Pamidronic acid: Difference between revisions

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{{drugbox
{{DrugProjectFormSinglePage
| IUPAC_name = (3-amino-1-hydroxy-1-phosphono-propyl)phosphonic acid
|authorTag=
| CAS_number = 40391-99-9
 
| ATC_prefix = M05
{{VP}}
| ATC_suffix = BA03
 
| PubChem = 4674
<!--Overview-->
| DrugBank = APRD01161
 
| C = 3 | H = 11 | N = 1 | O = 7 | P = 2
|genericName=
| molecular_weight = 235.07 g/mol
 
| bioavailability = n/a
 
| protein_bound = 54%
 
| metabolism = Nil
|aOrAn=
| elimination_half-life = 28 ± 7 hours
 
| excretion = [[Kidney|Renal]]
a
| pregnancy_AU = B3
 
| pregnancy_US = D
|drugClass=
| legal_AU = <!-- Unscheduled / S2 / S4 / S8 -->
 
| legal_UK = POM
 
| legal_US = Rx-only
 
| routes_of_administration = [[Intravenous therapy|Intravenous]]
|indication=
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|fdaLIADAdult=
 
=====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 (Adult)-->
 
|offLabelAdultGuideSupport=
 
=====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.
 
<!--Contraindications-->
 
|contraindications=
 
* Condition1
 
<!--Warnings-->
 
|warnings=
 
* Description
 
====Precautions====
 
* Description
 
<!--Adverse Reactions-->
 
<!--Clinical Trials Experience-->
 
|clinicalTrials=
 
There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
 
=====Body as a Whole=====
 
 
 
 
=====Cardiovascular=====
 
 
 
 
=====Digestive=====
 
 
 
 
=====Endocrine=====
 
 
 
 
=====Hematologic and Lymphatic=====
 
 
 
 
=====Metabolic and Nutritional=====
 
 
 
 
=====Musculoskeletal=====
 
 
 
 
=====Neurologic=====
 
 
 
 
=====Respiratory=====
 
 
 
 
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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=====
 
 
 
=====Miscellaneous=====
 
 
 
<!--Drug Interactions-->
 
|drugInteractions=
 
* Drug
:* Description
 
<!--Use in Specific Populations-->
 
|useInPregnancyFDA=
* '''Pregnancy Category'''
 
|useInPregnancyAUS=
* '''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.
 
|useInLaborDelivery=
There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
 
|useInNursing=
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|useInPed=
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=
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
 
|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-->
 
<!--Drug box 2-->
 
|drugBox=
 
 
 
<!--Mechanism of Action-->
 
|mechAction=
 
*
 
<!--Structure-->
 
|structure=
 
* Pamidronate Disodium is a sterile bone-resorption inhibitor available in 30 mg and 90 mg vials for intravenous administration. The pamidronate disodium obtained by combining pamidronic acid and sodium hydroxide is provided in a sterile, ready to use solution for injection. Each mL of the 30 mg vial contains, 3 mg Pamidronate Disodium, 47 mg Mannitol, USP; Water for Injection, USP, q.s.; Phosphoric acid to adjust pH. Each mL of the 90 mg vial contains, 9 mg Pamidronate Disodium, 37.5 mg Mannitol, USP; Water for Injection, USP, q.s.; Phosphoric acid to adjust pH.  The pH of a 1% solution of pamidronate disodium in distilled water is approximately 8.3. Pamidronate, a member of the group of chemical compounds known as bisphosphonates, is an analog of pyrophosphate. Pamidronate disodium is designated chemically as phosphonic acid (3-amino-1-hydroxypropylidene) bis-, disodium salt, and its structural formula is:
 
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
*Pamidronate disodium is soluble in water and in 2N sodium hydroxide, sparingly soluble in 0.1N hydrochloric acid and in 0.1N acetic acid, and practically insoluble in organic solvents. Its molecular formula is C3H9NO7P2Na2 and its molecular weight is 279.1 (calculated as the anhydrous form).
 
*Inactive Ingredients: Mannitol, Phosphoric acid (for adjustment to pH range of 6.0 to 7.0) and Water for Injection.
 
<!--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-->
 
|nonClinToxic=
 
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=
 
*
 
<!--Patient Counseling Information-->
 
|fdaPatientInfo=
 
There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
 
<!--Precautions with Alcohol-->
 
|alcohol=
 
* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
 
<!--Brand Names-->
 
|brandNames=
 
* ®<ref>{{Cite web | title =  | url =  }}</ref>
 
<!--Look-Alike Drug Names-->
 
|lookAlike=


{{SI}}
* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>


<!--Drug Shortage Status-->


==Overview==
|drugShortage=
'''Pamidronic acid''' ([[International Nonproprietary Name|INN]]) or '''pamidronate disodium''' ([[United States Approved Name|USAN]]), marketed as '''pamidronate disodium pentahydrate''' under the brand name '''Aredia®''', is a [[bisphosphonate]].
}}


==Uses==
<!--Pill Image-->
It is used to prevent [[bone]] loss, and treat [[osteoporosis]].  It is also used to strengthen bone in [[Paget's disease]], to prevent bone loss due to [[glucocorticoid|steroid]] use, and in certain [[cancer]]s with high propensity to bone, such as [[multiple myeloma]]. In multiple myeloma, it is usually administered as an intravenous infusion, lasting about 3 hours. The therapy is repeated monthly, and lasts for the life of the patient. Due to its ability to sequester [[calcium]] in bone, it is also used to treat [[hypercalcemia|high calcium levels]].


==Administration==
{{PillImage
[[Intravenous]], usually 90 mg monthly.  30 mg, 60 mg, and 90 mg vials are available, mixed with [[mannitol]].
|fileName=No image.jpg|This image is provided by the National Library of Medicine.
|drugName=
|NDC=
|drugAuthor=
|ingredients=
|pillImprint=
|dosageValue=
|dosageUnit=
|pillColor=
|pillShape=
|pillSize=
|pillScore=
}}


==Side effects==
<!--Label Display Image-->
Common side effects include bone pain, [[hypocalcemia|low calcium levels]], [[nausea]], and [[dizziness]].
[[Osteonecrosis of the jaw]] is a rare complication which has been associated with the use of bisphosphonates, including pamidronate.<ref name = Zarychanski>{{cite journal | author = Zarychanski R, Elphee E, Walton P, Johnston J | title = Osteonecrosis of the jaw associated with pamidronate therapy. | journal = Am J Hematol | volume = 81 | issue = 1 | pages = 73-5 | year = 2006 | id = PMID 16369966}}</ref>


Pamidronate activates human [[gamma/delta T cells|γδ T cells]] ''[[in vitro]]'' and ''[[in vivo]]'', which may lead to flu-like symptoms upon administration.
{{LabelImage
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
}}


==References==
{{LabelImage
<div class="references-small"><references/></div>
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
}}


{{Bisphosphonates}}
<!--Category-->
[[Category:Bisphosphonates]]
[[Category:Endocrinology]]


{{WikiDoc Help Menu}}
[[Category:Drug]]
{{WikiDoc Sources}}

Revision as of 21:36, 5 February 2015

Pamidronic acid
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: Vignesh Ponnusamy, M.B.B.S. [2]

Disclaimer

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Overview

Pamidronic acid is a that is FDA approved for the {{{indicationType}}} of . 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 Pamidronic acid in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Pamidronic acid 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 Pamidronic acid 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 Pamidronic acid in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Pamidronic acid in pediatric patients.

Contraindications

  • Condition1

Warnings

  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Pamidronic acid 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 Pamidronic acid 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 Pamidronic acid in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Pamidronic acid during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Pamidronic acid with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Pamidronic acid with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Pamidronic acid with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Pamidronic acid with respect to specific gender populations.

Race

There is no FDA guidance on the use of Pamidronic acid with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Pamidronic acid in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Pamidronic acid in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Pamidronic acid in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Pamidronic acid in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Pamidronic acid in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Pamidronic acid in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Pamidronic acid in the drug label.

Pharmacology

There is limited information regarding Pamidronic acid Pharmacology in the drug label.

Mechanism of Action

Structure

  • Pamidronate Disodium is a sterile bone-resorption inhibitor available in 30 mg and 90 mg vials for intravenous administration. The pamidronate disodium obtained by combining pamidronic acid and sodium hydroxide is provided in a sterile, ready to use solution for injection. Each mL of the 30 mg vial contains, 3 mg Pamidronate Disodium, 47 mg Mannitol, USP; Water for Injection, USP, q.s.; Phosphoric acid to adjust pH. Each mL of the 90 mg vial contains, 9 mg Pamidronate Disodium, 37.5 mg Mannitol, USP; Water for Injection, USP, q.s.; Phosphoric acid to adjust pH. The pH of a 1% solution of pamidronate disodium in distilled water is approximately 8.3. Pamidronate, a member of the group of chemical compounds known as bisphosphonates, is an analog of pyrophosphate. Pamidronate disodium is designated chemically as phosphonic acid (3-amino-1-hydroxypropylidene) bis-, disodium salt, and its structural formula is:
This image is provided by the National Library of Medicine.
  • Pamidronate disodium is soluble in water and in 2N sodium hydroxide, sparingly soluble in 0.1N hydrochloric acid and in 0.1N acetic acid, and practically insoluble in organic solvents. Its molecular formula is C3H9NO7P2Na2 and its molecular weight is 279.1 (calculated as the anhydrous form).
  • Inactive Ingredients: Mannitol, Phosphoric acid (for adjustment to pH range of 6.0 to 7.0) and Water for Injection.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Pamidronic acid in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Pamidronic acid in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Pamidronic acid in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Pamidronic acid in the drug label.

How Supplied

Storage

There is limited information regarding Pamidronic acid Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Pamidronic acid |?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::Pamidronic acid |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Pamidronic acid in the drug label.

Precautions with Alcohol

  • Alcohol-Pamidronic acid 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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