Loratadine was eventually approved by the FDA, and in 2001, its last year on patent, it accounted for 28% of Schering's total sales. Although an FDA advisory panel ruled that Loratadine was safe enough to be sold over the counter, Schering opposed such a decision on the grounds that it would reduce the price that could be charged for the drug. The drug continued to be available only by prescription in the U.S. until it went off patent in 2002. It was then immediately approved for over-the-counter sales. Once it became an unpatented over-the-counter drug, the price dropped precipitously, and insurance companies no longer paid for it. In response, Schering launched an expensive advertising campaign to convince users to switch to Clarinex (Desloratadine), which is a metabolized form of Loratadine. A 2003 study comparing the two drugs found that "There is no clinical advantage to switching a patient from loratadine to desloratadine. However, it may be an option for patients whose medical insurance no longer covers loratadine if the co-pay is less than the cost of the over-the-counter product.
In the U.S. and UK, loratadine is the only drug of its class available over the counter (though it is no longer the only second generation antihistamine available in this manner). In the UK, larger quantities are only available over the counter; they are "P-Line" and can only be sold in the presence of a pharmacist. However, packets of up to and including 7 tablets are available "off the shelf" (GSL). Desloratadine is an over the counter drug in Canada, but is a prescription drug in the U.S..
Also available are quick-dissolving tablets, which are marketed as being faster to get into one's circulatory system but which require special handling to avoid degrading in the package.
For allergic rhinitis (hay fever), loratadine is effective for both nasal and eye symptoms: sneezing, runny nose, itchy or burning eyes.
Loratadine's peak effect occurs in 1-2 hours, and its biological half-life is on average 8 hours with its metabolite's half-life being 28 hours. About 40% is excreted as conjugated metabolites into the urine, and a similar amount is excreted into the feces. Traces of unmetabolised loratadine can be found in the urine.
Although drowsiness is rare, patients should nevertheless be advised that it can occur and may affect performance of skilled tasks (e.g. driving); excess alcohol should be avoided.Most common side-effects Drowsiness, headache, psychomotor impairment, and antimuscarinic effects such as urinary retention, dry mouth, blurred vision, and gastrointestinal disturbances are the most common side effects.Other rarer side-effects Hypotension, extrapyramidal effects, dizziness, confusion, depression, sleep disturbances, lower back pain, tremor, convulsions, palpitation, arrhythmias, hypersensitivity reactions (including bronchospasm, angioedema, and anaphylaxis, rashes, and photosensitivity reactions), blood disorders, liver dysfunction, and angle-closure glaucoma are less common side effects.
Agency Reviews Patent Application Approval Request for "Pharmaceutical Formulations of Loratadine for Encapsulation and Combinations Thereof"
Dec 19, 2012; By a News Reporter-Staff News Editor at Biotech Week -- Accucaps Industries Limited has been issued patent application serial...