The elimination half-lives for loratadine and descarboethoxyloratadine were 24 hours and 37 hours, respectively, and increased with increasing severity of liver disease. There was considerable variability in the pharmacokinetic data in all studies of loratadine, probably due to the extensive first-pass metabolism.
Individual histograms of area under the curve, clearance, and volume of distribution showed a log normal distribution with a fold range in distribution in healthy subjects. Loratadine does not affect the plasma protein binding of warfarin and digoxin. Whole body autoradiographic studies in rats and monkeys, radiolabeled tissue distribution studies in mice and rats, and in vivo radioligand studies in mice have shown that neither loratadine nor its metabolites readily cross the blood-brain barrier.
Radioligand binding studies with guinea pig pulmonary and brain H1-receptors indicate that there was preferential binding to peripheral versus central nervous system H1-receptors. In a study in which loratadine alone was administered at four times the clinical dose for 90 days, no clinically significant increase in the QTc was seen on ECGs.
In a single-rising dose study of loratadine alone in which doses up to mg 16 times the clinical dose were administered, no clinically significnt changes on the QTc interval in the ECGs were observed.
Pseudoephedrine sulfate d-isoephedrine sulfate is an orally active sympathomimetic amine which exerts a decongestant action on the nasal mucosa. It is recognized as an effective agent for the relief of nasal congestion due to allergic rhinitis. Pseudoephedrine produces peripheral effects similar to those of ephedrine and central effects similar to, but less intense than, amphetamines. It has the potential for excitatory side effects.
The bioavailability of loratadine; pseudoephedrine sulfate from loratadine; pseudoephedrine sulfate 24 hour extended release tablets is similar to that achieved with separate administration of the components. Coadministration of loratadine and pseudoephedrine does not significantly affect the bioavailability of either component.
However, food did not significantly affect the pharmacokinetics of pseudoephedrine sulfate or descarboethoxyloratadine.
Limit alcoholic beverages, as it may intensify drug side effects. See also Side Effects. 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 and is unlikely to cause harm to a nursing infant.
Consult your doctor before breast -feeding. What should I know regarding pregnancy, nursing and administering Claritin-D 12 Hour to children or the elderly? Interactions 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. 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 , safinamide, 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: Check the labels on all your medicines e. 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.
Does Claritin-D 12 Hour interact with other medications? Overdose If someone has overdosed and has serious symptoms such as passing out or trouble breathing , call Cetirizine hydrochloride is a white, crystalline powder and is water-soluble. The chemical structure is shown below: Pseudoephedrine hydrochloride occurs as fine, white to off-white crystals or powder, having a faint characteristic odor. It is very soluble in water, freely soluble in alcohol, and sparingly soluble in chloroform.
The antihistaminic activity of cetirizine has been clearly documented in a variety of animal and human models. In vivo and Ex vivo animal models have shown negligible anticholinergic and antiserotonergic activity. In clinical trials, however, dry mouth was more common with cetirizine than with placebo. In vitro receptor binding studies have shown no measurable affinity for other than H1 receptors.
Autoradiographic studies with radiolabeled cetirizine in the rat have shown negligible penetration into the brain. Ex vivo experiments in the mouse have shown that systemically administered cetirizine does not significantly occupy cerebral H1 receptors.
Pseudoephedrine hydrochloride is an orally active sympathomimetic amine and exerts a decongestant action on the nasal mucosa. Pseudoephedrine hydrochloride is recognized as an effective agent for the relief of nasal congestion due to allergic rhinitis. Pseudoephedrine produces peripheral effects similar to those of ephedrine and central effects similar to, but less intense than, amphetamines. It has the potential for excitatory side effects.
Pharmacokinetics Absorption The bioavailability of cetirizine hydrochloride and pseudoephedrine hydrochloride from ZYRTEC-D 12 HOUR Extended Release Tablets is not significantly different from that achieved with separate administration of a cetirizine 5 mg tablet and a pseudoephedrine mg extended release caplet.
Co-administration of cetirizine and pseudoephedrine does not significantly affect the bioavailability of either component.
Food had no significant effect on the extent of cetirizine absorption AUC , but Tmax was delayed by 1. Food had no significant effect on the pharmacokinetics of pseudoephedrine. No plasma protein binding data in humans are available. Most of the rapid increase in peak plasma radioactivity was associated with parent drug, suggesting low first pass metabolism. Cetirizine is metabolized to a limited extent by oxidative O-dealkylation to a metabolite with negligible antihistaminic activity.
The enzyme or enzymes responsible for this metabolism have not been identified. One to seven percent of the pseudoephedrine dose appeared to be metabolized to norpseudoephedrine by N-demethylation after a single dose. It was reported that 0. Drug Interactions Pharmacokinetic interaction trials with cetirizine in adults were conducted with pseudoephedrine, antipyrine, ketoconazole, erythromycin and azithromycin.
No interactions were observed. The disposition of theophylline was not altered by concomitant cetirizine administration.
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