International Name: DOXOFYLLINE

Active Ingredient:
Doxofylline

Pharmacotherapeutic Group:
Medication for the treatment of bronchial asthma; broncholytic agent; phosphodiesterase inhibitor.

Composition and Dosage Form:
Tablets: 10 and 20 tablets per blister pack.
Each tablet contains:
Doxofylline ............ 400 mg

Excipients:
Colloidal silicon dioxide, wheat starch, mannitol, povidone, microcrystalline cellulose, talc, magnesium stearate.

Syrup 2%: in bottle form.
100 ml contains:
Doxofylline ............ 2 g

Excipients:
Sucrose, sodium saccharin, ammonium glycyrrhizinate, sodium methyl paraben, sodium propyl paraben, alpine ointment, peppermint flavor powder, purified water.

Indications:
Puroxan is prescribed for patients with bronchial asthma and chronic obstructive pulmonary diseases (COPD).

Dosage and Administration:

Tablets

• Adults:
  1 tablet (400 mg) twice daily. The dose may be increased up to 1200 mg per day according to a physician’s prescription.

• Elderly patients:
  In patients with cardiovascular, hepatic, or gastrointestinal disorders, the dose may be reduced to ½ tablet twice daily.

Syrup

• Children:
  The recommended daily dose of doxofylline is 12 mg/kg/day divided into two doses. If the result is insufficient, the dose may be increased up to 18 mg/kg/day under medical supervision.

• Adults:
  2 measuring cups – 20 ml (400 mg) twice daily.

• Elderly:
  1 measuring cup = 10 ml (200 mg) twice daily.

Side Effects:
♦ Rarely observed:
Nausea, vomiting, headache, irritability, insomnia, palpitations, and tachycardia.

Contraindications:
Contraindicated in patients with hypersensitivity to any of the drug’s components.

Pregnancy and Lactation:
Animal studies have shown that doxofylline does not harm the fetus or affect reproductive function. However, it should be prescribed during pregnancy only if absolutely necessary. There is no data regarding its use during breastfeeding.

Special Precautions:
◄ The half-life of doxofylline may be prolonged in cases of severe hepatic or cardiac insufficiency.
◄ Certain medications inhibit the excretion of xanthines (including doxofylline) from the body, such as erythromycin, troleandomycin, lincomycin (and other antibiotics of this group), allopurinol, cimetidine, propranolol, and influenza vaccine. In such cases, doxofylline dosage should be reduced.
◄ Phenytoin, other anticonvulsants, and tobacco smoking accelerate the elimination and shorten the half-life of doxofylline; in such cases, the dose may need to be increased.
◄ In patients with gastric or duodenal ulcers, or elderly patients with impaired liver function, doxofylline should be prescribed with caution.

Overdose:
Although no serious cardiac rhythm disturbances have been confirmed following doxofylline overdose, such a possibility cannot be ruled out since the drug belongs to the xanthine group.
Significant overdose may cause seizures, which are considered the first symptom of toxicity.
If side effects occur, treatment must be discontinued. Therapy may be resumed at reduced doses only under medical supervision.

Drug Interactions:
Doxofylline should not be prescribed together with other xanthine derivatives. Toxic synergism has been reported between xanthines and ephedrine.

Some drugs inhibit the excretion of xanthines (including doxofylline) from the body, such as erythromycin, troleandomycin, lincomycin (and other antibiotics of this group), allopurinol, cimetidine, ranitidine, propranolol, and influenza vaccine.
No correlation has been observed between serum doxofylline levels and adverse effects.