Dofolin Tablet 400 mg

Description

Indications
Dofolin is used for the treatment of:

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

Use this medication only as directed by a registered physician.

Pharmacology
Dofolin 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, 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. It also inhibits platelet-activating factor (PAF) and decreases 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 (e.g., for a child weighing 10 kg, give 3 ml (60 mg) twice daily) or as prescribed by the physician.
    If a daily dose of 400 mg is required, the Doxophylline SR tablet should be taken once daily or as directed by the physician.

Use this medication only as directed by a registered physician.

Interaction
Dofolin should not be taken with other xanthine preparations. It is advisable to limit the consumption of foods and beverages containing caffeine. Caution is necessary when administering Dofolin with ephedrine or other sympathomimetic drugs. The use of drugs such as erythromycin, TAO, lincomycin, clindamycin, allopurinol, cimetidine, influenza vaccine, and propranolol may decrease the hepatic clearance of xanthine derivatives, resulting in elevated plasma drug levels. On the other hand, phenytoin, other anticonvulsants, and smoking may enhance the clearance of xanthine derivatives, shortening their plasma half-life. In these situations, dosage adjustments may be necessary.

Contraindications
Dofolin 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
Patients using xanthine derivatives may experience nausea, vomiting, epigastric pain, headache, irritability, insomnia, tachycardia, extrasystoles, tachypnea, and, in rare cases, hyperglycemia or albuminuria. In the event of an overdose, severe cardiac arrhythmias and tonic-clonic seizures may occur, indicating early signs of intoxication. If side effects appear, discontinuation of treatment may be necessary, with the option to resume at lower doses after symptoms subside, at the physician’s discretion.

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

The drug does not impair alertness and therefore does not interfere with the ability to drive or operate machinery.

Precautions & Warnings
Several factors can reduce the hepatic clearance of xanthine derivatives, leading to higher plasma levels. These include age, congestive cardiac decompensation, COPD, severe liver disease, infections, and the concurrent use of medications such as erythromycin, TAO, lincomycin, clindamycin, allopurinol, cimetidine, influenza vaccine, and propranolol. In these cases, dosage adjustments may be required, and blood level monitoring is recommended to ensure therapeutic range control.

Caution is advised when administering Dofolin 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, patients with congestive heart failure may experience prolonged drug retention, with high levels persisting even after treatment is discontinued. There is no risk of addiction or dependence.

Overdose Effects
In case of overdose, severe cardiac arrhythmias and tonic-clonic seizures may occur, signaling early intoxication. Symptomatic treatment for cardiovascular collapse should be initiated. As there is no specific antidote, treatment may be resumed at lower doses after symptoms resolve, under 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 reach of children. Dofolin should be used only on the prescription of a specialist physician.