Lophos tablet is a medication that is prescribed to patients who are undergoing dialysis or have end-stage renal disease (ESRD) to treat high blood phosphate levels. The active ingredient in Lophos is calcium acetate, which is classified as a phosphate binder. This medication works by binding the phosphate in the food you eat, preventing its absorption into the bloodstream.
Composition:
Each tablet of LoPhos contains 667 mg of Calcium acetate, USP (anhydrous; Ca (CH3 COO)2; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium.
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 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 phosphate removal rate by dietary manipulation or 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 a clinically acceptable/outcome of treatment with phosphate binders.
Calcium acetate is highly soluble at neutral pH, making the calcium readily available for binding to phosphate in the proximal small intestine. The orally administered Calcium acetate from pharmaceutical dosage forms has been demonstrated to be systemically absorbed up to approximately 40% under fasting conditions and up to. approximately 30% under non fasting conditions. This range represents data from both healthy subjects and renal dialysis patients under various conditions.
Indications and Usage:
LoPhos is indicated for the control of hyperphosphatemia in end stage renal failure and does not promote aluminum absorption.
Contraindications:
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.
Progressive hypercalcemia due to overdose of Calcium acetate may be severe as to require emergency measures.
Chronic hypercalcemia may lead to vascular calcification and other soft tissue calcification. The serum calcium level should be monitored twice weekly during the early dose adjustment period. The serum calcium – phosphorous (CaXP) product should not be allowed to exceed 66. Radiographic evaluation of suspect anatomical region may be helpful in early detection of soft-tissue calcification.
Precautions:
General: Excessive dosage of Calcium acetate induces hypercalcemia; therefore, early in the treatment during dosage adjustment serum calcium should be determined twice weekly. If hypercalcemia develop, the dosage should be reduced or the treatment discontinued immediately depending on the severity of hypercalcemia. Calcium acetate should not be given to patients on digitalis because hypercalcemia may precipitate cardiac arrhythmias. Calcium acetate therapy should always be started at low dose and should not be increased without careful monitoring of serum calcium. An estimate of daily dietary calcium intake should be made initially and the intake adjusted as needed. Serum phosphorus should also be determined periodically.
Information for the patient: The patient should be informed about compliance with dosage instructions, adherence to instructions about diet and avoidance of the use of nonprescription antacids. Patients should be informed about the symptoms of hypercalcemia.
Drug Interactions: Calcium acetate may decrease the bioavailability of tetracyclines.
Pregnancy: It is also not known whether Calcium acetate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Calcium acetate should be given to a pregnant woman only if clearly needed.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: In clinical studies of Calcium acetate no overall differences in safety or effectiveness were observed between these subjects and younger subjects and other reported clinical experience has not identified differences in responses between the elderly and younger patients; but greater sensitivity of some older individuals cannot be ruled out.
Adverse Reactions:
In clinical studies, patients have occasionally experienced nausea during Calcium acetate therapy. 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. Mild hypercalcemia is easily controlled by reducing the Calcium acetate dose or temporarily discontinuing therapy. Severe hypercalcemia can be treated by acute hemodialysis and discontinuing Calcium acetate therapy. Decreasing dialysate calcium concentration could reduce the incidence and severity of Calcium acetate induced hypercalcemia. The long-term effect of Calcium acetate on the progression of vascular or soft-tissue calcification has not been determined. Isolated cases of pruritus have been reported which may represent allergic reactions.
Over-Dosage:
Administration of Calcium acetate in excess of the appropriate daily dosage can cause severe hypercalcemia.
Dosage and Administration:
Tablets: The recommended initial dose of LoPhos for the adult dialysis patient is 2 tablets with each meal. The dosage may be increased gradually to bring the serum value below 6 mg/di, as long as hypercalcemia does not develop. Most – patients require 3-4 tablets with each meal.
How Supplied:
Tablets: LoPhos is available in blister pack of 10×10 Tablets.
Instructions:
- Keep out of the reach of children.
- Store in a cool & dry place below 30°C.
- To be sold on the prescription of registered medical practitioner only.
- Please consult your pharmacist/doctor before taking this product.
FAQs:
- What is Lophos tablet used for?
- Lophos is prescribed to patients undergoing dialysis or with end-stage renal disease (ESRD) to treat high blood phosphate levels.
- What is the active ingredient in Lophos?
- The active ingredient in Lophos is calcium acetate, classified as a phosphate binder.
- How does Lophos work?
- Lophos works by binding phosphate in the food consumed during meals, preventing its absorption into the bloodstream.
- What is the recommended dosage of Lophos?
- The initial recommended dose for adult dialysis patients is 2 tablets with each meal, with the possibility of gradual dosage increase based on serum values.
- Are there any contraindications for using Lophos?
- Lophos is contraindicated for patients with hypercalcemia.
- What are the potential side effects of Lophos?
- Patients may occasionally experience nausea during therapy. Hypercalcemia may occur, with symptoms ranging from constipation to confusion, delirium, stupor, and coma.
- How should Lophos be stored?
- Lophos should be stored in a cool and dry place below 30°C and kept out of the reach of children.
- Can pregnant women take Lophos?
- It is not known whether Lophos can cause fetal harm, and administration to pregnant women should only occur if clearly needed.
- Is Lophos safe for pediatric use?
- Safety and effectiveness in pediatric patients have not been established.
- What precautions should be taken when using Lophos?
- Serum calcium levels should be monitored regularly, and the dosage should be adjusted accordingly. Patients on digitalis should avoid Lophos, and dietary calcium intake should be assessed.
- How is Lophos supplied?
- Lophos is available in blister packs containing 10×10 tablets.
- Are there any known drug interactions with Lophos?
- Calcium acetate may decrease the bioavailability of tetracyclines.
- What should patients be informed about Lophos?
- Patients should be educated on compliance with dosage instructions, adherence to diet instructions, and the symptoms of hypercalcemia.
- What should be done in case of Lophos overdose?
- Administration in excess can cause severe hypercalcemia, and emergency measures may be required.
Disclaimer!
Mediebook does not provide medical advice, treatment, or diagnoses. The information given here is for informational purposes only, and it should not be used as a replacement for the advice of a qualified doctor or physician.