cinacalcet 60 MG Oral Tablet
1 INDICATIONS AND USAGE Cinacalcet tablets are 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 tablets are not indicated for use in patients with CKD who are not on dialysis • Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). ( 1.2 ) • Severe hypercalcemia in adult patients with primary HPT 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 severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy [see Clinical Studies (14.3) ] .
Mylan Pharmaceuticals Inc.
OVAL GREEN M CT60
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16 HOW SUPPLIED/STORAGE AND HANDLING Cinacalcet Tablets are available containing cinacalcet 30 mg, 60 mg or 90 mg (equivalent to 33.064 mg, 66.127 mg or 99.191 mg of cinacalcet hydrochloride, respectively). The 30 mg tablets are green, film-coated, oval, unscored tablets debossed with M on one side of the tablet and CT30 on the other side. They are available as follows: NDC 0378-6197-93 bottles of 30 tablets The 60 mg tablets are green, film-coated, oval, unscored tablets debossed with M on one side of the tablet and CT60 on the other side. They are available as follows: NDC 0378-6196-93 bottles of 30 tablets The 90 mg tablets are green, film-coated, oval, unscored tablets debossed with M on one side of the tablet and CT90 on the other side. They are available as follows: NDC 0378-6195-93 bottles of 30 tablets Storage: Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]
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