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Author: Admin | 2025-04-28
Surface area), fertility and reproductive performance were not affected.In a published study, dietary administration of ibuprofen to male and female rats 8-weeks prior to and during mating at dose levels of 20 mg/kg (0.06-times the MRHD based on body surface area comparison) did not impact male or female fertility or litter size.In other studies, adult mice were administered ibuprofen intraperitoneally at a dose of 5.6 mg/kg/day (0.0085-times the MRHD based on body surface area comparison) for 35 or 60 days in males and 35 days in females. There was no effect on sperm motility or viability in males but decreased ovulation was reported in females.Use In Specific PopulationsPregnancyRisk SummaryUse of NSAIDs, including DUEXIS, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including DUEXIS, in pregnant women starting at 30 weeks of gestation (third trimester). There are no adequate and well-controlled studies of DUEXIS in pregnant women.IbuprofenThere are no adequate and well-controlled studies of ibuprofen in pregnant women. Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In published animal reproduction studies, there were no clear developmental effects at doses up to 0.4- times the maximum recommended human dose (MRHD) in the rabbit and 0.5-times in the MRHD rat when dosed throughout gestation. In contrast, an increase in membranous ventricular septal defects was reported in rats treated on Gestation Days 9 & 10 with 0.8-times the MRHD. Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as ibuprofen, resulted in increased pre- and post-implantation loss. Advise a pregnant woman of the potential risk to a fetus.FamotidineLimited published data do not report an increased risk of congenital malformations or other adverse pregnancy effects with use of H2- receptor antagonists, including DUEXIS, during pregnancy; however, these data are insufficient to adequately determine a drug-associated risk. Reproductive studies with famotidine have been performed in rats and
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