"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"...
Nebulized chelation therapy may be associated with exacerbation of asthma. Caution should be exercised when administering Zn-DTPA by the inhalation route. (See ADVERSE REACTIONS)
Treatment over several months with Zn-DTPA (pentetate zinc trisodium injection) could lead to depletion of body stores of endogenous metals (e.g., magnesium, manganese). These elements should be monitored routinely and, if appropriate, mineral or vitamin plus mineral supplements should be provided.
Serum electrolytes and essential metals should be closely monitored during Zn-DTPA (pentetate zinc trisodium injection) treatment. Mineral or vitamin plus mineral supplements may be given as appropriate. (See PRECAUTIONS)
Teratogenic Effects: Pregnancy Category B
There are no human pregnancy outcome data from which to assess the risk of Zn-DTPA (pentetate zinc trisodium injection) exposure on fetal development. Reproduction studies have been performed in pregnant mice at doses up to 11.5 mmol/kg (31 times the recommended daily dose of 1 gram based on body surface area [BSA] adjusted dose) and have revealed no evidence of impaired fertility or harm to the fetus. There was a slight reduction in the average birth weight.
Treatment of pregnant women should begin and continue with Zn-DTPA (pentetate zinc trisodium injection) . Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. The risk of toxicity from untreated internal radioactive contamination should be weighed against the risk of Zn-DTPA (pentetate zinc trisodium injection) treatment.
Studies to determine if Zn-DTPA (pentetate zinc trisodium injection) is excreted in breast milk have not been conducted.
Radiocontaminants are known to be excreted in breast milk. Women with known or suspected internal contamination with radiocontaminants should not breast feed, whether or not they are receiving chelation therapy. Precautions should be taken when discarding breast milk. (See PRECAUTIONS, Information for Patients)
The safety and effectiveness of Zn-DTPA (pentetate zinc trisodium injection) was established in the adult population and effcacy was extrapolated to the pediatric population for the intravenous route based on the comparability of pathophysiologic mechanisms. The dose is based on body size adjustment for an intravenous drug that is renally cleared. The safety and effectiveness of the nebulized route of administration has not been established in the pediatric population.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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