cinacalcet 90 mg
1 INDICATIONS AND USAGE Cinacalcet is a positive modulator of the calcium sensing receptor indicated for: Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1) Limitations of Use: Cinacalcet is not indicated for use in patients with CKD who are not on dialysis Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). (1.2) Hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy. (1.3) 1.1 Secondary Hyperparathyroidism Cinacalcet tablets are indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis [see Clinical Studies (14.1)]. Limitations of Use: Cinacalcet tablets are not indicated for use in patients with CKD who are not on dialysis because of an increased risk of hypocalcemia [see Warnings and Precautions (5.1)]. 1.2 Parathyroid Carcinoma Cinacalcet tablets are indicated for the treatment of hypercalcemia in adult patients with Parathyroid Carcinoma [see Clinical Studies (14.2)] . 1.3 Primary Hyperparathyroidism Cinacalcet tablets are indicated for the treatment of hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy [see Clinical Studies (14.3)] .
sun pharmaceutical industries, inc.
OVAL GREEN 600
600 OVAL GREEN
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16 HOW SUPPLIED/STORAGE AND HANDLING
CINACALCET tablets are supplied as follows: 30 mg light-green, film-coated, oval-shaped tablets, debossed with “379” on one side and plain on other side. Bottles of 30 with Child-resistant cap……………….…..NDC 47335-379-83 60 mg light-green, film-coated, oval-shaped tablets, debossed with “380” on one side and plain on other side. Bottles of 30 with Child-resistant cap……………….…..NDC 47335-380-83 90 mg light-green, film-coated, oval-shaped tablets, debossed with “600” on one side and plain on other side. Bottles of 30 with Child-resistant cap……………….…..NDC 47335-600-83 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature.] Dispense in tight, light-resistant container as per USP.
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