Calcium Acetate (Systemic)
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VA CLASSIFICATION
Primary: TN402
Commonly used brand name(s): PhosLo.
Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).
Category:
Antihyperphosphatemic—
Indications
Accepted
Hyperphosphatemia (treatment)—Calcium acetate is indicated in patients with end-stage renal failure to lower serum phosphate concentrations. It does not promote aluminum absorption {01}.
Pharmacology/Pharmacokinetics
Physicochemical characteristics:
Molecular weight—
158.17 {01}
Mechanism of action/Effect:
Calcium acetate, when taken with meals, combines with dietary phosphate to form insoluble calcium phosphate, which is excreted in the feces {01}.
Absorption:
Data from healthy subjects and renal dialysis patients under various conditions indicate that after oral administration of calcium acetate, approximately 40% is absorbed in the fasting state and approximately 30% is absorbed in the nonfasting state {01}.
Elimination:
Fecal {01}.
Precautions to Consider
Carcinogenicity
Long-term studies to evaluate carcinogenic potential of calcium acetate have not been performed {01}.
Pregnancy/Reproduction
Fertility—
Studies have not been done in either humans or animals {01}.
Pregnancy—
Studies in humans have not been done {01}.
Studies in animals have not been done {01}.
FDA Pregnancy Category C {01}.
Breast-feeding
It is not known whether calcium acetate is distributed into breast milk.
Pediatrics
No information is available on the relationship of age to the effects of calcium acetate in pediatric patients. Safety and efficacy have not been established {01}.
Geriatrics
No information is available on the relationship of age to the effects of calcium acetate in geriatric patients.
Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):
Note: Combinations containing any of the following, depending on the amount present, may also interact with this medication.
» Calcium-containing foods or preparations, including dietary supplements or antacids (concurrent use may cause hypercalcemia; dietary calcium should be estimated daily initially and intake adjusted as needed)
{01}
» Digitalis glycosides (concurrent use is not recommended because calcium acetate may cause hypercalcemia, which could precipitate cardiac arrhythmias)
{01}
Tetracyclines, oral (concurrent administration may decrease the bioavailability of tetracyclines)
{01}
Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).
Except under special circumstances, this medication should not be used when the following medical problem exists:
» Hypercalcemia (calcium acetate may exacerbate the condition)
{01}
Risk-benefit should be considered when the following medical problem exists
Sensitivity to calcium acetate
Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):
Calcium concentrations, serum and
Phosphate concentrations, serum (serum calcium concentrations should be monitored twice a week early in the treatment during the dosage adjustment period; serum calcium concentrations > 10.5 mg per dL (mg/dL) indicate mild hypercalcemia and serum concentrations > 12 mg/dL indicate severe hypercalcemia; the product of the serum calcium concentration and the serum phosphate concentration should not exceed 66; if hypercalcemia develops, calcium acetate should be discontinued or the dosage reduced, depending on the severity of hypercalcemia; serum phosphate concentrations should be monitored periodically and the dosage adjusted as needed to keep concentrations below 6 mg per dL)
{01}
Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:
Those indicating need for medical attention
Incidence rare
Hypercalcemia, mild (constipation; loss of appetite; nausea or vomiting){01}
hypercalcemia, severe (confusion; full or partial loss of consciousness; incoherent speech){01}
Note: Mild hypercalcemia may be asymptomatic.
Those indicating need for medical attention only if they continue or are bothersome
Incidence less frequent
Nausea
{01}
pruritus {01}(itching)
Note: Pruritus may represent an allergic reaction {01}.
Overdose
For more information on the management of overdose or unintentional ingestion, contact a Poison Control Center (see Poison Control Center Listing ).
Clinical effects of overdose
The following effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:
Acute and/or chronic
Hypercalcemia, mild (constipation; loss of appetite; nausea and vomiting){01}
hypercalcemia, severe (confusion; full or partial loss of consciousness; incoherent speech){01}
Note: Mild hypercalcemia may be asymptomatic.
Chronic hypercalcemia may lead to vascular calcification or other soft-tissue calcification {01}.
Treatment of overdose
Mild hypercalcemia may be controlled by reducing the dose of calcium acetate or temporarily discontinuing therapy {01}. Calcium acetate therapy should be discontinued in severe hypercalcemia {01}.
To enhance elimination—Severe hypercalcemia should be treated by hemodialysis {01}.
Monitoring—If chronic hypercalcemia develops, radiographic evaluation of the suspected anatomical region may detect soft-tissue calcification {01}.
Supportive care—Patients in whom intentional overdose is confirmed or suspected should be referred for psychiatric consultation.
Patient Consultation
As an aid to patient consultation, refer to —Advice for the Patient, Calcium Acetate (Systemic) .
In providing consultation, consider emphasizing the following selected» information ( = major clinical significance):
Before using this medication
» Conditions affecting use, especially:
Other medications, especially calcium-containing foods or preparations or digitalis glycosides
Other medical problems, especially hypercalcemia
Proper use of this medication
Taking with meals
» Proper dosing
Missed dose: Taking as soon as possible; not taking if almost time for next dose; not doubling doses
» Proper storage
Precautions while using this medication
Importance of close monitoring by physician
» Avoiding concurrent use with calcium-containing preparations, including dietary supplements and antacids
» Estimating daily dietary calcium intake and adjusting if needed
Side/adverse effects
Signs of potential side effects, especially mild and severe hypercalcemia
General Dosing Information
Most patients require 3 to 4 tablets with each meal {01}.
Diet/Nutrition
Calcium acetate should be taken with meals {01}.
Daily intake of dietary calcium should be estimated initially and adjusted if needed {01}.
Oral Dosage Forms
CALCIUM ACETATE TABLETS
Usual adult and adolescent dose
Antihyperphosphatemic
Oral, 2 tablets three times a day with meals {01}. The dosage may be increased gradually to keep serum phosphate concentrations below 6 mg per dL {01}.
Usual pediatric dose
Safety and efficacy have not been established {01}.
Strength(s) usually available
U.S.—
169 mg elemental calcium (667 mg calcium acetate) (Rx) [PhosLo{01}]
Packaging and storage:
Store below 40 ºC (104 ºF), preferably between 15 and 30 ºC (59 and 86 ºF), unless otherwise specified by the manufacturer {01}.
Auxiliary labeling:
• Take with meals {01}.
Developed: 03/23/1998
References
- PhosLo package insert (Braintree Laboratories—US), Rev 5/92, Rec 6/97.
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