Ferric sodium pyrophosphate

/LABORATORY ANIMALS: Developmental or Reproductive Toxicity/ Teratologic evaluations of ferrous sulfate and ferric sodium pyrophosphate have been carried out in rats and mice. For studies in mice, groups each of approximately 24 pregnant albino CD-1 mice were dosed by oral intubation with the test substance from day 6 through day 16 of gestation. Body weights were recorded on days 0, 6, 11, 15 and 17 of gestation. On day 17, all dams were subjected to cesarean section and the number of implantation sites, resorption sites and live and dead fetuses recorded. The body weight of the live pups was also taken. The urinogenital tract of each dam was examined in detail for abnormality. All fetuses were examined for the presence of external congenital abnormalities. One-third of the fetuses were examined for visceral abnormalities and the remaining two-thirds for skeletal abnormalities. For studies in rats, groups each of approximately 24 pregnant female albino rats (Wistar derived stock) were dosed daily by oral intubation from day 6 of gestation through day 15. Body weights were recorded on days 0, 6, 11, 15 and 20. On day 20, all dams were subjected to cesarean section, and observations for dams and fetuses similar to those described in the mouse study were carried out. ...Ferric sodium pyrophosphate showed no maternal toxicity or teratogenic effects at dose levels up to 160 mg/kg bw in mice or rats.

/GENOTOXICITY/ A number of ferrous and ferric salts have been tested for mutagenicity using the following organisms. Saccharomyces cerevisiae strain D-4, Salmonella typhimurium strains. TA-1535, TA-1537, and TA-1538 with and without activation. Plate tests as well as suspension tests were run with the Salmonella strains. ...Sodium ferric pyrophosphate /was/ inactive in all the systems used.

Basic treatment: Establish a patent airway. Suction if necessary. Watch for signs of respiratory insufficiency and assist ventilations if necessary. Administer oxygen by nonrebreather mask at 10 to 15 L/min. Monitor for shock and treat if necessary ... . For eye contamination, flush eyes immediately with water. Irrigate each eye continuously with normal saline during transport ... . Do not use emetics. For ingestion, rinse mouth and administer 5 ml/kg up to 200 ml of water for dilution if the patient can swallow, has a strong gag reflex, and does not drool. /Iron and related compounds/

Advanced treatment: Consider orotracheal or nasotracheal intubation for airway control in the patient who is unconscious. Monitor cardiac rhythm and treat arrhythmias if necessary ... . Start an IV with lactated Ringer's /SRP: "To keep open", minimal flow rate/. Watch for signs of fluid overload. For hypotension with signs of hypovolemia, administer fluid cautiously. Watch for signs of fluid overload ... . Use proparacaine hydrochloride to assist eye irrigation ... . /Iron and related compounds/

Maintain an open airway and assist ventilation if necessary. Treat shock caused by hemorrhagic gastrointestinitis aggressively with intravenous crystalloid fluids, and replace blood if needed. Patients are often markedly hypovolemic owing to gastrointestinal losses and third spacing of fluids into the intestinal wall and interstitial space. Treat coma, seizures, and metabolic acidosis if they occur. For seriously intoxicated victims (eg, shock, severe acidosis, and/or serum iron > 500-600 mcg/dL) administer deferoxamine. Monitor the urine for the urine for the characteristic orange or pink deferoxamine-iron complex. Therapy may be stopped when the urine returns to normal or when the serum iron level decreases to the normal range. Prolonged deferoxamine has been associated with adult respiratory distress syndrome and Yersinia sepsis.

Activated charcoal is not effective. Ipecac is not recommended, because it can aggravate iron-induced gastrointestinal irritation and interfere with whole bowel irrigation. Consider gastric lavage if product was a liquid formulation or tablets were chewed. Do-not use phosphate-containing solutions for lavage; these may result in life-threatening hypernatremia, hyperphosphatemia, and hypocalcemia. Bicarbonate and deferoxamine lavage are of doubtful efficacy. Deferoxamine lavage is not effective and may enhance iron absorption. Whole-bowel irrigation is very effective for ingested tablets and may be considered first-line treatment, especially if large numbers of tablets are visible on plain abdominal x-ray. Massive ingestions may lead to concretions or bezoars. Repeated or prolonged whole-bowel irrigation may remove tablets. Endoscopy or surgical gastrotomy is rarely required.

Hemodialysis and hemoperfusion are not effective for removing iron but may be necessary to remove iron-deferoxamine complex in patients with renal failure. Exchange transfusion is occasionally used for massive pediatric ingestions but is of questionable efficacy.