Fylox is used to treat in following indications:

• Bronchial asthma,
• Bronchospasm,
• Chronic obstructive pulmonary disease (COPD),
• Pulmonary disease with spastic bronchial component.

Doxophylline is a novel bronchodilator. It structurally differs from Theophylline due to the presence of a dioxolane group in position 7. Doxophylline selectively inhibits phosphodiesterase 4 thereby relaxes bronchial smooth muscle. However, differently from Theophylline, Doxophylline appears to have decreased affinities toward adenosine A1 and A2 receptors, which may account for the better safety profile of the drug. Doxophylline is reported to inhibit platelet activating factor (PAF) and generation of leukotriene production.

Elderly: 200 mg tablet two or three times daily.

Adults: 400 mg tablet two or three times daily or as prescribed by the physician.

Children:

• >12 years of age: 10 ml syrup or 200 mg tablet two or three times daily.
• 6-12 years of age: 6-9 mg/kg body weight two times daily, i.e. if body weight is 10 kg, 3 ml (60 mg) two times daily or as prescribed by the physician.

If required daily dose of Doxophylline is 400 mg then Doxophylline SR tablet to be taken once daily or as prescribed by the physician

Fylox should not be administered with other xanthine preparations. It is recommended to limit consumption of beverages and food containing caffeine. Caution should be exercised in administering Fylox together with ephedrine or other sympathomimetic drugs. The concurrent administration of many drugs such as erythromycin, TAO, lincomycin, clindamycin, allopurinol, cimetidine, influenza vaccine and propanolol may reduce the hepatic clearance of xanthine derivatives with an increase in the plasmatic levels of the drug. Phenytoin, other anticonvulsants and cigarette smoking may increase the clearance of xanthine derivatives with a reduction of plasmatic half-life. In these cases, it may be necessary to increase the dosage of the drug.

Doxophylline is contraindicated in individuals with known hypersensitivity to the drug or other xanthine derivatives. It is also contraindicated in patients with acute myocardial infarction, hypotension and during lactation.

Patients treated with xanthine derivatives may suffer nausea, vomiting, epigastric pain, headache, irritability, insomnia, tachycardia, extrasystoles, tachypnea and in rare cases hyperglycemia or albuminuria. In case of overdose severe cardiac arrhythmias and tonic-clonic seizure may occur. These effects may represent the first signs of intoxication. The appearance of side effects may require discontinuation of the treatment which, if necessary, at the physician’s discretion, may be resumed at lower doses after all signs and symptoms of toxicity have subsided.

Pregnancy and Lactation: Animal tests have shown that the active ingredient of Doxophylline does not interfere with pre and postnatal growth. However, as there is not sufficient clinical evidence about the effects of the drug during pregnancy, use of the drug during pregnancy should be evaluated carefully case by case on the basis of the risk-benefit ratio. The drug is contraindicated during lactation.

Effects on ability to drive and use machines: The product does not affect the patient’s alertness and therefore does not interfere with his/her ability to drive and use machines.

Numerous factors may reduce the hepatic clearance of xanthine derivatives with increased plasma levels of the drug. These factors include age, congestive cardiac decompensation, chronic obstructive pulmonary disease, severe liver disease, concomitant infections, and the concurrent administration of several drugs such as: erythromycin, TAO, lincomycin, clindamycin, allopurinol, cimetidine, influenza vaccine and propanolol. In these cases, it may be necessary to reduce the dosage of the drug. In case of factors that may influence the clearance of xanthine derivatives, monitoring of the concentration of the blood levels of the drug is recommended for the control of the therapeutic range.

Caution should be taken in administering the product to patients with cardiac disease, hypertension, in the elderly, in patients with severe hypoxemia, hyperthyroidism, chronic corpulmonale, congestive heart failure, liver disease, peptic ulcer and in those with renal impairment. In particular, it is to be used with caution in patients with congestive heart failure, since the clearance of the drug is considerably slower in these patients in which high blood levels may persist for long periods even after discontinuation of the treatment. There is no risk of addiction or any other form of dependence.

In case of overdose severe cardiac arrhythmias and tonic-clonic seizure may occur. These effects may represent the first signs of intoxication. The appearance of side effects may require discontinuation of the treatment which, if necessary, at the physician’s discretion, may be resumed at lower doses after all signs and symptoms of toxicity have subsided. As there is no specific antidote, in case of overdose a symptomatic treatment of cardiovascular collapse should be instituted.

Bronchodilator, Methyl xanthine derivatives

Keep in a dry place away from light and heat. Keep out of the reach of children. Fylox should be used only on prescription of specialist physician.