chlorhexidine topical (OTC)

Frequency Not Defined

Irritation

Sensitization

Allergic reactions (particularly in genital areas)

Dyspnea

Nasal congestion

Facial edema

Postmarketing Reports

Allergic reaction (wheezing/difficulty breathing, shock, facial swelling, hives, rash)

Contraindications

Hypersensitivity

Cautions

External use only

Avoid contact with eyes, ears, and mucous membranes; immediately rinse with cold water if contact occurs

If product inadvertently comes in contact with eyes, immediately flush with cool water for 15 minutes and contact a physician

If this product is inadvertently swallowed, contact a physician and/or poison control center immediately

Serious allergic reactions reported, including anaphylaxis that can occur within minutes presenting as wheezing, difficulty breathing, facial edema, hives, severe rash, or hypotension and shock

Do not use for deep wound cleansing; avoid if wound involves more than superficial skin layers

Hearing loss reported when instilled in middle ear through perforated tympanic membrane

Use with care in premature infants or infants aged <2 months; potential for irritation or chemical burns

Avoid applying over large surfaces

Not for presurgery preparation of face or head

Product may cause a severe allergic reaction. Symptoms may include, wheezing/ difficulty breathing, shock, facial swelling, hives, and rash; if allergic reaction occurs, stop use and seek medical help right away

High alcohol containing lotions are flammable; keep away from fire or flames

Pregnancy Category: B

Lactation: Unknown whether distributed in breast milk, LactMed states no toxicity observed in breastfed infants when topically applied

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Polybiguanide antiseptic and antimicrobial drug with bactericidal activity; at high concentrations of chlorhexidine the cytoplasmic contents of the bacterial cell precipitate and result in cell death

Pharmacokinetics

Duration of antibacterial protection: 6 hr