Doxoven 400 mg

Indications
Doxoven is prescribed for the treatment of the following conditions:

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

Use the medication as per the advice of a registered physician.

Pharmacology
Doxophylline is a new bronchodilator that differs from Theophylline due to the presence of a dioxolane group at position 7. It selectively inhibits phosphodiesterase 4, which leads to the relaxation of bronchial smooth muscles. Unlike Theophylline, Doxophylline has a reduced affinity for adenosine A1 and A2 receptors, contributing to its improved safety profile. Additionally, Doxophylline has been shown to inhibit platelet-activating factor (PAF) and reduce the production of leukotrienes.

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

Use the medication as per the advice of a registered physician.

Interaction
Doxoven should not be used in combination with other xanthine-based medications. It is advised to limit the intake of foods and beverages containing caffeine. Caution is advised when taking Doxoven with ephedrine or other sympathomimetic drugs. The concurrent use of certain medications such as erythromycin, TAO, lincomycin, clindamycin, allopurinol, cimetidine, the influenza vaccine, and propranolol may decrease the liver’s ability to clear xanthine derivatives, resulting in increased drug levels in the blood. Conversely, phenytoin, other anticonvulsants, and smoking can accelerate the clearance of xanthine derivatives, reducing their half-life. In these cases, dosage adjustments may be necessary.

Contraindications
Doxophylline is contraindicated for individuals with known hypersensitivity to the drug or other xanthine derivatives. It is also contraindicated for patients who have had an acute myocardial infarction, suffer from hypotension, or are breastfeeding.

Side Effects
Common side effects of xanthine derivatives include nausea, vomiting, epigastric pain, headache, irritability, insomnia, tachycardia, extrasystoles, tachypnea, and in rare cases, hyperglycemia or albuminuria. Severe side effects due to overdose may include cardiac arrhythmias and tonic-clonic seizures, which are early signs of intoxication. If side effects occur, the treatment should be discontinued. If necessary, after symptoms of toxicity subside, the physician may allow resumption of treatment at lower doses.

Pregnancy & Lactation
Animal studies have shown that Doxophylline does not affect prenatal or postnatal growth. However, due to insufficient clinical evidence regarding its effects during pregnancy, the use of Doxophylline during pregnancy should be carefully evaluated by the physician based on the risk-benefit ratio. Doxophylline is contraindicated during lactation.

Effects on Ability to Drive and Use Machines
Doxophylline does not impair alertness and, therefore, does not affect the ability to drive or operate machinery.

Precautions & Warnings
Factors such as age, congestive cardiac decompensation, chronic obstructive pulmonary disease (COPD), severe liver disease, and concurrent infections may reduce the hepatic clearance of xanthine derivatives, increasing their blood levels. Additionally, certain drugs, including erythromycin, TAO, lincomycin, clindamycin, allopurinol, cimetidine, the influenza vaccine, and propranolol, may interact with Doxophylline in this manner. If these factors are present, dosage reduction may be required, and regular monitoring of blood levels is recommended to maintain therapeutic efficacy.

Caution is advised when administering Doxophylline to patients with cardiac conditions, hypertension, the elderly, severe hypoxemia, hyperthyroidism, chronic cor pulmonale, congestive heart failure, liver disease, peptic ulcer, or renal impairment. Patients with congestive heart failure require particular attention, as the drug may remain in the body for longer periods, even after treatment cessation. There is no risk of addiction or dependence.

Overdose Effects
In case of overdose, severe cardiac arrhythmias and tonic-clonic seizures may occur. These are early signs of toxicity, and the treatment should be discontinued. There is no specific antidote for overdose; symptomatic treatment should be initiated for cardiovascular collapse.

Therapeutic Class
Bronchodilator, Methyl xanthine derivatives

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