Clarityn-D 24Hour Extended Release Special Precautions

Sympathomimetic agents should be used with caution in patients with glaucoma, prostatic hypertrophy or bladder neck obstruction, cardiovascular disease, increased intraocular pressure or diabetes mellitus.
Sympathomimetics should be used with caution in patients receiving digitalis.
Sympathomimetics may cause central nervous system (CNS) stimulation, excitability, convulsions and/or cardiovascular collapse with accompanying hypotension. Pseudoephedrine sulfate may cause excitability, especially in children.
Acute generalized exanthematous pustulosis (AGEP), a form of severe skin reaction, may occur with pseudoephedrine-containing products in isolated cases. If signs and symptoms such as fever, erythema or small (generalized) pustules are observed, patients should discontinue the drug and consult their physician.
Patients with severe liver impairment should be administered a lower initial dose because they may have reduced clearance of loratadine; an initial dose of 1 tablet every other day is recommended.
Patients who have a history of difficulty in swallowing tablets, or have had known upper gastrointestinal narrowing or abnormal esophageal peristalsis should not use this product.
Drug Abuse and Dependence: No data are available to indicate that abuse or dependency occurs with loratadine. Like other central nervous system stimulants, pseudoephedrine sulfate has a potential for abuse and increased doses may ultimately produce toxicity. Depression may follow rapid withdrawal.
Use in pregnancy & lactation: Safe use of Clarityn-D 24Hour Extended Release during pregnancy has not been established. Therefore, it should be used only if the potential benefit justifies the potential risk to the fetus.
Since loratadine and pseudoephedrine sulfate are excreted in breast milk, a decision should be made whether to discontinue nursing or to discontinue the use of Clarityn-D 24Hour Extended Release.
Use in children: Safety and efficacy of Clarityn-D 24Hour Extended Release in children <12 years have not been established.
Use in the elderly: In patients ≥60 years, sympathomimetics are more likely to cause adverse reactions eg, confusion, hallucination, convulsions, CNS depression and death. Consequently, caution should be exercised when administering a long-acting formulation to elderly patients.