CALCIUM ACETATE 667 MG- calcium acetate tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CALCIUM ACETATE (UNII: Y882YXF34X) (CALCIUM CATION - UNII:2M83C4R6ZB)

Available from:

Pharmin USA, LLC

INN (International Name):

CALCIUM ACETATE

Composition:

CALCIUM ACETATE 667 mg

Administration route:

ORAL

Therapeutic indications:

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

Authorization status:

Dietary Supplement

Summary of Product characteristics

CALCIUM ACETATE 667 MG- CALCIUM ACETATE TABLET, COATED
PHARMIN USA, LLC
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CALCIUM ACETATE TABLETS 667 MG
HIGHLIGHTS OF PRESCRIBING INFORMATION
DISPENSED UNDER CLINICAL SUPERVISION*
* CALCIUM ACETATE 667MG TABLETS ARE CATEGORIZED AS A HUMAN
PRESCRIPTION DRUG OR SUPPLEMENT
IN THE USA. THIS PRODUCT SHOULD BE DISPENSED UNDER CLINICAL
SUPERVISION IN COMPLIANCE WITH ALL
REGULATIONS AS SET FORTH BY THE UNITED STATES FOOD AND DRUG
ADMINISTRATION.
1 INDICATIONS AND USAGE
Calcium Acetate Tablet 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 Tablets 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 3-4
capsules with each meal.
3 DOSAGE FORMS AND STRENGTHS
Tablet: 667 mg calcium acetate per tablet.
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 usual