LUTEROL

Nomegestrol acetate, also known as NOMAC, is a progestin used in oral contraceptives, menopausal hormone therapy, and for the treatment of gynecological disorders.

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Patients with

ESRD retain phosphorus and can develop hyperphosphatemia.

High serum phosphorus can precipitate serum calcium resulting in ectopic calcification.

Hyperphosphatemia also plays a role in the development of secondary hyperparathyroidism in patients with ESRD. 12.1 Mechanism of Action Calcium acetate, when taken with meals, combines with dietary phosphate to form an insoluble calcium phosphate complex, which is excreted in the feces, resulting in decreased serum phosphorus concentration. 12.2 Pharmacodynamics Orally administered calcium acetate from pharmaceutical dosage forms is systemically absorbed up to approximately 40% under fasting conditions and up to approximately 30% under nonfasting conditions.

This range represents data from both healthy subjects and renal dialysis patients under various conditions.

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Administration of calcium acetate in excess of the appropriate daily dosage may result in hypercalcemia.

Patients with hypercalcemia.

The recommended initial dose of calcium acetate 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.

Starting dose is 2 capsules with each meal.

Titrate the dose every 2-3 weeks until acceptable serum phosphorus level is reached.

Each capsule is of size ‘00el’ hard gelatin capsule shell with blue opaque cap and white opaque body imprinted with “667 mg” on cap and “IG 377” on body in black ink filled with white to off white powder.

Supplied in

Bottles of 60 (NDC 69097-862-03) and 200 (NDC 69097-862-83).

Store at 20° to 25°C (68° to 77°F) .

Calcium acetate capsules contain calcium acetate.

Animal reproduction studies have not been conducted with calcium acetate, and there are no adequate and well controlled studies of calcium acetate use in pregnant women.

Patients with end stage renal disease may develop hypercalcemia with calcium acetate treatment.

Maintenance of normal serum calcium levels is important for maternal and fetal well being.

Hypercalcemia during pregnancy may increase the risk for maternal and neonatal complications such as stillbirth, preterm delivery, and neonatal hypocalcemia and hypoparathyroidism.

Calcium acetate treatment, as recommended, is not expected to harm a fetus if maternal calcium levels are properly monitored during and following treatment.

A calcium acetate capsule contains calcium acetate and is excreted in human milk.

Human milk feeding by a mother receiving calcium acetate is not expected to harm an infant, provided maternal serum calcium levels are appropriately monitored.

Safety and effectiveness in pediatric patients have not been established.

Clinical studies of calcium acetate did not include sufficient numbers of subjects aged and over to determine whether they respond differently from younger subjects.

Other clinical experience has not identified differences in responses between elderly and younger patients.

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.