Adult Dosing

Secondary hyperparathyroidism

• Parathyroid hormone < = 500 pg/mL: 1 mcg PO qd or 2 mcg PO thrice weekly
• Parathyroid hormone > 500 pg/mL: 2 mcg PO qd or 4 mcg PO thrice weekly
• Doses can be adjusted at q2-4 wk intervals based on intact PTH concentrations
• Closely monitor serum Ca, Po4 after initiation, during dose titration periods, and with co-administration of strong CYP3A inhibitors

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Secondary hyperparathyroidism associated with chronic kidney disease (CKD) stages 3 and 4, and CKD Stage 5 in patients on hemodialysis/peritoneal dialysis

• Hypersensitivity to any of the ingredients of the product
• Hypercalcemia
• Vitamin D toxicity

• N/A

Renal Dose Adjustment

• Renal impairment: No dose adjustments
• Hemodialysis: No supplement

Hepatic Dose Adjustment

• Mild to moderate impairment: No dose adjustments
• Severe impairment: Dose adjustments not defined

• Excessive administration of vitamin D compounds, including paricalcitol, can cause over suppression of PTH, hypercalcemia, hypercalciuria, hyperphosphatemia, and adynamic bone disease
• Hypercalcemia of any cause potentiates digitalis toxicity. Take precaution while prescribing digitalis compounds concomitantly with paricalcitol
• Cardiac arrhythmias and seizures may be exacerbated by hypercalcemia
• Avoid high intake of calcium and phosphate concomitant with vitamin D compounds
• Monitor Ca, PO4, iPTH at baseline, q2wks x 3 mo after starting treatment or following dose adjustments, then qmo for 3 months, then q3mo
• Avoid regular administration of aluminium to prevent aluminium toxicity and maintain the dialysate concentration of aluminum level <10 mcg/L

Cautions: Use cautiously in

• Cardiac disorders
• Arrhythmias
• Concurrent thiazide diuretics
• Concurrent magnesium containing drugs
• Concurrent calcium containing drugs
• Geriatric patients

Pregnancy Category:C

Breastfeeding: Paricalcitol is excreted in breastmilk of lactating rats. Manufacturer advises discontinuation of nursing or discontinuation of drug, taking into account the importance of the drug to the mother.

• METABOLIC: Hypervitaminosis D, hypercalcemia, hypercholesterolemia, hyperphosphatemia, hypercalciuria, weight loss, hyperthermia, hypoglycemia, uremia
• CV: Vascular calcification, arrhythmias, angioedema, hypertension, hypotension, palpitations, chest pain, syncope, peripheral edema
• CNS: Seizures, lightheadedness, headache, dizziness, vertigo, depression, somnolence, overt psychosis, asthenia, insomnia, anxiety
• RESP: Pneumonia, bronchitis, increased cough
• HEMA: Sepsis, hypervolemia, ecchymosis
• GI: Nausea, vomiting, GI bleeding, diarrhea, dry mouth, constipation, metallic taste, anorexia, elevated AST and ALT, gastroenteritis, peritonitis, dyspepsia
• DERM: Rash, urticaria, pruritus, skin ulcer
• GU: Decreased libido, elevated BUN, ectopic calcification, UTI
• LOCAL: Pain, edema
• MUSC: Soft tissue calcification, arthritis, bone pain, leg cramps, muscle pain, back pain
• EENT: Rhinitis, photophobia, rhinorrhea, sinusitis
• MISC: Adynamic bone disease, allergic reactions, chills, fever, influenza like symptoms, pain, viral infection, fever, fungal infection

• Synthetic active vitamin D analog of calcitriol; responsible for the stimulation of intestinal calcium absorption, phosphorus absorption and bone mineralization; also reduces PTH levels (vitamin D)
• Metabolized by liver; CYP450: 3A4 substrate
• Excreted In feces: 70% (2% unchanged); Urine: 18%
• Half-life: 4-6 hrs; renal impairment: 14-20 hrs

US Trade Name(s)

• Zemplar

US Availability

paricalcitol (generic)

• CAPS: 1, 2, 4 mcg

Zemplar

• CAPS: 1, 2, 4 mcg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• Zemplar

UK Availability

Zemplar

• CAPS: 1, 2, 4 mcg

Australian Trade Name(s)

• Zemplar

Australian Availability

Zemplar

• CAPS: 1, 2, 4 mcg

[Outline]

Endocrine/Metabolic

Vitamin D Analog

Fat Soluble Vitamins

Pricing data from www.DrugStore.com in U.S.A.

• Zemplar 1 MCG CAPS [Bottle] (ABBOTT)
  30 mcg = $286
  90 mcg = $843.95
• Zemplar 2 MCG CAPS [Bottle] (ABBOTT)
  30 mcg = $595.98
  90 mcg = $1630.01
• Zemplar 4 MCG CAPS [Bottle] (ABBOTT)
  30 mcg = $1121.94
  90 mcg = $3253.8

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

• Zemplar 0.001 MG Oral Capsule (Abbott Laboratories)
• Zemplar 0.002 MG Oral Capsule (Abbott Laboratories)
• Zemplar 0.004 MG Oral Capsule (Abbott Laboratories)