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One published study reports that budesonide is present in human milk following maternal inhalation of budesonide which resulted in infant doses approximately 0.3to 1of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 0.4 and 0.5Budesonide plasma concentrations were not detected and no adverse events were noted in the breastfed infants following maternal use of inhaled budesonideThe recommended daily dose of ENTOCORT EC capsules is higherup to 9 mg dailycompared with inhaled budesonideup to 800 mcg dailygiven to mothers in the above described studyThe maximum budesonide plasma concentration following a 9 mg daily dosein both single-and repeated-dose pharmacokinetic studiesof oral budesonide is approximately 5 to 10 nmol/L which is up to 10 times higher than the 1 to 2 nmol/L for a 800 mcg daily dose of inhaled budesonide at steady state in the above inhalation studyAssuming the coefficient of extrapolation between the inhaled and oral doses is constant across all dose levelsat therapeutic doses of ENTOCORT ECbudesonide exposure to the nursing child may be up to 10 times higher than that by budesonide inhalation.
Table 4Proportion of Pediatric Patients 8 to 17 years old with Peak Endogenous Cortisol Levelsabove 18 mcg/dLafter ACTH Stimulation and Normal Responseto ACTH Challenge Following Administration of ENTOCORT EC or Prednisolone for 8 weeks.
Psychiatric disordersagitationconfusioninsomnianervousnesssleep disorder.
One published study reports that budesonide is present in human milk following maternal inhalation of budesonide which resulted in infant doses approximately 0.3to 1of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 0.4 and 0.5Budesonide plasma concentrations were not detected and no adverse events were noted in the breastfed infants following maternal use of inhaled budesonideThe recommended daily dose of ENTOCORT EC capsules is higherup to 9 mg dailycompared with inhaled budesonideup to 800 mcg dailygiven to mothers in the above described studyThe maximum budesonide plasma concentration following a 9 mg daily dosein both single-and repeated-dose pharmacokinetic studiesof oral budesonide is approximately 5 to 10 nmol/L which is up to 10 times higher than the 1 to 2 nmol/L for a 800 mcg daily dose of inhaled budesonide at steady state in the above inhalation studyAssuming the coefficient of extrapolation between the inhaled and oral doses is constant across all dose levelsat therapeutic doses of ENTOCORT ECbudesonide exposure to the nursing child may be up to 10 times higher than that by budesonide inhalation.
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papa, chairman, president and ceo, perrigo, said the addition of entocort represents a strong strategic fit with our portfolio of prescription medicines.
