Adverse Reactions in ≥2% of Patients in the COMBIVENT RESPIMAT Group in a 12-Week COPD Clinical Trial1

Body System (Event) 12-Week Ipratropium-Controlled Trial
COMBIVENT RESPIMAT (20/100 mcg) [n=486] Ipratropium bromide plus albuterol in a CFC inhaler (36/206 mcg) [n=491] Ipratropium bromide in the RESPIMAT Inhaler (20 mcg) [n=483]
Patients with any adverse reaction 46 52 45
Respiratory, thoracic, and mediastinal disorders
Cough 3 2 2
Dyspnea 2 2 3
Nervous system disorders
Headache 3 2 3
Infections and infestations
Bronchitis 3 3 1
Nasopharyngitis 4 3 4
Upper respiratory infection 3 4 3
Adverse reactions that occurred in <2% in the COMBIVENT RESPIMAT (20/100 mcg) group observed in this 12-week trial include: Vascular disorders: hypertension; Nervous system disorders: dizziness and tremor; Musculoskeletal and connective tissue disorders: muscle spasms and myalgia; Gastrointestinal disorders: diarrhea, nausea, dry mouth, constipation, and vomiting; General disorders and administration site conditions: asthenia, influenza-like illness, and chest discomfort; Eye disorders: eye pain; Metabolism and nutritional disorders: hypokalemia; Cardiac disorders: palpitations and tachycardia; Skin and subcutaneous tissue disorders: pruritus and rash; Respiratory, thoracic, and mediastinal disorders: pharyngolaryngeal pain and wheezing.1

Recommended Dosing for COMBIVENT RESPIMAT

  • Dosed at 1 inhalation 4 times a day. The total number of inhalations should not exceed 6 in 24 hours1
  • Safety and efficacy of additional doses of COMBIVENT RESPIMAT beyond 6 inhalations/24 hours have not been studied. Also, the safety and efficacy of extra doses of ipratropium or albuterol in addition to the recommended doses of COMBIVENT RESPIMAT have not been studied1
  • Designed with a dose indicator for patient convenience1

*COPD = chronic obstructive pulmonary disease.

CFC = chlorofluorocarbon.

Reference:
  1. COMBIVENT RESPIMAT Prescribing Information. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; 2014.

Indication for Use

COMBIVENT RESPIMAT is 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.

Important Safety Information

COMBIVENT RESPIMAT is contraindicated in patients hypersensitive to any of the ingredients of the drug product or to atropine or its derivatives.

COMBIVENT RESPIMAT can produce paradoxical bronchospasm that can be life-threatening. If it occurs, therapy with COMBIVENT RESPIMAT should be discontinued immediately and alternative therapy instituted.

The albuterol sulfate contained in COMBIVENT RESPIMAT can produce a clinically significant cardiovascular effect in some patients. If cardiovascular symptoms occur, COMBIVENT RESPIMAT may need to be discontinued.

COMBIVENT RESPIMAT should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

COMBIVENT RESPIMAT contains ipratropium bromide and may increase intraocular pressure which may result in precipitation or worsening of narrow-angle glaucoma.

Patients should avoid spraying the aerosol into their eyes as this may cause acute eye pain or discomfort, temporary blurring of vision, mydriasis, visual halos, or colored images in association with red eyes from conjunctival or corneal congestion. Advise patients to consult their physician immediately if any of these symptoms develop while using COMBIVENT RESPIMAT.

Ipratropium bromide also may cause urinary retention.

COMBIVENT RESPIMAT should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia, or bladder-neck obstruction.

Since dizziness and blurred vision may occur with the use of COMBIVENT RESPIMAT, caution patients about engaging in activities such as driving a vehicle or operating appliances or machinery.

Do not exceed recommended dose. Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma.

Hypersensitivity reactions including urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema may occur. If such a reaction occurs, therapy with COMBIVENT RESPIMAT should be stopped at once and alternative treatment should be considered.

COMBIVENT RESPIMAT contains albuterol and should be used with caution in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus, and in patients who are unusually responsive to sympathomimetic amines. Albuterol may produce significant hypokalemia in some patients.

In clinical trials, the most common adverse reactions reported for COMBIVENT RESPIMAT were upper respiratory tract infection, nasopharyngitis, cough, bronchitis, headache, and dyspnea.

COMBIVENT RESPIMAT may interact additively with concomitantly used anticholinergic medications. Avoid co-administration with other anticholinergic-containing drugs.

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

See more

Indication for Use

COMBIVENT RESPIMAT is 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.

Important Safety Information

COMBIVENT RESPIMAT is contraindicated in patients hypersensitive to any of the ingredients of the drug product or to atropine or its derivatives.