Ascova Tablet 400 mg

Description

Indications
Ascova 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
Ascova 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, causing relaxation of bronchial smooth muscle. Unlike Theophylline, Doxophylline has decreased affinity for adenosine A1 and A2 receptors, which contributes to its better safety profile. Doxophylline also inhibits platelet-activating factor (PAF) and reduces the generation 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 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
Ascova should not be used with other xanthine preparations. It is recommended to limit the consumption of caffeine-containing beverages and food. Caution should be observed when administering Ascova with ephedrine or other sympathomimetic drugs. Concurrent administration with medications such as erythromycin, TAO, lincomycin, clindamycin, allopurinol, cimetidine, influenza vaccine, and propranolol may reduce hepatic clearance of xanthine derivatives, leading to increased plasma levels of the drug. Conversely, phenytoin, other anticonvulsants, and cigarette smoking may increase the clearance of xanthine derivatives, reducing plasma half-life, which may require dosage adjustments.

Contraindications
Ascova is contraindicated in individuals 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 associated with 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 symptoms may be early signs of intoxication and may require discontinuation of treatment. If necessary, treatment can be resumed at lower doses after symptoms resolve.

Pregnancy & Lactation
Animal studies have shown that Doxophylline does not interfere with prenatal or postnatal growth. However, due to insufficient clinical evidence regarding its effects during pregnancy, Ascova should be used cautiously during pregnancy, with careful consideration of the risk-benefit ratio. The drug is contraindicated during lactation.

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

Precautions & Warnings
Various factors may 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 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 Ascova to patients with cardiac disease, hypertension, the elderly, 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, leading to 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. These may represent early signs of intoxication. Symptomatic treatment of cardiovascular collapse should be instituted, as there is no specific antidote. Treatment may be resumed at lower doses under the physician’s discretion once symptoms have resolved.

Therapeutic Class
Bronchodilator, Methyl xanthine derivatives

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