Application Nr Approved Date Route Status External Links
ANDA091356 2014-12-12 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Predialysis Patients Calcitriol Capsule Is Indicated In The Management Of Secondary Hyperparathyroidism And Resultant Metabolic Bone Disease In Patients With Moderate To Severe Chronic Renal Failure (ccr 15 To 55 Ml/min) Not Yet On Dialysis. In Children, The Creatinine Clearance Value Must Be Corrected For A Surface Area Of 1.73 Square Meters. A Serum Ipth Level Of ≥ 100 Pg/ml Is Strongly Suggestive Of Secondary Hyperparathyroidism. Dialysis Patients Calcitriol Capsule Is Indicated In The Management Of Hypocalcemia And The Resultant Metabolic Bone Disease In Patients Undergoing Chronic Renal Dialysis. In These Patients, Calcitriol Administration Enhances Calcium Absorption, Reduces Serum Alkaline Phosphatase Levels, And May Reduce Elevated Parathyroid Hormone Levels And The Histological Manifestations Of Osteitis Fibrosa Cystica And Defective Mineralization. Hypoparathyroidism Patients Calcitriol Capsule Is Also Indicated In The Management Of Hypocalcemia And Its Clinical Manifestations In Patients With Postsurgical Hypoparathyroidism, Idiopathic Hypoparathyroidism, And Pseudohypoparathyroidism.

All Formulated Excipients (4 Total)

Name Structure Kind Function Status
1. Sorbitol SORBITOL Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
2. Shellac SHELLAC Unresolved
3. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
4. Isopropyl Alcohol ISOPROPYL ALCOHOL Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Calcitriol CALCITRIOL ZINC100015048

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