Each tablet contains: Doxofylline 400 mg.
Doxofylline is a theophylline derivative which is used as a bronchodilator in reversible airways obstruction. It is given by mouth in doses up to 1,200 mg daily.
Pharmacology: Pharmacokinetics: The half-life of Doxofylline is greater than 6 hours; so, this allows effective constant plasma levels with a thrice a day dose regimen. Single dose pharmacokinetic studies in humans after oral administration defined distribution and absorption of the drug. After administration, peak plasma levels are reached after 1 hour. Absolute bioavailability is about 62.6%; at pH 7.4, plasma proteins binding the compound are about 48%. Less than 4% of an orally administered dose is excreted unchanged in the urine. Doxofylline is almost completely metabolized in the liver (90% of the total drug clearance). Hydroxyethyltheophylline is the only detectable circulating metabolite of Doxofylline. After repeated administration, Doxofylline reaches the steady state in about 4 days; the elimination half-life during long-term treatment is 8-10 hours: this vaccine may decrease the hepatic clearance of xanthenes, causing an increase in blood levels. No evidence of a relationship between Doxofylline serum concentration and toxic events has been reported.
For maintenance therapy in patients suffering with asthma and Chronic Obstruction Pulmonary Disease (COPD). It is used as a bronchodilator in reversible airway obstructions.
Adult: 400 mg once a day. Single dose, administration in the evening reduces nocturnal, symptoms and helps to keep the patients complaint-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.
Doxofylline is contraindicated in individuals who have shown hypersensitivity to its components. It is also contraindicated in patients with acute myocardial infarction, hypotension, and in lactating women.
Use with caution in patients with hypertension, heart disease, hypoxaemia, hyperthyroidism, chrome right ventricular failure, congestive heart failure, liver disease, renal disease, in those with history of peptic ulcer, and in the elderly. Frequently, patients with congestive heart failure have markedly prolonged drug plasma levels following discontinuation of the drug. The half-life of xanthine derivatives is influenced by a number of known variables. It may be prolonged in patients with liver disease, in patients with congestive heart failure, in those affected with COPD or concomitant infections, and in those patients taking certain other drugs (erythromycin, troleandomycin, lincomycin and other antibiotics of the same group, allopurinol, cimetidine, propanolol and anti-flu vaccine). In these cases, a lower dose of Doxofylline may be needed.
After xanthine administration, nausea, vomiting, epigastric pain, cephalagia (headache), irritability, insomnia, tachycardia, extrasystole, tachypnoea and occasionally, hyperglycaemia and albuminuria may occur.
Seek medical attention immediately at the first sign of any adverse reaction.
Doxofylline should not be administered together with other xanthine derivatives. Toxic synergism with ephedrine has been documented for xanthine. Like other xanthenes, concomitant therapy with erythromycin, troleandomycin, lincomycin, clindamycin, allopurinol, cimetidine, ranitidine, propanolol and anti-flu vaccine may decrease the hepatic clearance of xanthenes, causing an increase in blood vessels. No evidence of a relationship between Doxofylline serum concentration and toxic events have been reported.
Store at temperatures not exceeding 30°C.
R03DA11 - doxofylline ; Belongs to the class of xanthines. Used in the systemic treatment of obstructive airway diseases.
Doxopro tab 400 mg
100's (P20/tab);30's (P20/tab)