Chlorhexidine gluconate: Difference between revisions

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* Usual dosage is 15 mL of undiluted Paroex®.
* Usual dosage is 15 mL of undiluted Paroex®.
|offLabelAdultGuideSupport======Condition1=====
|offLabelAdultGuideSupport======Condition1=====


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<!--Clinical Trials Experience-->
<!--Clinical Trials Experience-->
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
|clinicalTrials=* The most common side effects associated with chlorhexidine gluconate oral rinse are: 1) an increase in staining of the teeth and other oral surfaces; 2) an increase in calculus formation; and 3) an alteration in taste perception.
 
=====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-->
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
 
=====Body as a Whole=====
 


* Oral irritation and local allergy-type symptoms have been spontaneously reported as side effects associated with use of chlorhexidine gluconate rinse. The following oral mucosal side effects were reported during placebo-controlled adult clinical trails: aphthous ulcer, grossly obvious gingivitis, trauma, ulceration, [[erythema]], desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum. Each occurred at a frequency of less than 1.0%. Among post marketing reports, the most frequently reported oral mucosal symptoms associated with chlorhexidine gluconate oral rinse are [[stomatitis]], [[gingivits]], [[glossitis]], ulcer, dry mouth, hypesthesia, glossal edema, and [[paresthesia]]. Minor irritation and superficial desquamation of the oral mucosa have been noted in patients using chlorhexidine gluconate oral rinse. There have been cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis) reported in patients using chlorhexidine gluconate oral rinse.


=====Cardiovascular=====






=====Digestive=====


|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of Chlorhexidine gluconate in the drug label.




=====Endocrine=====






=====Hematologic and Lymphatic=====
=====Metabolic and Nutritional=====
=====Musculoskeletal=====
=====Neurologic=====
=====Respiratory=====
=====Skin and Hypersensitivy Reactions=====
=====Special Senses=====
=====Urogenital=====
=====Miscellaneous=====
<!--Drug Interactions-->
|drugInteractions=* Drug
|drugInteractions=* Drug
:* Description
:* Description
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|administration=* Oral
|administration=* Oral


* Intravenous
* Paroex® (Chlorhexidine Gluconate Oral Rinse USP, 0.12%) therapy should be initiated directly following a dental prophylaxis.
 
* Patients using Paroex® should be reevaluated and given a thorough prophylaxis at intervals no longer than six months
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.


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<!--Overdosage-->
<!--Overdosage-->
|overdose====Acute Overdose===
|overdose=* Ingestion of 1 or 2 ounces of Paroex® (Chlorhexidine Gluconate Oral Rinse USP, 0.12%) by a small child (~10 kg body weight) might result in gastric distress, including nausea. Medical attention should be sought if more than 4 ounces of Paroex® is ingested by a small child.


====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-->
|drugBox=<!--Mechanism of Action-->
|mechAction=*  
|mechAction=*  
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<!--How Supplied-->
<!--How Supplied-->
|howSupplied=*
|howSupplied=Paroex® is supplied as a pink liquid in the following sizes:
 
* 4 fl oz (118 ml) (NDC 52376-021-04) amber plastic bottles with child-resistant cap.
* 16 fl oz (473 ml) (NDC 52376-021-02) amber plastic bottles with child-resistant cap, individually shrink wrapped with a dosage cup.
|storage=STORE at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF).
|packLabel=<!--Patient Counseling Information-->
|packLabel=<!--Patient Counseling Information-->
|fdaPatientInfo=* Patients should be instructed not to rinse with water, or other mouthwashes, brush teeth, or eat immediately after using Paroex®.  
|fdaPatientInfo=* Patients should be instructed not to rinse with water, or other mouthwashes, brush teeth, or eat immediately after using Paroex®.  

Revision as of 19:40, 7 January 2015

Chlorhexidine gluconate
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

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Overview

Chlorhexidine gluconate is an antibacterial that is FDA approved for the treatment of gingivitis, periodontitis, skin cleansing procedure. Common adverse reactions include staining of the teeth and other oral surfaces, calculus formation, an alteration in taste perception.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indication

  • Treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing.

Dosage

  • Recommended use is twice daily, oral rinsing 30 seconds, morning and evening after toothbrushing.
  • Usual dosage is 15 mL of undiluted Paroex®.

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 Chlorhexidine gluconate in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Contraindications

  • Condition1

Warnings

  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

  • The most common side effects associated with chlorhexidine gluconate oral rinse are: 1) an increase in staining of the teeth and other oral surfaces; 2) an increase in calculus formation; and 3) an alteration in taste perception.
  • Oral irritation and local allergy-type symptoms have been spontaneously reported as side effects associated with use of chlorhexidine gluconate rinse. The following oral mucosal side effects were reported during placebo-controlled adult clinical trails: aphthous ulcer, grossly obvious gingivitis, trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum. Each occurred at a frequency of less than 1.0%. Among post marketing reports, the most frequently reported oral mucosal symptoms associated with chlorhexidine gluconate oral rinse are stomatitis, gingivits, glossitis, ulcer, dry mouth, hypesthesia, glossal edema, and paresthesia. Minor irritation and superficial desquamation of the oral mucosa have been noted in patients using chlorhexidine gluconate oral rinse. There have been cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis) reported in patients using chlorhexidine gluconate oral rinse.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Chlorhexidine gluconate in the drug label.

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 Chlorhexidine gluconate in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

There is no FDA guidance on the use of Chlorhexidine gluconate with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Chlorhexidine gluconate with respect to pediatric patients.

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Paroex® (Chlorhexidine Gluconate Oral Rinse USP, 0.12%) therapy should be initiated directly following a dental prophylaxis.
  • Patients using Paroex® should be reevaluated and given a thorough prophylaxis at intervals no longer than six months

Monitoring

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

  • Description

IV Compatibility

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

Overdosage

  • Ingestion of 1 or 2 ounces of Paroex® (Chlorhexidine Gluconate Oral Rinse USP, 0.12%) by a small child (~10 kg body weight) might result in gastric distress, including nausea. Medical attention should be sought if more than 4 ounces of Paroex® is ingested by a small child.

Pharmacology

There is limited information regarding Chlorhexidine gluconate Pharmacology in the drug label.

Mechanism of Action

Structure

File:Chlorhexidine gluconate01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Chlorhexidine gluconate in the drug label.

Clinical Studies

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

How Supplied

Paroex® is supplied as a pink liquid in the following sizes:

  • 4 fl oz (118 ml) (NDC 52376-021-04) amber plastic bottles with child-resistant cap.
  • 16 fl oz (473 ml) (NDC 52376-021-02) amber plastic bottles with child-resistant cap, individually shrink wrapped with a dosage cup.

Storage

STORE at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF).

Images

Drug Images

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Package and Label Display Panel

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

Patient Counseling Information

  • Patients should be instructed not to rinse with water, or other mouthwashes, brush teeth, or eat immediately after using Paroex®.
  • Paroex® is not intended for ingestion and should be expectorated after rinsing.

Precautions with Alcohol

  • Alcohol-Chlorhexidine gluconate 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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