Aerius D-12 Special Precautions

AERIUS D-12 Tablets should be used with caution in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism, renal impairment, liver impairment or prostatic hypertrophy. Central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension may be produced by sympathomimetic amines.
Severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) may occur with pseudoephedrine-containing products. Patients should be carefully monitored. If signs and symptoms such as pyrexia, erythema, or many small pustules are observed, administration of this drug should be discontinued and appropriate measures taken if needed.
Desloratadine should be administered with caution in patients with a medical or family history of seizures. In particular, young children may be more susceptible to developing new seizures under desloratadine treatment. Healthcare providers may consider discontinuing desloratadine in patients who experience a seizure while on treatment.
There have been rare cases of posterior reversible encephalopathy syndrome (PRES)/reversible cerebral vasoconstriction syndrome (RCVS) observed with pseudoephedrine-containing medicines. Reported symptoms include sudden onset of severe headache, nausea, vomiting, visual disturbances and other neurological signs and symptoms such as seizure and altered mental status. Most cases have resolved within days following discontinuation of the medication and appropriate treatment. Pseudoephedrine-containing products, AERIUS D-12 Tablets must be discontinued, and medical advice sought immediately if signs or symptoms of PRES or RCVS develop.
Use in Children: AERIUS D-12 Tablets are not appropriate dosage forms in pediatric patients and are not recommended in patients under 12 years of age due to a lack of data on safety and efficacy.
Use in the Elderly: Elderly patients are more likely to have adverse reactions to sympathomimetic amines. Dose selection for elderly patients should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in this population.