Clarityn-D 12Hour Repetabs Special Precautions

Sympathomimetics should be used with caution in patients with glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, 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.
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 with a lower initial dose because they may have reduced clearance of loratadine; an initial dose of 1 tablet daily is recommended.
Patients who have a history of difficulty in swallowing tablet; or have had upper GI narrowing or abnormal esophageal peristalsis should not use this product.
Drug Abuse and Dependence: There are no data available to indicate that abuse or dependency occurs with loratadine.
Pseudoephedrine sulfate, like other CNS stimulants, has been abused. At high doses, subjects commonly experience an elevation of mood, decreased appetite and a sense of increased physical energy, mental capacity and alertness. Anxiety, irritability and loquacity also have been experienced. With continued use, tolerance develops; the user increases the dose and ultimately toxicity occurs. Depression may follow rapid withdrawal.
Use in pregnancy & lactation: Safe use of Clarityn-D 12Hour Repetabs 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 12Hour Repetabs.
Use in children: Safety and efficacy of Clarityn-D 12Hour Repetabs in children <12 years have not yet been established.
Use in the elderly: In patients ≥60 years, sympathomimetics are also more likely to cause adverse reactions eg, confusion, hallucination, convulsions, CNS depression and death. Consequently, caution should be exercised when administering a repeat-action formulation to elderly patients.