Each tablet contains: Doxofylline 400 mg.
Pharmacology: Doxofylline (7-(1-,3-dioxoln-2-ylmethy) theophylline is a novel methylxanthine bronchodilator characterised by the presence of a dioxolane group in position 7, which differentiates it from theophylline. Doxofylline acts by inhibiting the phosphodiesterase enzymes in central and peripheral tissues. The increases intracellular concentration of cyclic AMP that causes smooth muscle relaxation. Doxofylline has shown more potent and bronchospastic activity and less extra respiratory effects in experimental studies than commonly used xanthine drugs.
Pharmacokinetics: Half life of doxofylline is greater than six hours which allows effective constant plasma levels with thrice daily dose regimen. The therapeutic range of doxofylline is significantly wider with respect to that of theophylline. Serum levels are stable and do not require monitoring.
For maintenance therapy in patients suffering with Asthma and Chronic Obstructive Pulmonary Disease (COPD).
Adult: 400 mg once a day. Single dose administration, in the evening reduces nocturnal, symptoms and helps to keep the patients complaints free during the day. However in certain cases, 400 mg twice daily is recommended on the basis of the clinical response. Doses as high as 1200 mg/day (400 mg 3 times a day) may also be prescribed.
Hypersensitivity to its components, acute myocardial infraction, hypotension, and in lactating women. Doxofylline must be used with caution in patients with hypertension, heart disease, hyperthyroidism, chronic right ventricular disease, congestive heart failure, liver diseases, renal diseases, in those with a history of peptic ulcer, and in the elderly.
Severe arrhythmias and seizure could be the first signs of potential overdose. Plasma concentration in doxofylline should be monitored in patients with liver disease, congestive heart failure and concomitant intake of certain drugs (erythromycin, troleandomycin, lincomycin, allopurinol, cimetidine, propranolol, and antiflu vaccine. In these cases a lower dose of doxofylline is needed Phenytoin, other anticonvulsants and smoking may cause an increase in clearance with a shorter mean half life. In these cases higher doses of doxofylline may be required.
Initial treatment of acute episodes of bronchospasm.
Pregnancy: Doxofylline should be given to pregnant women, if clearly needed as limited data is for use in humans during pregnancy.
Nausea, vomiting, epigastric pain, headache, irritability, insomnia, hyperglycemia, and albuminuria may occur.
No evidence of a relationship between doxofylline serum concentration and toxic events has been reported with potential drug interactions. Doxofylline reacts with broad variety of drugs that alter the rate of theophylline clearance leading to increase or decrease of serum theophylline concentration. Because of narrow therapeutic index, serum theophylline concentration need to be monitored. Conversely because of a wider therapeutic window there is no need to monitor doxofylline levels.
Store at temperatures not exceeding 30°C.
R03DA11 - doxofylline ; Belongs to the class of xanthines. Used in the systemic treatment of obstructive airway diseases.
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