Acebrophylline Sustained Release Tablets 200 mg
Each film coated sustained release tablet contains:
Acebrophylline...............................200 mg
Excipients....q.s.
Colour: Titanium Dioxide IP
Tablet 200 mg
For the treatment of adult patients with chronic obstructive pulmonary disease (COPD) and bronchial asthma.
Adults
1 tablet once daily.
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.
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.
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.
Aerolys SR Tablet does not usually affect the ability to drive.
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 authorization 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@zorvia.com
By reporting side effects, you can help provide more information on the safety of this medicine.
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.
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.
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.
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.
No known animal toxicology data
Aerolys contains acebrophylline, an airway mucoregulator and anti-inflammatory agent. It is a combination of ambroxol and theophylline-7-acetic acid.
Not applicable
Refer on pack
Refer on pack
Store protected from light & moisture, at a temperature not exceeding 30°C.
Improper storage may deteriorate the product.
Keep out of reach of children.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to: medico@zorvia.com
By reporting side effects, you can help provide more information on the safety of this medicine.