Chlorhexidine Gluconate is indicated for the prevention of omphalitis (infection of the umbilical cord) in newborns.

Chlorhexidine is a broad-spectrum biocidal agent effective against Gram-positive bacteria, Gram-negative bacteria, and fungi. Its activity may be bacteriostatic or bactericidal depending on concentration. It acts by disrupting the bacterial cell membrane, leading to cell death. In vitro, Chlorhexidine has been shown to eliminate nearly all Gram-positive and Gram-negative bacteria within 30 seconds of application. Due to its ability to act against a wide range of microorganisms, the risk of opportunistic infections is low. Chlorhexidine is cationic in nature and binds strongly to the skin. Data on its topical use in neonates are limited, and information on its metabolism after topical application is not available.

Topical solution: Immediately after cutting the cord, 7.1% Chlorhexidine Gluconate solution should be applied to the tip of the cord, the stump and around the base of the stump.

Topical gel: The recommended dose is 3 gram gel applied once daily for seven days. Healthcare providers should take account of local umbilical cord care guidelines regarding single dose application. The first application must occur within 24 hours of birth.

For infants born at less than 32 weeks gestation (or weighing less than 1.5 kg at birth), the recommended dose is a single 3 gram gel applied once only in the first 24 hours after birth.

Apply Chlorhexidine Gluconate gel as soon as possible within 24 hours after birth. Clean the umbilical cord stump and the skin around the base of the stump with a dry cloth prior to applying Chlorhexidine Gluconate gel. Apply adequate content of the tube to ensure complete coverage of the umbilical cord, from the cut surface to the base and including the immediate surrounding abdominal skin. Wash hands before and after use.

Chlorhexidine Gluconate gel should not be applied in combination with any other product. Occlusive dressings should not be applied to the umbilical cord stump, as doing so could increase the absorption of the product through the dermis.

Wash your hands thoroughly with soap and water before and after using Chlorhexidine. Pour the Chlorhexidine solution from the bottle and apply it properly to the cut umbilical cord stump and the surrounding area. Keep the navel well-moistened as often as possible. Do not cover the navel with anything after applying Chlorhexidine. Once applied, keep the area dry and do not apply anything else to the navel. Avoid contact with the eyes.

Not applicable for the intended patient population.

For external use only. Do not inject or swallow. Avoid contact with eyes and ears and do not apply over large areas of the body. If the solution comes into contact with the eyes, rinse immediately and thoroughly with clean water. Cases of hypersensitivity and skin irritation have been reported following topical use of Chlorhexidine, including rare instances of generalized allergic reactions and anaphylactic shock. Although such reactions are very uncommon, treatment should be discontinued and immediate medical attention sought if any signs of allergy occur. If skin irritation or redness develops, seek medical advice promptly.

Bleaching and Disinfectants

Store below 25°C, protected from light and moisture. Keep out of the reach of children.