Calcium Acetate by Chartwell RX, LLC. CALCIUM ACETATE capsule

Calcium Acetate by

Drug Labeling and Warnings

Calcium Acetate by is a Prescription medication manufactured, distributed, or labeled by Chartwell RX, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • 1 INDICATIONS AND USAGE

    Calcium Acetate Capsules are 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 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 Capsules. Avoid the use of calcium supplements, including calcium-based nonprescription antacids, concurrently with Calcium Acetate Capsules.

    An overdose of Calcium Acetate Capsules 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 Capsules 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 Capsules 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 Capsules 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 Capsules 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 × P) product below 55 mg2/dL2.

    5.2 Concomitant Use with Medications

    Hypercalcemia 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 Capsules were 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 Hemodialysis
    Preferred TermTotal adverse reactions reported for calcium acetate
    n=167
    n (%)    		3-mo, open-label study of calcium acetate
    n=98
    n (%)    		Double-blind, placebo-controlled, cross-over study of calcium acetate n=69
    Calcium 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 Capsules-induced hypercalcemia. Isolated cases pruritus have been reported, which may represent allergic reactions.

    6.2 Postmarketing 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 post-approval of calcium acetate: dizziness, edema, and weakness.

  • 7 DRUG INTERACTIONS

    The drug interaction of Calcium Acetate Capsules is characterized by the potential of calcium to bind to drugs with anionic functions (e.g., carboxyl, and hydroxyl groups). Calcium Acetate Capsules may decrease the bioavailability of tetracyclines or fluoroquinolones via this mechanism.

    There are no empirical data on avoiding drug interactions between calcium acetate or Calcium Acetate Capsules and most concomitant drugs. When administering an oral medication with Calcium Acetate Capsules 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 Capsules or 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 2.7 g, decreased the bioavailability of ciprofloxacin by approximately 50%.

  • 8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    Pregnancy Category C

    Calcium Acetate Capsules contain calcium acetate. Animal reproduction studies have not been conducted with Calcium Acetate Capsules, and there are no adequate and well controlled studies of Calcium Acetate Capsules 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 Capsules 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 Capsules on labor and delivery are unknown.

    8.3 Nursing Mothers

    Calcium Acetate Capsules contain calcium acetate and is excreted in human milk. Human milk feeding by a mother receiving Calcium Acetate Capsules 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 Capsules in excess of the appropriate daily dosage may result in hypercalcemia [see WARNINGS AND PRECAUTIONS (5.1)].

  • 11 DESCRIPTION

    Calcium Acetate Capsules act as a phosphate binder. Its chemical name is calcium acetate. Its molecular formula is C4H6CaO4, and its molecular weight is 158.17. Its structural formula is:

    Chemical Structure

    Each capsule has a white body and cap imprinted in black ink on the cap with "CE" and body with "0191" . Each capsule contains 667 mg calcium acetate, USP (anhydrous; Ca(CH3COO)2; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium, and 17.5 mg of the inert binder, polyethylene glycol 8000, and size 00 hard gelatin capsules. The hard gelatin capsule has the following inactive ingredients: gelatin, glycine, titanium dioxide, and citric acid. The black ink may contain shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, ammonia, black iron oxide, potassium hydroxide, FD&C Red #40, FD&C Blue #1, FD&C Yellow # 6, ammonium hydroxide, and simethicone.

    Calcium Acetate Capsules are administered orally for the control of hyperphosphatemia in end-stage renal failure.

  • 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 Capsules, 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 nonfasting conditions. This range represents data from both healthy subjects and renal dialysis patients under various conditions.

  • 13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis, Mutagenesis, Impairment and 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 points
    ParameterPre-StudyWeek 4 *Week 8Week 12p-value†
  • * Ninety-one patients completed at least 6 weeks of the study.
  • † ANOVA of difference in values at pre-study and study completion.
  • ‡ Values expressed as mean ± SE.
    • Phosphorus
    (mg/dL)‡    		7.4 ± 0.175.9 ± 0.165.6 ± 0.175.2± 0.17≤ 0.01
    Calcium (mg/dL)‡8.9 ± 0.099.5 ± 0.109.7 ± 0.109.7± 0.10≤ 0.01

    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 Phosphorus and Calcium Levels at Study Initiation and After Completion of Each Treatment Arm
    Post-Treatment
    ParameterPre-StudyCalcium AcetatePlacebop-value*
  • * ANOVA of calcium acetate vs. placebo after 2 weeks of treatment.
  • † Values expressed as mean ± SEM.
    • Phosphorus (mg/dL)†7.3 ± 0.185.9 ± 0.247.8 ± 0.22< 0.01
    Calcium (mg/dL)†8.9 ± 0.119.5 ± 0.138.8 ± 0.12< 0.01

    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

    Capsule: Each capsule for oral administration has a white body and cap imprinted in black ink on the cap with "CE"and body with "0191" containing 667 mg calcium acetate (anhydrous; Ca(CH3COO)2; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium.

    Capsules NDC: 62135-191-30 Bottles of 30
    Capsules NDC: 62135-191-22 Bottles of 200
    Capsules NDC: 62135-191-73 Bottles of 750

    Storage: Store at 20° to 25°C (68° to 77°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.

  • SPL UNCLASSIFIED SECTION

    Manufactured By:
    Chartwell Pharmaceuticals, LLC.
    Congers, NY 10920 USA

    Manufactured For:
    Chartwell RX, LLC.
    Congers, NY 10920 USA

    Made in USA

    Revised 02/2018

  • PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

    NDC 62135-191-30

    Calcium Acetate
    Capsules

    667 mg*

    Rx Only

    30
    Capsules

    Chartwell

    PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label
  • PRINCIPAL DISPLAY PANEL - 200 Capsule Bottle Label

    NDC 62135-191-22

    Calcium Acetate
    Capsules

    667 mg*

    Rx Only

    200
    Capsules

    Chartwell

    PRINCIPAL DISPLAY PANEL - 200 Capsule Bottle Label
  • PRINCIPAL DISPLAY PANEL - 750 Capsule Bottle Label

    NDC 62135-191-73

    Calcium Acetate
    Capsules

    667 mg*

    Rx Only

    750
    Capsules

    Chartwell

    PRINCIPAL DISPLAY PANEL - 750 Capsule Bottle Label
  • INGREDIENTS AND APPEARANCE
    CALCIUM ACETATE 
    calcium acetate capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 62135-191
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Calcium Acetate (UNII: Y882YXF34X) (Calcium Cation - UNII:2M83C4R6ZB) Calcium Acetate667 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCINE (UNII: TE7660XO1C)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SHELLAC (UNII: 46N107B71O)  
    ALCOHOL (UNII: 3K9958V90M)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    AMMONIA (UNII: 5138Q19F1X)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
    SILICA, TRIMETHYLSILYL CAPPED (UNII: VU10KU4B9S)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeCAPSULESize23mm
    FlavorImprint Code CE;0191
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 62135-191-3030 in 1 BOTTLE; Type 0: Not a Combination Product06/29/2018
    2NDC: 62135-191-22200 in 1 BOTTLE; Type 0: Not a Combination Product06/29/2018
    3NDC: 62135-191-73750 in 1 BOTTLE; Type 0: Not a Combination Product06/29/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09131206/29/2018
    Labeler - Chartwell RX, LLC. (079394054)
    Establishment
    NameAddressID/FEIBusiness Operations
    Chartwell Pharmaceuticals, LLC.962619982MANUFACTURE(62135-191)
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