Pregnancy of Puresis in details
Puresis crosses the human placenta, with some data showing equivalent umbilical cord serum and maternal serum Puresis concentrations. The fetus may experience pharmacologic effects of Puresis, including increased urine output and increased urinary sodium. Most experts do not recommend Puresis for the routine treatment of edema or hypertension during pregnancy because, as a potent diuretic agent, Puresis 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 Puresis might be indicated are pulmonary edema, severe hypertension, or congestive heart failure. One study has shown that Puresis 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 Puresis 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 Puresis 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 Puresis, 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 Puresis and birth defects, although other factors, including any underlying disease(s) of the mothers, are not accounted for.
Puresis 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. Puresis should only be given during pregnancy when benefit outweighs risk.
See references
Puresis breastfeeding
Puresis 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 Puresis to nursing women.
See references
References for pregnancy information
- Lindheimer MD, Katz AI "Sodium and diuretics in pregnancy." N Engl J Med 288 (1973): 891-44
- Christianson R, Page EW "Diuretic drugs and pregnancy." Obstet Gynecol 48 (1976): 647-52
- Beermann B, Groschinsky-Grind, Fahraeus L "Placental transfer of Puresis." Clin Pharmacol Ther 24 (1978): 560-2
- Green TP, Thompson TR, Johnson DE, Lock JE "Puresis promotes patent ductus arteriosus in premature infants with the respiratory-distress syndrome." N Engl J Med 308 (1983): 743-8
- Wladimiroff JW "Effect of frusemide on fetal urine production." Br J Obstet Gynaecol 82 (1975): 221-4
- "Product Information. Lasix (Puresis)." sanofi-aventis, Bridgewater, NJ.
References for breastfeeding information
- "Product Information. Lasix (Puresis)." sanofi-aventis, Bridgewater, NJ.
References
- 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).
- 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).
- 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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Information checked by Dr. Sachin Kumar, MD Pharmacology
