Drug Interaction:
Plasma concentration of acebrophylline may be increased by concurrent admin. of erythromycin, cephalexin, oxytetracycline, oligomycin, lincomycin, cimetidine, clindamycin, allopurinol, quinolones, anticoagulants etc.
If concurent use of acetobrophylline is essential the dose of acebrophylline should be reduced.
Concomittant use of acetobrophylline and furosemide can potentiate diuresis.
Concomittant of use of acetobrophylline and reserpine can cause tachycardia
Acetobrophylline plasma conc. may be decreased in patients by co-administration with drugs like phenytoin and barbiturates and in patients who smoke.
Advisable not to use acebrophylline with any other theophylline derivative, ambroxol derivative or central nervous stimulants.
Caution is adviced when acetobrophylline is used with ehpedrine, symapthominietics and other bronchodilator.
Indication:
U.S.FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
141. Acebrophylline capsules 100mg 29-05-08
For the treatment of adult patients with chronic
obstructive pulmonary disease and bronchial asthma
New drugs approved For Marketing by Drug Controller General of India(DCGI )
during the period January 1988 to November 2014
(Ref- IDMA Annual Publication 2015)
Name of Drug Indication Date of Approval
1.Acebrophylline capsules 100mg 29-05-2008
For the treatment of adult patients with chronic obstructive pulmonary
disease and bronchial asthma
2. Acebromophylline syrup 10mg/ml 09-01-2009
For the treatment of adult patients with chronic obstructive pulmonary
disease (COPD) and bronchial
3.Acebromophylline syrup 10mg/ml (Addl.Indn.) 30-03-2009
For the treatment of children (age 6 to 12 years) with chronic obstructive
pulmonary disease COPD) and bronchial asthma
COPD Asthma
Adverse Reaction:
Mild gastrointestinal discomfort stomach/abdominal distention vomiting abdominal pain
diarrrhea constipation heartburn loss of appetite oespophageal bleeding rashes urticaria
itching drowsiness difficulty in breathing leucocytosis and nasal
Rarely reported numbness in arm insomnia tachycardia fatigue hypertension albuminuria
glycosuria hypotension hyperglycemia
Contra-Indications:
Hypersentivity to ambroxol, acebromophylline, thophylline or any other xanthine derivative
Acute myocardial infarction
Hypotension, hemodynamic instability and arrhythmias
renal disease liver disorder
Dosages/ Overdosage Etc:
COPD
Asthma
Pharmacology/ Pharmacokinetics:
Pharmacology
Mechanism of action Acebrophylline is an anti-inflammatory and air way mucus regulator it contains ambroxol and theophylline -7 acetic acid, the former facilitates the biosynthesis of pulmonary surfactant while later raises blood levels of amboxol therby stimulating surfactant production The improvement in ciliary clearance results by reduction in the viscosity and adhesivity of mucus.
Pharmacokinetics
Ambroxol and theophylline -7 acetic acid reach optimal concentration and very low levels in the intestine respy. Ambroxol reaches its peak concentration in 2 hours and theophylline -7 acetic acid after 1 hour
Interaction with Food:
Not reported
Pregnancy and lactation:
Not reported