البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
LANTHANUM CARBONATE (UNII: 490D9F069T) (LANTHANUM CATION (3+) - UNII:O7FU5X12W5)
Cipla USA Inc.
ORAL
PRESCRIPTION DRUG
Lanthanum carbonate chewable tablets are 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. Contraindicated in bowel obstruction, including ileus and fecal impaction. Risk Summary Available data from case reports with use of lanthanum carbonate 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
Lanthanum carbonate is supplied as chewable tablets in three dosage strengths for oral administration: 500-mg tablets, 750-mg tablets, and 1000-mg tablets. Each 500-mg chewable tablet is off-white to yellowish white, round flat faced bevel edge debossed “IG” on one side with “476” on the other. 500- mg Patient Pack (2 bottles of 45 tablets, NDC 69097-934-57, per each patient pack) NDC 69097-934-98 Each 750-mg chewable tablet is off-white to yellowish white, round flat faced bevel edge debossed “IG” on one side with “477” on the other. 750-mg Patient Pack (6 bottles of 15 tablets, NDC 69097-935-89, per each patient pack) NDC 69097-935-98 Each 1000-mg chewable tablet is off-white to yellowish white, round flat faced bevel edge debossed “IG” on one side with “478” on the other. 1000-mg Patient Pack (9 bottles of 10 tablets, NDC 69097-936-65, per each patient pack) NDC 69097-936-98 Storage- Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]
Abbreviated New Drug Application
LANTHANUM CARBONATE- LANTHANUM CARBONATE TABLET, CHEWABLE Cipla USA Inc. ---------- MEDICATION GUIDE LANTHANUM CARBONATE CHEWABLE TABLETS (LAN-tha-num KAR-bo-nate) 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: • 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 c اقرأ الوثيقة كاملة
LANTHANUM CARBONATE- LANTHANUM CARBONATE TABLET, CHEWABLE CIPLA USA INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LANTHANUM CARBONATE CHEWABLE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LANTHANUM CARBONATE CHEWABLE TABLETS. LANTHANUM CARBONATE CHEWABLE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2004 RECENT MAJOR CHANGES Warnings and Precautions (5.1) 05/2023 INDICATIONS AND USAGE Lanthanum carbonate chewable tablets are phosphate binder indicated to reduce serum phosphate in patients with end- stage renal disease (ESRD). (1) DOSAGE AND ADMINISTRATION The recommended initial total daily dose of lanthanum carbonate chewable tablets are 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) Lanthanum carbonate chewable tablets: Chew or crush tablet completely before swallowing. (2) DOSAGE FORMS AND STRENGTHS Lanthanum carbonate chewable tablets: 500 mg, 750 mg, and 1,000 mg. (3) CONTRAINDICATIONS Bowel obstruction, ileus, and fecal impaction. (4) 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 has radio-opaque properties and, therefore, may give the appearance typical of an imaging agent during abdominal X-ray procedures. (5.2) ADVERSE REACTIONS In controlled trials, the most common adverse reactions that were more frequent (≥5% difference vs. placebo) in lanthanum carbonate were nausea, vomiting, and abdominal pain. (6.1) The following adverse reactions have been identified during post-approval use of lanthanum carbonate: constipation, dyspepsia, allergic skin reactions, and tooth injury while chewing the tablet. (6.2) TO REPORT SU اقرأ الوثيقة كاملة