CALCIUM ACETATE- calcium acetate tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Safecor Health, LLC

INN (nume internaţional):

CALCIUM ACETATE

Compoziție:

CALCIUM ACETATE 667 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Calcium Acetate Tablets, USP are indicated for the control of hyperphosphatemia in end stage renal failure and does not promote aluminum absorption. Patients with hypercalcemia.

Rezumat produs:

In tablet form with "P113" debossed on one side and plain on the other, for oral administration. Each white round tablet contains 667 mg calcium acetate (anhydrous; Ca(CH3 COO)2 ; MW = 158.17 grams) equal to 169 mg (8.45 mEq) calcium; polyethylene glycol 8000; and magnesium stearate. Tablets in unit dose blisters, NDC 48433-300-01; Box of 100 (NDC 48433-300-10) unit dose Robot-Rx® 1 pouches; Box of 75 (NDC 48433-300-75) unit dose Robot-Rx®1 pouches The product contained in these packages is from NDC 00574-0113. This package is not child resistant. For institutional use only. Packaged and Distributed by: Safecor Health, LLC 317 New Boston Street Woburn, MA 01801 Safecor Health, LLC 4060 Business Park Drive Columbus, OH 43204 Questions or comments? 1-800-447-1006 Rev: 114-00 09/2014 Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature]

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

CALCIUM ACETATE- CALCIUM ACETATE TABLET
SAFECOR HEALTH, LLC
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CALCIUM ACETATE TABLETS, USP
DES CRIPTION:
Each white to off-white, round, biconvex tablet (debossed with "P113"
on one face) contains 667 mg
calcium acetate, USP (anhydrous; Ca(CH COO) ; MW = 158.17 grams) equal
to 169 mg (8.45 mEq)
calcium; polyethylene glycol 8000; and magnesium stearate. Calcium
Acetate Tablets, USP are
administered orally for the control of hyperphosphatemia in end stage
renal failure.
CLINICAL 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
Tablets, USP are 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
sy