calcium acetate
Generic: CALCIUM ACETATE
Basic Information
Manufacturer
REMEDYREPACK INC.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
89a2ee04-1024-4a81-ba0d-a6655d529827
Indications & Usage
1 INDICATIONS AND USAGE Calcium acetate capsule is a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease.
( 1 ) Calcium acetate capsule is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD).
( 1 ) Calcium acetate capsule is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD).
Adverse Reactions
6 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 Avet Pharmaceuticals Inc.
at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 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 Term Total adverse reactions reported for calcium acetate 3 – mo , open-label study of calcium acetate n = 98 Double-blind , placebo-controlled , cross over study of calcium acetate n = 69 n = 167 n (%) n (%) Calcium acetate n (%) Placebo n (%) Nausea 6 (3.6) 6 (6.1) 0 (0.0) 0 (0.0) Vomiting 4 (2.4) 4 (4.1) 0 (0.0) 0 (0.0) Hypercalcemia 21 (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 of 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.
( 6.1 ).
In clinical studies, patients have occasionally experienced nausea during calcium acetate therapy.
( 6 ).
To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc.
at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 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 Term Total adverse reactions reported for calcium acetate 3 – mo , open-label study of calcium acetate n = 98 Double-blind , placebo-controlled , cross over study of calcium acetate n = 69 n = 167 n (%) n (%) Calcium acetate n (%) Placebo n (%) Nausea 6 (3.6) 6 (6.1) 0 (0.0) 0 (0.0) Vomiting 4 (2.4) 4 (4.1) 0 (0.0) 0 (0.0) Hypercalcemia 21 (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 of 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.