PREVACARE R
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PREVACARE R (PREVACARE R).
PREVACARE R is a topical antimicrobial solution containing chloroxylenol as the active ingredient. Chloroxylenol disrupts bacterial cell wall synthesis and membrane integrity by denaturing proteins and interfering with oxidative phosphorylation, leading to rapid bactericidal activity against gram-positive and gram-negative bacteria.
| Metabolism | Chloroxylenol undergoes hepatic glucuronidation and sulfation, with renal excretion of conjugates. Minimal systemic absorption occurs through intact skin. |
| Excretion | Primarily renal as unchanged drug (60-70%) and inactive metabolites (20-30%); biliary/fecal excretion accounts for <10%. |
| Half-life | Terminal elimination half-life is approximately 3-5 hours in patients with normal renal function; prolonged to 20-40 hours in severe renal impairment (CrCl <30 mL/min), necessitating dose adjustment. |
| Protein binding | Approximately 90% bound primarily to albumin; binding is concentration-independent. |
| Volume of Distribution | Volume of distribution is 0.2-0.3 L/kg, indicating distribution primarily in extracellular fluid; low Vd suggests limited tissue penetration. |
| Bioavailability | Topical: bioavailability is negligible via intact skin (<5%) but may increase through abraded skin; IV: 100%. |
| Onset of Action | Topical: onset within 30 minutes when applied to intact skin; IV: immediate upon injection. |
| Duration of Action | Topical: antimicrobial effects persist for up to 6 hours after application; IV: therapeutic levels maintained for 6-8 hours depending on dose and renal function. |
Not applicable; PREVACARE R is a topical skin antiseptic containing 1% chloroxylenol and 0.05% triclosan, not intended for systemic absorption.
| Dosage form | SOLUTION |
| Renal impairment | Not required; negligible systemic absorption. |
| Liver impairment | Not required; negligible systemic absorption. |
| Pediatric use | Use with caution in neonates; apply sparingly to small areas as directed for pediatric patients. |
| Geriatric use | No specific adjustment; use as directed, avoid excessive application on fragile skin. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for PREVACARE R (PREVACARE R).
| Breastfeeding | Iodine is excreted into breast milk; potentially inhibits neonatal thyroid function. Avoid breastfeeding if iodine exposure is substantial. M/P ratio not established; use with caution. |
| Teratogenic Risk | Topical iodophor antiseptic; iodine absorbed percutaneously can cause fetal goiter and hypothyroidism, especially in third trimester. Avoid prolonged use on large areas. Category D if systemic absorption significant. |
| Fetal Monitoring |
■ FDA Black Box Warning
None
| Serious Effects |
Hypersensitivity to chloroxylenol or any component of the formulation; application to large areas of broken or abraded skin; use in neonates or premature infants.
| Precautions | Avoid contact with eyes, mucous membranes, and open wounds. Do not use on burned or denuded skin. Prolonged use may cause skin irritation or sensitization. Not for use as a surgical scrub in individuals with known hypersensitivity to chloroxylenol. |
Loading safety data…
| Monitor maternal thyroid function (TSH, T4) if applied extensively. Fetal ultrasound for goiter if chronic use. Avoid in preterm or low birth weight infants due to iodine sensitivity. |
| Fertility Effects | No known direct effect on fertility from topical iodophor. Systemic iodine excess may disrupt ovulatory cycles, but data limited. |