Calcitriol (oral): Difference between revisions

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{{drugbox |
{{DrugProjectFormSinglePage
| image = calcitriol.png
|authorTag=
| width = 250px
 
| IUPAC_name = (1''R'',3''S'')- 5-<nowiki>[2-[(</nowiki>1R,3a''R'',7a''S'')-1- <nowiki>[</nowiki>(2''R'')-6-hydroxy-6-methyl-heptan-2-yl<nowiki>]</nowiki>- <br />7a-methyl-2,3,3a,5,6,7-hexahydro-1''H''- inden-4-ylidene]ethylidene]-<br /> 4-methylidene-cyclohexane-1,3-diol
 
| CAS_number = 32222-06-3
<!--Overview-->
| ATC_prefix= A11
 
| ATC_suffix= CC04
|genericName=
| ATC_supplemental = {{ATC|D05|AX03}}
 
| PubChem = 134070
 
| DrugBank = APRD00246
 
| C=27 | H=44 | O=3
|aOrAn=
| molecular_weight = 416.64 g/mol
 
| bioavailability =  
a
| metabolism = [[Renal]]
 
| elimination_half-life = 5–8 hours
|drugClass=
| excretion = Renal
 
| pregnancy_category = B3 <small>([[Australia|Au]])</small>, C <small>([[United States|U.S.]])</small>
 
| legal_status = S4 <small>(Au)</small>, POM <small>([[United Kingdom|UK]])</small>
 
| routes_of_administration = Oral, [[intravenous|IV]], topical
|indication=
}}
 
{{SI}}
 
{{CMG}}
 
__NOTOC__
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Yes
 
|adverseReactions=
 
 
 
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<!--FDA-Labeled Indications and Dosage (Adult)-->
 
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* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
* Dosing Information
 
:* Dosage
 
=====Condition3=====
 
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=====Condition1=====
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
<!--Non–Guideline-Supported Use (Adult)-->
 
|offLabelAdultNoGuideSupport=
 
=====Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
<!--Pediatric Indications and Dosage-->
 
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
 
|fdaLIADPed=
 
=====Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Off-Label Use and Dosage (Pediatric)-->
 
<!--Guideline-Supported Use (Pediatric)-->
 
|offLabelPedGuideSupport=
 
=====Condition1=====
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Non–Guideline-Supported Use (Pediatric)-->
 
|offLabelPedNoGuideSupport=
 
=====Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
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* Condition1
 
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|warnings=
 
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====Precautions====
 
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=====Body as a Whole=====
 
 
 
 
=====Cardiovascular=====
 
 
 
 
=====Digestive=====
 
 
 
 
=====Endocrine=====
 
 
 
 
=====Hematologic and Lymphatic=====
 
 
 
 
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=====Musculoskeletal=====
 
 
 
 
=====Neurologic=====
 
 
 
 
=====Respiratory=====
 
 
 
 
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=====Urogenital=====
 
 
 
 
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|postmarketing=
 
There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
 
=====Body as a Whole=====
 
 
 
=====Cardiovascular=====
 
 
 
=====Digestive=====
 
 
 
=====Endocrine=====
 
 
 
=====Hematologic and Lymphatic=====
 
 
 
=====Metabolic and Nutritional=====
 
 
 
=====Musculoskeletal=====
 
 
 
=====Neurologic=====
 
 
 
=====Respiratory=====
 
 
 
=====Skin and Hypersensitivy Reactions=====
 
 
 
=====Special Senses=====
 
 
 
=====Urogenital=====
 
 
 
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* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
 
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
 
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There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
 
|useInNursing=
There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
 
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There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
 
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There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
 
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There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
 
|useInRace=
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|useInRenalImpair=
There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
 
|useInHepaticImpair=
There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
 
|useInReproPotential=
There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
 
|useInImmunocomp=
There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
 
<!--Administration and Monitoring-->
 
|administration=
 
* Oral
 
* Intravenous
 
|monitoring=
 
There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
 
* Description
 
<!--IV Compatibility-->
 
|IVCompat=
 
There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
 
<!--Overdosage-->
 
|overdose=
 
===Acute Overdose===
 
====Signs and Symptoms====
 
* Description
 
====Management====
 
* Description
 
===Chronic Overdose===
 
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
 
<!--Pharmacology-->
 
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|mechAction=
 
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|structure=
 
*
 
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
<!--Pharmacodynamics-->
 
|PD=
 
There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
 
<!--Pharmacokinetics-->
 
|PK=
 
There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
 
<!--Nonclinical Toxicology-->
 
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There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
 
<!--Clinical Studies-->
 
|clinicalStudies=
 
There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
 
<!--How Supplied-->


|howSupplied=


==[[Calcitriol (patient information)|For patient information, click here]]==
*


==Overview==
<!--Patient Counseling Information-->


'''Calcitriol''' ([[International Nonproprietary Name|INN]]) ({{pronEng|ˌkælsɨˈtraɪɒl/, /ˌkælˈsɨtriːɒl}}) or '''1,25-dihydroxycholecalciferol''' (abbreviated '''1,25-(OH)<sub>2</sub>D<sub>3</sub>''') is the active form of [[vitamin D]] found in the body (vitamin D<sub>3</sub>). It increases the absorption of [[calcium]] and [[phosphate]] from  the [[gastrointestinal tract]] and [[kidneys]] and inhibits release of [[parathyroid hormone|PTH]].
|fdaPatientInfo=


Calcitriol is marketed under various trade names including '''Rocaltrol''' ([[Hoffman-La Roche|Roche]]), '''Calcijex''' ([[Abbott Laboratories|Abbott]]) and '''Decostriol''' (Mibe, Jesalis).
There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.


==Production and function==
<!--Precautions with Alcohol-->
It is produced in the kidneys via [[25-Hydroxyvitamin D3 1-alpha-Hydroxylase]] by conversion from 25-hydroxycholecalciferol ([[calcidiol]]).


This is stimulated by a decrease in serum [[calcium]] and/or [[phosphate]] (PO<sub>4</sub><sup>3−</sup>), and an increase in [[parathyroid hormone]] (PTH) levels. It increases blood calcium levels by increasing the absorption of calcium and phosphate from the [[gastrointestinal tract]], increasing calcium and phosphate reabsorption in the kidneys and inhibiting the release of PTH.
|alcohol=


Calcitriol is also commonly used as a medication in the treatment of [[hypocalcemia]] and [[osteoporosis]].
* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.


==Metabolism==
<!--Brand Names-->
Calcitriol becomes [[calcitroic acid]] through the action of 24-hydroxylase.  Calcitroic acid is excreted in the urine.


==Indications==
|brandNames=
Calcitriol is indicated for:<ref name="AMH2006">Rossi S, editor. [[Australian Medicines Handbook]] 2006. Adelaide: Australian Medicines Handbook; 2006. ISBN 0-9757919-2-3</ref>
*Treatment of [[hypocalcaemia]] – [[hypoparathyroidism]], [[osteomalacia]] (adults), [[rickets]] (infants, children), [[renal osteodystrophy]], chronic [[renal dialysis]]
*Treatment of [[osteoporosis]]
*Prevention of [[corticosteroid]]-induced osteoporosis


Calcitriol is also sometimes used topically in the treatment of [[psoriasis]], however the evidence to support its efficacy is inconclusive.<ref name="MicromedexDrugdex">Calcitriol. In: Klasco RK, editor. Drugdex system. vol 128. Greenwood Village (CO): Thomson Micromedex; 2006.</ref> The vitamin D analogue [[calcipotriol]] is more commonly used for psoriasis.
* ®<ref>{{Cite web | title = | url =  }}</ref>


==Adverse effects==
<!--Look-Alike Drug Names-->
The main [[adverse drug reaction]] associated with calcitriol therapy is [[hypercalcaemia]] – early symptoms include: nausea, vomiting, constipation, [[anorexia (symptom)|anorexia]], [[apathy]], headache, thirst, sweating, and/or [[polyuria]]). Compared to other vitamin D compounds in clinical use ([[cholecalciferol]], [[ergocalciferol]]), calcitriol has a higher risk of inducing hypercalcaemia. However, such episodes may be shorter and easier to treat due to its relatively short [[elimination half-life|half-life]].<ref name="AMH2006" />


==See also==
|lookAlike=
* [[Vitamin D#Synthesis mechanism .28form 3.29]]


==Pill Images==
* A® — B®<ref name="www.ismp.org">{{Cite web  | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher = | date = }}</ref>
{{TempDrugImages}}
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{{PillImage|fileName=Rocaltrol_NDC_306980143.jpg|drugName=Rocaltrol|NDC=306980143|drugAuthor=Validus Pharmaceuticals LLC|ingredients=CALCITRIOL[CALCITRIOL]|pillImprint=R25|dosageValue=0.25|dosageUnit=ug|pillColor=Orange|pillShape=Oval|pillSize=10|pillScore=1}}
{{PillImage|fileName=Rocaltrol_NDC_306980144.jpg|drugName=Rocaltrol|NDC=306980144|drugAuthor=Validus Pharmaceuticals LLC|ingredients=CALCITRIOL[CALCITRIOL]|pillImprint=R50|dosageValue=0.5|dosageUnit=ug|pillColor=Orange|pillShape=Oval|pillSize=12|pillScore=1}}
{{PillImage|fileName=Rocaltrol_NDC_433530633.jpg|drugName=Rocaltrol|NDC=433530633|drugAuthor=Aphena Pharma Solutions - Tennessee, Inc.|ingredients=CALCITRIOL[CALCITRIOL]|pillImprint=R25|dosageValue=0.25|dosageUnit=ug|pillColor=Orange|pillShape=Oval|pillSize=10|pillScore=1}}
{{PillImage|fileName=CALCITRIOL_NDC_633040239.jpg|drugName=CALCITRIOL|NDC=633040239|drugAuthor=Ranbaxy Pharmaceuticals Inc.|ingredients=CALCITRIOL[CALCITRIOL]|pillImprint=R25|dosageValue=0.25|dosageUnit=ug|pillColor=Orange|pillShape=Oval|pillSize=10|pillScore=1}}
{{PillImage|fileName=CALCITRIOL_NDC_633040240.jpg|drugName=CALCITRIOL|NDC=633040240|drugAuthor=Ranbaxy Pharmaceuticals Inc.|ingredients=CALCITRIOL[CALCITRIOL]|pillImprint=R50|dosageValue=0.5|dosageUnit=ug|pillColor=Orange|pillShape=Oval|pillSize=12|pillScore=1}}
{{PillImage|fileName=Calcitriol_NDC_00930657.jpg|drugName=Calcitriol|NDC=00930657|drugAuthor=Teva Pharmaceuticals USA Inc|ingredients=CALCITRIOL[CALCITRIOL]|pillImprint=93;657|dosageValue=0.25|dosageUnit=ug|pillColor=Red;Yellow|pillShape=Oval|pillSize=10|pillScore=1}}
{{PillImage|fileName=Calcitriol_NDC_00930658.jpg|drugName=Calcitriol|NDC=00930658|drugAuthor=Teva Pharmaceuticals USA Inc|ingredients=CALCITRIOL[CALCITRIOL]|pillImprint=93;658|dosageValue=0.5|dosageUnit=ug|pillColor=Brown;Pink|pillShape=Oval|pillSize=13|pillScore=1}}
{{PillImage|fileName=Calcitriol_NDC_00540007.jpg|drugName=Calcitriol|NDC=00540007|drugAuthor=Roxane Laboratories, Inc.|ingredients=CALCITRIOL[CALCITRIOL]|pillImprint=547|dosageValue=0.25|dosageUnit=ug|pillColor=Yellow|pillShape=Oval|pillSize=16|pillScore=1}}


<!--Drug Shortage Status-->


==Additional images==
|drugShortage=
<gallery>
}}
Image:Calcitriol-Synthesis.png|Calcitriol synthesis
</gallery>


==References==
<!--Pill Image-->
{{reflist|2}}
<br>


{{Hormones}}
{{PillImage
{{Vitamin}}
|fileName=No image.jpg|This image is provided by the National Library of Medicine.
{{Antipsoriatics}}
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|NDC=
|drugAuthor=
|ingredients=
|pillImprint=
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[[Category:Vitamins]]
<!--Label Display Image-->
[[Category:Secosteroids]]
[[Category:Endocrinology]]


{{LabelImage
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
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{{LabelImage
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[[de:Calcitriol]]
<!--Category-->
[[dv:ކެލްސިޓްރިއޯލް]]
[[es:Calcitriol]]
[[mk:Калцитриол]]
[[pl:Kalcytriol]]
[[pt:Calcitriol]]


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Revision as of 18:50, 18 September 2014

Calcitriol (oral)
Black Box Warning
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];

Disclaimer

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Black Box Warning

Title
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content

Overview

Calcitriol (oral) is a that is FDA approved for the {{{indicationType}}} of . There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition1
  • Dosing Information
  • Dosage
Condition2
  • Dosing Information
  • Dosage
Condition3
  • Dosing Information
  • Dosage
Condition4
  • Dosing Information
  • Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Contraindications

  • Condition1

Warnings

Title
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Calcitriol (oral) in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Calcitriol (oral) in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

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 (oral) in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

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

  • Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

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

Pharmacology

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

Mechanism of Action

Structure

File:Calcitriol (oral)01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

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

Images

Drug Images

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

Patient Counseling Information

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

Precautions with Alcohol

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

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

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

  1. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)


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