"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
For measurement of ERPF, small doses of PAH are used. However, in research procedures to measure TmPAH, high plasma levels are required to saturate the capacity of the tubular cells. During these procedures, the intravenous administration of PAH solutions should be carried out slowly and with caution. The patient should be continuously observed for any adverse reactions.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals have not been done to evaluate any effects upon fertility or carcinogenic potential of PAH.
Pregnancy Category C. Animal reproduction studies have not been done with PAH. It is also not known whether PAH can cause fetal harm when given to a pregnant woman or can affect reproduction capacity. PAH should be given to a pregnant woman only if clearly needed.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when PAH is administered to a nursing woman.
Safety and effectiveness in pediatric patients have not been established.
Clinical studies of PAH did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
Last reviewed on RxList: 10/14/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Aminohippurate Sodium Information
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