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Calcium Acetate
Overview
What is Calcium Acetate?
Each white opaque/blue opaque gelcap contains 667 mg of calcium acetate, (anhydrous; Ca(CH3COO)2; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium. Each capsule also contains FD&C blue #1, FD&C red #3, gelatin, magnesium stearate, polyethylene glycol 8000, and titanium dioxide. In addition to the ingredients listed above, each capsule contains Opacode (Black) monogrammingink. Opacode (Black) contains ethanol, FD&C blue #2, FD&C red #40, FD&C yellow #6, iron oxide black, Nbutyl alcohol, propylene glycol, and shellac. Calcium Acetate Capsules are administered orally for the control of hyperphosphatemia in end stage renal failure.
What does Calcium Acetate look like?
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What are the available doses of Calcium Acetate?
Sorry No records found.
What should I talk to my health care provider before I take Calcium Acetate?
Sorry No records found
How should I use Calcium Acetate?
Calcium Acetate Capsules are indicated for the control of hyperphosphatemia in end stage renal failure and do not promote aluminum absorption.
The recommended initial dose of calcium acetate capsules for the adult dialysis patient is 2 capsules with each meal. The dosage may be increased gradually to bring the serum phosphate value below 6 mg/dl, as long as hypercalcemia does not develop. Most patients require 3 to 4 capsules with each meal.
What interacts with Calcium Acetate?
Patients with hypercalcemia.
What are the warnings of Calcium Acetate?
Since benztropine mesylate contains structural features of atropine, it may produce anhidrosis. For this reason, it should be administered with caution during hot weather, especially when given concomitantly with other atropine-like drugs to the chronically ill, the alcoholic, those who have central nervous system disease, and those who do manual labor in a hot environment. Anhidrosis may occur more readily when some disturbance of sweating already exists. If there is evidence of anhidrosis, the possibility of hyperthermia should be considered. Dosage should be decreased at the discretion of the physician so that the ability to maintain body heat equilibrium by perspiration is not impaired. Severe anhidrosis and fatal hyperthermia have occurred.
What are the precautions of Calcium Acetate?
General
Excessive dosage of calcium acetate induces hypercalcemia; therefore, early in the treatment during dosage adjustment serum calcium should be determined twice weekly. Should hypercalcemia develop, the dosage should be reduced or the treatment discontinued immediately depending on the severity of hypercalcemia. Calcium acetate should not be given to patients on digitalis, because hypercalcemia may precipitate cardiac arrhythmias. Calcium acetate therapy should always be started at low dose and should not be increased without careful monitoring of serum calcium. An estimate of daily calcium intake should be made initially and the intake adjusted as needed. Serum phosphorus should also be determined periodically.
Information for patients
The patients should be informed about compliance with dosage instructions, adherence to instructions about diet and avoidance of the use of nonprescription antacids. Patients should be informed about the symptoms of hypercalcemia (see ).
Drug interactions
Calcium acetate may decrease the bioavailability of tetracyclines.
Carcinogenesis, mutagenesis, impairment of fertility
Long-term animal studies have notbeen performed to evaluate the carcinogenic potential, mutagenicity, or effect on fertility of calcium acetate.
Pregnancy
Teratogenic effects: Category C:
Animal reproduction studies have not been conducted with calcium acetate. It is not known whether calcium acetate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Calcium acetate should be given to a pregnant woman only if clearly needed.
Pediatric use
Safety and effectiveness in pediatric patients have not been established.
Geriatric use
Of the total number of subjects in clinical studies of calcium acetate (N=91), 25 percent were 65 and over, while 7 percent were 75 and over. No overall differences in safety or effectiveness were
observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
What are the side effects of Calcium Acetate?
In clinical studies, patients have occasionally experienced nausea during calcium acetate therapy. Hypercalcemia may occur during treatment with calcium acetate. Mild hypercalcemia (Ca>10.5 mg/dl) may be asymptomatic or manifest itself as constipation, anorexia, nausea and vomiting. More severe hypercalcemia (Ca>12 mg/dl) is associated with confusion, delirium, stupor and coma. Mild hypercalcemia is easily controlled by reducing the calcium acetate dose or temporarily discontinuing therapy. Severe hypercalcemia can be treated by acute hemodialysis and discontinuing calcium acetate therapy. Decreasing dialysate calcium concentration could reduce the incidence and severity of calcium acetate induced hypercalcemia. The long-term effect of calcium acetate on the progression of vascular or soft-tissue calcification has not been determined. Isolated cases of pruritus have been reported which may represent allergic reactions.
Overdosage
Administration of calcium acetate in excess of the appropriate daily dosage can cause severe hypercalcemia (see ).
What should I look out for while using Calcium Acetate?
Patients with hypercalcemia.
Patients with end stage renal failure may develop hypercalcemia when given calcium with meals. No other calcium supplements should be given concurrently with calcium acetate capsules. Progressive hypercalcemia due to overdose of calcium acetate may be severe as to require emergency measures. Chronic hypercalcemia may lead to vascular calcification, and other soft-tissue calcification. The serum calcium level should be monitored twice weekly during the early dose adjustment period.
Radiographic evaluation of suspect anatomical region may be helpful in early detection of soft-tissue calcification.
What might happen if I take too much Calcium Acetate?
Sorry No Records found
How should I store and handle Calcium Acetate?
Store bottles of 1000 SINGULAIR 5-mg chewable tablets and 8000 SINGULAIR 10-mg film-coated tablets at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original container. When product container is subdivided, repackage into a well-closed, light resistant container. Calcium Acetate Capsules are supplied as white opaque/blue opaque capsules imprinted with “54 215” on the cap and body.They are supplied by as follows:STORAGEStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]This product was Manufactured By: Roxane Laboratories, Inc.And Repackaged By:State of Florida DOH Central PharmacyCalcium Acetate Capsules are supplied as white opaque/blue opaque capsules imprinted with “54 215” on the cap and body.They are supplied by as follows:STORAGEStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]This product was Manufactured By: Roxane Laboratories, Inc.And Repackaged By:State of Florida DOH Central PharmacyCalcium Acetate Capsules are supplied as white opaque/blue opaque capsules imprinted with “54 215” on the cap and body.They are supplied by as follows:STORAGEStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]This product was Manufactured By: Roxane Laboratories, Inc.And Repackaged By:State of Florida DOH Central PharmacyCalcium Acetate Capsules are supplied as white opaque/blue opaque capsules imprinted with “54 215” on the cap and body.They are supplied by as follows:STORAGEStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]This product was Manufactured By: Roxane Laboratories, Inc.And Repackaged By:State of Florida DOH Central PharmacyCalcium Acetate Capsules are supplied as white opaque/blue opaque capsules imprinted with “54 215” on the cap and body.They are supplied by as follows:STORAGEStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]This product was Manufactured By: Roxane Laboratories, Inc.And Repackaged By:State of Florida DOH Central PharmacyCalcium Acetate Capsules are supplied as white opaque/blue opaque capsules imprinted with “54 215” on the cap and body.They are supplied by as follows:STORAGEStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]This product was Manufactured By: Roxane Laboratories, Inc.And Repackaged By:State of Florida DOH Central PharmacyCalcium Acetate Capsules are supplied as white opaque/blue opaque capsules imprinted with “54 215” on the cap and body.They are supplied by as follows:STORAGEStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]This product was Manufactured By: Roxane Laboratories, Inc.And Repackaged By:State of Florida DOH Central PharmacyCalcium Acetate Capsules are supplied as white opaque/blue opaque capsules imprinted with “54 215” on the cap and body.They are supplied by as follows:STORAGEStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]This product was Manufactured By: Roxane Laboratories, Inc.And Repackaged By:State of Florida DOH Central Pharmacy
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Patients with advanced renal insufficiency (creatinine clearance less than 30 mL/min) exhibit phosphate retention and some degree of hyperphosphatemia. The retention of phosphate plays a pivotal role in causing secondary hyperparathyroidism associated with osteodystrophy, and soft-tissue calcification. The mechanism by which phosphate retention leads to hyperparathyroidism is not clearly delineated. Therapeutic efforts directed toward the control of hyperphosphatemia include reduction in the dietary intake of phosphate, inhibition of absorption of phosphate in the intestine with phosphate binders, and removal of phosphate from the body by more efficient methods of dialysis. The rate of removal of phosphate by dietary manipulation or by dialysis is insufficient. Dialysis patients absorb 40% to 80% of dietary phosphorus. Therefore, the fraction of dietary phosphate absorbed from the diet needs to be reduced by using phosphate binders in most renal failure patients on maintenance dialysis. Calcium acetate when taken with meals, combines with dietary phosphate to form insoluble calcium phosphate which is excreted in the feces. Maintenance of serum phosphorus below 6.0 mg/dl is generally considered as a clinically acceptable outcome of treatment with phosphate binders. Calcium acetate is highly soluble at neutral pH, making the calcium readily available for binding to phosphate in the proximal small intestine. Orally administered calcium acetate from pharmaceutical dosage forms has been demonstrated to be 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.
Non-Clinical Toxicology
Patients with hypercalcemia.Patients with end stage renal failure may develop hypercalcemia when given calcium with meals. No other calcium supplements should be given concurrently with calcium acetate capsules. Progressive hypercalcemia due to overdose of calcium acetate may be severe as to require emergency measures. Chronic hypercalcemia may lead to vascular calcification, and other soft-tissue calcification. The serum calcium level should be monitored twice weekly during the early dose adjustment period. Radiographic evaluation of suspect anatomical region may be helpful in early detection of soft-tissue calcification.
Calcium acetate may decrease the bioavailability of tetracyclines.
Excessive dosage of calcium acetate induces hypercalcemia; therefore, early in the treatment during dosage adjustment serum calcium should be determined twice weekly. Should hypercalcemia develop, the dosage should be reduced or the treatment discontinued immediately depending on the severity of hypercalcemia. Calcium acetate should not be given to patients on digitalis, because hypercalcemia may precipitate cardiac arrhythmias. Calcium acetate therapy should always be started at low dose and should not be increased without careful monitoring of serum calcium. An estimate of daily calcium intake should be made initially and the intake adjusted as needed. Serum phosphorus should also be determined periodically.
In clinical studies, patients have occasionally experienced nausea during calcium acetate therapy. Hypercalcemia may occur during treatment with calcium acetate. Mild hypercalcemia (Ca>10.5 mg/dl) may be asymptomatic or manifest itself as constipation, anorexia, nausea and vomiting. More severe hypercalcemia (Ca>12 mg/dl) is associated with confusion, delirium, stupor and coma. Mild hypercalcemia is easily controlled by reducing the calcium acetate dose or temporarily discontinuing therapy. Severe hypercalcemia can be treated by acute hemodialysis and discontinuing calcium acetate therapy. Decreasing dialysate calcium concentration could reduce the incidence and severity of calcium acetate induced hypercalcemia. The long-term effect of calcium acetate on the progression of vascular or soft-tissue calcification has not been determined. Isolated cases of pruritus have been reported which may represent allergic reactions.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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