Doxolar Tablet 200 mg

Description

Indications
Doxolar is used to treat:

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

Use this medication only as directed by a registered physician.

Pharmacology
Doxolar contains Doxophylline, a novel bronchodilator that differs from Theophylline due to the presence of a dioxolane group at position 7. It selectively inhibits phosphodiesterase 4, which results in the relaxation of bronchial smooth muscle. Unlike Theophylline, Doxophylline has lower affinity for adenosine A1 and A2 receptors, which may contribute to its better safety profile. Additionally, Doxophylline inhibits platelet-activating factor (PAF) and reduces 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: 10 ml syrup or 200 mg tablet two or three times daily.
  • 6-12 years: 6-9 mg/kg body weight twice daily (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, Doxophylline SR tablets should be taken once daily or as prescribed by the physician.

Use this medication only as directed by a registered physician.

Interaction
Doxolar should not be used with other xanthine preparations. It is recommended to limit consumption of caffeine-containing food and beverages. Caution should be observed when taking Doxolar with ephedrine or other sympathomimetic drugs. The concurrent 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 drug plasma levels. On the other hand, phenytoin, other anticonvulsants, and smoking may increase xanthine clearance and reduce plasma half-life, necessitating potential dosage adjustments.

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

Side Effects
Common side effects of xanthine derivatives include nausea, vomiting, epigastric pain, headache, irritability, insomnia, tachycardia, extrasystoles, tachypnea, and, rarely, hyperglycemia or albuminuria. In case of overdose, severe cardiac arrhythmias and tonic-clonic seizures may occur. These may be early signs of intoxication, which may require discontinuation of treatment. If necessary, the treatment can be resumed at lower doses after symptoms resolve.

Pregnancy & Lactation
Animal studies suggest that Doxophylline does not affect prenatal or postnatal growth. However, due to insufficient clinical evidence regarding the effects of the drug during pregnancy, the use of Doxolar should be carefully evaluated on a case-by-case basis, weighing the risks and benefits. Doxolar is contraindicated during lactation.

The product does not affect alertness and does not interfere with the ability to drive or use machinery.

Precautions & Warnings
Several factors can reduce hepatic clearance of xanthine derivatives, leading to increased plasma levels of the drug. These factors include age, congestive cardiac decompensation, COPD, severe liver disease, infections, and the use of medications like erythromycin, TAO, lincomycin, clindamycin, allopurinol, cimetidine, influenza vaccine, and propranolol. In such cases, dosage reductions and blood level monitoring may be necessary.

Caution should be exercised when administering Doxolar to patients with cardiac disease, hypertension, the elderly, those with severe hypoxemia, hyperthyroidism, chronic corpulmonale, congestive heart failure, liver disease, peptic ulcers, or renal impairment. In particular, Doxolar should be used with caution in patients with congestive heart failure, as clearance of the drug is considerably slower in these patients, leading to prolonged high plasma levels even after discontinuation. There is no risk of addiction or dependence.

Overdose Effects
In case of overdose, severe cardiac arrhythmias and tonic-clonic seizures may occur. These may represent early signs of intoxication. Symptomatic treatment of cardiovascular collapse should be instituted, as there is no specific antidote. After symptoms resolve, treatment may be resumed at lower doses under the physician’s discretion.

Therapeutic Class
Bronchodilator, Methyl xanthine derivatives

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