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  • CLASSES

    Mineral Binding Agents

    DEA CLASS

    Rx

    DESCRIPTION

    Oral, non-aluminum, non-calcium-containing phosphate binder
    Used for treatment of hyperphosphatemia in end-stage renal disease
    Serious cases of GI obstruction, perforation, and ileus reported, particularly with chewable tablets

    COMMON BRAND NAMES

    Fosrenol

    HOW SUPPLIED

    Fosrenol Oral Pwd: 750mg, 1000mg
    Fosrenol/Lanthanum Carbonate Oral Tab Chew: 500mg, 750mg, 1000mg

    DOSAGE & INDICATIONS

    For the treatment of hyperphosphatemia in patients with end stage renal disease (ESRD).
    NOTE: In addition to reduction of intestinal phosphate absorption with phosphate binders, management of hyperphosphatemia in ESRD patients usually also includes reduction in dietary intake of phosphate and removal of phosphate by dialysis.[44406]
    Oral dosage
    Adults

    Initially, 1,500 mg PO daily divided and taken with or immediately after meals. Titrate dosage in 750 mg/day increments every 2 to 3 weeks until an acceptable serum phosphate concentration is achieved. Monitor serum phosphate concentrations as needed during dosage titration and on a regular basis thereafter. Most patients require daily doses ranging from 1,500 to 3,000 mg to reduce plasma phosphate concentrations to less than 6 mg/dL. Doses up to 4,500 mg/day PO have been evaluated for ESRD.[44406]

    MAXIMUM DOSAGE

    Adults

    Doses up to 4500 mg/day PO have been evaluated in ESRD.

    Geriatric

    Doses up to 4500 mg/day PO have been evaluated in ESRD.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

    Renal Impairment

    Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

    ADMINISTRATION

    For storage information, see specific product information within the How Supplied section.

    Oral Administration

    Administer with or immediately after a meal for adequate binding of dietary phosphate.
    Lanthanum carbonate may bind other orally administered medications; consider separating the administration of other oral medications. The timing of the recommended separation depends on the concomitant drug.
    Avoid coadministration of oral agents known to interact with antacids within 2 hours of lanthanum carbonate dosing.
    Separate oral quinolone antibiotics by at least 1 hour before or 4 hours after lanthanum carbonate administration.
    Separate levothyroxine or other thyroid hormones by at least 2 hours before or 2 hours after lanthanum carbonate administration.
    For a concomitant oral medication 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 lanthanum carbonate. The duration of separation depends upon the absorption characteristics of the medication concomitantly administered. Where possible, consider monitoring clinical responses and/or blood concentrations of concomitant drugs that have a narrow therapeutic range.
    Consider the oral powder in patients with poor dentition or who have difficulty chewing tablets.[44406]

    Oral Solid Formulations

    Chew tablets completely before swallowing. Do not swallow intact tablets. Serious gastrointestinal complications have been reported in association with unchewed or incompletely chewed tablets.

    Other Oral Formulations

    Oral Powder:
    Do not open until ready to use. Sprinkle powder on a small amount of applesauce or other similar food and consume immediately. Do not store for future use once mixed with food. The powder is insoluble; do not attempt to dissolve in liquid for administration.

    STORAGE

    Fosrenol:
    - Avoid extreme temperatures
    - Keep away from heat and flame
    - Store at controlled room temperature (between 68 and 77 degrees F)
    - Store in a cool, well ventilated, dry place
    - Store in original container

    CONTRAINDICATIONS / PRECAUTIONS

    Constipation, Crohn's disease, diverticulitis, fecal impaction, gastric cancer, gastroparesis, GI disease, GI obstruction, ileus, peptic ulcer disease, peritonitis, surgery, ulcerative colitis

    Lanthanum carbonate is contraindicated in patients with GI obstruction, ileus, and fecal impaction. Serious cases, some necessitating surgery or hospitalization, of GI obstruction, ileus, subileus, GI perforation, and fecal impaction have been reported. Risk factors for GI obstruction and perforation identified in postmarketing reports include abnormal GI anatomy (e.g., colon cancer, gastric cancer, diverticulitis, peritonitis, history of GI surgery, gastrointestinal ulceration), hypomotility disorders (e.g., constipation, diabetic gastroparesis, ileus, subileus), and concomitant medications (e.g., calcium channel blockers). Some cases of GI obstruction were reported in patients with no history of GI disease. Advise patients to chew lanthanum tablets thoroughly to reduce the risk of GI complications. During treatment with lanthanum carbonate, remain vigilant for signs and symptoms of gastrointestinal disorders, especially constipation and abdominal pain/distention, which may indicate bowel obstruction, ileus, or subileus. Re-evaluate treatment with lanthanum carbonate in patients who develop severe constipation or other severe gastrointestinal signs and symptoms. Patients with significant GI disease, such as acute peptic ulcer disease, ulcerative colitis, Crohn's disease, or GI obstruction, were not included in clinical trials of lanthanum carbonate.[44406]

    Children, infants, neonates

    The safety and efficacy of lanthanum in neonates, infants, children, or adolescents have not been established. Long-term animal studies have shown lanthanum carbonate to be deposited into developing bone; including growth plate. Since the consequences of this deposition in developing bone in pediatric patients is not known, the use of lanthanum carbonate in children and adolescents is not recommended.

    Diagnostic test interference

    Administration of lanthanum carbonate may result in diagnostic test interference. Lanthanum carbonate has radio-opaque properties and therefore may give the appearance typical of an imaging agent during abdominal X-ray procedures.

    Pregnancy

    Use a non-lanthanum containing phosphate binder in pregnancy. Available data from case reports with lanthanum carbonate use in human pregnancy 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 at doses 5 times the MRHD was associated with maternal toxicity and resulted in increased post-implantation loss, reduced fetal weights, and delayed fetal ossification. Deposition of lanthanum into developing bone, including growth plate, was observed in juvenile animals in long-term animal studies with lanthanum carbonate.[44406]

    Breast-feeding

    Use a non-lanthanum containing phosphate binder in a breast-feeding woman. There are no data on the presence of lanthanum carbonate in human milk, the effects on the breast-fed 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.[44406]

    ADVERSE REACTIONS

    Severe

    GI perforation / Delayed / Incidence not known
    GI obstruction / Delayed / Incidence not known
    ileus / Delayed / Incidence not known

    Moderate

    hypocalcemia / Delayed / 5.0-5.0
    constipation / Delayed / Incidence not known
    hypophosphatemia / Delayed / Incidence not known

    Mild

    vomiting / Early / 7.0-18.0
    nausea / Early / 7.0-18.0
    diarrhea / Early / 7.0-18.0
    abdominal pain / Early / 5.0-5.0
    dyspepsia / Early / Incidence not known
    skin irritation / Early / Incidence not known

    DRUG INTERACTIONS

    Acetaminophen: (Minor) The manufacturer recommends that oral compounds known to interact with antacids, such as acetaminophen, should not be taken within 2 hours of dosing with lanthanum carbonate.
    Acetaminophen; Aspirin, ASA; Caffeine: (Minor) The manufacturer recommends that oral compounds known to interact with antacids, such as acetaminophen, should not be taken within 2 hours of dosing with lanthanum carbonate.
    Acetaminophen; Aspirin: (Minor) The manufacturer recommends that oral compounds known to interact with antacids, such as acetaminophen, should not be taken within 2 hours of dosing with lanthanum carbonate.
    Acetaminophen; Aspirin; Diphenhydramine: (Minor) The manufacturer recommends that oral compounds known to interact with antacids, such as acetaminophen, should not be taken within 2 hours of dosing with lanthanum carbonate.
    Acetaminophen; Caffeine: (Minor) The manufacturer recommends that oral compounds known to interact with antacids, such as acetaminophen, should not be taken within 2 hours of dosing with lanthanum carbonate.
    Acetaminophen; Caffeine; Dihydrocodeine: (Minor) The manufacturer recommends that oral compounds known to interact with antacids, such as acetaminophen, should not be taken within 2 hours of dosing with lanthanum carbonate.
    Acetaminophen; Caffeine; Pyrilamine: (Minor) The manufacturer recommends that oral compounds known to interact with antacids, such as acetaminophen, should not be taken within 2 hours of dosing with lanthanum carbonate.
    Acetaminophen; Chlorpheniramine: (Minor) The manufacturer recommends that oral compounds known to interact with antacids, such as acetaminophen, should not be taken within 2 hours of dosing with lanthanum carbonate.
    Acetaminophen; Chlorpheniramine; Dextromethorphan: (Minor) The manufacturer recommends that oral compounds known to interact with antacids, such as acetaminophen, should not be taken within 2 hours of dosing with lanthanum carbonate.
    Acetaminophen; Chlorpheniramine; Dextromethorphan; Phenylephrine: (Minor) The manufacturer recommends that oral compounds known to interact with antacids, such as acetaminophen, should not be taken within 2 hours of dosing with lanthanum carbonate.
    Acetaminophen; Chlorpheniramine; Dextromethorphan; Pseudoephedrine: (Minor) The manufacturer recommends that oral compounds known to interact with antacids, such as acetaminophen, should not be taken within 2 hours of dosing with lanthanum carbonate.
    Acetaminophen; Chlorpheniramine; Phenylephrine : (Minor) The manufacturer recommends that oral compounds known to interact with antacids, such as acetaminophen, should not be taken within 2 hours of dosing with lanthanum carbonate.
    Acetaminophen; Codeine: (Minor) The manufacturer recommends that oral compounds known to interact with antacids, such as acetaminophen, should not be taken within 2 hours of dosing with lanthanum carbonate.
    Acetaminophen; Dextromethorphan: (Minor) The manufacturer recommends that oral compounds known to interact with antacids, such as acetaminophen, should not be taken within 2 hours of dosing with lanthanum carbonate.
    Acetaminophen; Dextromethorphan; Doxylamine: (Minor) The manufacturer recommends that oral compounds known to interact with antacids, such as acetaminophen, should not be taken within 2 hours of dosing with lanthanum carbonate.
    Acetaminophen; Dextromethorphan; Guaifenesin; Phenylephrine: (Minor) The manufacturer recommends that oral compounds known to interact with antacids, such as acetaminophen, should not be taken within 2 hours of dosing with lanthanum carbonate.
    Acetaminophen; Dextromethorphan; Guaifenesin; Pseudoephedrine: (Minor) The manufacturer recommends that oral compounds known to interact with antacids, such as acetaminophen, should not be taken within 2 hours of dosing with lanthanum carbonate.
    Acetaminophen; Dextromethorphan; Phenylephrine: (Minor) The manufacturer recommends that oral compounds known to interact with antacids, such as acetaminophen, should not be taken within 2 hours of dosing with lanthanum carbonate.
    Acetaminophen; Dextromethorphan; Pseudoephedrine: (Minor) The manufacturer recommends that oral compounds known to interact with antacids, such as acetaminophen, should not be taken within 2 hours of dosing with lanthanum carbonate.
    Acetaminophen; Dichloralphenazone; Isometheptene: (Minor) The manufacturer recommends that oral compounds known to interact with antacids, such as acetaminophen, should not be taken within 2 hours of dosing with lanthanum carbonate.
    Acetaminophen; Diphenhydramine: (Minor) The manufacturer recommends that oral compounds known to interact with antacids, such as acetaminophen, should not be taken within 2 hours of dosing with lanthanum carbonate.
    Acetaminophen; Guaifenesin; Phenylephrine: (Minor) The manufacturer recommends that oral compounds known to interact with antacids, such as acetaminophen, should not be taken within 2 hours of dosing with lanthanum carbonate.
    Acetaminophen; Hydrocodone: (Minor) The manufacturer recommends that oral compounds known to interact with antacids, such as acetaminophen, should not be taken within 2 hours of dosing with lanthanum carbonate.
    Acetaminophen; Oxycodone: (Minor) The manufacturer recommends that oral compounds known to interact with antacids, such as acetaminophen, should not be taken within 2 hours of dosing with lanthanum carbonate.
    Acetaminophen; Pamabrom; Pyrilamine: (Minor) The manufacturer recommends that oral compounds known to interact with antacids, such as acetaminophen, should not be taken within 2 hours of dosing with lanthanum carbonate.
    Acetaminophen; Pentazocine: (Minor) The manufacturer recommends that oral compounds known to interact with antacids, such as acetaminophen, should not be taken within 2 hours of dosing with lanthanum carbonate.
    Acetaminophen; Pseudoephedrine: (Minor) The manufacturer recommends that oral compounds known to interact with antacids, such as acetaminophen, should not be taken within 2 hours of dosing with lanthanum carbonate.
    Amlodipine; Benazepril: (Moderate) ACE Inhibitors should not be taken within 2 hours of dosing with lanthanum carbonate. Oral compounds known to interact with cationic antacids may similarly be bound with lanthanum carbonate and have their absorption reduced. If these agents are used concomitantly, separate the dosing intervals appropriately. Monitor the clinical condition of the patient to ensure the proper clinical response to the ACE inhibitor is obtained.
    Angiotensin-converting enzyme inhibitors: (Moderate) ACE Inhibitors should not be taken within 2 hours of dosing with lanthanum carbonate. Oral compounds known to interact with cationic antacids may similarly be bound with lanthanum carbonate and have their absorption reduced. If these agents are used concomitantly, separate the dosing intervals appropriately. Monitor the clinical condition of the patient to ensure the proper clinical response to the ACE inhibitor is obtained.
    Benazepril: (Moderate) ACE Inhibitors should not be taken within 2 hours of dosing with lanthanum carbonate. Oral compounds known to interact with cationic antacids may similarly be bound with lanthanum carbonate and have their absorption reduced. If these agents are used concomitantly, separate the dosing intervals appropriately. Monitor the clinical condition of the patient to ensure the proper clinical response to the ACE inhibitor is obtained.
    Benazepril; Hydrochlorothiazide, HCTZ: (Moderate) ACE Inhibitors should not be taken within 2 hours of dosing with lanthanum carbonate. Oral compounds known to interact with cationic antacids may similarly be bound with lanthanum carbonate and have their absorption reduced. If these agents are used concomitantly, separate the dosing intervals appropriately. Monitor the clinical condition of the patient to ensure the proper clinical response to the ACE inhibitor is obtained.
    Benzhydrocodone; Acetaminophen: (Minor) The manufacturer recommends that oral compounds known to interact with antacids, such as acetaminophen, should not be taken within 2 hours of dosing with lanthanum carbonate.
    Bisphosphonates: (Moderate) To limit absorption problems, the oral bisphosphonates should not be taken within 2 hours of dosing with lanthanum carbonate. Oral drugs known to interact with cationic antacids, like the oral bisphosphonates, may also be bound by lanthanum carbonate. Separating times of administration will maximize absorption and clinical benefit of the bisphosphonate. Separate the times of administration appropriately. Monitor the patient's clinical status and bone density as recommended to ensure the appropriate response to bisphosphonate therapy is obtained.
    Butalbital; Acetaminophen: (Minor) The manufacturer recommends that oral compounds known to interact with antacids, such as acetaminophen, should not be taken within 2 hours of dosing with lanthanum carbonate.
    Butalbital; Acetaminophen; Caffeine: (Minor) The manufacturer recommends that oral compounds known to interact with antacids, such as acetaminophen, should not be taken within 2 hours of dosing with lanthanum carbonate.
    Butalbital; Acetaminophen; Caffeine; Codeine: (Minor) The manufacturer recommends that oral compounds known to interact with antacids, such as acetaminophen, should not be taken within 2 hours of dosing with lanthanum carbonate.
    Captopril: (Moderate) ACE Inhibitors should not be taken within 2 hours of dosing with lanthanum carbonate. Oral compounds known to interact with cationic antacids may similarly be bound with lanthanum carbonate and have their absorption reduced. If these agents are used concomitantly, separate the dosing intervals appropriately. Monitor the clinical condition of the patient to ensure the proper clinical response to the ACE inhibitor is obtained.
    Captopril; Hydrochlorothiazide, HCTZ: (Moderate) ACE Inhibitors should not be taken within 2 hours of dosing with lanthanum carbonate. Oral compounds known to interact with cationic antacids may similarly be bound with lanthanum carbonate and have their absorption reduced. If these agents are used concomitantly, separate the dosing intervals appropriately. Monitor the clinical condition of the patient to ensure the proper clinical response to the ACE inhibitor is obtained.
    Cefdinir: (Moderate) To limit absorption problems, cefdinir should not be taken within 2 hours of dosing with lanthanum carbonate. Oral drugs known to interact with cationic antacids, like cefdinir, may be bound by lanthanum carbonate. Separate the times of administration appropriately. Monitor the patient to ensure the appropriate response to cefdinir is obtained.
    Cefditoren: (Major) To limit absorption problems, cefditoren should not be taken within 2 hours of dosing with lanthanum carbonate. Oral drugs known to interact with cationic antacids, like cefditoren, may also be bound by lanthanum carbonate. Separate the times of administration appropriately. Monitor the patient to ensure the appropriate response to cefditoren is obtained.
    Cefpodoxime: (Major) To limit absorption problems, cefpodoxime should not be taken within 2 hours of dosing with lanthanum carbonate. Oral drugs known to interact with cationic antacids, like cefpodoxime, may also be bound by lanthanum carbonate. Separate the times of administration appropriately. Monitor the patient to ensure the appropriate response to cefpodoxime is obtained.
    Cefuroxime: (Major) To limit absorption problems, oral cefuroxime should not be taken within 2 hours of dosing with lanthanum carbonate. Oral drugs known to interact with cationic antacids, like cefuroxime, may also be bound by lanthanum carbonate. Separate the times of administration appropriately. Monitor the patient to ensure the appropriate response to cefuroxime is obtained.
    Chloroquine: (Major) Oral compounds known to interact with antacids, like chloroquine, should not be taken within 4 hours of dosing with lanthanum carbonate. If these agents are used concomitantly, space the dosing intervals appropriately. Monitor serum concentrations and clinical condition.
    Chlorpromazine: (Major) Oral compounds known to interact with antacids, like phenothiazines, should not be taken within 2 hours of dosing with lanthanum carbonate. If these agents are used concomitantly, space the dosing intervals appropriately. Monitor serum concentrations and clinical condition.
    Ciprofloxacin: (Major) Administer oral ciprofloxacin at least 2 hours before or 6 hours after lanthanum carbonate. When oral quinolones are given for short courses, consider eliminating the lanthanum carbonate doses that would be normally scheduled near the time of quinolone intake. Ciprofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. The bioavailability of ciprofloxacin was decreased by approximately 50% when coadministered with lanthanum carbonate.
    Cysteamine: (Major) In general, cysteamine may be administered with electrolyte and mineral replacements necessary for managing Fanconi syndrome, as well as with vitamin D and thyroid hormone. However, delayed-release cysteamine (Procysbi) should be administered at least 1 hour before or 1 after medications that increase gastric pH, including those containing bicarbonate or carbonate (i.e., lanthanum carbonate). Drugs that increase the gastric pH, such as bicarbonate and carbonate, may cause the premature release of cysteamine from delayed-release capsules, leading to an increase in WBC cystine concentration.
    Delafloxacin: (Major) Administer oral delafloxacin at least 2 hours before or 6 hours after lanthanum carbonate. When oral quinolones are given for short courses, consider eliminating the lanthanum carbonate doses that would be normally scheduled near the time of quinolone intake. Delafloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations.
    Delavirdine: (Major) Oral compounds known to interact with antacids, like delavirdine, should not be taken within 2 hours of dosing with lanthanum carbonate. If these agents are used concomitantly, space the dosing intervals appropriately. Monitor serum concentrations and clinical condition.
    Dextromethorphan; Quinidine: (Major) The manufacturer recommends that oral compounds known to interact with antacids should not be taken within 2 hours of dosing with lanthanum carbonate, including quinidine. If these agents are used concomitantly, space the dosing intervals appropriately; monitoring of serum concentrations and clinical condition may be prudent.
    Enalapril, Enalaprilat: (Moderate) ACE Inhibitors should not be taken within 2 hours of dosing with lanthanum carbonate. Oral compounds known to interact with cationic antacids may similarly be bound with lanthanum carbonate and have their absorption reduced. If these agents are used concomitantly, separate the dosing intervals appropriately. Monitor the clinical condition of the patient to ensure the proper clinical response to the ACE inhibitor is obtained.
    Enalapril; Felodipine: (Moderate) ACE Inhibitors should not be taken within 2 hours of dosing with lanthanum carbonate. Oral compounds known to interact with cationic antacids may similarly be bound with lanthanum carbonate and have their absorption reduced. If these agents are used concomitantly, separate the dosing intervals appropriately. Monitor the clinical condition of the patient to ensure the proper clinical response to the ACE inhibitor is obtained.
    Enalapril; Hydrochlorothiazide, HCTZ: (Moderate) ACE Inhibitors should not be taken within 2 hours of dosing with lanthanum carbonate. Oral compounds known to interact with cationic antacids may similarly be bound with lanthanum carbonate and have their absorption reduced. If these agents are used concomitantly, separate the dosing intervals appropriately. Monitor the clinical condition of the patient to ensure the proper clinical response to the ACE inhibitor is obtained.
    Erdafitinib: (Major) Avoid coadministration of lanthanum carbonate with erdafitinib before the initial dose increase period (days 14 to 21) which is based on serum phosphate levels. Lanthanum carbonate decreases serum phosphate levels. The initial dose increase of erdafitinib on days 14 to 21 is based on serum phosphate levels; changes in serum phosphate levels by lanthanum carbonate may interfere with the determination of this initial dose increase.
    Ethotoin: (Major) Oral compounds known to interact with antacids, like ethotoin, should not be taken within 2 hours of dosing with lanthanum carbonate. If these agents are used concomitantly, space the dosing intervals appropriately. Monitor serum concentrations and clinical condition.
    Fluphenazine: (Major) Oral compounds known to interact with antacids, like phenothiazines, should not be taken within 2 hours of dosing with lanthanum carbonate. If these agents are used concomitantly, space the dosing intervals appropriately. Monitor serum concentrations and clinical condition.
    Fosinopril: (Moderate) ACE Inhibitors should not be taken within 2 hours of dosing with lanthanum carbonate. Oral compounds known to interact with cationic antacids may similarly be bound with lanthanum carbonate and have their absorption reduced. If these agents are used concomitantly, separate the dosing intervals appropriately. Monitor the clinical condition of the patient to ensure the proper clinical response to the ACE inhibitor is obtained.
    Fosinopril; Hydrochlorothiazide, HCTZ: (Moderate) ACE Inhibitors should not be taken within 2 hours of dosing with lanthanum carbonate. Oral compounds known to interact with cationic antacids may similarly be bound with lanthanum carbonate and have their absorption reduced. If these agents are used concomitantly, separate the dosing intervals appropriately. Monitor the clinical condition of the patient to ensure the proper clinical response to the ACE inhibitor is obtained.
    Gabapentin: (Major) Oral compounds known to interact with antacids, like gabapentin, should not be taken within 2 hours of dosing with lanthanum carbonate. If these agents are used concomitantly, space the dosing intervals appropriately. Monitor serum concentrations and clinical condition.
    Gemifloxacin: (Major) Administer lanthanum carbonate at least 3 hours before or 2 hours after gemifloxacin. When oral quinolones are given for short courses, consider eliminating the lanthanum carbonate doses that would be normally scheduled near the time of quinolone intake. Gemifloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations.
    HMG-CoA reductase inhibitors: (Major) To limit absorption problems, HMG-CoA reductase inhibitors ("statins") should not be taken within 2 hours of dosing with lanthanum carbonate. Oral drugs known to interact with cationic antacids, like statin cholesterol treatments, may also be bound by lanthanum carbonate. Separate the times of administration appropriately. Monitor the patient's lipid profile to ensure the appropriate response to statin therapy is obtained.
    Hydrochlorothiazide, HCTZ; Moexipril: (Moderate) ACE Inhibitors should not be taken within 2 hours of dosing with lanthanum carbonate. Oral compounds known to interact with cationic antacids may similarly be bound with lanthanum carbonate and have their absorption reduced. If these agents are used concomitantly, separate the dosing intervals appropriately. Monitor the clinical condition of the patient to ensure the proper clinical response to the ACE inhibitor is obtained.
    Hydroxychloroquine: (Major) Oral compounds known to interact with antacids, like hydroxychloroquine, may interact with lanthanum carbonate. Hydroxychloroquine absorption may be reduced by antacids as has been observed with the structurally similar chloroquine. Administer hydroxychloroquine and lanthanum carbonate at least 4 hours apart. Of note, a study demonstrated no significant difference in hydroxychloroquine serum concentration in patients taking concomitant antacids (n = 14) compared to those not taking antacids (n = 495).
    Iron: (Major) Oral compounds known to interact with antacids, like iron salts, should not be taken within 2 hours of dosing with lanthanum carbonate. If these agents are used concomitantly, space the dosing intervals appropriately. Monitor serum concentrations and clinical condition.
    Lactulose: (Minor) The manufacturer recommends that oral compounds known to interact with antacids, such as lactulose, should not be taken within 2 hours of dosing with lanthanum carbonate.
    Levofloxacin: (Major) Administer lanthanum carbonate at least 2 hours before or 2 hours after orally administered levofloxacin. When oral quinolones are given for short courses, consider eliminating the lanthanum carbonate doses that would be normally scheduled near the time of quinolone intake. Levofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. Chelation of divalent cations with levofloxacin is less than with other quinolones.
    Levothyroxine: (Moderate) Administer oral thyroid hormones at least 4 hours before or after the administration of lanthanum carbonate. Concurrent use may reduce the efficacy of levothyroxine by binding and delaying or preventing oral absorption, potentially resulting in hypothyroidism. Thyroid stimulating hormone (TSH) concentrations should be carefully monitored. The bioavailability of levothyroxine was decreased by approximately 40% when administered with lanthanum carbonate.
    Levothyroxine; Liothyronine (Porcine): (Moderate) Administer oral thyroid hormones at least 4 hours before or after the administration of lanthanum carbonate. Concurrent use may reduce the efficacy of levothyroxine by binding and delaying or preventing oral absorption, potentially resulting in hypothyroidism. Thyroid stimulating hormone (TSH) concentrations should be carefully monitored. The bioavailability of levothyroxine was decreased by approximately 40% when administered with lanthanum carbonate.
    Levothyroxine; Liothyronine (Synthetic): (Moderate) Administer oral thyroid hormones at least 4 hours before or after the administration of lanthanum carbonate. Concurrent use may reduce the efficacy of levothyroxine by binding and delaying or preventing oral absorption, potentially resulting in hypothyroidism. Thyroid stimulating hormone (TSH) concentrations should be carefully monitored. The bioavailability of levothyroxine was decreased by approximately 40% when administered with lanthanum carbonate.
    Liothyronine: (Moderate) Administer oral thyroid hormones at least 4 hours before or after the administration of lanthanum carbonate. Concurrent use may reduce the efficacy of levothyroxine by binding and delaying or preventing oral absorption, potentially resulting in hypothyroidism. Thyroid stimulating hormone (TSH) concentrations should be carefully monitored. The bioavailability of levothyroxine was decreased by approximately 40% when administered with lanthanum carbonate.
    Lisinopril: (Moderate) ACE Inhibitors should not be taken within 2 hours of dosing with lanthanum carbonate. Oral compounds known to interact with cationic antacids may similarly be bound with lanthanum carbonate and have their absorption reduced. If these agents are used concomitantly, separate the dosing intervals appropriately. Monitor the clinical condition of the patient to ensure the proper clinical response to the ACE inhibitor is obtained.
    Lisinopril; Hydrochlorothiazide, HCTZ: (Moderate) ACE Inhibitors should not be taken within 2 hours of dosing with lanthanum carbonate. Oral compounds known to interact with cationic antacids may similarly be bound with lanthanum carbonate and have their absorption reduced. If these agents are used concomitantly, separate the dosing intervals appropriately. Monitor the clinical condition of the patient to ensure the proper clinical response to the ACE inhibitor is obtained.
    Moexipril: (Moderate) ACE Inhibitors should not be taken within 2 hours of dosing with lanthanum carbonate. Oral compounds known to interact with cationic antacids may similarly be bound with lanthanum carbonate and have their absorption reduced. If these agents are used concomitantly, separate the dosing intervals appropriately. Monitor the clinical condition of the patient to ensure the proper clinical response to the ACE inhibitor is obtained.
    Moxifloxacin: (Major) Administer oral moxifloxacin at least 4 hours before or 8 hours after lanthanum carbonate. When oral quinolones are given for short courses, consider eliminating the lanthanum carbonate doses that would be normally scheduled near the time of quinolone intake. Moxifloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations.
    Mycophenolate: (Major) Oral compounds known to interact with antacids, like mycophenolate, should not be taken within 2 hours of dosing with lanthanum carbonate. If these agents are used concomitantly, space the dosing intervals appropriately. Monitor serum concentrations and clinical condition.
    Ofloxacin: (Major) Administer lanthanum carbonate at least 2 hours before or 2 hours after ofloxacin. When oral quinolones are given for short courses, consider eliminating the lanthanum carbonate doses that would be normally scheduled near the time of quinolone intake. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations.
    Perindopril: (Moderate) ACE Inhibitors should not be taken within 2 hours of dosing with lanthanum carbonate. Oral compounds known to interact with cationic antacids may similarly be bound with lanthanum carbonate and have their absorption reduced. If these agents are used concomitantly, separate the dosing intervals appropriately. Monitor the clinical condition of the patient to ensure the proper clinical response to the ACE inhibitor is obtained.
    Perindopril; Amlodipine: (Moderate) ACE Inhibitors should not be taken within 2 hours of dosing with lanthanum carbonate. Oral compounds known to interact with cationic antacids may similarly be bound with lanthanum carbonate and have their absorption reduced. If these agents are used concomitantly, separate the dosing intervals appropriately. Monitor the clinical condition of the patient to ensure the proper clinical response to the ACE inhibitor is obtained.
    Perphenazine: (Major) Oral compounds known to interact with antacids, like phenothiazines, should not be taken within 2 hours of dosing with lanthanum carbonate. If these agents are used concomitantly, space the dosing intervals appropriately. Monitor serum concentrations and clinical condition.
    Perphenazine; Amitriptyline: (Major) Oral compounds known to interact with antacids, like phenothiazines, should not be taken within 2 hours of dosing with lanthanum carbonate. If these agents are used concomitantly, space the dosing intervals appropriately. Monitor serum concentrations and clinical condition.
    Phenytoin: (Major) Oral compounds known to interact with antacids, like phenytoin, should not be taken within 2 hours of dosing with lanthanum carbonate. If these agents are used concomitantly, space the dosing intervals appropriately. Monitor serum concentrations and clinical condition.
    Prochlorperazine: (Major) Oral compounds known to interact with antacids, like phenothiazines, should not be taken within 2 hours of dosing with lanthanum carbonate. If these agents are used concomitantly, space the dosing intervals appropriately. Monitor serum concentrations and clinical condition.
    Protease inhibitors: (Major) Oral compounds known to interact with antacids, like protease inhibitors, should not be taken within 2 hours of dosing with lanthanum carbonate. If these agents are used concomitantly, space the dosing intervals appropriately. Monitor serum concentrations and clinical condition.
    Quinapril: (Moderate) ACE Inhibitors should not be taken within 2 hours of dosing with lanthanum carbonate. Oral compounds known to interact with cationic antacids may similarly be bound with lanthanum carbonate and have their absorption reduced. If these agents are used concomitantly, separate the dosing intervals appropriately. Monitor the clinical condition of the patient to ensure the proper clinical response to the ACE inhibitor is obtained.
    Quinapril; Hydrochlorothiazide, HCTZ: (Moderate) ACE Inhibitors should not be taken within 2 hours of dosing with lanthanum carbonate. Oral compounds known to interact with cationic antacids may similarly be bound with lanthanum carbonate and have their absorption reduced. If these agents are used concomitantly, separate the dosing intervals appropriately. Monitor the clinical condition of the patient to ensure the proper clinical response to the ACE inhibitor is obtained.
    Quinidine: (Major) The manufacturer recommends that oral compounds known to interact with antacids should not be taken within 2 hours of dosing with lanthanum carbonate, including quinidine. If these agents are used concomitantly, space the dosing intervals appropriately; monitoring of serum concentrations and clinical condition may be prudent.
    Quinine: (Major) Oral compounds known to interact with antacids, like quinine sulfate, should not be taken within 2 hours of dosing with lanthanum carbonate. If these agents are used concomitantly, space the dosing intervals appropriately. Monitor serum concentrations and clinical condition.
    Ramipril: (Moderate) ACE Inhibitors should not be taken within 2 hours of dosing with lanthanum carbonate. Oral compounds known to interact with cationic antacids may similarly be bound with lanthanum carbonate and have their absorption reduced. If these agents are used concomitantly, separate the dosing intervals appropriately. Monitor the clinical condition of the patient to ensure the proper clinical response to the ACE inhibitor is obtained.
    Sucralfate: (Major) Oral compounds known to interact with antacids, like sucralfate, should not be taken within 2 hours of dosing with lanthanum carbonate. If these agents are used concomitantly, space the dosing intervals appropriately. Monitor serum concentrations and clinical condition.
    Tetracyclines: (Major) Oral compounds known to interact with antacids, like tetracyclines, should not be taken within 2 hours of dosing with lanthanum carbonate. If these agents are used concomitantly, space the dosing intervals appropriately. Monitor serum concentrations and clinical condition.
    Thioridazine: (Major) Oral compounds known to interact with antacids, like phenothiazines, should not be taken within 2 hours of dosing with lanthanum carbonate. If these agents are used concomitantly, space the dosing intervals appropriately. Monitor serum concentrations and clinical condition.
    Thyroid hormones: (Moderate) Administer oral thyroid hormones at least 4 hours before or after the administration of lanthanum carbonate. Concurrent use may reduce the efficacy of levothyroxine by binding and delaying or preventing oral absorption, potentially resulting in hypothyroidism. Thyroid stimulating hormone (TSH) concentrations should be carefully monitored. The bioavailability of levothyroxine was decreased by approximately 40% when administered with lanthanum carbonate.
    Tramadol; Acetaminophen: (Minor) The manufacturer recommends that oral compounds known to interact with antacids, such as acetaminophen, should not be taken within 2 hours of dosing with lanthanum carbonate.
    Trandolapril: (Moderate) ACE Inhibitors should not be taken within 2 hours of dosing with lanthanum carbonate. Oral compounds known to interact with cationic antacids may similarly be bound with lanthanum carbonate and have their absorption reduced. If these agents are used concomitantly, separate the dosing intervals appropriately. Monitor the clinical condition of the patient to ensure the proper clinical response to the ACE inhibitor is obtained.
    Trandolapril; Verapamil: (Moderate) ACE Inhibitors should not be taken within 2 hours of dosing with lanthanum carbonate. Oral compounds known to interact with cationic antacids may similarly be bound with lanthanum carbonate and have their absorption reduced. If these agents are used concomitantly, separate the dosing intervals appropriately. Monitor the clinical condition of the patient to ensure the proper clinical response to the ACE inhibitor is obtained.
    Trifluoperazine: (Major) Oral compounds known to interact with antacids, like phenothiazines, should not be taken within 2 hours of dosing with lanthanum carbonate. If these agents are used concomitantly, space the dosing intervals appropriately. Monitor serum concentrations and clinical condition.
    Valproic Acid, Divalproex Sodium: (Major) Oral compounds known to interact with antacids, like valproic acid, should not be taken within 2 hours of dosing with lanthanum carbonate. If these agents are used concomitantly, space the dosing intervals appropriately. Monitor serum concentrations and clinical condition.

    PREGNANCY AND LACTATION

    Pregnancy

    Use a non-lanthanum containing phosphate binder in pregnancy. Available data from case reports with lanthanum carbonate use in human pregnancy 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 at doses 5 times the MRHD was associated with maternal toxicity and resulted in increased post-implantation loss, reduced fetal weights, and delayed fetal ossification. Deposition of lanthanum into developing bone, including growth plate, was observed in juvenile animals in long-term animal studies with lanthanum carbonate.[44406]

    Use a non-lanthanum containing phosphate binder in a breast-feeding woman. There are no data on the presence of lanthanum carbonate in human milk, the effects on the breast-fed 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.[44406]

    MECHANISM OF ACTION

    After oral administration, lanthanum carbonate dissociates to lanthanum ions in the acidic environment of the upper GI tract. The lanthanum ions bind dietary phosphate released from food during digestion. Once lanthanum binds phosphate, the water-insoluble lanthanum phosphate complex formed is poorly absorbed across the gut wall and is eventually excreted in the feces. Ultimately, with repeated dosing, serum phosphate concentrations are decreased.

    PHARMACOKINETICS

    Lanthanum is administered orally. In vitro, lanthanum is > 99% bound to plasma proteins. Animal studies have revealed lanthanum concentrations in many tissues, particularly GI tract, bone, and liver, were several times greater than plasma concentrations and remained in these tissues for longer than 6 months after cessation of dosing. Bone biopsies from subjects treated with lanthanum carbonate for up to 4.5 years revealed rising levels of lanthanum over time, the effect of which is unknown. The half-life of lanthanum is approximately 53 hours. Nearly all (94—99%) of an oral dose is excreted in the feces. Biliary excretion is the predominant route of elimination for circulating lanthanum.

    Oral Route

    Systemic absorption following oral administration is very low, with a bioavailability of < 0.002% following single or multiple oral doses to healthy subjects. Furthermore, no accumulation in plasma is apparent following administration of standard therapeutic doses of lanthanum carbonate for over 2 years. The effect of food on the bioavailability of lanthanum carbonate has not been evaluated but the timing of a dose relative to food intake (with and 30 minutes after food) has a negligible effect on lanthanum plasma concentrations. In order to bind phosphate efficiently, and since tolerability is poor when given without food, lanthanum carbonate should be administered with or immediately after a meal.