Axofyl Tablet 200 mg

Description

Indications
Axofyl is used for the treatment of:

• 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
Axofyl contains Doxophylline, a novel bronchodilator. Structurally, it differs from Theophylline by the presence of a dioxolane group at position 7. Doxophylline selectively inhibits phosphodiesterase 4 (PDE4), leading to the relaxation of bronchial smooth muscle. Unlike Theophylline, Doxophylline has a reduced affinity for adenosine A1 and A2 receptors, which may contribute to its improved safety profile. Additionally, Doxophylline is known 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: 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 Doxophylline is required, a sustained-release (SR) tablet should be taken once daily or as prescribed by the physician.

Use this medication only as directed by a registered physician.

Interaction
Axofyl should not be taken with other xanthine derivatives. Consumption of caffeine-containing foods and beverages should be limited. Caution is required when using Axofyl with ephedrine or other sympathomimetic drugs. Concurrent use of medications such as erythromycin, TAO, lincomycin, clindamycin, allopurinol, cimetidine, influenza vaccine, and propranolol may reduce hepatic clearance of xanthine derivatives, increasing their plasma levels. Phenytoin, other anticonvulsants, and cigarette smoking may accelerate xanthine clearance, shortening the drug’s half-life and necessitating potential dosage adjustments.

Contraindications
Axofyl is contraindicated in individuals with:

• Hypersensitivity to Doxophylline or other xanthine derivatives
• Acute myocardial infarction
• Hypotension
• Lactation

Side Effects
Patients treated with xanthine derivatives may experience:

• Common: Nausea, vomiting, epigastric pain, headache, irritability, insomnia, tachycardia, extrasystoles, tachypnea
• Rare: Hyperglycemia, albuminuria
• Overdose Symptoms: Severe cardiac arrhythmias and tonic-clonic seizures, which may indicate early signs of intoxication. If side effects occur, treatment may need to be discontinued or resumed at lower doses under medical supervision.

Pregnancy & Lactation
Animal studies suggest that Doxophylline does not interfere with prenatal or postnatal growth. However, due to insufficient clinical data, its use during pregnancy should be carefully considered based on a risk-benefit analysis. The drug is contraindicated during lactation.

Effects on Driving & Machine Operation
Axofyl does not impair alertness and does not interfere with the ability to drive or operate machinery.

Precautions & Warnings
Factors that may reduce hepatic clearance of xanthine derivatives, increasing plasma drug levels, include:

• Age
• Congestive cardiac decompensation
• Chronic obstructive pulmonary disease
• Severe liver disease
• Concomitant infections
• Concurrent use of medications such as erythromycin, TAO, lincomycin, clindamycin, allopurinol, cimetidine, influenza vaccine, and propranolol

In these cases, dose adjustments and blood level monitoring are recommended to maintain the therapeutic range.

Special Caution Required for Patients with:

• Cardiac disease
• Hypertension
• Severe hypoxemia
• Hyperthyroidism
• Chronic corpulmonale
• Congestive heart failure
• Liver disease
• Peptic ulcer
• Renal impairment

Particularly in congestive heart failure, drug clearance is slower, and high plasma levels may persist even after treatment discontinuation. There is no risk of addiction or dependence.

Overdose Effects
Overdose may cause severe cardiac arrhythmias and tonic-clonic seizures, which could indicate early toxicity. If overdose occurs, symptomatic treatment for cardiovascular collapse should be initiated, as there is no specific antidote. Treatment may be resumed at lower doses once symptoms subside under the guidance of a physician.

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