Doximar Syrup 100 mg/5 ml

Description

Indications
Doximar is used to treat the following conditions:

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

Pharmacology
Doxophylline is a novel bronchodilator. Structurally, it differs from Theophylline due to the presence of a dioxolane group in position 7. Doxophylline selectively inhibits phosphodiesterase 4, leading to the relaxation of bronchial smooth muscle. Unlike Theophylline, Doxophylline has a lower affinity for adenosine A1 and A2 receptors, which contributes to its better safety profile. It also inhibits platelet-activating factor (PAF) and the generation of 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 of age: 10 ml syrup or 200 mg tablet, two or three times daily.
  • 6-12 years of age: 6-9 mg/kg body weight, two times daily (e.g., for a child weighing 10 kg, 3 ml (60 mg) two times daily).
    If the daily dose is 400 mg, Doxophylline SR tablet should be taken once daily or as prescribed by the physician.

Interaction
Doximar should not be administered with other xanthine preparations. Consumption of caffeine-containing beverages and food should be limited. Caution is advised when administering Doximar with ephedrine or other sympathomimetic drugs. Several drugs, such as erythromycin, TAO, lincomycin, clindamycin, allopurinol, cimetidine, influenza vaccine, and propranolol, may reduce the hepatic clearance of xanthine derivatives, leading to an increase in plasma levels. Conversely, drugs like phenytoin and anticonvulsants, or cigarette smoking, may increase the clearance of xanthine derivatives, potentially reducing plasma half-life, which may necessitate dosage adjustments.

Contraindications
Doxophylline is contraindicated in individuals with known hypersensitivity to the drug or other xanthine derivatives. It is also contraindicated in patients with acute myocardial infarction, hypotension, and during lactation.

Side Effects
Patients treated with xanthine derivatives may experience 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 may represent signs of intoxication, and the appearance of side effects may require discontinuation of the treatment. If necessary, treatment may be resumed at lower doses after all signs and symptoms of toxicity have subsided.

Pregnancy & Lactation
Animal studies have shown that Doxophylline does not interfere with pre- and postnatal growth. However, due to insufficient clinical evidence on the effects during pregnancy, the use of the drug should be carefully evaluated on a case-by-case basis, considering the risk-benefit ratio. The drug is contraindicated during lactation.
The product does not affect the patient’s alertness, so it does not interfere with their ability to drive or use machines.

Precautions & Warnings
Certain factors may 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 use of certain drugs like erythromycin, TAO, and others. In these cases, dosage reduction may be necessary. It is recommended to monitor blood concentrations of the drug in patients with these risk factors.
Use caution in patients with cardiac disease, hypertension, the elderly, severe hypoxemia, hyperthyroidism, chronic corpulmonale, congestive heart failure, liver disease, peptic ulcers, and renal impairment. In particular, patients with congestive heart failure should be closely monitored as the drug may remain in their system longer, 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, which may represent the first signs of intoxication. Symptomatic treatment of cardiovascular collapse should be initiated as there is no specific antidote. If necessary, treatment may be resumed at lower doses after signs of toxicity subside.

Therapeutic Class
Bronchodilator, Methyl xanthine derivatives

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