Durasalyn-CR Warnings


Raptakos, Brett


Full Prescribing Info
Status asthmaticus is a medical emergency and is not rapidly responsive to usual doses of conventional bronchodilators. Oral theophylline products alone are not appropriate for status asthmaticus.
Toxicity: Excessive doses may cause severe toxicity. Incidence of toxicity increased significantly at serum levels >20 mcg/mL. Serum levels >20 mcg/mL are rarely found after appropriate administration of recommended doses. However, in patients in whom theophylline plasma clearance is reduced for any reason (eg, hepatic function impairment; patients >55 years, particularly males and those with chronic lung disease; cardiac failure and sustained high fever), even conventional doses may result in increased serum levels and potential toxicity. Serious side effects eg, ventricular arrhythmias, convulsions or even death may appear as the 1st sign of toxicity (eg, nausea, restlessness) may occur frequently when initiating therapy, but are usually transient when such signs are persistent during maintenance therapy. They are often associated with serum concentrations >20 mcg/mL.
Cardiac Effects: Theophylline may cause dysrhythmias or worsen preexisting arrhythmias. Any significant change in cardiac rate or rhythm warrants monitoring and further investigation.
General: Immediate hypersensitivity reactions may occur after administration of salbutamol as demonstrated by rare cases of urticaria, angioedema, rash and oropharyngeal edema. Salbutamol can produce a significant cardiovascular effect in some patients as measured by pulse rate, blood pressure symptoms and/or electrocardiographic changes.
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