Share on Facebook
Share on Twitter
Share on LinkedIn
Share by Email
Print
Zemplar Capsules Generic Name & Formulations
Legal Class
Rx
General Description
Paricalcitol 1mcg, 2mcg; soft gel caps.
Pharmacological Class
Vit. D analog.
See Also
How Supplied
Caps—30; Single-dose vials (2mcg, 5mcg)—25; Multi-dose vials (5mcg)—25
Manufacturer
Generic Availability
YES
Zemplar Capsules Indications
Indications
Secondary hyperparathyroidism due to chronic kidney disease (CKD) Stages 3 and 4, or with CKD Stage 5 in patients on hemodialysis or peritoneal dialysis.
Zemplar Capsules Dosage and Administration
Adult
Take without regard to food. CKD Stages 3/4: base initial dose on baseline intact parathyroid hormone (iPTH) levels. iPTH ≤500pg/mL: 1mcg daily or 2mcg 3 times weekly (no more often than every other day). iPTH >500pg/mL: 2mcg daily or 4mcg 3 times weekly. CKD Stage 5: base initial dose on baseline iPTH level (pg/mL)/80; give 3 times a week (no more often than every other day); treat only after baseline serum calcium adjusted to ≤9.5mg/dL. Dose titration: see full labeling.
Children
Take without regard to food. <10yrs: not established. 10–16yrs: CKD Stages 3/4: initially 1mcg 3 times weekly (no more often than every other day). CKD Stage 5: base initial dose on baseline iPTH level (pg/mL)/120; give 3 times a week (no more often than every other day). Dose titration: see full labeling.
Zemplar Capsules Contraindications
Contraindications
Vit. D toxicity. Hypercalcemia.
Zemplar Capsules Boxed Warnings
Not Applicable
Zemplar Capsules Warnings/Precautions
Warnings/Precautions
Risk of hypercalcemia. Monitor serum calcium, phosphorus, and iPTH at least every 2 weeks for 3 months during initiation or after dose adjustments, then monthly for 3 months, then every 3 months thereafter. IV: monitor serum calcium twice weekly and iPTH every 2–4 weeks after initiation or dose adjustment. If hypercalcemia occurs, reduce dose or withhold until normal. Severe hepatic impairment: not studied. Pregnancy. Nursing mothers: not recommended.
Zemplar Capsules Pharmacokinetics
See Literature
Zemplar Capsules Interactions
Interactions
Potentiated by strong CYP3A4 inhibitors (eg, boceprevir, clarithromycin, conivaptan, grapefruit juice, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole); monitor and dose adjustment may be needed. Caps: cholestyramine or mineral oil may impair absorption; separate dosing by ≥1hr before or 4–6hrs after. Increased risk of hypercalcemia with concomitant calcium-containing products (at high doses), thiazide diuretics, other Vit. D compounds, phosphate; monitor and may need to adjust paricalcitol dose. Caution with concomitant digitalis compounds; increased toxicity. Concomitant aluminum-containing preparations (eg, antacids, phosphate binders); may cause aluminum bone toxicity.
Zemplar Capsules Adverse Reactions
Adverse Reactions
Diarrhea, nasopharyngitis, dizziness, vomiting, hypertension, hypersensitivity, nausea, edema; hypercalcemia, hypercalciuria, hyperphosphatemia, suppression of PTH, adynamic bone disease.
Zemplar Capsules Clinical Trials
See Literature
Zemplar Capsules Note
Not Applicable
Zemplar Capsules Patient Counseling
See Literature
Images
