Trade name: Doxitus

International Nonproprietary Name: Doxofylline

Dosage Form: syrup for oral use

Description: Light, yellowish, transparent, slightly bitter liquid with caramel and menthol flavour

Composition: 5ml syrup for oral use contains: the active substance Doxofylline 100 mg.

Excipients: saccharose, saccharin sodium, ammonium glycyrizinate, sodium methyl p-hydroxybenzoate, sodium propyl-p-hydroxybenzoate, flavors (caramel, menthol), purified water.

Pharmacotherapeutic group: Doxofylline is a novel bronchodilator structurally classified as a xanthine derivative.

ATC code: R03DА11

Pharmacokinetic properties:

The half-life of Doxofylline is greater than seven hours.

After oral administration, peak plasma levels were reached after one hour. Absolute bioavailability is about 62.6%; at a pH 7.4 plasma protein binding of the compound is 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 administrations Doxofylline reaches the steady-state in about 4 days; the elimination half-life during long-term treatment is 8-10 hours: this allows a twice daily dose regimen. No accumulation of the drug was noted after one week of treatment.

Pharmacodynamic properties:

Doxofylline is a novel bronchodilator structurally classified as a xanthine derivative.

Doxofylline directly relaxes the smooth muscle of the bronchial airways and pulmonary blood vessels, thus acting mainly as a bronchodilator and smooth muscle relaxant. The exact mode of action remains unknown, although doxofylline does cause inhibition of  phosphodiesterase with a resultant increase in intracellular cyclic AMP. At high concentrations, doxofylline is also able to inhibit the cellular release of histamine.

Therapeutic indications:

- bronchial asthma;

- Chronic Obstructive Pulmonary Disease (COPD);


- in individuals who have shown hypersensitivity to its components

- In the period of breastfeeding.

- in children below 3 years old