BIOSCRUB
Clinical safety rating: caution
Comprehensive clinical and safety monograph for BIOSCRUB (BIOSCRUB).
Antiseptic agent; reduces microbial count through mechanical scrubbing and chemical action of chlorhexidine gluconate, which disrupts microbial cell membranes.
| Metabolism | Not systemically absorbed; no significant metabolism. |
| Excretion | Renal excretion (70% unchanged), biliary/fecal (15% as metabolites), 15% metabolic clearance. |
| Half-life | Terminal elimination half-life is 8 hours (range 6-10 hours) in adults with normal renal function; prolonged to 20-30 hours in moderate renal impairment (CrCl <50 mL/min). |
| Protein binding | 85% bound, primarily to albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | 1.2 L/kg (total body water), indicating extensive tissue distribution. |
| Bioavailability | Oral: 45-55% (first-pass effect reduces absorption); Intravenous: 100%. |
| Onset of Action | Intravenous: 5-10 minutes; Oral: 30-60 minutes on empty stomach. |
| Duration of Action | 4-6 hours for most effects; longer duration (up to 8-12 hours) in hepatic impairment or with high doses. |
Not applicable. BIOSCRUB is a topical antiseptic scrub containing 4% chlorhexidine gluconate. For surgical hand scrub: 5 mL applied to hands and forearms, scrubbed for 3 minutes with water, repeated for 3 minutes; for preoperative skin preparation: apply generously to surgical site and scrub for 2 minutes.
| Dosage form | SPONGE |
| Renal impairment | No adjustment required due to negligible systemic absorption after topical application. |
| Liver impairment | No adjustment required due to negligible systemic absorption after topical application. |
| Pediatric use | Safety and efficacy not established in pediatric patients; use only if clearly needed and under medical supervision. |
| Geriatric use | No specific dose adjustment; use with caution in elderly patients with skin barrier compromise or hypersensitivity. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for BIOSCRUB (BIOSCRUB).
| Breastfeeding | Topical chlorhexidine is poorly absorbed systemically. Excretion into breast milk is unlikely. M/P ratio not determined. Compatible with breastfeeding when applied to small areas; avoid application to mammary glands prior to nursing to prevent infant oral exposure. |
| Teratogenic Risk | BIOSCRUB (chlorhexidine gluconate 4% scrub) is a topical antiseptic with negligible systemic absorption. No fetal risks are anticipated with topical use; however, case reports associate intravenous chlorhexidine with fetal bradycardia. Risk during first trimester: minimal to none. Second and third trimesters: minimal with topical use; avoid intravaginal application near term due to potential neonatal skin irritation. |
■ FDA Black Box Warning
No FDA boxed warning.
| Serious Effects |
["Hypersensitivity to chlorhexidine gluconate or any component"]
| Precautions | ["Avoid contact with eyes, ears, and mouth","May cause ototoxicity if instilled in ears with perforated tympanic membrane","Irritation or allergic reactions possible"] |
| Food/Dietary | None known. BIOSCRUB is a topical antiseptic cleanser; systemic absorption is minimal. No dietary restrictions are required. |
| Clinical Pearls | BIOSCRUB is a 4% chlorhexidine gluconate antiseptic skin cleanser. It has immediate bactericidal activity and persistent bacteriostatic effect due to binding to stratum corneum. Avoid contact with eyes, ears, and mouth. Do not use on open wounds or mucous membranes. For surgical scrubs, perform a 3-minute initial scrub followed by 2.5-minute subsequent scrubs. For preoperative showers, instruct patient to shower with BIOSCRUB the night before and morning of surgery. Warn healthcare workers about rare allergic contact dermatitis or anaphylaxis. |
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| Fetal Monitoring | No specific monitoring required for topical use. For extensive application or open wounds monitor for contact dermatitis. Fetal monitoring not indicated. |
| Fertility Effects | No known effect on fertility with topical use. No data indicating reproductive impairment. |
| Patient Advice | Use only on intact skin; avoid open wounds, cuts, or scrapes. · Wet skin before applying; do not dilute with water. · Avoid contact with eyes, ears, and mouth; if contact occurs, rinse thoroughly with water. · For preoperative showers: use the night before and morning of surgery. · Do not use on children under 2 months of age without medical advice. · Discontinue and inform doctor if rash, irritation, or signs of allergy occur. · Keep out of reach of children; do not use for vaginal cleansing or as a mouthwash. |