Monograph Details
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Urogenital System
> Miscellaneous urogenital disorders
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ZEMPLAR CAPSULES |
| Manufacturer |
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Abbott Laboratories |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Vit. D analogue. |
| Generic Name |
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Paricalcitol 1microgram, 2micrograms, 4micrograms; soft gel caps. |
| Also |
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• ZEMPLAR INJECTION
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| Indications |
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Secondary hyperparathyroidism due to chronic kidney disease stage 3 and 4. |
| Children |
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<18yrs: not recommended. |
| Adults |
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≥18yrs: Base initial dose on baseline intact parathyroid hormone (iPTH) levels. iPTH ≤500pg/mL: 1mcg daily or 2mcg 3 times week (every other day). iPTH >500pg/mL: 2mcg daily or 4mcg 3 times weekly. Titrate based on iPTH levels (see literature). |
| Contraindications |
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Vit. D toxicity. Concurrent Vit. D or phosphate therapy. Hypercalcemia. |
| Precautions |
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Severe hepatic impairment. Monitor serum calcium, phosphorus, and iPTH at least every 2 weeks for 3 months after starting or dose changes, then monthly for 3 months, then every 3 months. If hypercalcemia or elevated Ca x P product occurs, reduce dose or stop until normal; restart at lower dose. Pregnancy (Cat.C). Nursing mothers: not recommended. |
| Interactions |
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Potentiated by potent CYP3A4 inhibitors (eg, ketoconazole). Arrhythmias with digitalis if hypercalcemia occurs. Caps: cholestyramine may impair absorption. |
| Adverse Reactions |
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Hypercalcemia, hypercalciuria, hyperphosphatemia, suppression of PTH, hypervitaminosis D. |
| How Supplied |
Caps—30
Vial (1mL, 2mL, 4mL)—1 |
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