Application Nr Approved Date Route Status External Links
ANDA076917 2006-03-27 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Predialysis Patients Calcitriol Capsules Are 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 Capsules Are 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 Capsules Are Also Indicated In The Management Of Hypocalcemia And Its Clinical Manifestations In Patients With Postsurgical Hypoparathyroidism, Idiopathic Hypoparathyroidism, And Pseudohypoparathyroidism.

All Formulated Excipients (5 Total)

Name Structure Kind Function Status
1. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
2. Isopropyl Alcohol ISOPROPYL ALCOHOL Molecular
3. Polyvinyl Acetate Phthalate POLYVINYL ACETATE PHTHALATE Unresolved
4. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
5. Water WATER Molecular

Active Ingredients ( 1 Total)

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

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