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
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.
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.
- 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
Dosage and method of administration:
Doxitus syrup can be used in children aged 3 years and older.
The recommended dosage of Doxofylline is 12 mg/kg daily, divided into 2 doses. In case of unsatisfactory response it can be increased up to 18 mg/kg daily under medical supervision.
20 ml (400 mg) 2 times daily.
The dose may be increased to 20 ml (400 mg) 3 times daily.
10 ml (200 mg) 2 times daily.
Contact your doctor if an overdosage with this medicine is suspected.
Seizures - these symptoms could be the first sign of an overdosage.
If you forget to take Doxitus syrup:
Do not take a double dose to recover the unaccepted dose.
If you forget to take a dose, and the time is right for the next dose, take only one dose and continue the treatment as indicated on the package.
If you missed several doses in a row, inform your doctor or pharmacist. You may need to start the next course of treatment with Doxitus Syrup.
It is not recommended to discontinue the drug treatment at its own discretion.
If you have additional questions on the use of the drug, contact your doctor or pharmacist.
Adverse Drug Reactions:
After xanthine administration nausea, vomiting, epigastric pain, cephalalgia, irritability, insomnia, tachycardia, extrasystole, tachypnea, and occasionally hyperglycemia and albuminuria may occur.
If a potential oral overdose is established, the patient may present with severe arrhythmias and seizure; these symptoms could be the first sign of intoxication. Adverse reactions may cause the withdrawal from treatment; a lower dose rechallenge may start only after the advice of a physician.
Doxofylline should not be administered together with other xanthine derivatives, including beverages and foods containing caffeine. Toxic synergism with ephedrine has been documented for xanthines.
Like other xanthines, concomitant therapy with erythromycin, troleandomycin, lincomycin, clindamycin, allopurinol, cimetidine, ranitidine propanolol and anti-flu vaccine may decrease the hepatic clearance of xanthines causing an increase in blood levels. No evidence of a relationship between Doxofylline serum concentrations and toxic events has been reported.
Food and drug interactions:
Special instructions are not described.
Effects on ability to drive and use machines:
Driving and other activities related with the use of machines are not affected by Doxofylline.
Pregnancy and lactation:
Talk to your doctor or healthcare provider before starting any new medication.
Doxitus syrup is contraindicated in nursing mothers.
Precautions and warnings:
Doxitus syrup is used 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 with impaired hepatic function.
- Be sure to tell your doctor or pharmacist what medicines you have taken recently, including drugs that you took without a doctor's prescription.
- Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should consult with doctor.
100 ml, in a glass bottle, with dosage cup and leaflet insert in a paperboard box.
Shelf life: 2 years.
Do not use medicine after the expiry date, which is listed on the bottle label and paperboard box.
Expiration date expires on the last day of the specified month.
Store below 25°C.
Keep out of the reach of children.
Prescription only medicine.
"Medical Horizon" LLC
Republic of Armenia, Ararat province, Masis, Masis station, Gortsaranain 22
Marketing authorization holder