The solution is not for intravenous administration. The solution shall not be taken orally.
Accidental ingestion should be treated with a stomach lavage consisting of milk, egg white, gelatin or mild soap.
Idiosyncratic reactions to Chlorhexidine Acetate BP and Cetrimide Ph.Eur. have been reported.
Hypersensitivity Reactions
Hypersensitivity reactions, including anaphylactic/anaphylactoid reactions, have been reported with chlorhexidine. Fatal anaphylactic reactions have been reported with other products containing chlorhexidine (See Section 4.8 Adverse Reactions).
If any signs or symptoms of a suspected hypersensitivity reaction develop, immediately stop use. Appropriate therapeutic countermeasures must be instituted as clinically indicated.
Chemical Burns in Neonates
The use of chlorhexidine solutions, both alcohol based and aqueous, for skin antisepsis prior to invasive procedures has been associated with skin reactions such as chemical burns in neonates. This risk appears to be higher in preterm infants, especially those born before 32 weeks of gestation and within the first 2 weeks of life.
Remove any soaked materials, drapes or gowns before proceeding with the intervention. Do not use excessive quantities and do not allow the solution to pool in skin folds or under the patient or drip on sheets or other material in direct contact with the patient. Where occlusive dressings are to be applied to areas previously exposed to chlorhexidine, care must be taken to ensure no excess product is present prior to application of the dressing.
Preoperative Skin Preparation
Caution should be exercised when chlorhexidine is used in preoperative skin preparations for face or head (See Section 4.3 Contraindications).
Chlorhexidine must not come into contact with the eye. Serious cases of persistent corneal injury, potentially requiring corneal transplant, were reported following accidental ocular exposure to chlorhexidine containing medicinal products despite taking eye protective measures due to migration of solution beyond the intended surgical preparation area. Extreme care must be taken during application to ensure that chlorhexidine does not migrate beyond its intended application site into the eyes. Particular care should be taken in anesthetized patients, who are unable to immediately report ocular exposure. If chlorhexidine comes into contact with the eyes, wash out promptly and thoroughly with water. An ophthalmologist's advice should be sought.
Use in Pediatric Patients
The use of chlorhexidine solutions has been associated with skin reactions such as chemical burns in neonates (See Section 4.4 Warnings – Chemical Burns in Neonates).This product should only be used in specialist units familiar with the appropriate selection of patients.