Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Liquid, External:
Betasept Surgical Scrub: 4% (118 mL, 237 mL, 473 mL, 946 mL, 3780 mL [DSC])
Hibiclens: 4% (15 mL, 118 mL, 236 mL, 473 mL, 946 mL, 3790 mL) [contains fd&c red #40, isopropyl alcohol]
Generic: 2% (118 mL); 4% (118 mL, 237 mL, 473 mL, 946 mL, 3800 mL)
Miscellaneous, External:
Tegaderm CHG Dressing: (Dressing) (1 ea)
Pad, External:
Generic: 2% (2 ea, 6 ea)
Solution, External:
Antiseptic Skin Cleanser: 4% (118 mL [DSC], 237 mL [DSC]) [dye free; contains isopropyl alcohol]
ChloraPrep One Step: 2% (3 mL [DSC], 10.5 mL [DSC]) [latex free]
Dyna-Hex 2: 2% (473 mL) [contains isopropyl alcohol]
Dyna-Hex 4: 4% (118 mL, 473 mL) [contains isopropyl alcohol]
Pharmacology
Mechanism of Action
Chlorhexidine has activity against gram-positive and gram-negative organisms, facultative anaerobes, aerobes, and yeast; it is both bacteriostatic and bactericidal, depending on its concentration. The bactericidal effect of chlorhexidine is a result of the binding of this cationic molecule to negatively charged bacterial cell walls and extramicrobial complexes. At low concentrations, this causes an alteration of bacterial cell osmotic equilibrium and leakage of potassium and phosphorous resulting in a bacteriostatic effect. At high concentrations of chlorhexidine, the cytoplasmic contents of the bacterial cell precipitate and result in cell death.
Pharmacokinetics/Pharmacodynamics
Absorption
Topical: Neonates: Detectable serum concentrations have been noted following topical chlorhexidine administration (Chapman 2013; Cowen 1979; Garland 2009)
Use: Labeled Indications
Antiseptic: Skin cleanser for preoperative skin preparation, skin wound and general skin cleanser for patients; surgical scrub and antiseptic hand rinse for healthcare personnel
Contraindications
Hypersensitivity to chlorhexidine or any component of the formulation
Dosage and Administration
Dosing: Adult
Note: General dosing guidelines provided; refer to specific product labeling for dosing instructions.
Antiseptic: Topical:
Surgical scrub: Scrub hands and forearms with ~5 mL for 3 minutes paying close attention to nails, cuticles, and interdigital spaces, and rinse thoroughly, wash for an additional 3 minutes with 5 mL, rinse, and dry thoroughly.
Health care personnel hand antiseptic: Liquid or solution: Wash with ~5 mL for 15 seconds; rinse thoroughly with water and dry
Preoperative skin preparation:
Solution: Apply liberally to surgical site and swab for at least 2 minutes. Dry with sterile towel. Repeat procedure (swab for additional 2 minutes and dry with sterile towel).
Applicator (ChloraPrep One-Step):
Dry surgical sites (eg, abdomen, arm): Completely wet treatment area; use gentle back and forth strokes for ~30 seconds. Allow solution to air dry for ~30 seconds. If using an ignition source (eg, electrocautery), allow solution to completely dry for a minimum of 3 minutes for hairless skin and up to 1 hour in hair; do not blot or wipe away. Note: Prior to use with electrocautery procedures, consult specific product labeling to determine if the ChloraPrep product may be used near an ignition source.
Moist surgical sites (eg, inguinal area): Completely wet treatment area; use gentle back and forth strokes for ~2 minutes. Allow solution to air dry for ~ 1 minute. If using an ignition source (eg, electrocautery), allow solution to completely dry for a minimum of 3 minutes for hairless skin and up to 1 hour in hair; do not blot or wipe away. Note: Prior to use with electrocautery procedures, consult specific product labeling to determine if the ChloraPrep product may be used near an ignition source.
Wound care and general skin cleansing: Rinse area with water, then apply minimum amount necessary to cover skin or wound area and wash gently. Rinse again thoroughly.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Skin cleanser for preoperative skin preparation, skin wound and general skin cleanser for patients: Topical:
Infants <2 months: Note: It is recommended to use with care in this population due to potential risk of dermal irritation or chemical burns. Expert suggestions are variable depending upon site and clinical scenario. Not all products may be appropriate for use in this population; refer to product specific labeling. Some experience in neonatal patients applicable to this patient population (Garland 2009; Tamma 2010).
Preoperative skin preparation: Solution: Apply liberally to surgical site and swab for at least 2 minutes. Dry with sterile towel. Repeat procedure (swab for additional 2 minutes and dry with sterile towel).
Wound care and general skin cleansing: Rinse area with water, then apply the minimum amount of chlorhexidine necessary to cover skin or wound area and wash gently. Rinse again thoroughly.
Infants ≥2 months, Children, and Adolescents: Topical solution:
Preoperative skin preparation: Solution: Apply liberally to surgical site and swab for at least 2 minutes. Dry with sterile towel. Repeat procedure (swab for additional 2 minutes and dry with sterile towel).
Wound care and general skin cleansing: Rinse area with water, then apply the minimum amount of chlorhexidine necessary to cover skin or wound area and wash gently. Rinse again thoroughly.
Administration
Topical: Keep out of eyes, ears, and mouth. Do not routinely apply to wounds which involve more than superficial layers of skin. Avoid contact with meninges (ie, do not use on lumbar puncture sites). Solutions may be flammable (may contain alcohol); consult specific product labeling to determine if product may be used with electrocautery procedures; if product can be used near an ignition source (eg, cautery, laser), avoid exposure to open flame and/or ignition source until completely dry; avoid application to hairy areas which may significantly delay drying time. When using the ChloraPrep applicator, do not touch sponge. Hold applicator sponge down and pinch wings of applicator once to activate ampul and release antiseptic.
Storage
Store at room temperature. Alcohol-containing topical products are flammable; keep away from flames or fire.
Drug Interactions
There are no known significant interactions.
Test Interactions
If chlorhexidine is used as a disinfectant before midstream urine collection, a false-positive urine protein may result (when using dipstick method based upon a pH indicator color change).
Adverse Reactions
Dermatologic: Allergic sensitization, erythema, hypersensitivity reaction, rough skin, xeroderma
<1%, postmarketing, and/or case reports: Anaphylaxis (Health Canada May 2016), dyspnea, facial edema, nasal congestion
Warnings/Precautions
Concerns related to adverse effects:
- Hypersensitivity reactions: Serious allergic reactions, including anaphylaxis, have been reported.
Dosage form specific issues:
- Topical: For topical use only. Keep out of eyes, ears, and the mouth; if contact occurs, rinse with cold water immediately; permanent eye injury may result if agent enters and remains in the eye. Deafness has been reported following instillation in the middle ear through perforated ear drums. Avoid applying to wounds that involve more than the superficial skin layers. Avoid repeated use as general skin cleansing of large surfaces (unless necessary for condition). Not for preoperative preparation of face or head; avoid contact with meninges (do not use on lumbar puncture sites). Avoid applying to genital areas; generalized allergic reactions, irritation, and sensitivity have been reported. Solutions may be flammable (products may contain alcohol); avoid exposure to open flame and/or ignition source (eg, electrocautery) until completely dry; avoid application to hairy areas which may significantly delay drying time. Use with caution in children <2 months of age due to potential for increased absorption, and risk of irritation or chemical burns. May cause staining of fabrics (brown stain) due to a chemical reaction between chlorhexidine gluconate bound to fabric and chlorine (if sufficient chlorine is present from certain laundry detergents used during laundering process).
Other warnings/precautions:
- Appropriate use: Topical: When used as a topical antiseptic, improper use may lead to product contamination. Although infrequent, product contamination has been associated with reports of localized and systemic infections. To reduce the risk of infection, ensure antiseptic products are used according to the labeled instructions; avoid diluting products after opening; and apply single-use containers only one time to one patient and discard any unused solution (FDA Drug Safety Communication 2013).
Pregnancy
Pregnancy Considerations
No reports of adverse effects in newborns have been reported, even though chlorhexidine is commonly used during labor and in the neonate. Moreover, only very small amounts of disinfectant reach the maternal circulation and the fetus.
Patient Education
What is this drug used for?
- It is used to clean the skin.
Frequently reported side effects of this drug
- Dryness
- Itching
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Skin irritation
- Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
