By the time Schering submitted the drug to the U.S. Food and Drug Administration (FDA) for approval, the agency had already approved a competitors nonsedating antihistamine, terfenadine (trade name Seldane), and, therefore, put loratadine on a lower priority. However, terfenadine had to be removed from the U.S. market by the manufacturer in late 1997 after reports of serious ventricular arrhythmias among those taking the drug.Loratadine was approved by the FDA in 1993. The drug continued to be available only by prescription in the U.S. until it went off patent in 2002. It was then subsequently approved for over-the-counter sales. Once it became an unpatented over-the-counter drug, the price dropped significantly.Schering also developed desloratadine (Clarinex/Aerius), which is an active metabolite of loratadine. Society and culture
Over the counter
In 1998, in an unprecedented action in the United States, an American insurance company, Anthem Inc., petitioned the federal Food and Drug Administration to allow loratadine and two other antihistamines to be made available over the counter (OTC) while they were still protected by patents; the administration granted the request, which was not binding on manufacturers. In the United States, Schering-Plough made loratadine available over the counter in 2002. In 2015, loratadine was available over the counter in many countries. Brands
In 2017, loratadine was available under many brand names and in many forms worldwide, including several combination drug formulations with pseudoephedrine, paracetamol, betamethasone, ambroxol, salbutamol, phenylephrine, and dexamethasone.
Loratadine, sold under the brand name Claritin among others, is a medication used to treat allergies. This includes allergic rhinitis (hay fever) and hives. It is also available in combination with pseudoephedrine, a decongestant, known as loratadine/pseudoephedrine. It is taken orally.Common side effects include sleepiness, dry mouth, and headache. Serious side effects are rare and include allergic reactions, seizures, and liver problems. Use during pregnancy appears to be safe but has not been well studied. It is not recommended in children less than two years old. It is in the second-generation antihistamine family of medication.Loratadine was patented in 1980 and came to market in 1988. It is on the World Health Organizations List of Essential Medicines. Loratadine is available as a generic medication. In the United States, it is available over the counter. In 2019, it was the 66th most commonly prescribed medication in the United States, with more than 11 million prescriptions. Medical uses
Loratadine is indicated for the symptomatic relief of allergy such as hay fever (allergic rhinitis), urticaria (hives), chronic idiopathic urticaria, and other skin allergies. For allergic rhinitis, loratadine is indicated for both nasal and eye symptoms - sneezing, runny nose, and itchy or burning eyes.Similarly to cetirizine, loratadine attenuates the itching associated with Kimuras disease. Forms
The drug is available in many different forms, including tablets, oral suspension, and syrup, and in combination with pseudoephedrine. Also available are quick-dissolving tablets. Contraindications
Patients with severe hepatic (liver) disorders may need to start with a lower dose.