Chlorhexidine Gluconate [7.1%]

Germicord is indicated for prophylaxis of omphalitis (infection of the umbilical cord) in newborn.

Chlorhexidine is a broad-spectrum biocide effective against Gram-positive bacteria, Gramnegative bacteria and fungi. It has both bacteriostatic and bactericidal action, depending on its concentration. Chlorhexidine kills by disrupting the cell membrane. Upon application in vitro, Chlorhexidine can kill nearly 100% of Gram-positive and Gram-negative bacteria within 30 seconds. Since Chlorhexidine formulations can destroy the majority of categories of microbes, there is limited risk for the development of opportunistic infections. Chlorhexidine is cationic in nature and binds strongly to skin. Data relating to topical administration in neonates are limited. There are no data on metabolism of Chlorhexidine following topical administration.

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.

Not applicable for the intended patient population.

For external use only. Do not inject or swallow. Keep out of the eyes and ears and do not use over large areas of the body. If the product comes into contact with the eyes, wash out promptly and thoroughly with clean water. There have been reports of hypersensitivity and skin irritation after topical administration of Germicord, including generalized allergic reactions and anaphylactic shock. The prevalence of Germicord hypersensitivity is not known, but available literature suggests this is likely to be very rare. The application of Germicord should be discontinued and immediate medical help should be sought in case of any symptoms which may indicate an allergic reaction. If skin irritation or redness occurs, prompt medical advice should be sought.

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