Excretion. The quantities of radio- activity eliminated in the urine, feces, and expired air shall be determined separately at appropriate time inter- vals. The collection of the intact test substance or its metabolites, including carbon dioxide, may be discontinued when less than 1 percent of the admin- istered dose is found to be exhaled as radioactive carbon dioxide in 24 hours.
Excretion. The quantities of radio- activity eliminated in the urine, feces, and expired air shall be determined separately at time intervals that pro- vide accurate measurement of clear- ance and excretory rates. The collec- tion of carbon dioxide may be discon- tinued when less than one percent of the dose is found to be exhaled as ra- dioactive carbon dioxide in 24 hours.
Excretion. T h e q u a n t i t ies of r a dio- a c t ivi t y eli m i n a t ed i n t h e ur i n e, feces, a n d expi r ed a i r s h a ll be de t e r m i n ed sep a r a t el y a t a pp r op r i a t e t i m e i n t e r - v a l s. T h e collec t io n of c a r bo n dioxide m a y be disco n t i nu ed w h e n less t h a n o n e pe r ce n t of t h e dose i s fo un d t o be ex h a led a s r a dio a c t ive c a r bo n dioxide i n 24 h o ur s.
Excretion. Hydrocodone and its metabolites are eliminated primarily in the kidneys, with a mean plasma half- life of 4.5 hours. The half-life of acetaminophen is about 2 to 3 hours in adults. It is somewhat shorter in children and somewhat longer in neonates and in cirrhotic patients. Acetaminophen is eliminated from the body primarily by formation of glucuronide and sulfate conjugates in a dose-dependent manner. Less than 9% of acetaminophen is excreted unchanged in the urine.
Excretion. After bupivacaine has been released from EXPAREL and is absorbed systemically, bupivacaine excretion is expected to be the same as for other bupivacaine formulations. The kidney is the main excretory organ for most local anesthetics and their metabolites. Only 6% of bupivacaine is excreted unchanged in the urine. Urinary excretion is affected by urinary perfusion and factors affecting urinary pH. Acidifying the urine hastens the renal elimination of local anesthetics. Various pharmacokinetic parameters of the local anesthetics can be significantly altered by the presence of renal disease, factors affecting urinary pH, and renal blood flow.
Excretion. Excretion of ETX2514 following IV administration was determined in the urine of rats and dogs (Study Report PC2514-2016-0027 and Study Report PC2514-2016-0026, respectively) and the bile of rats (Study Report PC2514-2016-0032). Urinary excretion of unchanged drug accounted for 59% of a 3 mg/kg dose administered to rats and 71% of a 0.45 mg/kg dose administered to dogs. Recovery of unchanged drug in the bile of rats following administration of a 25 mg/kg dose of ETX2514 to bile duct cannulated rats was very low, ranging from 0.2% to 0.5% of the dose. In this same study, urinary excretion of unchanged drug was quite variable, ranging from 36.0% to 94.1% of the dose (mean = 64.7 ± 29.1%). Analysis of urinary concentrations of unchanged ETX2514 and sulbactam from Phase 1 FIH and renal impairment studies demonstrated that both compounds are primarily cleared via urinary excretion. ETX2514 mean recovery in urine ranged from 50% to 76% and sulbactam recovery ranged from 62% to 66% across FIH cohorts.
