In rabbits, fetal weight reduction and cleft palate were observed at a fluticasone propionate dose approximately times the MRHDID for adults (on a mg/m² basis at a maternal subcutaneous dose of 4 mcg/kg/day). However, no teratogenic effects were reported at fluticasone propionate doses up to approximately 20 times the MRHDID for adults (on a mg/m² basis at a maternal oral dose up to 300 mcg/kg/day). No fluticasone propionate was detected in the plasma in this study, consistent with the established low bioavailability following oral administration [see CLINICAL PHARMACOLOGY ].
The safety of montelukast sodium 4-mg and 5-mg chewable tablets in pediatric patients aged 2 to 14 years with allergic rhinitis is supported by data from studies conducted in pediatric patients aged 2 to 14 years with asthma. A safety study in pediatric patients 2 to 14 years of age with seasonal allergic rhinitis demonstrated a similar safety profile [see Adverse Reactions () ] . The safety of montelukast sodium 4-mg oral granules in pediatric patients as young as 6 months of age with perennial allergic rhinitis is supported by extrapolation from safety data obtained from studies conducted in pediatric patients 6 months to 23 months of age with asthma and from pharmacokinetic data comparing systemic exposures in patients 6 months to 23 months of age to systemic exposures in adults.
For laboratory use, sodium acetate is inexpensive and usually purchased instead of being synthesized. It is sometimes produced in a laboratory experiment by the reaction of acetic acid , commonly in the 5–8% solution known as vinegar , with sodium carbonate ("washing soda"), sodium bicarbonate ("baking soda"), or sodium hydroxide ("lye", or "caustic soda"). Any of these reactions produce sodium acetate and water. When a sodium and carbonate ion-containing compound is used as the reactant, the carbonate anion from sodium bicarbonate or carbonate, reacts with hydrogen from the carboxyl group (-COOH) in acetic acid, forming carbonic acid . Carbonic acid readily decomposes under normal conditions into gaseous carbon dioxide and water. This is the reaction taking place in the well-known "volcano" that occurs when the household products, baking soda and vinegar, are combined.