Zemplar Capsules (Soft Gelatin)
Paricalcitol
1mcg
ABBVIE Inc.
| Pack size | 30's HDPE Bottle |
|---|---|
| Dispensing mode | POM |
| Source | USA |
| Agent | CITY MEDICAL STORE |
| Retail Price | 682.00 AED |
Indications
Zemplar Capsules (Soft Gelatin) is used for:
Secondary hyperparathyroidism
Adult Dose
Oral
Prevention & Treatment of Secondary Hyperparathyroidism
Associated with Chronic Kidney Disease (Stage 3 & 4)
PTH <500 pg/mL: 1 mcg PO qDay OR 2 mcg PO 3 times/week
PTH >500 pg/mL: 2 mcg PO qDay OR 4 mcg PO 3 times/week
Do not administer 3 times/week dosing no more frequently than every other day
Titrate dose based on response.
Monitoring parameters (Stage 3 & 4)
Serum PTH at 2-4 week intervals
PTH same or increased: Increase by 1 mcg/day OR 2 mcg three times/week
PTH decreased <30%: Increase by 1 mcg/day OR 2 mcg three times/week
PTH decreased >30% or <60%: Maintain current dose
PTH decreased >60%: Decrease 1 mcg/day OR 2 mcg three times/week
PTH <60 pg/mL: Decrease 1 mcg/day OR 2 mcg three times/week
Child Dose
Renal Dose
Administration
May be taken with or without food.
Contra Indications
Hypersensitivity, Hypercalcemia, hypervitaminosis D
Precautions
Monitor serum calcium and phosphorus frequently; reduce dose or stop the drug if calcium (in mg/dL) times phosphorus (in mg/dL) product >75
Patients receiving digitalis; digitalis toxicity is potentiated by hypercalcemia
Strong CYP3A4 inhibitors may increase paricalcitol AUC. May increase serum creatinine in pre-dialysis patients. Hepatic impairment
Lactation: not known if distributed into breast milk, use caution
Pregnancy-Lactation
Pregnancy
Limited data with Paricalcitol Injection in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage; there are risks to mother and fetus associated with chronic kidney disease in pregnancy
Lactation
There is no information available on the presence of paricalcitol in human milk, the effects of the drug on the breastfed infant or effects of drug on milk production; studies in rats have shown that drug and/or its metabolites are present in milk of lactating rats; when a drug is present in animal milk, it is likely that drug will be present in human milk
Infants exposed to drug through breast milk should be monitored for signs and symptoms of hypercalcemia; the developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for drug and any potential adverse effects on breastfed child from drug or from underlying maternal condition
Infants exposed to drug through breast milk should be monitored for signs and symptoms
of hypercalcemia, including seizures, vomiting, constipation, and weight loss; monitoring of serum calcium in the infant should be considered
Interactions
Digitalis; ketoconazole & other strong P450 3A inhibitors including atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole. May interfere absorption w/ cholestyramine (cap only). Increased risk of hypercalcemia w/ prescription-based phosphate or vit D-related medicinal products & Ca-containing prep or thiazide diuretics. Mg- & Al-containing prep (eg, antacids, phosphate-binders).
Adverse Effects
Side effects of Paricalcitol :
>10%
Nausea (13%)
1-10%
Vomiting, Edema, Palpitation, Chills, Pneumonia, Lightheadedness, GI bleeding, Flu, Sepsis, Hypokalemia, Hypercalcemia, Increase in blood creatinine
Mechanism of Action
Synthetic vitamin D analog, reduces parathyroid hormone (PTH).
Note
Zemplar 1mcg Capsules (Soft Gelatin) manufactured by ABBVIE Inc.. Its generic name is Paricalcitol. Zemplar is availble in United Arab Emirates.
Farmaco UAE drug index information on Zemplar Capsules (Soft Gelatin) is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.