Paricalcitol USP
Composition: Each Soft Gelatin Capsule Contains Paricalcitol USP 1mcg.
Indication: It is indicated for the treatment
and prevention of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 and 4, Stage 5 in
patients on hemodialysis (HD) or peritonial dialysis (PD).
Dosage & Administration: Chronic Kidney Disease Stages 3 and 4: Paricalcitol capsules may be
administered daily or three times a week. When dosing three times weekly, the
dose should be administered not more frequently than every other day.
Initial Dose:The Initial dose of this capsules for CKD Stage 3 and
4 patients is based on baseline intact parathyroid hormone (iPTH) levels.
Baseline iPTH Level |
Daily Dose |
Three Times a Week Dose |
≤500pg/ml |
1 mcg |
2mcg |
>500pg/ml |
2mcg |
4mcg |
Chronic Kidney Disease Stages 5:
This
Capsules are to be administered three times a week. Or, as directed by the
registered physicians.
Use in Pregnancy & Lactation: There are no adequate and well-controlled clinical studies in pregnant women. This Capsules should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. It is not known whether paricalcitol is excreted in human milk. It should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Packing: Each box contains 1x10’s soft capsules in blister pack.