Ipratropium Br/albuterol Pulmonology A combination used to improve pulmonary function tests in COPD
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The settlement alleges that the company misrepresented its antiplatelet drug, Aggrenox, that was effective for many conditions 'below the neck,' such as heart attacks and congestive heart failure, and that it was superior to Plavix, without evidence to substantiate that claim; misrepresented that Micardis protected patients from early morning strokes and heart attacks and treated metabolic syndrome; misrepresented that Combivent could be used as a first-line treatment for bronchospasms associated with chronic obstructive pulmonary disease (COPD); Falsely stated that Atrovent and Combivent could be used at doses that exceeded the maximum dosage recommendation in the product labelling and that the drugs were essential for treatment of COPD.
The settlement made between all 50 states and the District of Columbia solves allegations that BIPI engaged in unfair, deceptive, or misleading practices in its promotion of Micardis, Aggrenox, Atrovent, and Combivent by allegedly representing that the prescription drugs had sponsorship, approval, characteristics, ingredients, uses, benefits, quantities, or qualities that they did not have.
One of the major complains of patient was the shortness of breath lately; the patient was prescribed a combivent combination inhaler to control her shortness of breath (table 2).
25 mg/4 ml Combivent IB 500 [micro]g, salbutamol 2.
Combivent, which comes in a metered dose inhaler containing both ipratropium bromide and albuterol, seems to be beneficial for many patients with this disease.
The DOJ announced yesterday that Boehringer will pay $95 million to resolve the allegations that it improperly promoted its anti-stroke drug Aggrenox, its chronic obstructive pulmonary disease drugs Atrovent and Combivent, and its hypertension drug Micardis.
The product, marketed as Combivent Respimat inhalation spray, does not contain chlorofluorocarbons (CFCs) and "is a suitable alternative for patients who are currently using Combivent (ipratropium bromide and albuterol sulfate) inhalation aerosol," according to the statement, issued by the Division of Drug Information (DDI) in the FDA's Center for Drugs, Evaluation and Research (CDER).
Medications prescribed were: Beclazone (250 mcg), theophylline (200 mcg/300mg), Ventolin (1-4 puffs), and/or Atrovent/ Combivent (1-2 puffs) as required.
The Combivent Metered Aerosol Inhaler, which is used to treat chronic obstructive pulmonary disease (COPD), will be discontinued this year.
The American Association for Respiratory Care submitted comments saying that approximately 2 million patients with chronic obstructive pulmonary disease would have to replace Combivent with two separate prescriptions and use two delivery devices to get the same clinical result.