The FDA ( Food and Drug Administration ) has approved Combivent Respimat, a new, propellant-free inhaler product that uses a slow-moving mist to deliver the same active ingredients of COmbivent Inhalation Aerosol in a metered dose inhaler ( Combivent MDI ).
Combivent Respimat and Combivent MDI are indicated for use in 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.

In a 12-week, randomized, double-blind, placebo and active-controlled clinical trial, Combivent Respimat was shown to be clinically comparable to Combivent MDI, in terms of FEV1. FEV1 is the maximal amount of air that can be forcefully exhaled in one second. In the study, treatment was administered to patients with COPD four times a day.

Clinical studies in patients with COPD have shown that the combination of Ipratropium bromide and Albuterol sulfate provides patients significantly greater improvement in lung function than either component alone.

Combivent Respimat uses a new type of inhaler with a propellant-free delivery mechanism to produce an slow-moving mist. Combivent Respimat requires one inhalation per dose as compared to Combivent MDI, which requires two inhalations per dose. Combivent Respimat also offers a dose indicator to inform patients of the amount of remaining medication in the inhaler.

Chronic obstructive pulmonary disease ( COPD ) is also known as chronic bronchitis and emphysema. Common symptoms of COPD include coughing, with or without mucus, or shortness of breath. These symptoms are often confused with normal signs of aging. As COPD progresses, symptoms tend to get worse and more damage occurs in the lungs. Breathing gradually becomes more difficult until people with COPD feel like they are inhaling and exhaling through a small straw.

Safety information

Combivent Inhalation Aerosol and Combivent Respimat are contraindicated in patients hypersensitive to any of components of the drug product or to Atropine or its derivatives. Combivent Inhalation Aerosol is also contraindicated in patients with a history of hypersensitivity to soya lecithin or related food products such as soybean and peanut.

Combivent Inhalation Aerosol and Combivent Respimat can produce paradoxical bronchospasm that can be life-threatening. If it occurs, the Combivent therapy should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister of Combivent Inhalation Aerosol.

Hypersensitivity reactions including urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema may occur after administration of Ipratropium bromide or Albuterol sulfate. If such a reaction occurs, therapy with Combivent should be stopped at once and alternative treatment should be considered.

The Albuterol sulfate contained in Combivent Inhalation Aerosol and Combivent Respimat, like other beta adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, and/or symptoms. If these symptoms occur, Combivent may need to be discontinued. There is some evidence from post-marketing data and published literature of rare occurrences of myocardial ischemia associated with Albuterol. In addition, beta adrenergic agents have been reported to produce electrocardiogram ( ECG ) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. Therefore, Combivent Inhalation Aerosol and Combivent Respimat should be used with caution in patients with cardiovascular disorders; especially coronary insufficiency, cardiac arrhythmias, and hypertension.

Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma. The exact cause of death is unknown, but cardiac arrest following an unexpected development of a severe acute asthmatic crisis and subsequent hypoxia is suspected.

Comvivent Inhalation Aerosol and Combivent Respimat contain Albuterol sulfate, a beta-adrenergic sympathomimetic amine and, therefore, should be used with caution in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus, and in patients who are unusually responsive to sympathomimetic amines. Beta adrenergic agents may produce significant hypokalemia in some patients which has the potential to produce adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring supplementation.

Ipratropium bromide, a component of Combivent Inhalation Aerosol and Combivent Respimat, is an anticholinergic and may cause urinary retention. Therefore, caution is advised when administering either medication to patients with prostatic hyperplasia or bladder-neck obstruction. Ipratropium bromide, also may increase intraocular pressure. This may result in precipitation or worsening of narrow-angle glaucoma. Therefore, Combivent should be used with caution in patients with narrow angle glaucoma.

Caution patients to avoid spraying the aerosol into their eyes and be advised that this may result in precipitation or worsening of narrow angle glaucoma, mydriasis, increased intraocular pressure, acute eye pain or discomfort, temporary blurring of vision, visual halos or colored images in association with red eyes from conjunctival and corneal congestion. Patients should also be advised that should any combination of these symptoms develop, they should consult their physician immediately. Since dizziness, accommodation disorder, mydriasis, and blurred vision may occur with use of Combivent; patients should be cautioned about engaging in activities requiring balance and visual acuity such as driving a car or operating appliances or machinery.

There is potential for an additive interaction with concomitantly used anticholinergic medications. Therefore, avoid coadministration of Combivent with other anticholinergic containing drugs as this may lead to an increase in anticholinergic adverse effects.

Caution is advised in co-administration of other beta-adrenergic agents, beta-receptor blocking agents, and non-potassium sparing diuretics. Extreme caution should be used in the co-administration of Combivent and monoamine oxidase inhibitors or tricyclic antidepressants.

In clinical trials, the most common adverse reactions reported for Combivent were bronchitis, upper respiratory tract infection, headache, dyspnea, cough, pain, respiratory disorder, sinusitis, pharyngitis and nausea, nasopharyngitis.

Source: Boehringer Ingelheim Pharmaceuticals, 2011

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