“May all be happy, may all be healed, may all be at peace and may no one ever suffer."
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.
This inhalation aerosol is indicated for use in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continues to have evidence of bronchospasm and who requires a second bronchodilator.
Using an Inhaler seems simple, but most patients do not know how to use it in the right way. If the Inhaler is used in the wrong way, less medicine can reach the lungs. Correct and regular use of the Inhaler will prevent or lessen the severity of asthma attacks.
Following simple steps can help to use Inhaler effectively (According to "National Asthma Guidelines for Medical Practitioners" published by Asthma Association):
Instructions for Cleaning Inhaler: Clean your Inhaler at least once a week. Remove canister and rinse the plastic actuator and cap in warm water but do not put the metal canister into water. Dry the actuator and cap thoroughly and gently replace the metal canister into the actuator with a twisting motion. Put the cap on the mouthpiece.
This inhalation aerosol is contraindicated in patients with a history of hypersensitivity to Soya-Lecithin or related food products such as soybean and peanut. This inhalation aerosol is also contraindicated in patients hypersensitive to any other components of the drug product or to atropine or its derivatives.
Due to presence of Salbutamol, mild tremor and headache have been reported. These usually disappear with continuous treatment. There have been very rare reports of treatments muscle cramp, hypersensitivity reactions including angioedema, urticaria, bronchospasm and hypotension.
For the presence of Ipratropium Bromide headache, influenza, chest pain, nausea, dyspnea, coughing, pharyngitis, sinusitis are rarely reported.
Overdose Effects
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.
Pregnancy & Lactation
Ipratropium Bromide: Pregnancy category B. Studies have demonstrated no teratogenic effects as a result of ipratropium.
Salbutamol: Pregnancy category C. Salbutamol has been shown to be teratogenic in animals.
There are, however no adequate and well-controlled studies of Salpium Inhalation Aerosol (Salbutamol and Ipratropium Bromide combination) in pregnant woman. This inhalation aerosol should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus. It is not known whether the components of the Salpium InhalationAerosol are excreted in human milk. As many drugs are excreted in human milk, Salpium should be cautiously administered to a nursing mother.
Use in Special Populations
This inhalation aerosol contains Ipratropium Bromide and, therefore, should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy or bladder-neck obstruction. Preparations containing sympathomimetic amines such as Salbutamol Sulphate should be used with caution in patients with convulsive disorders, hyperthyroidism, diabetes mellitus and in patients who are unusually responsive to sympathomimetic amines.