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Combivent Respimat

"COPD is a serious lung disease that makes breathing difficult and worsens over time. Symptoms can include wheezing, cough, chest tightness, and shortness of breath. Cigarette smoking is the leading cause of COPD. According to the National Heart, "...

Combivent Respimat

Combivent Respimat Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Combivent Respimat is a combination of ipratropium bromide and albuterol indicated for the treatment of chronic obstructive pulmonary disease (COPD). These two drugs are available in generic preparations. Combivent Inhalation Aerosol is being phased out by December 31, 2013 because it contains chlorofluorocarbons (CFCs) used as propellants, but are chemical compounds that deplete the ozone layer. However, a new propellant for this same drug combination is being planned for release in 2013. Combivent Respimat contains two different types of medicines that open airways in the lungs to help patients with COPD breathe better. Combivent Respimat contains ipratropium bromide and albuterol. Side effects of Combivent Respimat use can include urinary retention and irregular heartbeat.

The Combivent Respimat inhaler delivers 20 mcg of ipratropium bromide (monohydrate) and 100 mcg albuterol (equivalent to 120 mcg albuterol sulfate) from the mouthpiece. The recommended dose of Combivent Respimat is one inhalation four times a day. Patients may take additional inhalations as required; however, the total number of inhalations should not exceed six within 24 hours.Serious side effects may include bronchospasms, ocular changes, and cardiac complications. Patients who are pregnant or nursing should contact their physicians about the use of Combivent Respimat. Still, Combivent Respimat should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Doctors should exercise caution when administering Combivent Respimat to a nursing mother. Safety and effectiveness in pediatric patients have not been established for Combivent Respimat.

Our Combivent Respimat Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Combivent Respimat in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using albuterol and ipratropium and call your doctor at once if you have a serious side effect such as:

  • wheezing, choking, or other breathing problems (especially after starting a new canister of this medicine);
  • chest pain, pounding heartbeats or fluttering in your chest;
  • dangerously high blood pressure (severe headache, anxiety, uneven heartbeats);
  • swelling of your ankles or feet;
  • eye pain, or seeing halos around lights;
  • painful or difficult urination; or
  • low potassium (confusion, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling).

Other common side effects may include:

  • mild headache; or
  • cold symptoms such as stuffy nose, sneezing, cough, or sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Combivent Respimat (Ipratropium Bromide and Albuterol) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Combivent Respimat FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Use of albuterol, a beta-adrenergic agonist, may be associated with the following:

Albuterol is a component of COMBIVENT RESPIMAT.

Use of ipratropium bromide, an anticholinergic, may result in the following:

Ipratropium bromide is a component of COMBIVENT RESPIMAT.

Clinical Trials Experience

COMBIVENT RESPIMAT 12-Week Clinical Trials

The safety data described in Table 1 below are derived from one 12-week, randomized, multi-center, double-blind, double-dummy, parallel-group trial that compared COMBIVENT RESPIMAT (20/100 mcg), CFC-propelled COMBIVENT Inhalation Aerosol (36/206 mcg), and ipratropium bromide delivered by the RESPIMAT inhaler (20 mcg) administered four times a day in 1460 adult COPD patients (955 males and 505 females) 40 years of age and older. Of these patients, 486 were treated with COMBIVENT RESPIMAT. The COMBIVENT RESPIMAT group was composed of mostly Caucasian (88.5%) patients with a mean age of 63.8 years, and a mean percent predicted FEV1 at screening of 41.5%. Patients with narrow-angle glaucoma, symptomatic prostatic hypertrophy or bladder-neck obstruction were excluded from the trial.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Table 1 shows all adverse reactions that occurred with a frequency of ≥ 2% in the COMBIVENT RESPIMAT treatment group in the 12-week COPD trial. The frequency of the corresponding adverse reactions in the CFC-propelled COMBIVENT Inhalation Aerosol and ipratropium bromide delivered by the RESPIMAT inhaler groups is included for comparison. The rates are derived from all reported adverse reactions of that type not present at baseline, whether considered drug-related or not by the clinical investigator.

Table 1: Adverse Reactions in ≥ 2% of Patients in the COMBIVENT RESPIMAT Group in a 12-Week COPD Clinical Trial

Body System (Event) 12-Week Ipratropium-Controlled Trial
COMBIVENT RESPIMAT (20/100 mcg)
[n=486]
CFC-propelled COMBIVENT Inhalation Aerosol (36/206 mcg)
[n=491]
Ipratropium bromide by 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 disorder: 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.

A separate 12-week trial evaluated a higher than approved dose of COMBIVENT RESPIMAT in 1118 COPD patients. Patients were randomized to COMBIVENT RESPIMAT (40/200 mcg) (n=345), CFC-propelled COMBIVENT Inhalation Aerosol (36/206 mcg) (n=180), ipratropium delivered by the RESPIMAT (40 mcg) (n=252) or placebo (n=341). The overall incidence and nature of adverse reactions observed were similar to the adverse reactions seen with COMBIVENT RESPIMAT 20/100 mcg.

COMBIVENT RESPIMAT Long Term (48-week) Safety Trial

Long term chronic use safety data for COMBIVENT RESPIMAT were obtained from one 48-week, randomized, multi-center, open-label, parallel-group trial that compared COMBIVENT RESPIMAT (20/100 mcg), CFC-propelled COMBIVENT Inhalation Aerosol (36/206 mcg) and the free combination of ipratropium bromide (34 mcg) and albuterol (180 mcg) HFA inhalation aerosols administered 4 times a day in 465 adult COPD patients (273 males and 192 females) 40 years of age and older. Of these patients, 157 were treated with COMBIVENT RESPIMAT. The COMBIVENT RESPIMAT group was composed of mostly Caucasian (93.5%) patients with a mean age of 62.9 years, and a mean percent predicted FEV1 at screening of 47.0%. An evaluation of the safety data from the trial revealed that most adverse reactions were similar in type and rate between treatment groups. However, cough occurred more frequently in patients enrolled in the COMBIVENT RESPIMAT group (7.0%) compared to those in the CFC-propelled COMBIVENT Inhalation Aerosol (2.6%) or the free combination of ipratropium bromide and albuterol HFA inhalation aerosols (3.9%) groups.

In addition to the adverse reactions reported in the controlled clinical trial with COMBIVENT RESPIMAT, adverse reaction information concerning CFC-propelled COMBIVENT Inhalation Aerosol is derived from two 12-week controlled clinical trials (N=358 for CFC-propelled COMBIVENT Inhalation Aerosol). Adverse reactions reported in ≥ 2% of patients in the CFC-propelled COMBIVENT Inhalation Aerosol treatment group include: bronchitis, upper respiratory tract infection, headache, dyspnea, cough, pain, respiratory disorder, sinusitis, pharyngitis and nausea. Adverse reactions reported in < 2% of patients in the CFC-propelled COMBIVENT Inhalation Aerosol treatment group include: edema, fatigue, hypertension, dizziness, nervousness, tremor, dysphonia, insomnia, diarrhea, dry mouth, dyspepsia, vomiting, arrhythmia, palpitation, tachycardia, arthralgia, angina, increased sputum, taste perversion, urinary tract infection, dysuria, dry throat and bronchospasm.

Post-Marketing Experience

In addition to the adverse reactions reported during clinical trials, the following adverse reactions have been identified during post approval use of CFC-propelled COMBIVENT Inhalation Aerosol. Since CFC-propelled Combivent Inhalation Aerosol and Combivent Respimat contain the same active ingredients, one should take into account the fact that the adverse reactions seen with CFC-propelled Combivent Inhalation Aerosol could also occur with Combivent Respimat. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Eye disorders: glaucoma, blurred vision, mydriasis, conjunctival hyperemia, halo vision, accommodation disorder ocular irritation and corneal edema

Gastrointestinal disorders: gastrointestinal motility disorder, drying of secretions, stomatitis and mouth edema

Immune system disorders: hypersensitivity;

Investigations: intraocular pressure increased, blood pressure diastolic decreased and blood pressure systolic increased

Musculoskeletal and connective tissue disorders: muscular weakness

Psychiatric disorders: CNS stimulation, mental disorder

Respiratory, thoracic, and mediastinal disorders: throat irritation, paradoxical bronchospasm, wheezing, nasal congestion and pharyngeal edema

Skin and subcutaneous tissue disorders: angioedema, hyperhidrosis, and skin reaction

Urinary disorders: urinary retention

Cardiac disorders: myocardial ischemia

Allergic-type reactions such as skin reactions including rash, pruritus, and urticaria (including giant urticaria), angioedema including that of tongue, lips and face, laryngospasm, and anaphylactic reaction have also been reported with CFC-propelled COMBIVENT Inhalation Aerosol, with positive re-challenge in some cases [see WARNINGS AND PRECAUTIONS].

In a 5-year placebo-controlled trial, hospitalizations for supraventricular tachycardia and/or atrial fibrillation occurred with an incidence rate of 0.5% in COPD patients receiving CFC-propelled Atrovent® (ipratropium bromide) Inhalation Aerosol.

Metabolic acidosis has been reported with use of albuterol-containing products.

Read the entire FDA prescribing information for Combivent Respimat (Ipratropium Bromide and Albuterol) »

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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