Dexpanthenol: Difference between revisions

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(Created page with "{{DrugProjectFormSinglePage |aOrAn=a |indicationType=treatment |hasBlackBoxWarning=Yes |adverseReactions=<!--Black Box Warning--> |blackBoxWarningTitle=<span style="color:#FF0...")
 
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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag={{RB}}
|genericName=Dexpanthenol
|aOrAn=a
|aOrAn=a
|indicationType=treatment
|drugClass=gastrointestinal stimulant
|hasBlackBoxWarning=Yes
|indicationType=prophylaxis
|adverseReactions=<!--Black Box Warning-->
|indication=major abdominal surgery to minimize the possibility of paralytic ileus
|adverseReactions=allergic reactions
 
 
<!--Black Box Warning-->
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>


* Content
 


<!--Adult Indications and Dosage-->
<!--Adult Indications and Dosage-->


<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult======Condition1=====
|fdaLIADAdult=====Indications====
 
* Prophylactic use immediately after major abdominal surgery to minimize the possibility of paralytic ileus. Intestinal atony causing abdominal distention; postoperative or postpartum retention of flatus, or postoperative delay in resumption of intestinal motility; paralytic ileus.
* 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:  
====Dosage====
Prevention of post-operative adynamic ileus: 250 mg (1 mL) or 500 mg (2 mL) intramuscularly. Repeat in 2 hours and then every 6 hours until all danger of adynamic ileus has passed.


* Strength of Evidence:  
Treatment of adynamic ileus: 500 mg (2 mL) intramuscularly. Repeat in 2 hours and then every 6 hours as needed.


* Dosing Information
Intravenous administration: Dexpanthenol Injection 2 mL (500 mg) may be mixed with bulk I.V. solutions such as glucose or Lactated Ringer’s and slowly infused intravenously.


:* Dosage
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
 
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


<!--Non–Guideline-Supported Use (Adult)-->
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport======Condition1=====
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
* 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-->
<!--Pediatric Indications and Dosage-->


<!--FDA-Labeled Indications and Dosage (Pediatric)-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed======Condition1=====
|fdaLIADPed=There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
 
* 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)-->
<!--Off-Label Use and Dosage (Pediatric)-->


<!--Guideline-Supported Use (Pediatric)-->
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport======Condition1=====
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
* 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)-->
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport======Condition1=====
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


* Dosing Information
<!--Contraindications-->
|contraindications=* There are no known contraindications to the use of Dexpanthenol Injection.


:* Dosage
<!--Warnings-->
|warnings=* There have been rare instances of allergic reactions of unknown cause during the concomitant use of Dexpanthenol Injection with drugs such as antibiotics, narcotics and barbiturates.


=====Condition2=====
Administration of Dexpanthenol Injection directly into the vein is not advised (See Dosage and Administration).


There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
Dexpanthenol Injection should not be administered within one hour of succinylcholine.


<!--Contraindications-->
====Precautions====
|contraindications=* Condition1


<!--Warnings-->
General
|warnings=* Description
If any signs of a hypersensitivity reaction appear, Dexpanthenol Injection should be discontinued. If ileus is a secondary consequence of mechanical obstruction, primary attention should be directed to the obstruction.


====Precautions====
The management of adynamic ileus includes the correction of any fluid and electrolyte imbalance (especially hypokalemia), anemia and hypoproteinemia, treatment of infection, avoidance where possible of drugs which are known to decrease gastrointestinal motility and decompression of the gastrointestinal tract when considerably distended by nasogastric suction or use of a long intestinal tube.
 
* Description


<!--Adverse Reactions-->
<!--Adverse Reactions-->


<!--Clinical Trials Experience-->
<!--Clinical Trials Experience-->
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
|clinicalTrials=There have been a few reports of allergic reactions and single reports of several other adverse events in association with the administration of dexpanthenol. A causal relationship is uncertain. One patient experienced itching, tingling, difficulty in breathing. Another patient had red patches of skin. Two patients had generalized dermatitis and one patient urticaria.
 
=====Body as a Whole=====
 
 
 
 
=====Cardiovascular=====
 
 
 
 
=====Digestive=====
 
 
 
 
=====Endocrine=====
 
 
 
 
=====Hematologic and Lymphatic=====
 
 
 
 
=====Metabolic and Nutritional=====
 
 
 
 
=====Musculoskeletal=====
 
 
 
 
=====Neurologic=====
 


One patient experienced temporary respiratory difficulty following administration of dexpanthenol injection 5 minutes after succinylcholine was discontinued.


One patient experienced a noticeable but slight drop in blood pressure after administration of dexpanthenol while in the recovery room.


=====Respiratory=====
One patient experienced intestinal colic one-half hour after the drug was administered.


Two patients vomited following administration and two patients had diarrhea 10 days post-surgery and after Dexpanthenol Injection.


 
One elderly patient became agitated after administration of the drug.
 
=====Skin and Hypersensitivy Reactions=====
 
 
 
 
=====Special Senses=====
 
 
 
 
=====Urogenital=====
 
 
 
 
=====Miscellaneous=====
 
 
 
<!--Postmarketing Experience-->
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.


Line 244: Line 133:


<!--Drug Interactions-->
<!--Drug Interactions-->
|drugInteractions=* Drug
|drugInteractions=* The effects of succinylcholine appeared to have been prolonged in a woman administered dexpanthenol.
:* Description


<!--Use in Specific Populations-->
<!--Use in Specific Populations-->
|useInPregnancyFDA=* '''Pregnancy Category'''
|FDAPregCat=C
|useInPregnancyFDA=* Animal reproduction studies have not been conducted with Dexpanthenol Injection. It is also not known whether Dexpanthenol Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dexpanthenol Injection should be given to a pregnant
 
woman only if clearly needed.
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) 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.
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.
|useInLaborDelivery=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.
|useInNursing=* It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Dexpanthenol Injection is administered to a nursing woman.
|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInPed=* Safety and effectiveness in children have not been established.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
Line 264: Line 155:


<!--Administration and Monitoring-->
<!--Administration and Monitoring-->
|administration=* Oral
|administration=* Intravenous
* intramuscular
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.


* Intravenous
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.


* Description


<!--IV Compatibility-->
<!--IV Compatibility-->
Line 275: Line 165:


<!--Overdosage-->
<!--Overdosage-->
|overdose====Acute Overdose===
|overdose=There is limited information regarding <i>Overdose</i> of {{PAGENAME}} in the drug label.
 
====Signs and Symptoms====
 
* Description
 
====Management====
 
* Description
 
===Chronic Overdose===
 
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.


<!--Pharmacology-->
<!--Pharmacology-->
Line 307: Line 185:


<!--Nonclinical Toxicology-->
<!--Nonclinical Toxicology-->
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
|nonClinToxic=Carcinogenicity, Mutagenicity, and Impairment of Fertility - There have been no studies in animals to evaluate the carcinogenic, mutagenic, or impairment of fertility potential of dexpanthenol.


<!--Clinical Studies-->
<!--Clinical Studies-->

Revision as of 19:20, 31 March 2015

Dexpanthenol
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: Rabin Bista, M.B.B.S. [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

Dexpanthenol is a gastrointestinal stimulant that is FDA approved for the prophylaxis of major abdominal surgery to minimize the possibility of paralytic ileus. Common adverse reactions include allergic reactions.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • Prophylactic use immediately after major abdominal surgery to minimize the possibility of paralytic ileus. Intestinal atony causing abdominal distention; postoperative or postpartum retention of flatus, or postoperative delay in resumption of intestinal motility; paralytic ileus.

Dosage

Prevention of post-operative adynamic ileus: 250 mg (1 mL) or 500 mg (2 mL) intramuscularly. Repeat in 2 hours and then every 6 hours until all danger of adynamic ileus has passed.

Treatment of adynamic ileus: 500 mg (2 mL) intramuscularly. Repeat in 2 hours and then every 6 hours as needed.

Intravenous administration: Dexpanthenol Injection 2 mL (500 mg) may be mixed with bulk I.V. solutions such as glucose or Lactated Ringer’s and slowly infused intravenously.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Dexpanthenol in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Dexpanthenol in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Dexpanthenol in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Dexpanthenol in pediatric patients.

Non–Guideline-Supported Use

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

Contraindications

  • There are no known contraindications to the use of Dexpanthenol Injection.

Warnings

  • There have been rare instances of allergic reactions of unknown cause during the concomitant use of Dexpanthenol Injection with drugs such as antibiotics, narcotics and barbiturates.

Administration of Dexpanthenol Injection directly into the vein is not advised (See Dosage and Administration).

Dexpanthenol Injection should not be administered within one hour of succinylcholine.

Precautions

General If any signs of a hypersensitivity reaction appear, Dexpanthenol Injection should be discontinued. If ileus is a secondary consequence of mechanical obstruction, primary attention should be directed to the obstruction.

The management of adynamic ileus includes the correction of any fluid and electrolyte imbalance (especially hypokalemia), anemia and hypoproteinemia, treatment of infection, avoidance where possible of drugs which are known to decrease gastrointestinal motility and decompression of the gastrointestinal tract when considerably distended by nasogastric suction or use of a long intestinal tube.

Adverse Reactions

Clinical Trials Experience

There have been a few reports of allergic reactions and single reports of several other adverse events in association with the administration of dexpanthenol. A causal relationship is uncertain. One patient experienced itching, tingling, difficulty in breathing. Another patient had red patches of skin. Two patients had generalized dermatitis and one patient urticaria.

One patient experienced temporary respiratory difficulty following administration of dexpanthenol injection 5 minutes after succinylcholine was discontinued.

One patient experienced a noticeable but slight drop in blood pressure after administration of dexpanthenol while in the recovery room.

One patient experienced intestinal colic one-half hour after the drug was administered.

Two patients vomited following administration and two patients had diarrhea 10 days post-surgery and after Dexpanthenol Injection.

One elderly patient became agitated after administration of the drug.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Dexpanthenol 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

  • The effects of succinylcholine appeared to have been prolonged in a woman administered dexpanthenol.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C

  • Animal reproduction studies have not been conducted with Dexpanthenol Injection. It is also not known whether Dexpanthenol Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dexpanthenol Injection should be given to a pregnant

woman only if clearly needed.
Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

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

Labor and Delivery

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

Nursing Mothers

  • It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Dexpanthenol Injection is administered to a nursing woman.

Pediatric Use

  • Safety and effectiveness in children have not been established.

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Intravenous
  • intramuscular

Monitoring

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

IV Compatibility

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

Overdosage

There is limited information regarding Overdose of Dexpanthenol in the drug label.

Pharmacology

There is limited information regarding Dexpanthenol Pharmacology in the drug label.

Mechanism of Action

Structure

File:Dexpanthenol01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

Carcinogenicity, Mutagenicity, and Impairment of Fertility - There have been no studies in animals to evaluate the carcinogenic, mutagenic, or impairment of fertility potential of dexpanthenol.

Clinical Studies

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

How Supplied

Storage

There is limited information regarding Dexpanthenol Storage in the drug label.

Images

Drug Images

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

Patient Counseling Information

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

Precautions with Alcohol

  • Alcohol-Dexpanthenol 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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