Calcium Acetate 667 mg/1
Calcium Acetate · CAPSULE · Chartwell RX, LLC.
Calcium Acetate is a capsule containing calcium acetate at 667 mg/1, taken oral. Manufactured by Chartwell RX, LLC..
Key Facts
- Brand Name
- Calcium Acetate
- Generic Name
- Calcium Acetate
- NDC Code (Product)
62135-191- Manufacturer
- Chartwell RX, LLC.
- Strength
- 667 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA091312
- Marketing Start
- 06/29/2018
Recall History
Aidapak Services, LLC
Labeling: Label Mixup: CALCIUM ACETATE, Tablet, 667 mg may have potentially been mislabeled as one of the following drugs: ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: AD30028_34, EXP: 5/7/2014; HYOSCYAMINE SULFATE ODT, Tablet, 0.125 mg, NDC 00574024701, Pedigree: W003614, EXP: 6/25/2014.
Aidapak Services, LLC
Labeling: Label Mixup: CALCIUM ACETATE, Capsule, 667 mg may be potentially mislabeled as one of the following drugs: ZOLPIDEM TARTRATE, Tablet, 2.5 mg (1/2 of 5 mg), NDC 64679071401, Pedigree: AD28355_1, EXP: 5/8/2014; acetaZOLAMIDE, Tablet, 250 mg, NDC 51672402301, Pedigree: AD62865_1, EXP: 5/23/2014; ZINC GLUCONATE, Tablet, 50 mg, NDC 00904319160, Pedigree: W003028, EXP: 6/12/2014; PROPRANO
Fresenius Medical Care Holdings, Inc.
Cross Contamination with Other Products: Potential for contaminant on the cotton packaging inside the bottle. Chemical analysis of the contaminant found on the cotton was identified as a formulation of 4% Trimipramine methanesulfonate - a tricyclic antidepressant..
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Nostrum Laboratories Inc
Presence of Foreign Tablets/Capsules
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 Calcium acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD). Calcium acetate is a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION The recommended initial dose of calcium acetate for the adult dialysis patient is 2 capsules with each meal. Increase the dose gradually to lower serum phosphorus levels to the target range, as long as hypercalcemia does not develop. Most patients require 3-4 capsules with each meal. Starting dose is 2 capsules with each meal. (2) Titrate the dose every 2-3 weeks until acceptable serum phosphorus level is reached. Most patients require 3-4 capsules with each meal. (2)
Contraindications
4 CONTRAINDICATIONS Patients with hypercalcemia. Hypercalcemia. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS The drug interaction of calcium acetate is characterized by the potential of calcium to bind to drugs with anionic functions (e.g., carboxyl, and hydroxyl groups). Calcium acetate may decrease the bioavailability of tetracyclines or fluoroquinolones via this mechanism. There are no empirical data on avoiding drug interactions between calcium acetate and most concomitant drugs. When administering an oral medication with calcium acetate where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy, administer the drug one hour before or three hours after calcium acetate. Monitor blood levels of the concomitant drugs that have a narrow therapeutic range. Patients taking anti-arrhythmic medications for the control of arrhythmias and anti-seizure medications for the control of seizure disorders were excluded from the clinical trials with all forms of calcium acetate. Calcium acetate may decrease the bioavailability of tetracyclines or fluoroquinolones. ( 7 ) When clinically significant drug interactions are expected, administer the drug at least one hour before or at least three hours after calcium ac…
Adverse Reactions
6 ADVERSE REACTIONS Hypercalcemia is discussed elsewhere [see Warnings and Precautions (5.1) ]. The most common (>10%) adverse reactions are hypercalcemia, nausea and vomiting. ( 6.1 ) In clinical studies, patients have occasionally experienced nausea during calcium acetate therapy. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Cipla Ltd. at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trial 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. In clinical studies, calcium acetate has been generally well tolerated. Calcium acetate was studied in a 3-month, open-label, non-randomized study of 98 enrolled ESRD hemodialysis patients and an alternate liquid formulation of calcium acetate was studied in a two week double-blind, placebo-controlled, cross-over study with 69 enrolled ESRD hemodialysis patients. Adverse reactions (>2% on treatment) from these trials are presented in Table 1. Table 1: Adverse Reactions in Patients with …
Frequently Asked Questions
What is Calcium Acetate used for?
Calcium Acetate contains Calcium Acetate. It is a capsule taken oral. Consult your doctor for specific uses.
Is Calcium Acetate a controlled substance?
Calcium Acetate is not classified as a controlled substance by the DEA.
What is the generic name for Calcium Acetate?
The generic name for Calcium Acetate is Calcium Acetate. There are 4 other brand versions of Calcium Acetate.
What is the NDC code for Calcium Acetate 667 mg/1?
The NDC (National Drug Code) for Calcium Acetate 667 mg/1 is 62135-191, listed by Chartwell RX, LLC..