Indications

This combination 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.

Composition

Pharmacology

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.

Dosage & Administration

Adult dose (Including the elderly) : 2 puffs of Salpium 4 times a day (Patients may take additional puffs as required but a total number of puffs should not exceed 12 in 24 hours). Or as directed by the physician.

Contraindications

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.

Side Effects

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.

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.

Precautions & Warnings

Therapeutic Class

Combined bronchodilators

Storage Conditions

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.