CHLORAPREP WITH TINT
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CHLORAPREP WITH TINT (CHLORAPREP WITH TINT).
Chlorhexidine gluconate disrupts microbial cell membranes and precipitates cytoplasmic contents, providing rapid bactericidal activity against gram-positive and gram-negative bacteria. Isopropyl alcohol denatures proteins and disrupts cell membranes, enhancing antimicrobial activity.
| Metabolism | Not systemically absorbed; no significant metabolic pathways. |
| Excretion | CHLORAPREP WITH TINT (2% chlorhexidine gluconate and 70% isopropyl alcohol) is a topical antiseptic; systemic absorption is negligible. Renal excretion of absorbed chlorhexidine is minimal (<1% of dose). Biliary/fecal elimination accounts for ~90% of absorbed dose as unchanged drug or metabolites. >90% of topical dose remains on skin. |
| Half-life | Chlorhexidine is rapidly eliminated from plasma after IV administration with a terminal half-life of 2-5 hours due to extensive tissue distribution; for topical use, half-life is not clinically relevant as drug acts locally without significant systemic levels. |
| Protein binding | Chlorhexidine is highly protein bound (>99%) primarily to albumin, but systemic levels after topical use are minimal. |
| Volume of Distribution | For chlorhexidine, Vd is approximately 5.6 L/kg after IV administration, indicating extensive tissue binding; for topical use, Vd is not applicable due to negligible absorption. |
| Bioavailability | Topical application: systemic bioavailability is <0.5% of applied dose due to minimal percutaneous absorption. |
| Onset of Action | Isopropyl alcohol: immediate (<1 minute) bactericidal effect. Chlorhexidine: onset within 30 seconds of application, with maximal antimicrobial activity within 2-3 minutes. |
| Duration of Action | Chlorhexidine provides persistent antimicrobial activity on skin for up to 6 hours after single application, with residual bacteriostatic effect lasting up to 24 hours. Isopropyl alcohol effect is short-lived (minutes). |
Apply topically to intact skin as a single-use applicator; allow to dry for at least 3 minutes or until dry; do not use on open wounds or mucous membranes.
| Dosage form | SPONGE |
| Renal impairment | No dose adjustment required; CHLORAPREP WITH TINT is a topical antiseptic with negligible systemic absorption. |
| Liver impairment | No dose adjustment required; hepatic impairment does not affect topical application. |
| Pediatric use | Apply topically to intact skin as a single-use applicator; use smallest volume necessary to cover the surgical site; safety and efficacy in neonates and infants have not been established. |
| Geriatric use | No specific dose adjustment required; use standard adult dosing with caution on thin or fragile skin. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CHLORAPREP WITH TINT (CHLORAPREP WITH TINT).
| Breastfeeding | Unknown if excreted in human milk; caution advised. M/P ratio not determined. Use only if potential benefit outweighs risk. |
| Teratogenic Risk | No evidence of teratogenicity in animal studies; human data insufficient. Risk cannot be excluded; use only if clearly needed. Topical application minimizes systemic absorption. |
| Fetal Monitoring |
■ FDA Black Box Warning
Do not use for lumbar puncture or on meninges due to risk of neurotoxicity. Avoid contact with eyes, ears, and mouth.
| Serious Effects |
Hypersensitivity to chlorhexidine or isopropyl alcohol. Premature infants or low-birth-weight infants. Known allergy to any component.
| Precautions | Avoid use on open wounds, mucous membranes, or broken skin. Hypersensitivity reactions including anaphylaxis may occur. Do not allow pooling under tourniquets or in body cavities. Flammable - allow to dry before electrocautery. |
| Food/Dietary | No known food interactions. Avoid use near food or ingestion. |
| Clinical Pearls |
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| Monitor for maternal skin irritation or allergic reactions; fetal monitoring not routinely required due to minimal systemic absorption. |
| Fertility Effects | No known effects on fertility based on available data. |
| Chloraprep with Tint is a combination antiseptic containing 2% chlorhexidine gluconate and 70% isopropyl alcohol. The tint (usually FD&C Yellow No. 6 or other) is added to visualize skin coverage. Allow to dry completely for at least 3 minutes (or per institutional policy) to ensure bactericidal activity and reduce fire risk. Avoid pooling in skin folds; use a sterile applicator. Do not use on mucous membranes, eyes, or open wounds. It is flammable; avoid ignition sources until dry. Contraindicated in patients with known hypersensitivity to chlorhexidine or any component. |
| Patient Advice | This solution is applied to your skin before a procedure to prevent infection. · Do not wash or rub the area after application; let it dry naturally. · Inform your healthcare provider if you have ever had an allergic reaction to chlorhexidine or alcohol. · This product is flammable; stay away from open flames, electrical cautery, or other ignition sources until the skin is dry. · It may temporarily stain fabric or linen; avoid contact with clothing. |