OVERDOSAGE The symptoms associated with overdose are adverse reactions such as headache, nausea and vomiting. In clinical trials in healthy adults, gastrointestinal (GI) symptoms were reported with daily doses up to 6,000 mg/day of lanthanum carbonate administered with food. Given the topical activity of lanthanum in the gut, and the excretion of the majority of the dose in feces, 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 2,000 mg/kg (1.7, 3.4, and 11.3 times the MRHD, respectively, on a mg/m 2 basis).
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism 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.
12.2Pharmacodynamics 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 to 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.
In order to bind dietary phosphate, lanthanum carbonate chewable tablets must be administered with or immediately after meals. In five phase 1 pharmacodynamic studies comparing the reduction from baseline of urinary phosphorus excretion in healthy volunteers (N=143 taking lanthanum carbonate), it was shown that the mean intestinal phosphate binding capacity of lanthanum ranged from 235 to 468 mg phosphorus/day when lanthanum was administered at a dose of 3 g per day with food. By comparison, in one study with an untreated control group (n=10) and another study with a placebo group (n=3), the corresponding mean changes from baseline were 3 mg phosphorus/day and 87 mg phosphorus/day, respectively.
In healthy subjects, lanthanum carbonate oral powder and lanthanum carbonate chewable tablets produced similar effects on urinary phosphate excretion.
12.3Pharmacokinetics Absorption and Distribution - Following single- or multiple-dose oral administration of lanthanum carbonate chewable tablets to healthy subjects, the concentration of lanthanum in plasma was very low (bioavailability <0.002%). Following oral administration in patients, the mean lanthanum C max was 1.0 ng/mL. During long-term administration (52 weeks) in patients with ESRD, the mean lanthanum concentration in plasma was approximately 0.6 ng/mL.
There was a minimal increase in plasma lanthanum concentrations with increasing doses within the therapeutic dose range. The timing of food intake relative to lanthanum administration (during and 30 minutes after food intake) has a negligible effect on the systemic level of lanthanum. Systemic exposure to lanthanum was approximately 30% higher following administration of lanthanum carbonate oral powder when compared to lanthanum carbonate chewable tablets.
However, systemic exposure to lanthanum from both formulations in this study was within the range seen in previous pharmacokinetic studies of Chewable Tablets in healthy individuals. In vitro , lanthanum is highly bound (>99%) to human plasma proteins, including human serum albumin, α1-acid glycoprotein, and transferrin. Binding to erythrocytes in vivo is negligible in rats.
In animal studies, lanthanum concentrations in several tissues, particularly gastrointestinal tract, mesenteric lymph nodes, bone, and liver, increased over time to levels several orders of magnitude higher than those in plasma. The level of lanthanum in the liver was higher in renally impaired rats due to higher intestinal absorption. Lanthanum was found in the lysosomes and the biliary canal consistent with transcellular transport.
Steady state tissue concentrations in bone and liver were achieved in dogs between 4 and 26 weeks. Relatively high levels of lanthanum remained in these tissues for longer than 6 months after cessation of dosing in dogs. There is no evidence from animal studies that lanthanum crosses the blood-brain barrier.
In 105 bone biopsies from patients treated with lanthanum carbonate chewable tablets for up to 4.5 years, rising levels of lanthanum were noted over time. Estimates of elimination half-life from bone ranged from 2.0 to 3.6 years. Steady state bone concentrations were not reached during the period studied.
Metabolism and Elimination…
🧬 Mechanism of Action ▾
12.1Mechanism 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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1Lanthanum carbonate chewable tablets Lanthanum carbonate chewable tablets are available as: 500 mg: White to off-white, round, flat-faced, beveled-edge tablet, debossed with stylized b over 1137 on one side and plain on the other side. Available in a Patient Pack: 2 Bottles of 45 Tablets (NDC 0093-5938-98). 750 mg: White to off-white, round, flat-faced, beveled-edge tablet, debossed with stylized b over 750 on one side and plain on the other side.
Available in a Patient Pack: 6 Bottles of 15 Tablets (NDC 0093-5939-98). 1,000 mg: White to off-white, round, flat-faced, beveled-edge tablet, debossed with stylized b over 1139 on one side and plain on the other side. Available in a Patient Pack: 9 Bottles of 10 Tablets (NDC 0093-5940-98).
Storage and Handling Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION Lanthanum carbonate chewable tablets contain lanthanum carbonate with molecular formula La 2 (CO 3 ) 3 xH 2 O (on average x=4 to 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 white to off-white, lanthanum carbonate chewable tablet contains lanthanum carbonate hydrate equivalent to 500 mg, 750 mg, or 1,000 mg of elemental lanthanum and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dextrates (hydrated), and magnesium stearate.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Advise patients to take lanthanum carbonate chewable tablets with or immediately after meals [ see Dosage and Administration (2) ] . Instruct patients on concomitant medications that should be dosed apart from lanthanum carbonate chewable tablets [ see Drug Interactions (7) ].
Instruct patients who are prescribed lanthanum carbonate chewable tablets to chew or crush tablets completely before swallowing. Emphasize that lanthanum carbonate chewable tablets should not be swallowed intact. Consider crushing lanthanum carbonate chewable tablets completely or prescribing the oral powder formulation for patients with poor dentition or who have difficulty chewing tablets [ see Dosage and Administration (2) ] .
Advise patients who are taking an oral medication where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy to separate the dosing of lanthanum carbonate chewable tablets from the dosing of the affected drug by several hours [ see Drug Interactions (7) ] . Advise patients to notify their physician that they are taking lanthanum carbonate chewable tablets prior to an abdominal X-ray or if they have a history of gastrointestinal disease [see Warnings and Precautions ( 5.1 , 5.2 )] .
Manufactured In India By: Watson Pharma Private Limited Verna, Salcette Goa 403 722 India Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. D 1/2025
💬 Medication Guide ▾
MEDICATION GUIDE Lanthanum Carbonate (lan' tha num kar' bo nate ) Chewable Tablets Read this Medication Guide before you start taking lanthanum carbonate chewable tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
What is the most important information I should know about lanthanum carbonate chewable tablets? Lanthanum carbonate chewable tablets may cause a bowel blockage, a hole in the bowel, or severe constipation, which can be serious, and sometimes lead to surgery or treatment in a hospital. You may have a higher risk of bowel blockage, a hole in the bowel, or severe constipation if you take lanthanum carbonate chewable tablets and have: a history of surgery, ulcers or cancer in the stomach or bowel a history of bowel blockage, or problems resulting in a decreased movement of food through your stomach and bowel (e.g., feeling full quickly after eating or constipation) an infection or inflammation of the stomach/bowel (peritonitis) Do not swallow lanthanum carbonate chewable tablets whole.
Chew tablets completely before swallowing. If you cannot chew tablets completely, you may crush the tablets thoroughly before swallowing or discuss the oral powder formulation with your healthcare provider. What are lanthanum carbonate chewable tablets?
Lanthanum carbonate chewable tablets are a prescription medicine used in people with end-stage renal disease (ESRD) to lower the amount of phosphate in the blood. Who should not take lanthanum carbonate chewable tablets? Do not take lanthanum carbonate chewable tablets if you: are allergic to lanthanum carbonate or any of the other ingredients of this medicine have blocked bowels have severe constipation Lanthanum carbonate chewable tablets have not been studied in children and adolescents under 18 years of age.
What should I tell my healthcare provider before taking lanthanum carbonate chewable tablets? Lanthanum carbonate chewable tablets may not be right for you. Before starting lanthanum carbonate chewable tablets, tell your healthcare provider if you: have a history of surgery, ulcers or cancer in the stomach or bowel have a history of a bowel blockage, constipation, or problems resulting in a decreased movement of food through your stomach and bowel especially if you also have diabetes have ulcerative colitis, Crohn’s disease or an infection or inflammation of the stomach/bowel (peritonitis) plan to have an X-ray of your stomach (abdomen) have any other medical conditions are pregnant, plan to become pregnant, or plan to breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take: antacids antibiotics thyroid medicine Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I take lanthanum carbonate chewable tablets? Take lanthanum carbonate chewable tablets exactly as prescribed by your healthcare provider Your healthcare provider will tell you how many lanthanum carbonate chewable tablets to take Your healthcare provider may change your dose if needed Do not swallow tablets whole. Chew tablets completely before swallowing.
If you cannot chew tablets completely, or if you have tooth disease, you may crush the tablets thoroughly before swallowing or discuss the oral powder formulation with your healthcare provider. Take lanthanum carbonate chewable tablets with or right after meals If you take an antacid medicine, take the antacid 2 hours before or 2 hours after you take lanthanum carbonate chewable tablets If you take medicine for your thyroid (levothyroxine), take the thyroid medicine 2 hours before or 2 hours after you take lanthanum carbonate chewable tablets If you take an antibiotic medicine, take…