Chlorhexidine gluconate (topical)
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]
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Overview
Chlorhexidine gluconate (topical) is an antibacterial cleansing agent 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,headache and anaphylaxis. Common adverse reactions include headache and anaphylaxis.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
- Surgical hand scrub
- Healthcare personnel handwash
- Patient preoperative skin preparation
- Skin wound and general skin cleansing
Dosage
Surgical hand scrub:
- Wet hands and forearms under running water for 30 seconds. Clean fingernails using a nail stick or similar cleaner.
- Scrub for 1.5 minutes with about 8 mL of product with or without a wet brush paying close attention to the nails, cuticles and skin between the fingers.
- Rinse thoroughly under running water for 30 seconds
- Wash for an additional 1.5 minutes with 8 mL of product and rinse under running water for 30 seconds
- Dry thoroughly
Healthcare personnel handwash
- Wet hands with water
- Dispense about 5 mL of product into cupped hands and wash in a vigorous manner for 15 seconds
- Rinse and dry thoroughly
Patient preoperative skin preparation
- Apply product liberally to surgical site and swab for at least 2 minutes and dry with a sterile towel
- Repeat procedure for an additional 2 minutes and dry with a sterile towel
Skin wound and general skin cleansing
- Thoroughly rinse the area to be cleaned with water
- Apply the minimum amount of product necessary to cover the skin or wound area and wash gently
- Rinse again thoroughly
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Chlorhexidine gluconate (topical) in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Chlorhexidine gluconate (topical) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Chlorhexidine gluconate (topical) in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Chlorhexidine gluconate (topical) in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Chlorhexidine gluconate (topical) in pediatric patients.
Contraindications
There is limited information regarding Chlorhexidine gluconate (topical) Contraindications in the drug label.
Warnings
- For external use only
- KEEP OUT OF REACH OF CHILDREN
- Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Chlorhexidine gluconate (topical) in the drug label.
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Chlorhexidine gluconate (topical) in the drug label.
Drug Interactions
There is limited information regarding Chlorhexidine gluconate (topical) Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Chlorhexidine gluconate (topical) in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Chlorhexidine gluconate (topical) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Chlorhexidine gluconate (topical) during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Chlorhexidine gluconate (topical) with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Chlorhexidine gluconate (topical) with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Chlorhexidine gluconate (topical) with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Chlorhexidine gluconate (topical) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Chlorhexidine gluconate (topical) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Chlorhexidine gluconate (topical) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Chlorhexidine gluconate (topical) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Chlorhexidine gluconate (topical) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Chlorhexidine gluconate (topical) in patients who are immunocompromised.
Administration and Monitoring
Administration
- Topical
Monitoring
There is limited information regarding Monitoring of Chlorhexidine gluconate (topical) in the drug label.
IV Compatibility
There is limited information regarding IV Compatibility of Chlorhexidine gluconate (topical) in the drug label.
Overdosage
There is limited information regarding Chronic Overdose of Chlorhexidine gluconate (topical) in the drug label.
Pharmacology
Mechanism of Action
There is limited information regarding Chlorhexidine gluconate (topical) Mechanism of Action in the drug label.
Structure
There is limited information regarding Chlorhexidine gluconate (topical) Structure in the drug label.
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Chlorhexidine gluconate (topical) in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Chlorhexidine gluconate (topical) in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Chlorhexidine gluconate (topical) in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Chlorhexidine gluconate (topical) in the drug label.
How Supplied
Storage
- Store at 20-25 deg C (68-77 deg F)
- Avoid excessive heat above 40 deg C (104 deg F)
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Chlorhexidine gluconate (topical) Patient Counseling Information in the drug label.
Precautions with Alcohol
- Alcohol-Chlorhexidine gluconate (topical) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- APLICARE CHLORHEXIDINE GLUCONATE 2% SOLUTION®[1]
Look-Alike Drug Names
- A® — B®[2]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
- ↑ "chlorhexidine gluconate solution".
- ↑ "http://www.ismp.org". External link in
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