Filodox Syrup 100 mg/5 ml

Description

Indications
Filodox 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
Filodox contains Doxophylline, a novel bronchodilator that structurally differs from Theophylline due to 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 reduced affinity for adenosine A1 and A2 receptors, resulting in a better 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 (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
Filodox should not be taken with other xanthine derivatives. Consumption of caffeine-containing foods and beverages should be limited. Caution is required when using Filodox 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 the hepatic clearance of xanthine derivatives, increasing plasma levels. Phenytoin, other anticonvulsants, and cigarette smoking may accelerate xanthine clearance, leading to a shorter half-life, which may require a dosage adjustment.

Contraindications
Filodox is contraindicated in patients with:

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

Side Effects
Patients taking 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 be 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 indicate that Doxophylline does not interfere with prenatal or postnatal development. However, due to insufficient clinical data, its use during pregnancy should be carefully evaluated based on risk-benefit analysis. The drug is contraindicated during lactation.

Effects on Driving & Machine Operation
Filodox 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, leading to increased 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.

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 significantly slower, leading to 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 can 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, as per 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 the reach of children. Filodox should only be used under the prescription of a specialist physician.