NDC 16571-813 Calcium Acetate

Calcium Acetate

NDC Product Code 16571-813

NDC CODE: 16571-813

Proprietary Name: Calcium Acetate What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Calcium Acetate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Calcium acetate is used to prevent high blood phosphate levels in patients who are on dialysis due to severe kidney disease. Dialysis removes some phosphate from your blood, but it is difficult to remove enough to keep your phosphate levels balanced. Decreasing blood phosphate levels can help keep your bones strong, prevent unsafe buildup of minerals in your body, and possibly decrease the risk of heart disease and strokes that can result from high phosphate levels. Calcium acetate is a natural mineral that works by holding onto phosphate from the diet so that it can pass out of your body.

Product Characteristics

Color(s):
BLUE (C48333 - CAP, OPAQUE)
WHITE (C48325 - BODY,OPAQUE)
Shape: CAPSULE (C48336)
Size(s):
22 MM
Imprint(s):
SUVEN;667

NDC Code Structure

  • 16571 - Rising Pharma Holdings, Inc.

NDC 16571-813-20

Package Description: 200 CAPSULE in 1 BOTTLE, PLASTIC

NDC Product Information

Calcium Acetate with NDC 16571-813 is a a human prescription drug product labeled by Rising Pharma Holdings, Inc.. The generic name of Calcium Acetate is calcium acetate. The product's dosage form is capsule and is administered via oral form.

Dosage Form: Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Calcium Acetate Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • D&C RED NO. 28 (UNII: 767IP0Y5NH)
  • WATER (UNII: 059QF0KO0R)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Blood Coagulation Factor - [EPC] (Established Pharmacologic Class)
  • Increased Coagulation Factor Activity - [PE] (Physiologic Effect)
  • Calcium - [CS]
  • Cations -
  • Divalent - [CS]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Rising Pharma Holdings, Inc.
Labeler Code: 16571
FDA Application Number: ANDA211038 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 11-01-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Information for Patients

Calcium Acetate

Calcium Acetate is pronounced as (kal' see um as' e tate)

Why is calcium acetate medication prescribed?
Calcium acetate is used to control high blood levels of phosphorus in people with kidney disease who are on dialysis (medical treatment to clean the blood when the kidney...
[Read More]

* Please review the disclaimer below.

Calcium Acetate Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

These Highlights Do Not Include All The Information Needed To Use Calcium Acetate Capsules Safely And Effectively. Please See Full Prescribing Information For Calcium Acetate Capsules. Calcium Acetate Capsules, For Oral Use Initial U.S. Approval: 1990

  • HIGHLIGHTS OF PRESCRIBING INFORMATION
  • These highlights do not include all the information needed to use
  • CALCIUM ACETATE CAPSULES safely and effectively. See full prescribing information for CALCIUM ACETATE CAPSULES.CALCIUM ACETATE capsules, for oral use
  • Initial U.S. Approval: 1990
  • --------------------INDICATIONS AND USAGE---------------Calcium acetate is a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease.(1)---------------DOSAGE AND ADMINISTRATION-----------Starting dose is 2 capsules with each meal.(2)Titrate the dose every 2 to 3 weeks until acceptable serum phosphorus level is reached. Most patients require 3 to 4 capsules with each meal.(2)---------------DOSAGE FORMS AND STRENGTHS--------Capsule: 667 mg calcium acetate capsule.(3)--------------------CONTRAINDICATIONS---------------------Hypercalcemia.(4)------------------WARNINGS AND PRECAUTIONS-------------Treat mild hypercalcemia by reducing or interrupting calcium acetate and Vitamin D. Severe hypercalcemia may require hemodialysis and discontinuation of calcium acetate.(5.1)Hypercalcemia may aggravate digitalis toxicity.(5.2)-------------------------ADVERSE REACTIONS--------------------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 SUVEN PHARMACEUTICALS LIMITED at 1-855-642-2594 or Rising Pharma Holdings, Inc. at 1-866-562-4597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch--------------DRUG INTERACTIONS---------------------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 acetate or consider monitoring blood levels of the drug.(7)See 17 for PATIENT COUNSELING INFORMATIONRevised: 08/2021FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE2 DOSAGE AND ADMINISTRATION
  • 3 DOSAGE FORMS AND STRENGTHS
  • 4 CONTRAINDICATIONS
  • 5 WARNINGS AND PRECAUTIONS
  • 5.1 Hypercalcemia
  • 5.2 Concomitant Use with Medications
  • 6 ADVERSE REACTIONS6.1 Clinical Trials Experience
  • 6.2 Post marketing Experience
  • 7 DRUG INTERACTIONS7.1 Ciprofloxacin8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy
  • 8.2 Labor and Delivery
  • 8.3 Nursing Mothers
  • 8.4 Pediatric Use8.5 Geriatric Use10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility14 CLINICAL STUDIES15 HOW SUPPLIED/STORAGE AND HANDLING17 PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not listed

1 Indications And Usage

Calcium acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD).

2 Dosage And Administration

The recommended initial dose of calcium acetate capsules 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 to 4 capsules with each meal.

3 Dosage Forms And Strengths

Capsule: 667 mg calcium acetate, USP per capsule.

4 Contraindications

Patients with hypercalcemia.

5 Warnings And Precautions

5.1 Hypercalcemia
Patients with end stage renal disease may develop hypercalcemia when treated with calcium, including calcium acetate. Avoid the use of calcium supplements, including calcium based nonprescription antacids, concurrently with calcium acetate.
An overdose of calcium acetate may lead to progressive hypercalcemia, which may require emergency measures. Therefore, early in the treatment phase during the dosage adjustment period, monitor serum calcium levels twice weekly. Should hypercalcemia develop, reduce the calcium acetate dosage, or discontinue the treatment, depending on the severity of hypercalcemia.More severe hypercalcemia (Ca >12 mg/dL) is associated with confusion, delirium, stupor and coma. Severe hypercalcemia can be treated by acute hemodialysis and discontinuing calcium acetate therapy.Mild hypercalcemia (10.5 to 11.9 mg/dL) may be asymptomatic or manifest as constipation, anorexia, nausea, and vomiting. Mild hypercalcemia is usually controlled by reducing the calcium acetate dose or temporarily discontinuing therapy. Decreasing or discontinuing Vitamin D therapy is recommended as well.Chronic hypercalcemia may lead to vascular calcification and other soft-tissue calcification. Radiographic evaluation of suspected anatomical regions may be helpful in early detection of soft tissue calcification. The long-term effect of calcium acetate on the progression of vascular or soft tissue calcification has not been determined.Hypercalcemia (>11 mg/dL) was reported in 16% of patients in a 3-month study of solid dose formulation of calcium acetate; all cases resolved upon lowering the dose or discontinuing treatment.

Maintain the serum calcium-phosphorus (Ca x P) product below 55 mg2/dL2.
5.2 Concomitant Use with MedicationsHypercalcemia may aggravate digitalis toxicity.

6 Adverse Reactions

Hypercalcemia is discussed elsewhere [
see Warnings and Precautions (5.1)]
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 End-Stage Renal Disease Undergoing HemodialysisPreferred

Term
Total adverse reactions reported for calcium acetaten=167

n (%)
3-mo, open- label study of calcium acetaten=98

n (%)
Double blind, placebo-controlled, cross-over study of liquid calcium acetaten=69Calcium

acetate

n (%)
Placebo

n (%)
Nausea6 (3.6)6 (6.1)0 (0.0)0 (0.0)Vomiting4 (2.4)4 (4.1)0 (0.0)0 (0.0)Hypercalcemia21 (12.6)16 (16.3)5 (7.2)0 (0.0)Mild hypercalcemia may be asymptomatic or manifest itself as constipation, anorexia, nausea, and vomiting. More severe hypercalcemia is associated with confusion, delirium, stupor, and coma. Decreasing dialysate calcium concentration could reduce the incidence and severity of calcium acetate-induced hypercalcemia. Isolated cases pruritus have been reported, which may represent allergic reactions.6.2 Post marketing Experience
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or to establish a causal relationship to drug exposure. The following additional adverse reactions have been identified during postapproval of calcium acetate: dizziness, edema, and weakness.

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.7.1 Ciprofloxacin
In a study of 15 healthy subjects, a co-administered single dose of 4 calcium acetate tablets, approximately 2.7g, decreased the bioavailability of ciprofloxacin by approximately 50%.

8 Use In Specific Populations

8.1 PregnancyPregnancy Category C
Calcium acetate capsules contains calcium acetate. Animal reproduction studies have not been conducted with calcium acetate, and there are no adequate and well controlled studies of calcium acetate use in pregnant women. Patients with end stage renal disease may develop hypercalcemia with calcium acetate treatment [
see Warnings and Precautions (5.1)]. Maintenance of normal serum calcium levels is important for maternal and fetal well-being. Hypercalcemia during pregnancy may increase the risk for maternal and neonatal complications such as stillbirth, preterm delivery, and neonatal hypocalcemia and hypoparathyroidism. Calcium acetate treatment, as recommended, is not expected to harm a fetus if maternal calcium levels are properly monitored during and following treatment.
8.2 Labor and Delivery
The effects of calcium acetate on labor and delivery are unknown.
8.3 Nursing Mothers
Calcium acetate is excreted in human milk. Human milk feeding by a mother receiving calcium acetate is not expected to harm an infant, provided maternal serum calcium levels are appropriately monitored.
8.4 Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
8.5 Geriatric Use
Clinical studies of calcium acetate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

10 Overdosage

Administration of calcium acetate in excess of the appropriate daily dosage may result in hypercalcemia [
see Warnings and Precautions (5.1)].

11 Description

Calcium acetate, USP acts as a phosphate binder. Its chemical name is Calcium acetate, USP. Its molecular formula is C
4H
6CaO
4, and its molecular weight is 158.17. Its structural formula is:
Each opaque capsule with a blue cap and white body is spin printed in blue and white ink with “SUVEN” printed on the cap and “667” printed on the body. Each capsule contains 667 mg calcium acetate, USP (anhydrous; Ca(CH
3COO)
2; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium, and water as the inert binder, crospovidone and sodium stearyl fumarate . The gelatin cap and body have the following inactive ingredients: FD&C blue 1, D&C red 28, titanium dioxide and gelatin. Imprinting ink on capsule body contains shellac and FD&C 2 Aluminum Lake and imprinting ink on capsule cap contains shellac, titanium dioxide and potassium hydroxide. Calcium acetate capsules are administered orally for the control of hyperphosphatemia in end-stage renal failure. Meets USP Dissolution Test 4

12 Clinical Pharmacology

Patients with ESRD retain phosphorus and can develop hyperphosphatemia. High serum phosphorus can precipitate serum calcium resulting in ectopic calcification. Hyperphosphatemia also plays a role in the development of secondary hyperparathyroidism in patients with ESRD.12.1 Mechanism of Action
Calcium acetate, when taken with meals, combines with dietary phosphate to form an insoluble calcium phosphate complex, which is excreted in the feces, resulting in decreased serum phosphorus concentration.
12.2 Pharmacodynamics
Orally administered calcium acetate from pharmaceutical dosage forms is systemically absorbed up to approximately 40% under fasting conditions and up to approximately 30% under non-fasting conditions. This range represents data from both healthy subjects and renal dialysis patients under various conditions.

13 Nonclinical Toxicology

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
No carcinogenicity, mutagenicity, or fertility studies have been conducted with calcium acetate.

14 Clinical Studies

Effectiveness of calcium acetate in decreasing serum phosphorus has been demonstrated in two studies of the calcium acetate solid oral dosage form.Ninety-one patients with end-stage renal disease who were undergoing hemodialysis and were hyperphosphatemic (serum phosphorus >5.5 mg/dL) following a 1-week phosphate binder washout period contributed efficacy data to an open-label, non-randomized study.The patients received calcium acetate 667 mg tablets at each meal for a period of 12 weeks. The initial starting dose was 2 tablets per meal for 3 meals a day, and the dose was adjusted as necessary to control serum phosphorus levels. The average final dose after 12 weeks of treatment was 3.4 tablets per meal. Although there was a decrease in serum phosphorus, in the absence of a control group the true magnitude of effect is uncertain.The data presented in Table 2 demonstrate the efficacy of calcium acetate in the treatment of hyperphosphatemia in end-stage renal disease patients. The effects on serum calcium levels are also presented.Table 2: Average Serum Phosphorous and Calcium Levels at Pre-Study, Interim, and Study Completion Time pointsParameterPre-StudyWeek 4
bWeek 8Week 12p-value
cPhosphorous (mg/dL)
a7.4 ± 0.175.9 ± 0.165.6 ± 0.175.2 ± 0.17≤0.01Calcium8.9 ± 0.099.5 ± 0.109.7 ± 0.109.7 ± 0.10≤0.01a Values expressed as mean ± SE.
b Ninety-one patients completed at least 6 weeks of the study.
c ANOVA of difference in values at pre-study and study completion.
There was a 30% decrease in serum phosphorus levels during the 12-week study period (p<0.01). Two-thirds of the decline occurred in the first month of the study. Serum calcium increased 9% during the study mostly in the first month of the study.Treatment with the phosphate binder was discontinued for patients from the open-label study, and those patients whose serum phosphorus exceeded 5.5 mg/dL were eligible for entry into a double-blind, placebo-controlled, cross-over study. Patients were randomized to receive calcium acetate or placebo, and each continued to receive the same number of tablets as had been individually established during the previous study. Following 2 weeks of treatment, patients switched to the alternative therapy for an additional 2 weeks.
The phosphate binding effect of calcium acetate is shown in the Table 3.
Table 3: Serum Phosphorous and Calcium Levels at Study Initiation and After Completion of Each Treatment ArmParameterPre-StudyPost Treatmentp-value
bCalcium AcetatePlaceboPhosphorous (mg/dL)
a7.3 ± 0.185.9 ± 0.247.8 ± 0.22<0.01Calcium (mg/dL)a8.9 ± 0.119.5 ± 0.138.8 ± 0.12<0.01a Values expressed as mean ± SEM
b ANOVA of calcium acetate vs. placebo after 2 weeks of treatment.
Overall, 2 weeks of treatment with calcium acetate statistically significantly (p<0.01) decreased serum phosphorus by a mean of 19% and increased serum calcium by a statistically significant (p<0.01) but clinically unimportant mean of 7%.

16 How Supplied/Storage And Handling

Calcium Acetate capsules USP, 667 mg are hard gelatin capsules with blue opaque cap imprinted with “SUVEN” in white color ink and a white opaque body imprinted with “667” blue color ink. Each capsule contains 667 mg calcium acetate (anhydrous Ca(CH
3COO)
2; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium.

NDC 16571-813-20 Bottles of 200 with child-resistant closure.

Storage

Store at 20°-25°C (68°-77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

17 Patient Counseling Information

Inform patients to take calcium acetate capsules with meals, adhere to their prescribed diets, and avoid the use of calcium supplements including nonprescription antacids. Inform the patients about the symptoms of hypercalcemia [
see Warnings and Precautions (5.1) and Adverse Reactions (6.1)].

Advise patients who are taking an oral medication where reduction in the bioavailability of that medication would have clinically significant effect on its safety or efficacy to take the drug one hour before or three hours after calcium acetate capsules.

Manufactured By:

Suven Pharmaceuticals Limited,

Pashamylaram, Telangana, 502307, India

ML No: 24/MD/AP/2009/F/CC
Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816Lb50318-3-00

Calcium Acetate Capsules Usp

Rising Pharmaceuticals NDC 16571-813-20Calcium AcetateCapsules USP667 mg*200 Capsules Rx Only*Each capsule contains: 667 mg calcium
acetate, USP equivalent to 169 mg calciumDIRECTIONS: SWALLOW CAPSULE. DO NOT
CHEW. Take as directed by your physician.KEEP THIS AND ALL DRUGS OUT OF REACHOF CHILDREN.Store at 20° to 25°C (68° to 77°F); excursionspermitted to 15° to 30°C (59° to 86°F) [See USPControlled Room Temperature].Manufactured By:Suven Pharmaceuticals Limited

Pashamylaram, Telangana, 502307, India
M.L No.: 24/MD/AP/2009/F/CCDistributed By: Rising Pharma Holdings, Inc.

East Brunswick, NJ, 08816

Lb50318-1-00 Rev. 08/2021

* Please review the disclaimer below.