cinacalcet hydrochloride 90 mg 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) 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) ] .

amneal pharmaceuticals llc

FDA Reported Adverse Reactions
`[1] fatigue` `[2] drug ineffective` `[3] dyspnoea` `[4] nausea` `[5] diarrhoea` `[6] pain` `[7] off label use` `[8] headache` `[9] dizziness` `[10] vomiting`

2 years ago

OVAL GREEN 213

16 HOW SUPPLIED/STORAGE AND HANDLING

CINACALCET tablets, 30 mg are formulated as green color, film-coated, oval-shaped tablets debossed with “155” on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-155-03 Bottles of 100: NDC 65162-155-10 Bottles of 250: NDC 65162-155-25

CINACALCET tablets, 60 mg are formulated as green color, film-coated, oval-shaped tablets debossed with “157” on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-157-03 Bottles of 100: NDC 65162-157-10 Bottles of 250: NDC 65162-157-25

CINACALCET tablets, 90 mg are formulated as green color, film-coated, oval-shaped tablets debossed with “213” on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-213-03 Bottles of 100: NDC 65162-213-10 Bottles of 250: NDC 65162-213-25 Storage Store at 20º to 25ºC (68º to 77ºF); excursions permitted between 15° to 30ºC (59° to 86ºF) [see USP Controlled Room Temperature].

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