Brezofil 400 mg

Description

Indications
Brezofil is prescribed for the treatment of the following conditions:

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

Use as directed by a registered healthcare professional.

Pharmacology
Brezofil contains Doxophylline, a new bronchodilator that differs from Theophylline due to the presence of a dioxolane group at position 7. Doxophylline primarily works by selectively inhibiting phosphodiesterase 4, leading to the relaxation of bronchial smooth muscles. Unlike Theophylline, Doxophylline has a lower affinity for adenosine A1 and A2 receptors, which contributes to its improved safety profile. Additionally, Doxophylline has been shown to inhibit platelet-activating factor (PAF) and the production of leukotrienes.

Dosage & Administration

• For elderly patients: Take 200 mg tablet two or three times daily.
• For adults: Take 400 mg tablet two or three times daily, or follow the dosage as prescribed by your physician.
• For children (ages 12 and above): Take 10 ml syrup or 200 mg tablet two or three times daily.
• For children (ages 6-12 years): Take 6-9 mg/kg of body weight twice daily. For example, if the child’s weight is 10 kg, administer 3 ml (60 mg) twice daily, or as prescribed by your doctor.
• If the required daily dose is 400 mg, a Doxophylline SR tablet should be taken once daily, or as prescribed by your physician.

Follow your healthcare provider’s guidance for usage.

Interactions
Brezofil should not be used alongside other xanthine-based medications. It is advisable to limit the intake of caffeine-containing foods and beverages. Extra caution is necessary when combining Brezofil with ephedrine or other sympathomimetic medications. Co-administration with drugs like erythromycin, TAO, lincomycin, clindamycin, allopurinol, cimetidine, influenza vaccine, or propranolol may reduce the liver’s ability to clear xanthine derivatives, leading to increased drug levels in the blood. On the other hand, medications like phenytoin, certain anticonvulsants, and smoking may speed up drug clearance, possibly reducing its effectiveness. In such cases, dosage adjustments may be necessary.

Contraindications
Doxophylline should not be used in patients who are hypersensitive to the drug or other xanthine derivatives. It is also contraindicated for individuals with acute myocardial infarction, hypotension, or those who are breastfeeding.

Side Effects
Common side effects of xanthine derivatives may include nausea, vomiting, stomach pain, headaches, irritability, insomnia, fast heart rate, irregular heartbeats, rapid breathing, and, in rare cases, hyperglycemia or albuminuria. In case of an overdose, severe heart arrhythmias or tonic-clonic seizures may occur, signaling potential toxicity. If these side effects arise, the treatment may need to be stopped. If necessary, your doctor may reintroduce the medication at a lower dose once symptoms have subsided.

Pregnancy & Lactation
Animal studies suggest that Doxophylline does not interfere with pre-and postnatal development. However, due to the lack of sufficient clinical evidence regarding its safety during pregnancy, the drug should only be used when the potential benefits outweigh the risks. Doxophylline is contraindicated during breastfeeding.

Effect on Ability to Drive and Operate Machinery
Brezofil does not affect alertness, so it does not impair the ability to drive or operate machinery.

Precautions & Warnings
Factors such as age, chronic conditions like heart failure or COPD, liver disease, and infections can slow the liver’s ability to clear the drug, leading to higher blood levels. In these cases, the dosage may need to be adjusted. Patients with heart disease, hypertension, liver or kidney problems, or those who are elderly should use Brezofil cautiously. In particular, caution is needed in patients with heart failure, as the drug’s clearance may be delayed, resulting in prolonged high blood levels. The drug is non-addictive and does not cause dependence.

Overdose Effects
In case of an overdose, severe heart arrhythmias and tonic-clonic seizures may occur, indicating potential toxicity. Discontinuation of treatment may be necessary. Symptomatic treatment should be provided, as there is no specific antidote for overdose. The dosage may be re-adjusted once the toxicity signs have disappeared.

Therapeutic Class
Bronchodilator, Methyl Xanthine Derivative

Storage Conditions
Store in a dry place, protected from light and heat. Keep out of reach of children. Use only as prescribed by a specialist physician.