cinacalcet hydrochloride 30 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
OVAL GREEN 155
Related Pills
cinacalcet hydrochloride 90 mg tablet
amneal pharmaceuticals llc
cinacalcet hydrochloride 60 mg tablet
amneal pharmaceuticals llc
Buprenorphine 8 MG Naloxone 2 MG Sublingual Tablet
Actavis Elizabeth LLC
Simvastatin 40 MG Oral Tablet
Teva Pharmaceuticals USA Inc
esomeprazole magnesium capsule delayed release
torrent pharmaceuticals limited
atorvastatin calcium tablet film coated
greenstone llc
atorvastatin 80 mg
cipla usa inc.,
DISCLAIMER:
"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."
"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."
"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
PillSync may earn a commission via links on our site
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].
More pills like OVAL 155