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Oral Sodium Phosphates Laxative Package Limitations Proffered Again

This article was originally published in The Tan Sheet

Executive Summary

Sale of OTC oral sodium phosphates laxatives will be limited to packages 45 mL or less in size under an upcoming proposed rule being prepared by FDA.

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Sodium phosphate

Physicians should measure baseline, post-treatment levels of electrolytes, creatinine in patients directed to take more than 45 mL oral sodium phosphate within 24 hours "to avert serious electrolyte problems," according to FDA backgrounder posted on CDER Web site Oct. 12. Report discusses data gleaned from medical literature, AER and Drug Quality Reporting System databases, implicating bowel cleanser/laxative in serious electrolyte disturbances. FDA recently announced its intention to limit oral sodium phosphate packages to 45 mL or less (1"The Tan Sheet" Aug. 6, p. 8)

Sodium phosphate

Physicians should measure baseline, post-treatment levels of electrolytes, creatinine in patients directed to take more than 45 mL oral sodium phosphate within 24 hours "to avert serious electrolyte problems," according to FDA backgrounder posted on CDER Web site Oct. 12. Report discusses data gleaned from medical literature, AER and Drug Quality Reporting System databases, implicating bowel cleanser/laxative in serious electrolyte disturbances. FDA recently announced its intention to limit oral sodium phosphate packages to 45 mL or less (1"The Tan Sheet" Aug. 6, p. 8)

Sodium phosphate

Physicians should measure baseline, post-treatment levels of electrolytes, creatinine in patients directed to take more than 45 mL oral sodium phosphate within 24 hours "to avert serious electrolyte problems," according to FDA backgrounder posted on CDER Web site Oct. 12. Report discusses data gleaned from medical literature, AER and Drug Quality Reporting System databases, implicating bowel cleanser/laxative in serious electrolyte disturbances. FDA recently announced its intention to limit oral sodium phosphate packages to 45 mL or less (1"The Tan Sheet" Aug. 6, p. 8)

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