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However, following administration of 400 mcg of Rhinocort Aqua Nasal Spray to 7 male and 8 female volunteers in a pharmacokinetic study, no major gender differences in the pharmacokinetic parameters were found. Therefore, larger than recommended doses of Rhinocort Aqua Nasal Spray should be avoided and the minimal effective dose for the patient should be used (see DOSAGE AND ADMINISTRATION). The impact of budesonide on human pregnancy outcomes has been evaluated through assessments of birth registries linked with maternal usage of inhaled budesonide (ie, PULMICORT TURBUHALER) and intranasally administered budesonide (ie, Rhinocort Aqua Nasal Spray). Patients using Rhinocort Aqua Nasal Spray over several months or longer should be examined periodically for evidence of Candida infection or other signs of adverse effects on the nasal mucosa. Nevertheless, because the studies in humans cannot rule out the possibility of harm, Rhinocort Aqua should be used during pregnancy only if clearly needed. The clinical activity of Rhinocort Aqua Nasal Spray is therefore believed to be due to the parent drug, budesonide.

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