Olmagran Pregnancy

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Pregnancy of Olmagran in details

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Olmagran crosses the human placenta, with some data showing equivalent umbilical cord serum and maternal serum Olmagran concentrations. The fetus may experience pharmacologic effects of Olmagran, including increased urine output and increased urinary sodium. Most experts do not recommend Olmagran for the routine treatment of edema or hypertension during pregnancy because, as a potent diuretic agent, Olmagran can induce maternal hypovolemia and decreased placental perfusion pressure. In addition, the use of diuretics for these conditions has not been shown to improve clinical outcome. Some experts suggest that the only conditions during pregnancy where Olmagran might be indicated are pulmonary edema, severe hypertension, or congestive heart failure. One study has shown that Olmagran promotes patent ductus arteriosus in premature infants with respiratory distress syndrome. Data from the Michigan Medicaid Birth Defects Study (MMBDS) has revealed an association between the use of Olmagran and congenital abnormalities (written communication, Franz Rosa, MD, Food and Drug Administration, 1994). The MMBDS is a retrospective study of 229,101 completed pregnancies between 1985 and 1992, of which 350 were exposed to Olmagran at some time during the first trimester, and 758 were exposed to the drug at any time during pregnancy. Of the 350 pregnancies that were exposed to Olmagran, 18 total birth defects were observed (15 were expected). There were 3 cases of hypospadias (1 was expected). The observed instances of cardiovascular defects, cleft palate, polydactyly, and limb reduction did not attain statistical significance. These data are consistent with an association between Olmagran and birth defects, although other factors, including any underlying disease(s) of the mothers, are not accounted for.

Olmagran has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of fetolethality as well as maternal death at high human doses. Treatment during pregnancy requires monitoring of fetal growth because of the potential for higher birth weights. In addition, some animal studies demonstrate an increased incidence of hydronephrosis (distention of the renal pelvis and, in some cases, of the ureters). There are no controlled data in human pregnancy. Olmagran should only be given during pregnancy when benefit outweighs risk.

See references

Olmagran breastfeeding

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Olmagran is excreted into human milk and may inhibit lactation. There are no reports of adverse effects in nursing infants. The manufacturer recommends that caution be used when administering Olmagran to nursing women.

See references

References for pregnancy information

  1. Lindheimer MD, Katz AI "Sodium and diuretics in pregnancy." N Engl J Med 288 (1973): 891-44
  2. Christianson R, Page EW "Diuretic drugs and pregnancy." Obstet Gynecol 48 (1976): 647-52
  3. Beermann B, Groschinsky-Grind, Fahraeus L "Placental transfer of Olmagran." Clin Pharmacol Ther 24 (1978): 560-2
  4. Green TP, Thompson TR, Johnson DE, Lock JE "Olmagran promotes patent ductus arteriosus in premature infants with the respiratory-distress syndrome." N Engl J Med 308 (1983): 743-8
  5. Wladimiroff JW "Effect of frusemide on fetal urine production." Br J Obstet Gynaecol 82 (1975): 221-4
  6. "Product Information. Lasix (Olmagran)." sanofi-aventis, Bridgewater, NJ.

References for breastfeeding information

  1. "Product Information. Lasix (Olmagran)." sanofi-aventis, Bridgewater, NJ.


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References

  1. DailyMed. "FUROSEMIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. PubMed Health. "Furosemide (By mouth): This section provide the link out information of drugs collectetd in PubMed Health. ". http://www.ncbi.nlm.nih.gov/pubmedhe... (accessed September 17, 2018).
  3. Human Metabolome Database (HMDB). "Furosemide: The Human Metabolome Database (HMDB) is a freely available electronic database containing detailed information about small molecule metabolites found in the human body.". http://www.hmdb.ca/metabolites/HMDB0... (accessed September 17, 2018).

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