Novetor Tablet 200 mg

Description

Indications
Novetor is used for 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
Novetor contains Doxophylline, a novel bronchodilator that structurally differs from Theophylline by the presence of a dioxolane group at position 7. Doxophylline selectively inhibits phosphodiesterase 4 (PDE4), which relaxes bronchial smooth muscle. Unlike Theophylline, Doxophylline has a lower affinity for adenosine A1 and A2 receptors, contributing to its better safety profile. Additionally, Doxophylline inhibits platelet-activating factor (PAF) and reduces 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 a daily dose of 400 mg Doxophylline is required, a sustained-release (SR) tablet should be taken once daily or as prescribed by the physician.

Use this medication only as directed by a registered physician.

Interaction
Novetor should not be taken with other xanthine derivatives. Limit the intake of caffeine-containing foods and drinks. Caution is advised when using Novetor alongside ephedrine or other sympathomimetic drugs. Concurrent use of medications such as erythromycin, TAO, lincomycin, clindamycin, allopurinol, cimetidine, influenza vaccine, and propranolol may reduce the liver clearance of xanthine derivatives, increasing their plasma levels. Phenytoin, other anticonvulsants, and cigarette smoking can increase the clearance of xanthines, decreasing their plasma half-life, which may necessitate dose adjustments.

Contraindications
Novetor is contraindicated in individuals with:

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

Side Effects
Patients treated with xanthine derivatives may experience:

• Common: Nausea, vomiting, epigastric pain, headache, irritability, insomnia, tachycardia, extrasystoles, tachypnea
• Rare: Hyperglycemia, albuminuria
• Overdose Symptoms: Severe cardiac arrhythmias and tonic-clonic seizures, which may indicate early signs of intoxication. Discontinuation of the drug may be necessary, with possible resumption at lower doses under the physician’s discretion.

Pregnancy & Lactation
Animal studies show that Doxophylline does not affect pre- or postnatal growth. However, due to insufficient clinical data, its use during pregnancy should be evaluated based on the risk-benefit ratio. Novetor is contraindicated during lactation.

Effects on Driving & Machine Operation
Novetor does not impair alertness, so it does not affect the ability to drive or operate machinery.

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

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

In these cases, it may be necessary to reduce the dose, and blood level monitoring is advised to maintain therapeutic efficacy.

Special Caution Required for Patients with:

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

Particularly in congestive heart failure, drug clearance is slower, and high plasma levels may persist, even after treatment is stopped. No risk of addiction or dependence.

Overdose Effects
In overdose cases, cardiac arrhythmias and tonic-clonic seizures may occur. These are early signs of intoxication. In such cases, symptomatic treatment for cardiovascular collapse should be initiated. No specific antidote exists, so treatment should focus on managing overdose symptoms.

Therapeutic Class
Bronchodilator, Methyl xanthine derivatives

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