Lanthanum Carbonate 1000 mg/1
Lanthanum Carbonate · TABLET, CHEWABLE · Lupin Pharmaceuticals, Inc.
Lanthanum Carbonate is a tablet, chewable containing lanthanum carbonate at 1000 mg/1, taken oral. Manufactured by Lupin Pharmaceuticals, Inc..
Key Facts
- Brand Name
- Lanthanum Carbonate
- Generic Name
- Lanthanum Carbonate
- NDC Code (Product)
68180-821- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Strength
- 1000 mg/1
- Dosage Form
- TABLET, CHEWABLE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA090978
- Marketing Start
- 08/30/2017
Recall History
Cipla USA, Inc.
Failed stability specifications: Out of specification for hardness test
Aidapak Services, LLC
Labeling: Label Mixup; LANTHANUM CARBONATE Chew Tablet, 500 mg may be potentially mislabeled as ISONIAZID, Tablet, 300 mg, NDC 00555007102, Pedigree: AD32757_31, EXP: 5/13/2014; CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00536355601, Pedigree: AD32757_53, EXP: 5/14/2014; MAGNESIUM CHLORIDE, Tablet, 64 mg, NDC 68585000575, Pedigree: W002712, EXP: 6/6/2014; MAGNESIUM CHLORIDE, Tablet, 64 mg, NDC 68
Cipla USA, Inc.
Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Cipla USA, Inc.
Failed stability specifications: Out of specification for hardness test
Cipla USA, Inc.
Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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. Lanthanum carbonate chewable tablets are phosphate binder indicated to reduce serum phosphate in patients with end- stage renal disease (ESRD). ( 1 )
Dosage & 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. Information for lanthanum carbonate chewable tablets 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 …
Contraindications
4 CONTRAINDICATIONS Contraindicated in patients with: hypersensitivity to Lanthanum carbonate or to any ingredient in the formulation. bowel obstruction, including ileus and fecal impaction. Hypersensitivity to Lanthanum carbonate or to any ingredient in the formulation. ( 4 ) Bowel obstruction, ileus, and fecal impaction. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS There is a potential for lanthanum carbonate 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 ) 7.1 Drugs Binding to Antacids There is a potential for lanthanum carbonate to interact with compounds which bind to cationic antacids (i.e., aluminum-, magnesium-, or calcium-based); therefore, do not administer such compounds within 2 hours of dosing with lanthanum carbonate. Examples of relevant classes of compounds where antacids have been …
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 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 SUSPECTED ADVERSE REACTIONS, contact Exelan pharmaceutical,Inc. at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical 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 …
Frequently Asked Questions
What is Lanthanum Carbonate used for?
Lanthanum Carbonate contains Lanthanum Carbonate. It is a tablet, chewable taken oral. Consult your doctor for specific uses.
Is Lanthanum Carbonate a controlled substance?
Lanthanum Carbonate is not classified as a controlled substance by the DEA.
What is the generic name for Lanthanum Carbonate?
The generic name for Lanthanum Carbonate is Lanthanum Carbonate. There are 7 other brand versions of Lanthanum Carbonate.
What is the NDC code for Lanthanum Carbonate 1000 mg/1?
The NDC (National Drug Code) for Lanthanum Carbonate 1000 mg/1 is 68180-821, listed by Lupin Pharmaceuticals, Inc..