"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"...
In the U.S. Registry, a total of 646 individuals received at least one dose of either Ca-DTPA or Zn-DTPA (pentetate zinc trisodium injection) . Of these, 62 received Zn-DTPA (pentetate zinc trisodium injection) by one or more routes of administration. Forty-eight individuals were dosed by intravenous administration, 18 by inhalation and 8 by other or unknown routes of administration.
Of the individuals that received Zn-DTPA (pentetate zinc trisodium injection) , 23/62 (37%) received one dose and 8 (13%) received two doses. The remaining 31 individuals received three or more doses. The largest number of Zn-DTPA (pentetate zinc trisodium injection) doses to a single individual was 574 doses delivered over 3.5 years.
Overall, the presence or absence of adverse events was recorded in 310/646 individuals. Of these 19 (6.1%) individuals reported at least one adverse event. The total number of recorded adverse events was 20. Of the 20 adverse events, 1 individual treated with Zn-DTPA (pentetate zinc trisodium injection) reported headache, lightheadedness, and pelvic pain.
Read the Zn-DTPA (pentetate zinc trisodium injection) Side Effects Center for a complete guide to possible side effects
Adequate and well-controlled drug-drug interaction studies in humans were not identifed in the literature. When an individual is contaminated with multiple radiocontaminants, or when the radiocontaminants are unknown, additional therapies may be needed (e.g., Prussian blue, potassium iodide).
Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies with Zn-DTPA (pentetate zinc trisodium injection) to evaluate carcinogenesis, mutagenesis and impairment of fertility have not been performed. Data for Zn-DTPA (pentetate zinc trisodium injection) effects on spermatogenesis are not available.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/9/2009
Additional Zn-DTPA Information
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