Maxivent

Presentation

Maxivent tablet: Each film coated tablet contains Doxophylline lNN 400 mg.

 

Description

Doxophylline 7-(1,3 dioxolane-2-yl methyl) is a newer xanthine derivative which differs from theophylline in containing the dioxolane group at position 7. As with theophylline, its mechanism of action is related to the inhibition of the phosphodiesterase enzymes, but it has been claimed to have decreased affinities towards the adenosine A1 and A2 receptors, which has been claimed as a reason for its better safety profile.

 

Indication

• Bronchial asthma.

• Chronic Obstructive Pulmonary Disease (COPD).

• Pulmonary disease associated with bronchospasm.

 

Dosage and administration

Maxivent 400 mg tablet- Adults: 1 tablet two to three times daily.

 

Contraindication

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.

 

Adverse effect

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.

 

Use in special group

Pregnant women: Animal tests have shown that the active ingredient of Doxophylline does not interfere with pre- and postnatal growth. However, as there is no 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.

 

Lactating mother: The drug is contraindicated during lactation.

 

Precaution

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, the concurrent administration of several drugs such as: erythromycin, TAO, lincomycin, clindamycin, allopurinol, cimetidine, influenza vaccine and propranolol.

 

In these cases, it may prove 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 observed in administering the product to patients with cardiac disease, hypertension, in the elderly, in patients with severe hypoxemia, hyperthyroidism, chronic cor pulmonale, 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.


Drug interaction

Doxophylline 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 Doxophylline together with ephedrine or other sympathomimetic drugs. The concurrent administration of many drugs such as erythromycin, TAO, lincomycin, clindamycin, allopurinol, cimetidine, influenza vaccine and propranolol 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 prove necessary to increase the dosage of the drug.


Storage

Keep out of the reach of children. Keep below 300 C, protect from light.

 

How supplied

Maxivent tablet: Each box contains 3x10’s tablet in blister pack.