Remophos 667mg

Tablet
Calcium Acetate
ACI Pharmaceuticals

Other Strength:

Alternative:
- Hypophos 667mg



Remophos
Description
Remophos®is a preparation of Calcium Acetate.Calcium acetate(Remophos®) when taken with mealscombines with dietary phosphate to form insoluble calcium phosphate which is excreted in the feces.

Indications
Remophos®isindicated forthe -
oTreatment of hyperphosphatemia
oControl of hyperphosphatemia in end stage renal failure

Dosage and administration
The recommended initial dose of Remophos®for the adult dialysis patient is 2 tablets with each meal. The dosage may be increased gradually to bring the serum phosphate value below 6mg/dl, as long as hypercalcemia does not develop. Most patients require 3-4 tablets with each meal.

Use in pregnancy& lactation
Animal reproduction studies have not been conducted with Calcium Acetate. It is not known whether Calcium Acetatecan cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Calcium Acetateshould be given to a pregnant woman only if clearly needed.There are no adequate studies in women for determining infant risk when using the medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Precautions
Excessive dosage of Calcium Acetateinduces hypercalcemia; therefore, early in the treatment during dosage adjustment serum calcium should be determined twice weekly. Ifhypercalcemia develops, the dosage should be reduced or the treatment should be discontinued immediately depending on the severity of hypercalcemia. Calcium Acetateshould not be given to patients on digitalis, because hypercalcemia mayprecipitate cardiac arrhythmias. Calcium Acetatetherapy 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.

Side effects
In clinical studies, patients have occasionally experienced nauseaduring Calcium Acetatetherapy. Hypercalcemia may occur during treatment with Calcium Acetate. Mild hypercalcemia (Ca> 10.5mg/dl) may be asymptomatic or manifest itself as constipation, anorexia, nausea and vomiting. More severe hypercalcemia (Ca>12mg/dl) is associated with confusion, delirium, stupor and coma. The long-term effect of Calcium Acetateon the progression of vascular or soft-tissue calcification has not been determined. Isolated cases of pruritus have been reported which may represent allergic reactions.

Contraindications
Calcium Acetate is contraindicated in patients with hypercalcemia.

Warnings
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.

Drug interactions
Calcium Acetatemay decrease the bioavailability of tetracyclines.

Over dosage
Administration of Calcium Acetatein excess of the appropriate daily dosage can cause severe hypercalcemia. Mild hypercalcemia is easily controlled by reducing the Calcium Acetatedose or temporarily discontinuing therapy. Severe hypercalcemia can be treated by acute hemodialysis and discontinuing Calcium Acetatetherapy. Decreasing dialysate calcium concentration could reduce the incidence and severity of Calcium Acetateinduced hypercalcemia.

Pharmaceutical precautions
Store in a cool& dryplaceat room temperature. Protectfrom light, heat & moisture.

Presentation
Remophos®tablet: Each tablet contains Calcium Acetate667 mgUSP.

Package quantities
Remophos®tablet: Carton of 50 tablets in Alu-PVCblister.

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