Prescribing information
Acebrophylline Capsules : AB Phylline
Dosage Form : Capsules
Composition: Each capsule contains Acebrophylline 100 mg
CJinica! Pharmacology : Acebrophylline, chemically ambroxo! theophylline-7-acetate (ambroxol acephyllinate), is a compound with both mucolytic and bronchodilator properties.
Mechanism of Action : Acebrophylline is a compound which has been found to act both as a mucoregulating and a bronchodilating drug, due to its components ambroxol and
theophyl!ine-7-acetate. Theophyl!ine-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 ihe relaxation of bronchial muscles. Ambroxoi modifies the mucous gel phase of secretions by decreasing the viscosity
and increasing the serous gei phase! It increases the mucociiiary clearance by stimulating cilia motility and it stimulates the synthesis of surfactant by acting on the type II pneumocytes.
Clinical studies have shown that acebrophylline is useful in the treatment of acute exacerbations of chronic bronchitis or COPD and its effect is greater than that obtained with ambroxol or
theophylline alone. Comparative studies performed with acebrophylline antftheophylline have shown that while both drugs are effective in irnprovingjespiratory function, acebrophylline
has a more marked effect on the most important rheologic parameters, such as a motβ’β’> rapid disappearance of coughing and expectoration and more reduction of severity and frequency of
asthma attack. Comparative clinical studies conducted on acebrophyiline versus ambroxol, demonstrated acebrophylline to be more active than ambroxol in relieving clinical signs and
symptoms (amount and appearance of sputum, auscultatory signs and dyspnea), and improving respiratory function. Also, acebrophylline's action was significantly more superior to that of
ambroxoi as a result ofthe stronger stimulation of pulmonary surfactant production and more effective mucoreguiation. Acebrophylline also significantly reduced the frequency of the bronchospastic attacks.
Pharmacokinetics : In healthy volunteers, given 200 mg oral acebrophyliine, the two components of the molecule ambroxol and theophylline-7 acetic acid are released in the stomach
β’and absorbed there and in the intestine, reaching optimal concentrations of ambroxol within 2 hours and theophyiline-7-acetic acid after 1 hour. The plasma half life varies from 4-9 hours after oral administration. The drug is metabolized in the liver and eliminated renally.
Indications: AB Phyliine is indicated for the treatment of adult patients with chronic obstructive pulmonary disease (COPD) and branch ialjasthma.
Centra-indications: Hypersensitivity to ambroxol, acebrophylline, theophylline or any other xanthine derivative. ~
Β« Patient suffering from acute myocardial infarction.
β’ Patients with hypotension, hemodynamic instability and arrhythmias'. . β’ , Patients with renal disease or liver disorder.
Warnings and Precautions : Caution is advised in patients with cardiac insufficiency, other cardiovascular diseases, coronary artery disease, hypertension and preexisting arrhythmia's. Acebrophyiline capsule should be carefully administered in patients with a history of epilepsy and hyperthyroidism. Care should be taken in patients having gastrointestinal disorders like duodenal ulcer. Caution is advised in patients with severe respiratory disease. Careful monitoring is advised in elderly patients, those consuming alcohol, or smoking, patients with renal and/or hepatic impairment, those with vascular occlusion or congestive heart failure, since these may lead to higher plasma levels of the drug. A lower dose may be required under these conditions. Prolonged use may lead to increased plasma levels of the drug. -
Pregnancy & Lactation : Acebrophylline is not recommended in pregnaricy-as well as during parturition. The safety of acebrophyiline is not established during lactation period. Hence the use of acebrophyliine is not advisable in nursing mothers.
Drug Interactions : The plasma concentration of acebrophylline may be increased by concurrent administration of erythromycin, cephalexin, oxytetracyline, oligomycin, lincomycin, cimetidine, clindamycin, ailopurinoi, quinolones, anticoagulants, etc. If concomitant use is essential, the dose of acebrophylline should be reduced. The concomitant Bse of acebrophylline and furosemide can potentiate diuresis, while concomitant use of acebrophylline with reserpine can cause tachycardia. Acebrophylline plasma concentration may be decreased in patients
β’by coadministration with drugs like phenytoin and barbiturates and in patients who smoke. It is advisable not to use acebrophylline with any other theophylline derivative,.,ambroxol derivative or central nervous system stimulants. Caution is advised when acebrophylline is used with ephedrine, sympathomimetics and any other bronchodilator.
Side effects : Transient nausea and dizziness may occur on taking this drug, but these effects are reversible. On cessation of therapy, these symptoms automatically 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 nasai inflammation. If chills and fever 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:
Overdosage : There is no clinical data available on overdosage with acebrophylline. However, if overdosage with acebrophylline occurs, it can cause ventricular tachycardia and cardiac arrhythmia. In case of overdosage, patient should be given active charcoal with laxative and emesis should be induced. Ventilation should be ensured, and respiratory rate and biood pressure should be closely monitored. If acebrophylline treatment is required again even after an overdose, the treatment should begin after complete recovery, using smaller doses.
Dosage and Administration : The usually recommended dose of AB Phylline for adults is one capsule twice daily. Elderly: Dosage should be adjusted if required in elderly patients. Pediatric use: Acebrophylline capsules are not recommended in children.
Incompatibilities: None known. β’
Storage & Handling: Store in a cool, dry place, protected from light. Keep out of reach of children.
Expiry Date: Refer product label for expiry date. Do not use after expiry date.
Presentation: AB Phylline is available in the strips of 10 capsules.
Radiant A division of /'P\ Sun Pharmaceutical Industries Ltd