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Loratadine (INN) is a second-generation H1 histamine antagonist drug used to treat allergies. In structure, it is closely related to tricyclic antidepressants, such as imipramine, and is distantly related to the atypical antipsychotic quetiapine.
Loratadine is marketed by Schering-Plough[needs update] under several trade names (e.g., Claritin) and also by Shionogi in Japan. It is available as a generic drug and is marketed for its nonsedating properties. In a version named Claritin-D or Clarinase, it is combined with pseudoephedrine, a decongestant; this makes it useful for colds, as well as allergies but adds potential side effects of insomnia, anxiety, and nervousnes
History
Schering-Plough developed loratadine as part of a quest for a potential blockbuster drug: a nonsedating antihistamine. However, by the time Schering submitted the drug to the U.S. Food and Drug Administration (FDA) for approval, the agency had already approved a competitor's nonsedating antihistamine, terfenadine (trade name Seldane), and, therefore, put loratadine on a lower priority.
Loratadine was approved by the FDA in 1993.[3]The drug continued to be available only by prescription in the U.S. until it went off patent in 2002.[citation needed] 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), which is an active metabolite of loratadine.
Indications
Loratadine is indicated for the symptomatic relief of allergy such as hay fever (allergic rhinitis), urticaria (hives), chronic idiopathic urticaria,[4] and other skin allergies. For allergic rhinitis (hay fever), loratadine is effective for both nasal and eye symptoms: sneezing, runny nose, itchy or burning eyes. Loratadine could be also used to treat mild to moderate pain from headaches.
Similarly to cetirizine, loratadine attenuates the itching associated with Kimura's disease.
Forms
The drug is available many different forms, such as: tablets, oral suspension, and syrup, and in combination with pseudoephedrine. Also available are quick-dissolving tablets, which are marketed as being faster to get into one's circulatory system, but require special handling to avoid degrading in the package.
Cautions and contraindications
Patients with severe hepatic (liver) disorders may need to start with a lower dose. No dose adaptation is necessary for elderly or renally (kidney) impaired patients.
Loratadine is usually compatible with breast-feeding (classified category L-2 by the American Academy of Pediatrics).In the U.S., it is classified as category B in pregnancy, meaning animal reproduction studies have failed to demonstrate a risk to the fetus, and no adequate and well-controlled studies in pregnant women have been conducted.
Adverse effects
As a "nonsedating" antihistamine, loratadine causes less (but still significant, in some cases) sedation and psychomotor retardation than the older antihistamines because it penetrates the blood/brain barrier to a smaller extent. Although drowsiness is rare at the common 10-mg dose, patients should, nevertheless, be advised that it can occur and may affect performance of skilled tasks (e.g., driving). Patients who do experience drowsiness while taking loratadine should avoid the use of alcohol, as it can cause excessive drowsiness. Otherwise, loratadine and alcohol are unlikely to cause problems. Nevertheless, it would be in the patient's best interest to take caution when combining alcohol and any medication.
Other possible side effects include headache and antimuscarinic effects such as urinary retention, dry mouth, blurred vision, and gastrointestinal disturbances.
Mechanism of action
Loratadine is a tricyclic antihistamine, which acts as a selective inverse agonist of peripheral histamine H1-receptors. Histamine is responsible for many features of allergic reactions.
Pharmacokinetics
Loratadine is given orally, is well absorbed from the gastrointestinal tract, and has rapid first-pass hepatic metabolism; it is metabolized by isoenzymes of the cytochrome P450 system, including CYP3A4, CYP2D6, and, to a lesser extent, several others.
Loratadine; pseudoephedrine sulfate extended release tablets should be used with caution in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism, renal impairment, or prostatic hypertrophy. Central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension may be produced by sympathomimetic amines.
Use in Patients Approximately 60 Years of Age and Older: The safety and efficacy of loratadine; pseudoephedrine sulfate extended release tablets in patients greater than 60 years old have not been investigated in placebo-controlled clinical trials. The elderly are more likely to have adverse reactions to sympathomimetic amines.
Loratadine is an antihistamine which provides relief of seasonal allergy symptoms such as watery and itching eyes, runny nose, and sneezing. Pseudoephedrine is a decongestant which helps relieve a stuffy nose, promotes sinus draining, and improves breathing.
This medication is not recommended for use in children under 12 years of age due to the high amount of pseudoephedrine.
How to use Wal-itin D
Take this medication by mouth usually once daily; or take as directed by your doctor. Take with a full glass of water. Do not crush or chew this medication. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.
Do not increase your dose or take this more often than directed.
Do not take this medication for several days before allergy testing since test results can be affected. Consult your doctor or pharmacist for more information.
Dry mouth, mild stomach upset, trouble sleeping, dizziness, headache, nervousness, loss of appetite, or thirst may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these serious side effects occur: fast/irregular heartbeat, uncontrolled shaking or tremor.
Tell your doctor immediately if any of these unlikely but serious side effects occur: seizures, mental/mood changes, difficulty urinating.
This medication does not usually cause drowsiness when used at recommended doses and under normal circumstances. However, this drug may make you dizzy; therefore use caution engaging in activities that require alertness such as driving or using machinery.
A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
Before taking loratadine with pseudoephedrine, tell your doctor or pharmacist if you are allergic to it; or to desloratadine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: glaucoma (narrow angle type), severe difficulty urinating (urinary retention), severe high blood pressure, severe heart/blood vessel disease (coronary artery disease), liver disease, serious difficulty in swallowing, throat/stomach problems (e.g., stenosis/stricture/abnormal peristalsis of the esophagus or upper gastrointestinal tract), experienced serious side effects with decongestants (irregular heart rhythm).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, problems urinating (e.g., enlarged prostate), high blood pressure, diabetes, heart problems (e.g., ischemic heart disease), thyroid problems (hyperthyroidism), glaucoma (open angle type).
Limit alcoholic beverages, as it may intensify drug side effects. (See also Side Effects)
Older adults may be more sensitive to the side effects of this drug, especially fast/irregular heartbeat, dizziness, problems urinating, trouble sleeping, or confusion. Dizziness, trouble sleeping, and confusion can increase the risk of falling.
This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.
This medication passes into breast milk. Consult your doctor before breast-feeding.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use, especially of: adrenalin-like drugs (e.g., ephedrine, methylphenidate), certain high blood pressure drugs (e.g., guanethidine, methyldopa, reserpine, beta-blockers such as propranolol), herbal products containing ephedra.
Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain additional decongestants that could increase your risk for side effects. Ask your pharmacist about the safe use of those products.
Loratadine is very similar to desloratadine. Do not use medications containing desloratadine while using loratadine.
This medication may interfere with certain laboratory tests (including allergy skin testing), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
If overdose is suspected, contact a poison control center or emergency room immediately. Symptoms of overdose may include: irregular or unusually slow or fast heartbeat, unusual nervousness or excitement, and seizures.
Notes
Do not share this medication with others.
Missed Dose
If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Storage
Store between 59-77 degrees F (15-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised March 2014. Copyright(c) 2014 First Databank, Inc.
