CINACALCIT ? 30 MG ( CINACALCET ) 10 FILM-COATED TABLETS

Cinacalcit?

Directly lowers PTH levels by increasing the sensitivity of the calcium-sensing receptor to extracellular calcium.

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Directly lowers PTH levels by increasing the sensitivity of the calcium-sensing receptor to extracellular calcium.

ACTIVE INGREDIENTS:

Cinacalcet 30 mg FCT: Each tablet contains 30 mg cinacalcet (as hydrochloride).

Cinacalcet 60 mg FCT: Each tablet contains 60 mg cinacalcet (as hydrochloride).

Cinacalcet 90 mg FCT: Each tablet contains 90 mg cinacalcet (as hydrochloride).

DOSAGE & ADMINISTRATION:

For oral use.

Tablets should be taken whole and should not be chewed, crushed, or divided.

It is recommended that Cinacalcet be taken with food or shortly after a meal, as studies have shown that the bioavailability of cinacalcet is increased when taken with food.

INDICATIONS:

Treatment of secondary hyperparathyroidism (HPT) in adult patients with end-stage renal disease (ESRD) on maintenance dialysis therapy.

Cinacalcet may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate.

Reduction of hypercalcemia in adult patients with:

parathyroid carcinoma.

? primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated

PACKAGE:

Cinacalcet 30 mg:

Carton box containing 1, 2, 3, or 10 (Al / PVC) strips, each of 10 film-coated tablets and an inner leaflet.