Calcitriol (injection)

Calcitriol (injection)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Overview

Calcitriol (injection) is a {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• Calcijex (calcitriol injection) is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It has been shown to significantly reduce elevated parathyroid hormone levels. Reduction of PTH has been shown to result in an improvement in renal osteodystrophy.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Calcitriol (injection) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Calcitriol (injection) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Calcitriol (injection) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Calcitriol (injection) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Calcitriol (injection) in pediatric patients.

Contraindications

• Calcijex (calcitriol injection) should not be given to patients with hypercalcemia or evidence of vitamin D toxicity.

• Calcijex (calcitriol injection) is contraindicated in patients with previous hypersensitivity to calcitriol or any of its excipients.

Warnings

• Since calcitriol is the most potent metabolite of vitamin D available, prescription-based doses of vitamin D and its derivatives should be withheld or used with caution during treatment to avoid the risk of hypercalcemia.

• A non-aluminum phosphate-binding compound should be used to control serum phosphorus levels in patients undergoing dialysis.

• Overdosage of any form of vitamin D is dangerous. Progressive hypercalcemia due to overdosage of vitamin D and its metabolites may be so severe as to require emergency attention. Chronic hypercalcemia can lead to generalized vascular calcification, nephrocalcinosis, and other soft-tissue calcification. The serum calcium times phosphate (Ca x P) product should not be allowed to exceed 70 mg2/dL2. Radiographic evaluation of suspect anatomical regions may be useful in the early detection of this condition.

Adverse Reactions

Clinical Trials Experience

• Adverse effects of Calcijex (calcitriol injection) are, in general, similar to those encountered with excessive vitamin D intake. The early and late signs and symptoms of vitamin D intoxication associated with hypercalcemia include:

Early

• Weakness, headache, somnolence, nausea, vomiting, dry mouth, constipation, muscle pain, bone pain, metallic taste, anorexia, abdominal pain, and epigastric discomfort.

Late

• Polyuria, polydipsia, anorexia, weight loss, nocturia, conjunctivitis (calcific), pancreatitis, photophobia, rhinorrhea, pruritus, hyperthermia, decreased libido, elevated BUN, albuminuria, hypercholesterolemia, elevated SGOT and SGPT, ectopic calcification, hypertension, cardiac arrhythmias, nephrocalcinosis, sensory disturbance, dehydration, apathy, and rarely, overt psychosis.

• Occasional mild pain on injection has been observed.

Postmarketing Experience

• Rare cases of hypersensitivity reactions have been reported, including anaphylaxis.

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Calcitriol (injection) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Calcitriol (injection) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Calcitriol (injection) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Calcitriol (injection) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Calcitriol (injection) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Calcitriol (injection) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Calcitriol (injection) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Calcitriol (injection) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Calcitriol (injection) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Calcitriol (injection) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Calcitriol (injection) in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Calcitriol (injection) in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Calcitriol (injection) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Calcitriol (injection) in the drug label.

Pharmacology

There is limited information regarding Calcitriol (injection) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Calcitriol (injection)01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Calcitriol (injection) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Calcitriol (injection) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Calcitriol (injection) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Calcitriol (injection) in the drug label.

How Supplied

Storage

There is limited information regarding Calcitriol (injection) Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Calcitriol (injection) |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Calcitriol (injection) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Calcitriol (injection) in the drug label.

Precautions with Alcohol

• Alcohol-Calcitriol (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• CALCIJEX®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

{{#subobject:

 |Page Name=Calcitriol (injection)
 |Pill Name=No image.jpg
 |Drug Name=
 |Pill Ingred=|+sep=;
 |Pill Imprint=
 |Pill Dosage={{{dosageValue}}} {{{dosageUnit}}}
 |Pill Color=|+sep=;
 |Pill Shape=
 |Pill Size (mm)=
 |Pill Scoring=
 |Pill Image=
 |Drug Author=
 |NDC=

}}

{{#subobject:

 |Label Page=Calcitriol (injection)
 |Label Name=Calcitriol (injection)11.png

}}

{{#subobject:

 |Label Page=Calcitriol (injection)
 |Label Name=Calcitriol (injection)11.png

}}