Oxofyline Syrup 100 mg/5 ml

Description

Indications
Oxofyline is prescribed for the treatment of:

• Bronchial asthma
• Bronchospasm
• Chronic obstructive pulmonary disease (COPD)
• Pulmonary diseases with a spastic bronchial component

Use this medication only as directed by a registered physician.

Pharmacology
Oxofyline contains Doxophylline, a novel bronchodilator structurally distinct from Theophylline due to the presence of a dioxolane group at position 7. It selectively inhibits phosphodiesterase 4, leading to bronchial smooth muscle relaxation. Unlike Theophylline, Doxophylline has a lower affinity for adenosine A1 and A2 receptors, which contributes to its improved safety profile. Additionally, it inhibits platelet-activating factor (PAF) and reduces leukotriene production.

Dosage & Administration

• Elderly: 200 mg tablet two or three times daily.
• Adults: 400 mg tablet two or three times daily or as prescribed by the physician.
• Children:
  • Over 12 years: 10 ml syrup or 200 mg tablet two or three times daily.
  • 6-12 years: 6-9 mg/kg body weight twice daily (e.g., for a child weighing 10 kg, 3 ml (60 mg) twice daily) or as prescribed by the physician.
    If a daily dose of 400 mg is required, the Doxophylline SR tablet should be taken once daily or as directed by the physician.

Use this medication only as directed by a registered physician.

Interaction
Oxofyline should not be used with other xanthine preparations. It is advisable to limit the consumption of caffeine-containing foods and beverages. Caution is necessary when taking Oxofyline with ephedrine or other sympathomimetic drugs. The use of medications such as erythromycin, TAO, lincomycin, clindamycin, allopurinol, cimetidine, influenza vaccine, and propranolol may reduce hepatic clearance of xanthine derivatives, leading to increased plasma levels. Conversely, phenytoin, other anticonvulsants, and smoking may enhance xanthine clearance, reducing plasma half-life. In such cases, dosage adjustments may be necessary.

Contraindications
Oxofyline is contraindicated in individuals with hypersensitivity to Doxophylline or other xanthine derivatives. It is also contraindicated in patients with acute myocardial infarction, hypotension, and during lactation.

Side Effects
Patients taking xanthine derivatives may experience nausea, vomiting, epigastric pain, headache, irritability, insomnia, tachycardia, extrasystoles, tachypnea, and, in rare cases, hyperglycemia or albuminuria. Overdose may result in severe cardiac arrhythmias and tonic-clonic seizures, which could indicate early signs of toxicity. If side effects occur, treatment may need to be discontinued, with the possibility of resuming at lower doses once symptoms subside, as advised by a physician.

Pregnancy & Lactation
Animal studies suggest that Doxophylline does not affect pre- or postnatal growth. However, due to a lack of sufficient clinical data, the use of Oxofyline during pregnancy should be evaluated on a case-by-case basis, considering the risk-benefit ratio. This drug is contraindicated during lactation.

Oxofyline does not impair alertness and therefore does not interfere with the ability to drive or operate machinery.

Precautions & Warnings
Several factors can reduce hepatic clearance of xanthine derivatives, leading to elevated plasma levels. These factors include age, congestive cardiac decompensation, COPD, severe liver disease, infections, and concurrent use of medications such as erythromycin, TAO, lincomycin, clindamycin, allopurinol, cimetidine, influenza vaccine, and propranolol. In these cases, dose reduction and blood level monitoring may be required.

Caution is advised when administering Oxofyline to patients with cardiac disease, hypertension, elderly patients, those with severe hypoxemia, hyperthyroidism, chronic corpulmonale, congestive heart failure, liver disease, peptic ulcers, or renal impairment. In particular, patients with congestive heart failure may have slower drug clearance, resulting in prolonged high plasma levels even after discontinuation. There is no risk of addiction or dependence.

Overdose Effects
Overdose may lead to severe cardiac arrhythmias and tonic-clonic seizures, which are early signs of toxicity. In such cases, symptomatic treatment for cardiovascular collapse should be initiated. As there is no specific antidote, treatment may be resumed at lower doses once symptoms resolve, under the physician’s guidance.

Therapeutic Class
Bronchodilator, Methyl xanthine derivatives

Storage Conditions
Store in a dry place, away from light and heat. Keep out of reach of children. Oxofyline should be used only on the prescription of a specialist physician.