Doxonorm Tablet 400 mg

Description

Indications
Doxonorm 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
Doxonorm contains Doxophylline, a novel bronchodilator that differs from Theophylline by the presence of a dioxolane group at position 7. Doxophylline selectively inhibits phosphodiesterase 4, causing relaxation of bronchial smooth muscle. Unlike Theophylline, Doxophylline has reduced affinity for adenosine A1 and A2 receptors, which may contribute to its superior safety profile. Additionally, Doxophylline inhibits platelet-activating factor (PAF) and reduces leukotriene generation.

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 the daily dose of Doxophylline is 400 mg, 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
Doxonorm should not be used with other xanthine preparations. It is advised to limit consumption of caffeine-containing foods and beverages. Caution is needed when administering Doxonorm with ephedrine or other sympathomimetic drugs. Concurrent use of drugs like erythromycin, TAO, lincomycin, clindamycin, allopurinol, cimetidine, influenza vaccine, and propranolol can reduce the hepatic clearance of xanthine derivatives, increasing plasma drug levels. On the other hand, drugs such as phenytoin, other anticonvulsants, and cigarette smoking may accelerate xanthine clearance, shortening plasma half-life, potentially requiring dosage adjustments.

Contraindications
Doxonorm is contraindicated in individuals with known 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, in rare cases, hyperglycemia or albuminuria. In case of overdose, severe cardiac arrhythmias and tonic-clonic seizures may occur. These may be early signs of intoxication, requiring discontinuation of treatment. If necessary, treatment can be resumed at lower doses after symptoms resolve.

Pregnancy & Lactation
Animal studies have shown no interference with prenatal or postnatal growth by Doxophylline. However, due to insufficient clinical evidence on its effects during pregnancy, Doxonorm should be used cautiously during pregnancy after evaluating the risk-benefit ratio. The drug is contraindicated during lactation.

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

Precautions & Warnings
Various factors may reduce the hepatic clearance of xanthine derivatives, increasing plasma drug levels. These factors include age, congestive cardiac decompensation, COPD, severe liver disease, infections, and concurrent use of medications like erythromycin, TAO, lincomycin, clindamycin, allopurinol, cimetidine, influenza vaccine, and propranolol. In such cases, it may be necessary to reduce the dosage and monitor blood levels of the drug to ensure it remains within the therapeutic range.

Caution should be exercised when administering Doxonorm 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, it should be used with caution in patients with congestive heart failure, as drug clearance is significantly slower in these patients, resulting in prolonged high plasma levels. There is no risk of addiction or dependence.

Overdose Effects
In case of overdose, severe cardiac arrhythmias and tonic-clonic seizures may occur, signaling possible intoxication. Symptomatic treatment for cardiovascular collapse should be initiated, as there is no specific antidote. Treatment may be resumed at lower doses under the physician’s discretion once symptoms resolve.

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. Doxonorm should only be used under the prescription of a specialist physician.