Doximar®

Doxofylline

Prescribing Details



Description

Doximar® is a preparation of Doxofylline which is a xanthine derivative, used in the treatment of Asthma. II has both antitussive and bronchodilator effect and acts as a phosphodiesterase inhibitor. Doxofylline [7-(1,3-dioxalan-2-ylmethyl)-theophylline] is a novel xanthine bronchodilator. Its mechanism of action is related to the inhibition of phosphodiesterase activities. It inhibits phosphodiesterase (PDE-IV), thereby preventing breakdown of cyclic adenosine monophosphate (cAMP). Increase in cAMP inhibits activation of inflammatory cells resulting in bronchodilating effect. Doxofylline appears to have decreased affinities towards adenosine A1 and A2 receptors, which may account for its better safety profile.


Uses

No Data


Indications

Doximar® is indicated for the treatment of COPD (Chronic Obstructive Pulmonary Disease), bronchial asthma and bronchospasm.


Dosage and administration

Tablet
Adults: The dosage is 400 mg once daily in the evening. In certain cases on the basis of clinical response, 400 mg can be given two to three times daily as prescribe by the physician. The maximum daily dose is 1200 mg.


Children above 12 years of age: The recommended dose is 200 mg two to three times daily.


Elderly: The dosage may be decreased to 200 mg two to three times daily, in the every elderly patient with concomitant cardiovascular, hepatic, renal and gastric disease.

Syrup

Children above 6 years of age: The recommended daily dose is 6 mg/kg twice daily. The dose may be increased up to 9 mg/kg twice daily on the basis of clinical response by the supervision of the physician.

 


Use in pregnancy & lactation

Animal reproduction studies indicate that Doxofylline does not cause fetal harm when administered to pregnant animals nor can affect reproduction capacity. However, since there is limited experience in humans during pregnancy, Doxofylline should be used during pregnancy only if the potential benefit of mother justifies the potential risk of the fetus. Doxofylline is contraindicated in lactating mother.


Geriatric use
No Data

Precautions

Use with caution in patients with hypertension, heart disease, hypoxemia, hyperthyroidism, chronic right ventricular failure, congestive heart failure, liver disease, renal disease, in those with history of peptic ulcer and in the elderly. Frequently, patient with congestive heart failure have markedly prolonged drug plasma levels following discontinuation of the drug.

Doxofylline should be used only on prescription of a registered physician.


Side effects
The most common side effects include headache, irritability, nausea, vomiting, tachycardia, insomnia, abdominal pain, heart burn, shortening of breath, contractions, proteinuria and hyperglycemia.

Contraindications

Doxofylline is contraindicated in patients with hypotension & acute myocardial infarction. It is also contraindicated in patients with a history of hypersensitivity to Doxofylline or any of components.


Drug interactions

Doxofylline should not be administered together with other xanthine derivatives, including beverages and foods containing caffeine. Toxic synergism with ephedrine has been documented for xanlhines. Concomitant therapy with erythromycin, troleandomycin, lincomycin, clindamycin, allopurinol, cimetidine, propranolol and anti-flu vaccine may decrease the hepatic clearance of xanthines causing an increase in blood levels.


Overdose
No Data

Preparation

No Data


Pharmaceutical precautions

Store in a cool & dry place protected from light. Keep away from the reach of children.


Presentation

Doximar" 400 tablet: Each coated tablet contains Doxofylline INN 400 mg.

Doximarc 200 tablet: Each coated tablet contains Doxofylline INN 200 mg.

Doximar" syrup: Each 5 ml contains Doxofylline INN 100 mg.


Package quantitie

Package quantities
Doximar" 400 tablet: Carton of 50 tablets in blister pack.
Doximar" 200 tablet: Carton of 50 tablets in blister pack.
Doximar''' syrup: Bottle of 100 ml with food grade dropper.