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The safety profile of fexofenadine is quite favorable, as no cardiovascular or sedative effects have been shown to occur even when taking 10 times the recommended dose. [25] Research on humans ranges from a single 800-mg dose, to a twice-daily, 690-mg dose for a month, with no clinically significant adverse effects, when compared to a placebo.
It contains fexofenadine, as the hydrochloride, an antihistamine; and pseudoephedrine, as the hydrochloride, a nasal decongestant. [ 2 ] In 2021, it was the 279th most commonly prescribed medication in the United States, with more than 800,000 prescriptions.
The maximum dose is used, rather than a lower dose, to reduce the number of test subjects (and, among other things, the cost of testing), to detect an effect that might occur only rarely. This type of analysis is also used in establishing chemical residue tolerances in foods. Maximum tolerated dose studies are also done in clinical trials.
Misuse of the drug has been reported in one case at massive doses of 3,000 to 4,500 mg (100–150 × 30-mg tablets) per day, with the doses gradually increased over time by this individual. [1] [66] No fatalities due to pseudoephedrine misuse have been reported as of 2021. [17] However, death with pseudoephedrine has been reported generally.
Terfenadine acts as a peripherally-selective antihistamine, or antagonist of the histamine H 1 receptor. [3] It is a prodrug, generally completely metabolized to the active form fexofenadine in the liver by the enzyme cytochrome P450 3A4.
Upon study of records in mouse studies associated with 40 common medications ranging from antibiotics, antihistamines, aspirin, and hydrocortisone, that for subjects with melanoma and lung cancers, fexofenadine, one of three medications, along with loratadine, and cetirizine, that target histamine receptor H1 (HRH1), demonstrated significantly ...