Claritin-D Adverse Reactions

agitation
anaphylactoid reactions
angina
angioedema
anorexia
anxiety
arrhythmia exacerbation
bronchospasm
chest pain (unspecified)
dizziness
drowsiness
dysuria
erythema multiforme
fatigue
GI obstruction
hallucinations
headache
hypertension
insomnia
myocardial infarction
nausea/vomiting
ocular hypertension
palpitations
paresthesias
photophobia
premature ventricular contractions (PVCs)
psychosis
restlessness
seizures
sinus tachycardia
stroke
supraventricular tachycardia (SVT)
syncope
tremor
xerostomia

Claritin-D Adverse Reactions

Drowsiness and/or sedation is a frequent adverse reaction to most H₁-blockers, however, H₁-blockers vary in their ability to produce drowsiness, and this side effect does not correlate with peripheral antihistamine potency. Fatigue is also experienced in about 3% of patients taking the combination product. Patients should be warned about undertaking hazardous tasks while taking loratadine, although the risk is relatively low.

Anticholinergic side effects are minimal with loratadine compared to most other H-blockers; however, some patients (8%) experience xerostomia. As with any sympathomimetic agent, cardiovascular effects which may occur during pseudoephedrine therapy include cardiac arrhythmias (arrhythmia exacerbation), hypertension, stroke, myocardial infarction, chest pain (unspecified), or angina; these effects are more likely to occur at excessive dosage or in patients at risk (see Contraindications). Cardiac arrhythmias (< 2%) secondary to pseudoephedrine may include palpitations, premature ventricular contractions (PVCs), supraventricular tachycardia (SVT) or sinus tachycardia. 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, however, increased blood pressures may be seen in patients with uncontrolled hypertension. The manufacturer reports that in a single, rising-dose study in which doses up to 160 mg (16 times the clinical dose) were studied, loratadine did not cause any clinically significant changes on the QTc interval.

Evaluation of CNS effects from one study, Claritin-D® 24 hour extended release tablets was well tolerated, with a frequency of sedation similar to that seen with placebo, and a frequency of nervousness and insomnia similar to that seen with pseudoephedrine given alone. CNS effects such as agitation, anxiety, restlessness, confusion, dysphonia, headache, lightheadedness, dizziness, syncope, tremor, paresthesias, seizures, hyperkinesis, hypertonia, and psychological disturbances including depression, hallucinations and psychosis have been reported during therapy with pseudoephedrine. Elderly patients appear to be more sensitive to the CNS stimulation effects of the drug.

Ocular effects can occur with pseudoephedrine products. These can include increased intraocular pressure (ocular hypertension) and photophobia.

This product also can produce GI and GU effects such as nausea/vomiting, anorexia, cholelithiasis, GI obstruction, impotence, oliguria and dysuria. 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 have 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.

Cough, pharyngitis and dysmenorrhea were occasionally associated with this product (2 - 5%); however the incidences were similar to placebo. Other significant, less common (< 2%) reactions reported with this product include: anaphylactoid reactions, angioedema, bronchospasm, myalgia, erythema multiforme and dyspnea.

[ Last revised: 5/4/2003 9:04:00 PM ]

References
_{. Levander S, Hagermark O, Stahle M. Peripheral antihistamine and central sedative effects of three H₁-receptor antagonists. Eur J Clin Pharmacol 1985;28:523 - 9.}

. Coates ML, et al. Does pseudoephedrine increase blood pressure in patients with controlled hypertension? J Fam Pract 1995;40:22 - 6.

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