HIBICLENS
Clinical safety rating: caution
Comprehensive clinical and safety monograph for HIBICLENS (HIBICLENS).
Chlorhexidine gluconate is a cationic bisbiguanide antiseptic that disrupts microbial cell membranes by binding to negatively charged cell wall components, causing leakage of cytoplasmic contents and precipitation of proteins. It has broad-spectrum activity against Gram-positive and Gram-negative bacteria, fungi, and some viruses.
| Metabolism | Chlorhexidine is not significantly metabolized; it is excreted largely unchanged via feces (90%) and minimally in urine (<1%). Systemic absorption is negligible after topical application to intact skin but may occur through wounds or mucous membranes. |
| Excretion | Renal: <1% unchanged; fecal: >99% as chlorhexidine; biliary: negligible. |
| Half-life | Not applicable due to negligible systemic absorption; topical application results in skin retention with minimal systemic exposure. |
| Protein binding | <10% bound to plasma proteins (primarily albumin) if absorbed; clinically insignificant. |
| Volume of Distribution | Not applicable; negligible systemic absorption following topical use. Vd after accidental IV administration is approximately 0.3 L/kg, indicating distribution primarily into extracellular fluid. |
| Bioavailability | Topical: <1% systemic absorption; oral: negligible due to poor gastrointestinal absorption and extensive first-pass metabolism. |
| Onset of Action | Topical: immediate antimicrobial effect upon application (within seconds to minutes). |
| Duration of Action | Topical: sustained antimicrobial effect for up to 6 hours after a single application; residual activity declines gradually with subsequent washing. |
Apply 5 mL to wet skin, lather, and rinse thoroughly after 1 minute. For preoperative showering, use 5 mL twice daily for 2 days before surgery. For surgical scrub, brush 5 mL for 2 minutes, then rinse. For hand wash, use 5 mL for 15 seconds.
| Dosage form | SOLUTION |
| Renal impairment | No dose adjustment required for topical use; systemic absorption minimal. |
| Liver impairment | No dose adjustment required for topical use; systemic absorption minimal. |
| Pediatric use | Children 2 months and older: same as adult dosing; apply 5 mL to wet skin, lather, rinse. For preoperative showering: 5 mL twice daily for 2 days. For surgical scrub: brush 5 mL for 2 minutes. Safety in neonates <2 months not established. |
| Geriatric use | No specific dose adjustments; use same as adult dosing. Monitor skin irritation due to potential age-related skin fragility. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for HIBICLENS (HIBICLENS).
| Breastfeeding | Not systemically absorbed; excretion into breast milk unlikely. Use caution if applied to breast area to avoid infant ingestion. M/P ratio not available. |
| Teratogenic Risk | Chlorhexidine gluconate is not systemically absorbed after topical application; no known teratogenic risk. No adequate studies in pregnant women; animal studies do not indicate fetal harm. FDA Pregnancy Category B. |
| Fetal Monitoring |
■ FDA Black Box Warning
None
| Serious Effects |
["Absolute: known hypersensitivity to chlorhexidine or any component of the formulation.","Relative: use on open wounds, mucous membranes (except oral rinse for specific indications), or in body cavities; use in premature infants or neonates due to risk of systemic absorption and skin irritation; use in patients with prior history of allergic reaction to chlorhexidine-containing products."]
| Precautions | ["Hypersensitivity reactions, including anaphylaxis, have been reported.","Avoid contact with eyes, ears, mouth, and meninges; if accidental contact occurs, rinse thoroughly with water.","Do not use on open wounds, broken skin, or burns due to potential systemic absorption and toxicity.","Avoid use in patients with known hypersensitivity to chlorhexidine or any component.","Prolonged use may lead to bacterial resistance or fungal overgrowth.","Ototoxicity: avoid contact with middle ear tissue.","Do not use as a preoperative skin preparation in patients undergoing spinal anesthesia or lumbar puncture due to risk of neurotoxicity if solution enters the subarachnoid space."] |
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| No specific monitoring required; avoid contact with mucous membranes and eyes. Do not use on open wounds or during delivery due to potential ototoxicity if absorbed. |
| Fertility Effects | No known effects on fertility based on limited data and lack of systemic absorption. |