Doxomate Tablet 400 mg

Description

Indications
Doxomate is used in 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
Doxomate contains Doxophylline, a novel bronchodilator that differs structurally from Theophylline due to the presence of a dioxolane group at position 7. Doxophylline selectively inhibits phosphodiesterase 4 (PDE4), resulting in the relaxation of bronchial smooth muscle. Unlike Theophylline, Doxophylline has a reduced affinity for adenosine A1 and A2 receptors, which contributes to its enhanced safety profile. Additionally, Doxophylline inhibits platelet-activating factor (PAF) and decreases the production 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 required daily dose is 400 mg, sustained-release (SR) tablets should be taken once daily or as prescribed by the physician.

Use this medication only as directed by a registered physician.

Interaction
Doxomate should not be used with other xanthine derivatives. Limiting intake of caffeine-containing foods and beverages is recommended. Caution should be exercised when administering Doxomate with ephedrine or other sympathomimetic drugs. The concurrent use of drugs such as erythromycin, TAO, lincomycin, clindamycin, allopurinol, cimetidine, influenza vaccine, and propranolol may reduce the hepatic clearance of xanthine derivatives, increasing their plasma levels. Phenytoin, other anticonvulsants, and cigarette smoking can increase the clearance of xanthine derivatives, decreasing their plasma half-life, which may require dosage adjustments.

Contraindications
Doxomate is contraindicated in individuals with:

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

Side Effects
Common side effects may include:

• Nausea, vomiting, epigastric pain, headache, irritability, insomnia, tachycardia, extrasystoles, tachypnea.
• Rare effects may include: Hyperglycemia, albuminuria.
  In the case of an overdose, severe cardiac arrhythmias and tonic-clonic seizures may occur, which may be early signs of intoxication. Discontinuation of the drug may be necessary, and if deemed appropriate by the physician, treatment may be resumed at lower doses once the symptoms subside.

Pregnancy & Lactation
Animal studies indicate that Doxophylline does not interfere with prenatal or postnatal growth. However, due to insufficient clinical evidence regarding its effects during pregnancy, its use should be evaluated on a case-by-case basis, weighing the risk-benefit ratio. Doxomate is contraindicated during lactation.

Effects on Driving & Machine Operation
Doxomate does not impair the patient’s alertness and therefore does not affect the ability to drive or operate machinery.

Precautions & Warnings
Several factors can reduce the hepatic clearance of xanthine derivatives, increasing their plasma levels, such as:

• Age
• Congestive cardiac decompensation
• Chronic obstructive pulmonary disease
• Severe liver disease
• Concomitant infections
• Concurrent use of drugs like erythromycin, TAO, lincomycin, clindamycin, allopurinol, cimetidine, influenza vaccine, and propranolol

In these situations, it may be necessary to reduce the dosage, and monitoring blood levels of the drug is recommended to maintain its therapeutic range.

Use with Caution in Patients with:

• Cardiac disease
• Hypertension
• Severe hypoxemia
• Hyperthyroidism
• Chronic corpulmonale
• Congestive heart failure
• Liver disease
• Peptic ulcer
• Renal impairment

Particular caution is required in congestive heart failure, as drug clearance is slower in these patients, leading to higher plasma levels that may persist even after discontinuation of treatment. No risk of addiction or dependence.

Overdose Effects
In case of overdose, cardiac arrhythmias and tonic-clonic seizures may occur. These are early signs of toxicity. In the absence of a specific antidote, symptomatic treatment for cardiovascular collapse should be initiated.

Therapeutic Class
Bronchodilator, Methyl xanthine derivatives

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