cinacalcet 30 MG Oral Tablet
1 INDICATIONS AND USAGE Cinacalcet is a calcium-sensing receptor agonist indicated for: Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. ( 1.1 ) Limitations of Use : Cinacalcet hydrochloride 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 hydrochloride 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 hydrochloride 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 hydrochloride tablets are indicated for the treatment of hypercalcemia in adult patients with Parathyroid Carcinoma [see Clinical Studies ( 14.2 )]. 1.3 Primary Hyperparathyroidism Cinacalcet hydrochloride 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 )] .
Cadila Healthcare Limited
OVAL WHITE 1000
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16 HOW SUPPLIED/STORAGE AND HANDLING Cinacalcet hydrochloride Tablets 30 mg are formulated as white to off-white, oval shaped, film-coated tablets debossed with "1000" on one side and plain on other side and are supplied as: NDC 70771-1054-3 in bottle of 30 tablets NDC 70771-1054-9 in bottle of 90 tablets NDC 70771-1054-1 in bottle of 100 tablets Cinacalcet hydrochloride Tablets 60 mg are formulated as light yellow to yellow, oval shaped, film-coated tablets debossed with "1001" on one side and plain on other side and are supplied as: NDC 70771-1055-3 in bottle of 30 tablets NDC 70771-1055-9 in bottle of 90 tablets NDC 70771-1055-1 in bottle of 100 tablets Cinacalcet hydrochloride Tablets 90 mg tablets are formulated as light blue to blue, oval shaped, film-coated tablets debossed with "1002" on one side and plain on other side and are supplied as: NDC 70771-1056-3 in bottle of 30 tablets NDC 70771-1056-9 in bottle of 90 tablets NDC 70771-1056-1 in bottle of 100 tablets Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
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