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paricalcitol injection

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paricalcitol injection Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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1 INDICATIONS AND USAGE

Paricalcitol Injection is indicated for the prevention and treatment of secondary hyperparathyroidism in patients 5 years of age and older with...

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2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Information

  • Ensure serum calcium is not above the...
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3 DOSAGE FORMS AND STRENGTHS

Paricalcitol Injection is a clear, colorless solution available in multiple-dose vials as follows:

  • 2 mcg/mL
  • 5 mcg/mL
  • 10 mcg/2 mL (5 mcg/mL)
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4 CONTRAINDICATIONS

Paricalcitol Injection is contraindicated in patients with:

  • ...
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5 WARNINGS AND PRECAUTIONS

5.1 Hypercalcemia

Hypercalcemia may occur during Paricalcitol Injection treatment....

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6 ADVERSE REACTIONS

The following serious adverse reactions are described below and elsewhere in the labeling:

  • Hypercalcemia [see

    6.1 Clinical Trials Experience

    ...
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7 DRUG INTERACTIONS

Table 4 includes clinically significant drug interactions with Paricalcitol Injection.

Table 4. Clinically Significant Drug Interactions with Paricalcitol Injection...
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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Limited data with...

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11 DESCRIPTION

Paricalcitol, USP, the active ingredient in Paricalcitol Injection, is a synthetically manufactured active vitamin D2 analog. It is a white powder chemically designated as 19-nor-1α,3β...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Paricalcitol is a synthetic, biologically active vitamin D2 analog. Preclinical and...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 104-week carcinogenicity study in CD-1 mice conducted with another...

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14 CLINICAL STUDIES

The safety and efficacy of Paricalcitol Injection have been established based on adult studies of another paricalcitol injection product in patients with CKD on hemodialysis. Below is a display of the...

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16 HOW SUPPLIED/STORAGE AND HANDLING

Paricalcitol Injection is a clear, colorless solution available in trays of 25 vials as follows:

...
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17 PATIENT COUNSELING INFORMATION

Hypercalcemia

Advise patients to contact a health care provider if they develop symptoms of elevated...

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