Claritin-D Contraindications and Precautions
- acute myocardial infarction
- angina
- cardiac arrhythmias
- coronary artery disease
- MAOI therapy
- myocardial infarction
- neonates
- tachycardia
- breast-feeding
- cardiac disease
- cardiomyopathy
- children
- diabetes mellitus
- driving or operating machinery
- dysphagia
- elderly
- GI obstruction
- glaucoma
- heart failure
- hepatic disease
- hypertension
- hyperthyroidism
- pregnancy
- prostatic hypertrophy
- renal disease
- renal failure
- renal impairment
- urinary retention
Claritin-D Contraindications and Precautions
Because the doses of this fixed combination product cannot be individually titrated and hepatic insufficiency results in a reduced clearance of loratadine relative to pseudoephedrine, Claritin-D® 12 hour and 24 hour extended-release tablets should be avoided in patients with hepatic disease. Loratadine is extensively metabolized in the liver by the cytochrome P-450 system. Metabolism most likely occurs through the 3A4 isozyme, since interaction studies involving concurrent use of loratadine and potent 3A4 inhibitors such as ketoconazole and erythromycin have shown a several-fold increase in serum loratadine concentrations. Unlike astemizole and terfenadine, loratadine has not yet been associated with torsades de pointes.
Loratadine; pseudoephedrine may cause drowsiness in individual patients; therefore patients receiving this combination should be advised to avoid driving or operating machinery until the effects of the product are known.
Patients with renal impairment (CrCl<30 ml/min) associated with renal disease or renal failure should be given a reduced initial dose due to reduced clearance of loratadine and pseudoephedrine. The safety of this product in elderly patients (approximately 60 years of age and older) has not been investigated in placebo-controlled clinical trials. The elderly are more likely to have adverse reactions to sympathomimetic amines and reduced pseudoephedrine clearance.
Patients who have a history of dysphagia (ie. difficulty in swallowing tablets) or who have known upper GI obstruction with gastrointestinal narrowing or abnormal esophageal peristalsis should not use this product. Rare cases of mechanical obstruction have been reported in patients taking Claritin-D® 24 hour tablets. In some cases, endoscopy was required to remove the tablet. Most, but not all, of these patients had a history of difficulty swallowing, or had upper GI narrowing or abnormal esophageal peristalsis. In December 1998, an oval-shaped tablet replaced the round-shaped tablet of Claritin-D® 24 hour. It is not known whether the new formulation of Claritin-D® 24 hour tablets has the potential to cause mechanical obstruction. Patients should be reminded to drink a full glass of water when taking Claritin-D® 24 hour tablets. Claritin-D® 12 hour tablets have not been associated with upper GI tract obstruction.
Due to its pseudoephedrine component, this product should be used with caution in patients with narrow-angle glaucoma, diabetes mellitus, hyperthyroidism, or urinary retention due to prostatic hypertrophy, since it can exacerbate these conditions.
Well-controlled hypertensive patients receiving pseudoephedrine at recommended doses (60 mg PO four times daily) do not appear at risk for elevations in blood pressure. Since pseudoephedrine is a vasoconstrictor and may increase heart rate and blood pressure via sympathomimetic effects, it should be avoided in patients with uncontrolled or severe hypertension, acute cardiac arrhythmias (tachycardias), or significant coronary artery disease (including acute myocardial infarction, angina, or history of myocardial infarction). Considerable caution should be used in patients with controlled or mild hypertension, heart failure, cardiomyopathy, or other cardiac disease.
Patients who are or may become pregnant should be told that this product should be used in pregnancy or during breast-feeding only if the potential benefit justifies the potential risk to the fetus or nursing infant. This combination product is classified as pregnancy category B. Animal studies have not demonstrated a risk to the fetus but there are no adequate studies in pregnant women. It is not known if this combination product is excreted in human milk; however, loratadine and its metabolite are excreted into breast milk. Concentrations in the breast milk and serum are equivalent. Infants, particularly those that are premature, are at higher risk for adverse effects.
The safety and effectiveness of loratadine have not been established in children less than 12 years of age. The adverse effects of sympathomimetics such as pseudoephedrine can be severe, especially in infants and toddlers; CNS stimulation, hypertension and tachycardia may occur. Antihistamines generally should not be used in neonates due to the possibility of paradoxical CNS stimulation or seizures.
Loratadine; pseudoephedrine is contraindicated in individuals receiving MAOI therapy within two weeks of therapy (see Drug Interactions).
[ Last revised: 4/25/2005 3:21:00 PM ]
References
. Coates ML, et al. Does pseudoephedrine increase blood pressure in patients with controlled hypertension? J Fam Pract 1995;40:22 - 6.
. Gunn VL, Taha SH, Liebelt EL et al. Toxicity of over-the counter cough and cold medications. Pediatrics 2001;108:1 - 5.
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