Acetylcysteine, ambroxol HCl.
Each capsule contains acetylcysteine 300 mg and ambroxol hydrochloride 60 mg.
Pharmacotherapeutic Group: Mucolytic.
Pharmacology: Pharmacodynamics: Ambroxol, a substituted benzylamine, is a metabolite of bromhexine. It differs from bromhexine by the absence of a methyl group and the introduction of a hydroxyl group in the para-trans position of the cyclohexyl ring. Although its mechanism of action has yet to be completely elucidated; secretolytic and secretomotor effects have been found in various investigations. However, on average, action following oral administration commences after 30 min and persist for 6-12 hrs depending on the extent of the single dose.
In preclinical investigations, it increases the proportion of serous bronchial secretion. The transport of mucus is thought to be promoted by the reduction of viscosity and the activation of the ciliated epithelium. Ambroxol induces activation of the surfactant system by acting directly on the type II pneumocytes of the alveoles and the Clara cells in the region of the small airways. It promotes the formation and outward transfer of surface-active material in the alveolar and bronchial region of the lungs. These effects have been demonstrated in cell cultures and in vivo on various species.
Acetylcysteine undergoes rapid deacetylation in vivo to yield cysteine or oxidation to yield diacetylcysteine. Acetylcysteine is a potent mucolytic agent. The mucolytic action of acetylcysteine is probably due to the opening of disulfide bonds in the mucus mucoproteins by acetylcysteine’s sulfhydryl group. Acetylcysteine acts as surfactant to expel mucus. Exerts synergistic action due to ambroxol and acetylcysteine. Acetylcysteine also control cellular damage in pulmonary diseases.
All forms of tracheobronchitis, emphysema with bronchitis pneumoconiosis, chronic inflammatory pulmonary conditions, bronchiectasis, bronchitis with bronchospasm asthma. During acute exacerbations of bronchitis it should be given with the appropriate antibiotic. Respiratory tract disorders associated with increased or viscous mucus. Reducing mucus and helping with breathing in various lung conditions like cystic fibrosis.
1 cap twice daily or as directed by the physician.
Oral administration of acetylcysteine up to dosage of 25 mg/kg/day. In analogy to preclinical examinations, increased salivation, retching, vomiting and a drop in blood pressure may occur following extreme overdosage. Acute measures eg, instituting vomiting and gastric lavage are not generally indicated and are only to be considered following extreme overdose. A symptomatic therapy is recommended.
Brief restlessness and diarrhoea have been reported. Ambroxol has been tolerated well on oral administration up to a dosage of 25 mg/kg/day.
Hypersensitivity to ambroxol hydrochloride or to any of the excipients of Respo.
Allergy: If allergy is found, acetylcysteine has to be discontinued.
Elevated serum transaminases levels were temporally associated with acetylcysteine (the active ingredient contained in NAC) administration in a patient with cystic fibrosis.
Patient should not take acetylcysteine at the same time as antibiotics. Antibiotics can however, be taken at least 2 hrs after acetylcysteine.
Use with caution in asthmatic patients, history of bronchospasm and peptic ulceration. Caution in epileptic patients and a patient at risk of convulsions is recommended.
Dosage adjustment is necessary in patients with moderate or severe renal impairment. There have been very few reports of severe skin lesions eg, Stevens-Johnson syndrome and toxic epidermal necrolysis (TEN) in temporal association with the administration of expectorants eg, ambroxol hydrochloride. Do not use before bedtime.
Use in pregnancy: Acetylcysteine is possibly safe when taken orally, delivered through a hole in the windpipe or breathed in. Acetylcysteine crosses the placenta, but there is no evidence so far linking it with harm to the unborn child or mother. However, N-acetyl cysteine should only be used in pregnant women when clearly needed eg, as in cases of acetaminophen toxicity.
Use in pregnancy: Acetylcysteine is possibly safe when taken orally, delivered through a hole in the windpipe or breathed in. Acetylcysteine crosses the placenta, but there is no evidence so far linking it with harm to the unborn child or mother. However, N-acetyl cysteine should only be used in pregnant women when clearly needed eg, as in cases of acetaminophen toxicity.
It can cause nausea, vomiting and diarrhea or constipation. Rarely, it can cause rashes, fever, headache, drowsiness, low blood pressure and liver problems.
Simultaneous use of ambroxol and antibiotics (amoxicillin, cefuroxime, erythromycin, doxycyclin) results in an increase of concentration of the antibiotics in the lung tissue. Concomitant use with antitussive agents eg, codeine should be avoided, because they may inhibit cough reflex.
Nitroglycerin interacts with acetylcysteine. Nitroglycerin can dilate blood vessels and increase blood flow. Taking acetylcysteine seems to increase the effects of nitroglycerin. This could cause increased chance of adverse effects including headache, dizziness and light headedness.
Activated charcoal interacts with acetylcysteine. Activated charcoal sometimes used to prevent poisoning in people who take too much acetaminophen and other medications. Activated charcoal can bind up these medications in the stomach and prevent them from being absorbed by the body.
Store below 30°C. Protect from light and moisture.
R05CB10 - combinations ; Belongs to the class of mucolytics. Used in the treatment of wet cough.
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