Lanthanum carbonate anhydrous

SRP: At the time of review, criteria for land treatment or burial (sanitary landfill) disposal practices are subject to significant revision. Prior to implementing land disposal of waste residue (including waste sludge), consult with environmental regulatory agencies for guidance on acceptable disposal practices.

Drugs known to interact with antacids should not be administered within 2 hours of a lanthanum carbonate dose. Potential pharmacokinetic interaction (insoluble complex formation).

... Twelve patients randomly received in a crossover manner a single oral dose of ciprofloxacin 750 mg alone and plus lanthanum carbonate 1 g three times daily with meals for six doses, with a washout interval of 7 to 14 d. Serial blood and urine samples were collected for 24 hr after ciprofloxacin administration, and ciprofloxacin concentrations were determined using reverse-phase HPLC. Pharmacokinetic parameters of ciprofloxacin were calculated by noncompartmental methods, and the effect of lanthanum on ciprofloxacin pharmacokinetic parameters was assessed using ANOVA. Lanthanum decreased (P < 0.001) the mean ciprofloxacin area under the plasma concentration-time curve by 54% and the maximum plasma concentration by 56%. The 24-hr urinary recovery of ciprofloxacin was reduced by 52% by lanthanum (P < 0.001). No statistically significant differences in ciprofloxacin time to maximum plasma concentration, elimination half-life, and renal clearance occurred between the two arms. Lanthanum carbonate significantly reduces the systemic exposure to orally administered ciprofloxacin. Concomitant administration of both drugs should be avoided to prevent possible suboptimal response to ciprofloxacin.

/CASE REPORTS/ A 75-year-old woman was admitted with febrile confusion and abdominal pain. She was taking medications that included lanthanum carbonate. Examination, biology, a cerebral scan, and a review of her medications could not explain the confusion. The plain film of the abdomen revealed multiple diffuse calcium-like deposits throughout the digestive tract. The plasma levels of lanthanum were higher than normal. The confusion resolved after discontinuation of the lanthanum carbonate. This case raises the problem of the potential role played by lanthanum tablet residue in the genesis or aggravation of diverticular flare-up and the problem of the potential permeability of the blood-brain barrier with lanthanum use in case of its digestive accumulation, leading to increased serum concentrations.

/CASE REPORTS/ ... A 77-year-old man was admitted to a hospital for renal failure caused by complete obstructive ureterolithiasis in the solitary kidney. Hemodialysis was indicated due to elevated renal parameters (urea 28.0 mmol/L, serum creatinine 1079 umol/L, phosphorus 2.45 mmol/L). Treatment with lanthanum carbonate was started in order to normalize serum phosphate levels. Surgical treatment of ureteral obstruction was necessary but the patient presented with hemodynamically significant supraventricular tachycardia. The ECG proved atrial flutter that was the indication to electrical cardioversion by cardiologists. Therefore, transesophageal echocardiography had to be carried out to exclude intracardial thrombi; these were not detected. The echocardiography also demonstrated an inexplicable finding on the thoracic aorta, and thus, computed tomography of the aorta was performed. The CT scan did not reveal any significant pathology of the aorta. However, a high-contrast substance of unknown origin and significance was captured in the stomach. /Investigators/ performed an X-ray of lanthanum pills in a vial and detected the radio-opacity of lanthanum itself, even without calcium and phosphate. This confirmed our suspicion that the high-contrast metallic-like substance in the stomach was a tablet of lanthanum. ...

/EPIDEMIOLOGY STUDIES/ A specified subset of data from four Phase III clinical trials and subsequent extension studies is presented, in order to assess the effects of lanthanum carbonate on the liver. Hepatic biochemical tests for alanine transaminase, aspartate aminotransferase, alkaline phosphatase and bilirubin were performed. Adverse events classified as "liver and biliary system events" were recorded. In the four initial clinical trials, lanthanum carbonate was not associated with any adverse changes in transaminases or bilirubin. The incidence and nature of adverse events associated with the liver during lanthanum carbonate treatment was similar to that in the comparator groups. For patients who enrolled into the subsequent long-term follow-up study (up to 6 years of treatment), changes in transaminases were not clinically relevant and mean values were similar to those observed in the earlier trials. Overall, there was no increase in the incidence of adverse events associated with the liver reported after up to 6 years of treatment when compared with the results of the initial studies. There was no evidence of adverse effects of lanthanum carbonate on the liver in patients who received treatment for up to 6 years.

Drug Induced Liver Injury Rank (DILIrank 2.0)

Lanthanum carbonate

vNo-DILI-concern

0

No match

DOI:10.1016/j.drudis.2016.02.015

/LABORATORY ANIMALS: Subchronic or Prechronic Exposure/ ... The aim of this study was to determine whether long-term lanthanum exposure results in persistent alternations in nervous system function. Wistar rats were exposed to lanthanum chloride (LaCl(3)) through oral administration at 0, 0.1, 2 and 40mg/kg concentration from 4 weeks through 6 months of age. Morris water maze test showed that lanthanum exposure at 40mg/kg could significantly impair the behavioral performance. To fully investigate the neurotoxicological consequence of lanthanum exposure, brain elemental distributions and neurochemicals were also investigated. The distributions of brain elements such as Ca, Fe and Zn were significantly altered after lanthanum exposure. Moreover, 40mg/kg LaCl(3) significantly inhibited the activity of Ca(2+)-ATPase; the function of the central cholinergic system was also noticeably disturbed and the contents of some monoamines neurotransmitters were significantly decreased. These findings indicate that chronic exposure to lanthanum could possibly impair the learning ability and this deficit may be possibly attributed to the disturbance of the homeostasis of trace elements, enzymes and neurotransmitter systems in brain. ... /Lanthanum chloride/

/LABORATORY ANIMALS: Chronic Exposure or Carcinogenicity/ Oral administration of lanthanum carbonate to rats for up to 104 weeks, at doses up to 1500 mg of the salt per kg/day (2.5 times the maximum recommended daily human dose (MRHD) on a mg/sq m basis) revealed no evidence of carcinogenic potential.

/LABORATORY ANIMALS: Chronic Exposure or Carcinogenicity/ In the mouse, oral administration of lanthanum carbonate for up to 99 weeks, at a dose of 1500 mg/kg/day was associated with an increased incidence of glandular stomach adenomas in male mice.

/LABORATORY ANIMALS: Developmental or Reproductive Toxicity/ Lanthanum carbonate, at doses up to 2000 mg/kg/day, did not affect fertility or mating performance of male or female rats. In pregnant rats, oral administration of lanthanum carbonate at doses as high as 2000 mg/kg/day resulted in no evidence of harm to the fetus.

For more Non-Human Toxicity Excerpts (Complete) data for Lanthanum Carbonate (8 total), please visit the HSDB record page.

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 in this population is not recommended.

/SRP:/ Immediate first aid: Ensure that adequate decontamination has been carried out. If patient is not breathing, start artificial respiration, preferably with a demand valve resuscitator, bag-valve-mask device, or pocket mask, as trained. Perform CPR if necessary. Immediately flush contaminated eyes with gently flowing water. Do not induce vomiting. If vomiting occurs, lean patient forward or place on the left side (head-down position, if possible) to maintain an open airway and prevent aspiration. Keep patient quiet and maintain normal body temperature. Obtain medical attention. /Poisons A and B/

/SRP:/ Basic treatment: Establish a patent airway (oropharyngeal or nasopharyngeal airway, if needed). Suction if necessary. Watch for signs of respiratory insufficiency and assist ventilations if needed. Administer oxygen by nonrebreather mask at 10 to 15 L/min. Monitor for pulmonary edema and treat if necessary ... . Monitor for shock and treat if necessary ... . Anticipate seizures and treat if necessary ... . For eye contamination, flush eyes immediately with water. Irrigate each eye continuously with 0.9% saline (NS) during transport ... . Do not use emetics. For ingestion, rinse mouth and administer 5 mL/kg up to 200 mL of water for dilution if the patient can swallow, has a strong gag reflex, and does not drool ... . Cover skin burns with dry sterile dressings after decontamination ... . /Poisons A and B/

/SRP:/ Advanced treatment: Consider orotracheal or nasotracheal intubation for airway control in the patient who is unconscious, has severe pulmonary edema, or is in severe respiratory distress. Positive-pressure ventilation techniques with a bag valve mask device may be beneficial. Consider drug therapy for pulmonary edema ... . Consider administering a beta agonist such as albuterol for severe bronchospasm ... . Monitor cardiac rhythm and treat arrhythmias as necessary ... . Start IV administration of D5W /SRP: "To keep open", minimal flow rate/. Use 0.9% saline (NS) or lactated Ringer's if signs of hypovolemia are present. For hypotension with signs of hypovolemia, administer fluid cautiously. Watch for signs of fluid overload ... . Treat seizures with diazepam or lorazepam ... . Use proparacaine hydrochloride to assist eye irrigation ... . /Poisons A and B/

◉ Summary of Use during Lactation；No information is available on the use of lanthanum carbonate during breastfeeding in humans. In animal studies, lanthanum was deposited in the bones of juvenile animals. Lanthanum carbonate should not be used in nursing mothers. An alternate drug is recommended.；◉ Effects in Breastfed Infants；Relevant published information was not found as of the revision date.；◉ Effects on Lactation and Breastmilk；Relevant published information was not found as of the revision date.

Carbonic acid, lanthanum(3+) salt (3:2) is listed on the EPA's Chemical Data Reporting (CDR) system. Manufacturers and importers of Carbonic acid, lanthanum(3+) salt (3:2) are required to report information about their production and use of this chemical to the EPA under the Toxic Substances Control Act (TSCA). (40 eCFR Part 711)

Status: Active Update: 21-06-2022 https://echa.europa.eu/registration-dossier/-/registered-dossier/14359

The Approved Drug Products with Therapeutic Equivalence Evaluations List identifies currently marketed prescription drug products, incl lanthanum carbonate, approved on the basis of safety and effectiveness by FDA under sections 505 of the Federal Food, Drug, and Cosmetic Act.

THERAPEUTIC CATEGORY: Treatment of hyperphosphatemia

MEDICATION

2023: 1,000,000 - <5,000,000 lb；2022: 250,000 - <400,000 lb；2021: 1,000,000 - <2,500,000 lb；2020: 250,000 - <550,000 lb

Production volumes for non-confidential chemicals reported under the Inventory Update Rule. [Table#7426]

Production volumes for non-confidential chemicals reported under the Inventory Update Rule. [Table#7427]

Paint and Coating Manufacturing；Mining (except Oil and Gas) and support activities；All Other Basic Inorganic Chemical Manufacturing

Carbonic acid, lanthanum(3+) salt (3:2): ACTIVE