Brophyle Capsule

Acebrophylline Capsules 100 mg

Each hard gelatin capsule contains

Acebrophylline 100 mg

Excipients q.s.

Capsule 100 mg

4.1 Therapeutic indication

For the treatment of chronic obstructive pulmonary disease, bronchial asthma and bronchitis.

4.2 Posology and method of administration

Adults

The usually recommended dose of acebrophylline for adults is one Brophyle Capsules twice daily. Acebrophylline capsules are not recommended for use in children (who may find difficulty in swallowing capsules).

In elderly patients dosage may be adjusted if required.

4.3 Contraindications

• Hypersensitivity to ambroxol, acebrophylline, theophylline or any other xanthine derivative
• Patients suffering from acute myocardial infarction
• Patients with hypotension, hemodynamic instability, and arrhythmias
• Patients with renal disease or liver disorder

4.4 Special warnings and precautions for use

Careful monitoring is recommended for patients with congestive heart failure, chronic alcoholism, hepatic dysfunction, or viral infections. Caution should be exercised in patients with cardiac arrhythmias, other cardiovascular diseases, hyperthyroidism or hypertension, gastric and duodenal ulceration or convulsive disorders. Patients with hepatic and renal insufficiency should take it with caution.

4.5 Drugs interactions

The following reduce clearance and a reduced dosage may therefore be necessary to avoid side-effects: allopurinol, cimetidine, ciprofloxacin, corticosteroids, diltiazem, erythromycin, frusemide, isoprenaline, oral contraceptives, thiabendazole and verapamil, doxycycline, amoxicillin etc.

Xanthines can potentiate hypokalaemia resulting from beta2-agonist therapy, steroids, diuretics and hypoxia. Particular caution is advised in severe asthma. It is recommended that serum potassium levels are monitored in such situations.

No clinically relevant unfavourable interactions with other medications have been reported.

4.6 Use in special populations

Pregnancy

Acebrophylline is not recommended in pregnancy as well as during parturition.

Lactation

The safety of acebrophylline is not established during lactation period. Hence the use of acebrophylline is not advisable in lactating mothers.

4.7 Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been performed.

4.8 Undesirable effects

Transient nausea and dizziness may occur on taking this drug, but these effects are reversible. On cessation of therapy, these symptoms tend to disappear.

The commonly reported adverse effects with acebrophylline include abdominal discomfort, stomach/abdominal distension, vomiting, abdominal pain, diarrhea, constipation, heart burn, loss of appetite, esophageal bleeding, rashes, urticaria, itching, drowsiness, difficulty in breathing, leukocytosis, and nasal inflammation. If chills and fevers occur, the drug should be immediately discontinued.

Other rarely reported adverse events include headache, occasional numbness including numbness in arm, insomnia, tachycardia, fatigue, hypertension, albuminuria, glycosuria, hypotension and occasionally hyperglycemia.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via email to: medico@zuventus.com

Website: http://www.zuventus.co.in/safety.aspx

By reporting side effects, you can help provide more information on the safety of this medicine.

4.9 Overdose

Nausea, vomiting (which is often severe), epigastric pain and haematemesis. Pancreatitis if abdominal pain persists. Restlessness, hypertonia, exaggerated limb reflexes and convulsions. Tachycardia is common.

Symptomatic treatment should be provided.

5.1 Mechanism of Action

Acebrophylline is a compound which has been found to act as a bronchodilating, mucoregulating and anti-inflammatory drug due to its components theophylline-7-acetate and ambroxol.

Theophylline-7-acetate, as with other xanthinic derivatives, has a bronchodilator effect due to inhibition of the intracellular phosphodiesterases, followed by an increase of adenosine monophosphate cyclic levels, which promote the relaxation of bronchial muscles.

Ambroxol modifies the mucous gel phase of secretions by decreasing the viscosity and increasing the serous gel phase. It increases the mucociliary clearance by stimulating cilia motility.

5.2 Pharmacodynamic properties

Acebrophylline inhibits phospholipase A2 and phosphatidylcholine leading to lesser production of the powerful pro-inflammatory substances like leukotrienes and tumor necrosis factor. By inhibiting the synthesis and release of these inflammatory mediators, acebrophylline reduces inflammation, a key factor in airway obstruction, especially in chronic forms.

5.3 Pharmacokinetic properties

In healthy volunteers, given 200 mg oral acebrophylline, the two components of the molecule ambroxol and theophylline-7 acetic acid are released in the stomach and absorbed in the intestine, reaching optimal concentrations of ambroxol within 2 hours and of theophylline-7 acetic acid after 1 hour. The plasma half-life varies from 4 to 9 hours after oral administration. The drug is metabolized in the liver and eliminated renally.

6.1 Animal Toxicology or Pharmacology

Negative interference has been reported between theophylline and erythromycin and in animal’s simultaneous administration of theophylline together with erythromycin estolate at doses that alone are non-toxic enhanced the toxicity of the former, as indicated by the drastic drop in the LD50, i.e. the dose causing the death of half the animals. In similar experimental conditions, acebrophylline was not affected by simultaneous use of erythromycin, and not only was there no reduction in the LD50 but in some cases it was actually higher, indicating the safety of the two components as regards their potential tolerability in patients.

Acebrophylline, an airway mucoregulator and anti-inflammatory agent is a combination product of ambroxol and theophylline 7 acetic acid.

8.1 Incompatibilities

Not applicable

8.2 Shelf-life

Refer on pack

8.3 Packaging information

8.4 Storage and handing instructions

Store below 30°C. Protect from light & moisture.

• You have been prescribed Acebrophylline for prevention and treatment of asthma and chronic obstructive pulmonary disease (COPD).
• It should be taken at the same time each day, preferably in the evening after food.
• It does not work right away and should not be used to relieve sudden breathing problems. Always keep a fast-acting (rescue) inhaler with you.
• Your doctor may take regular blood test to monitor potassium level and the level of this medicine in your body.
• Notify your doctor if you have ever been diagnosed with kidney, liver or heart disease, or if you have a smoking history. Your dose may need to be adjusted.
• Do not discontinue use without consulting your doctor, even if you feel better.

18.05.2022