Patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator
This inhalation aerosol is a combination of Salbutamol (as Sulphate) and Ipratropium Bromide. It is a hydrofluoroalkane (HFA) based environment friendly inhaler. Because it does not contain chlorofluorocarbon (CFC) as propellant which is one of the main reasons of ozone layer depletion.
Salbutamol is a short acting beta2-adrenergic bronchodilator and Ipratropium Bromide is an anticholinergic bronchodilator. When used in combination, Ipratropium Bromide prevents the increase in intracellular concentration of cyclic guanosine monophosphate, which are caused by interaction of acetylcholine with the muscarinic receptor on bronchial smooth muscle. This inhalation aerosol is expected to maximize the response of the treatment in patients with chronic obstructive pulmonary disease (COPD) by reducing bronchospasm through two distinctly different mechanisms, anticholinergic (parasympatholytic) and sympathomimetic. Simultaneous administration of an anticholinergic (Ipratropium Bromide) and a beta 2-sympathomimetic (Salbutamol) is designed to benefit the patient by producing a greater bronchodilatory effect than when either drug is utilized alone at its recommended dosage.
One inhalation four times a day,not to exceed six inhalations in 24 hours.Inhaler solution: Inhalation solution in ampoule may be administered from a suitable nebuliser or an intermittent positive pressure ventilator. Adults (including elderly): One ampoule as required for the relief of symptoms or as directed. Up to three to four ampoules daily. Patients should be advised to consult a doctor or the nearest hospital immediately in the case of acute or rapidly worsening dyspnoea if additional inhalations do not produce an adequate improvement. Interaction
This inhalation aerosol has been used concomitantly with other drugs, including sympathomimetic bronchodilators, methylxanthines and steroids, commonly used in the treatment of COPD. No formal drug interaction studies have been performed with this inhalation aerosol and these or other medications commonly used in the treatment of COPD. Ipratropium Bromide should be co-administered cautiously with other anticholinergic agents and sympathomimetic agents, which may increase the risk of adverse cardiovascular effects. Beta-2-agonist containing drugs, like this inhalation aerosol, should be administrated with extreme caution in patients with non-potassium sparing diuretics, monoamine oxidase inhibitors or tricyclic antidepressants.
patients with a history of hypersensitivity to soya lecithin or related food products such as soybean and peanut. This Inhaler is also contraindicated in patients hypersensitive to any component of the drug product or to atropine or its derivatives.
upper respiratory infection,nasopharyngitis,cough, bronchitis,headache,and dyspnea
Teratogenic Effects: Pregnancy Category C. Nursing Mothers It is not known whether the components of this drug are excreted in human milk.
The effects of overdosage are expected to be related primarily to Salbutamol Sulphate. Manifestations of overdosage with Salbutamol may include anginal pain, hypertension, hypokalemia and tachycardia
Do not puncture, break or incinerate the pressurized canister even when apparently empty. Avoid storage in direct sunlight or heat. Store in a cool and dry place. Keep away from children. Keep away from eyes.
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