Amoxicillin can be reconstituted with breast milk for use in infants

By C. Vidya Shankar MD

NEW YORK (Reuters Health) - The bio-equivalence of amoxicillin powder dissolved in breast milk or water are comparable, according to a report from Canada.

"This study shows that antibiotics behave the same way even if it is dissolved in mother's milk, and given to an individual," lead author Dr. Shinya Ito from the Hospital for Sick Children in Toronto told Reuters Health by email.

Powder formulations of antibiotics are commonly used in resource-poor settings where liquid formulations of antibiotics are unaffordable and limited by lack of cold storage. "But it may be challenging to use water to dissolve it because there may be sanitary concerns," Dr. Ito said.

As reported online December 20th in the Archives of Disease in Childhood, Dr. Ito's team compared the bio-equivalence of amoxicillin powder mixed with water and breast milk in a randomized 2x2 crossover study involving 16 healthy adult volunteers ages 20 to 40.

A single 500-mg dose of amoxicillin powder (Novamoxin 250 from Novopharm, Toronto, Canada) was mixed to a concentration of 50 mg/ml with either water or breast milk obtained from a milk bank.

"The concentration we used (i.e., 50 mg/mL) is similar to that of a teaspoonful of 250 mg amoxicillin dissolved in human milk, which may be given to a 5 kg infant at a standard dose of 50 mg/kg," the authors noted.

Blood samples were collected for estimation of amoxicillin levels before administration and at 15 min, 30 min, 60 min, 90 min, and three, four and eight hours post-dose. After a washout period of one to two weeks, the process was repeated with the other treatment.

Volunteers were dosed after an overnight fast, with fluids restricted for two hours after the dose. Subjects did not engage in strenuous activity for eight hours after the dose.

Pharmacokinetic parameters, including area-under-the-curve, Cmax and half-life of the water-based and milk-based amoxicillin were similar, the researchers say, and add that the "90% confidence intervals of the ratios of these parameters in concomitant breast milk administration to those of water were within 89% and 116%, suggesting they are bioequivalent (defined as a range between 80% and 125%)."

"In general, pharmacokinetic parameters in adults are different from those reported in neonates and infants," the researchers acknowledged. "However, our study focus was on bio-equivalence between the two administration methods."

The researchers conclude that "dissolving powder antibiotics in breast milk may be an option for infants due to palatability and sanitary reasons."

SOURCE: http://bit.ly/1n7LJg6

Arch Dis Child 2013.

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