|Composition||Each 5ml contains|
|Mango Syrup Base||q.s.|
Oral Syrup (Alphonso Mango Flavoured)
Bronkolyte-PD ™ SYRUP is a combination of Terbutaline Sulphate, Ambroxol Hydrochloride and Guaiphenesin. Terbutaline is a selective beta2 -adrenergic agonist which predominantly stimulates beta2-receptors, thus producing relaxation of bronchial smooth muscle. Ambroxol possesses mucokinetic (improvement in mucus transport) and secretolytic (liquifies secretions) properties. It promotes the removal of tenacious secretions in the respiratory tract and reduces mucus stasis (arresting the secretion of mucus). Besides that, Ambroxol also exhibits anti-oxidant activity. Guaiphenesin, by increasing respiratory tract fluid, reduces the viscosity of tenacious secretions and acts as an expectorant. Another possible mechanism by which it acts is by increasing the water bonding in the sputum, thereby decreasing its viscosity and leading to an increase in mucokinesis. Guaiphenesin is effective in both productive and nonproductive coughs.
Terbutaline is a selective beta2 – adrenergic causing bronchodilation; increase in mucociliary clearance; suppression of oedema and anti-allergic effects. The pharmacologic effects of beta-adrenergic agonist drugs, including terbutaline, are at least in part, attributable to stimulation through beta-adrenergic receptors on intracellular adenyl cyclase, the enzyme that catalyses the conversion of adenosine triphosphate (ATP) to cyclic-3?,5?-adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels are associated with relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.
Basic parameters have been evaluated in man after oral administration of therapeutic doses, e.g. Renal clearance (CLR): 1.925/ml/min (males) Renal clearance (CLR): 2.32ml/min (females). Terminal half-life T½ has been determined after single and multiple dosing (mean values varied between 16-20 h)
Food reduces bioavailability following oral dosing (10% on average). Fasting values of 14-15% have been obtained. Metabolism: The main metabolite after oral dosing is the sulphate conjugate and also some glucoronide conjugate can be found in the urine.
Ambroxol (group of benzilamides) belongs to secretolitical and secretomotoric medicinal products. It possesses expressed expectorant effect. Mechanism of action of the medicinal product is stipulated by stimulation of serous cells of tonsils of bronchial tubes’ mucous membrane, increasing of mucous secretion content and changing of correlation of serous and mucous components of phlegm, breached under pathological processes in lungs. Under this hydrolyzing ferments activate and releasing of lizosoms from Clark’s cells strengthens, that causes decreasing of viscosity of phlegm. Ambroxol increases content of surfactant in lungs, which is dealt with strengthening of synthesis of the last and secretion in alveolar pneumocytes, and also with breach of its disintegration. The medicinal product increases mucociliar transport of phlegm. It suppresses coughing insignificantly. Ambroxol well penetrates through the placenta barrier, improving synthesis of surfactants during uterine life of foetus, and also it has an ability to warn syndrome of insufficient breathing in newborn. The medicinal product does not cause immense creating of secretion, reduces spastic hyperactivity of bronchial tubes- one of the main factors of developing of bronchial asthma under allergy. Ambroxol is more effective, than its predecessor – Bromhexine; it is non-toxic one and well endured by patients. Action of retard form of Ambroxol is kept in 9-10 hours after administration inside.
Ambroxol is rapidly absorbed (70-80%) after oral administration. The time to reach peak plasma concentration is approximately 2 hours. The distribution half-life of ambroxol is around 1.3 hours. Metabolite is dibromoanthranilic acid (activity unspecified). Excretion is primarily via the kidneys. Renal clearance (rate) is approximately 53 ml/minute; approximately 5-6% of a dose is excreted unchanged in the urine. The elimination half-life of ambroxol is biphasic, with an alpha half-life of 1.3 hours and a beta half-life of 8.8 hours.
Guaiphenesin is thought to exert its pharmacological action by stimulating receptors in the gastric mucosa. This increases the output from secretory glands of the gastrointestinal system and reflexly increases the flow of fluids from glands lining the respiratory tract. The result is an increase in volume and decrease in viscosity of bronchial secretions. Other actions may include stimulating vagal nerve endings in bronchial secretory glands and stimulating certain centres in the brain, which in turn enhance respiratory fluid flow. Guaiphenesin produces its expectorant action within 24 hours.
Guaiphenesin is well absorbed from the gastro-intestinal tract following oral administration, although limited information regarding its pharmacokinetics is available. After the administration of 600 mg Guaiphenesin to healthy adult volunteers, the Cmax was approximately 1.4ug/ml, with tmax occurring approximately 15 minutes after drug administration. Guaiphenesin appears to undergo both oxidation and demethylation. Following an oral dose of 600 mg guaifenesin to 3 healthy male volunteers, the t½ was approximately 1 hour and the drug was not detectable in the blood after approximately 8 hours.
Bronkolyte-PD ™ SYRUP is indicated for clinical relief of cough associated with bronchitis, bronchial asthma, emphysema and other bronchopulmonary disorders where bronchospasm, mucous plugging and problems of expectoration co-exist.
DOSAGE AND ADMINISTRATION
10-20 ml thrice daily
Children (6-12 years):
10 ml thrice daily
Children (under 6 years):
5-10 ml thrice daily
Hypersensitivity to any of the components of the formulation. It should not be used in patients with pre-existing ischaemic heart disease or those patients with significant risk factors for ischaemic heart disease. It is also contraindicated in patients with gastric ulceration.
WARNINGS AND PRECAUTIONS
As for all beta2-agonists caution should be observed in patients with thyrotoxicosis. Cardiovascular effects may be seen with sympathomimetic drugs, including terbutaline. There is some evidence from post-marketing data and published literature of myocardial ischaemia associated with beta agonists. Due to the positive inotropic effect of beta2-agonists, these drugs should not be used in patients with hypertrophic cardiomyopathy.
Terbutaline should be used with caution in tocolysis and supervision of cardiorespiratory function, including ECG monitoring, should be considered. Treatment should be discontinued if signs of myocardial ischaemia (such as chest pain or ECG changes) develop. Terbutaline should not be used as a tocolytic agent in patients with significant risk factors for or pre-existing heart disease. During infusion treatment in pregnant women with beta2-stimulants in combination with corticosteroids a rare complication with a pathological picture resembling pulmonary oedema, has been reported. Increased tendency to uterine bleeding has been reported in connection with Caesarean section. However, this can be effectively stopped by propranolol 1-2 mg injected intravenously.
Patients with underlying severe heart disease (e.g. ischaemic heart disease, arrhythmia or severe heart failure) who are receiving Terbutaline should be warned to seek medical advice if they experience chest pain or other symptoms of worsening heart disease. Attention should be paid to assessment of symptoms such as dyspnoea and chest pain, as they may be of either respiratory or cardiac origin. Due to the hyperglycaemic effects of beta2-agonists, additional blood glucose controls are recommended initially in diabetic patients. Potentially serious hypokalaemia may result from beta2-agonist therapy.
Particular caution is recommended in acute severe asthma as the associated risk may be augmented by hypoxia. The hypokalaemic effect may be potentiated by concomitant treatments. It is recommended that serum potassium levels are monitored in such situations. If a previously effective dosage regimen no longer gives the same symptomatic relief, the patient should urgently seek further medical advice. Consideration should be given to the requirements for additional therapy (including increased dosages of anti-inflammatory medication). Severe exacerbations of asthma should be treated as an emergency in the usual manner.
Care to be taken to avoid contact with eye, skin, serious ingestion or inhalation.
Guaiphenesin should be not used for persistent or chronic cough, such as occurs with asthma, or where cough is accompanied by excessive secretions, unless directed by a physician. Caution should be exercised in the presence of severe renal or severe hepatic impairment. Patients with rare hereditary problems of fructose intolerance should not take this medicine. Not more than 4 doses should be given in any 24 hours. Avoid with any other cough and cold medicine. Consult a pharmacist or other healthcare professional before use in children under 6 years.
Beta-blocking agents (including eye drops); especially the non-selective ones such as propranolol, may partially or totally inhibit the effect of beta-stimulants. Therefore terbutaline preparations and non-selective beta-blockers should not normally be administered concurrently. Terbutaline should be used with caution in patients receiving other sympathomimetics. Hypokalaemia may result from beta2-agonist therapy and may be potentiated by concomitant treatment with xanthine derivatives, corticosteroids and diuretics.
No data available
If urine is collected within 24 hours of a dose of Guaiphenesin, its metabolite may cause a colour interference with laboratory determinations of urinary 5- hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA). Others
Bronkolyte-PD ™ SYRUP should be used with caution in patients with diabetes mellitus, serious cardiovascular disorders, hypertension, hyperthyroidism and peptic ulcers.
However, there are no adequate and well-controlled studies of this combination in pregnant women. Hence this combination should be administered with caution in pregnancy.
It is not known whether this combination is secreted in breast milk. However terbutaline is secreted in breast milk, but effect on the infant is unlikely at therapeutic doses. Therefore this combination should be used with caution nursing mothers.
Bronkolyte-PD ™ SYRUP Bottle of 60 ml
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