Combivent Respimat

What Is Combivent Respimat?

Combivent Respimat (ipratropium bromide and albuterol) Inhalation Spray is a combination of an anticholinergic bronchodilator and a selective beta2-adrenergic bronchodilator that open airways in the lungs to help patients with COPD breathe better indicated for the treatment of chronic obstructive pulmonary disease (COPD). Combivent Respimat contains ipratropium bromide and albuterol. These two drugs are available in generic preparations.

What Are Side Effects of Combivent Respimat?

Side effects of Combivent Respimat include:

• headache,
• cold symptoms (stuffy nose, sneezing, cough, or sore throat),
• flu-like symptoms,
• nausea,
• vomiting,
• nervousness,
• difficulty breathing,
• urinary retention and
• fast or irregular heartbeat.

Serious side effects of Combivent Respimat include:

• bronchospasms,
• eye (ocular) changes, and
• heart (cardiac) complications.

Dosage for Combivent Respimat

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.

What Drugs, Substances, or Supplements Interact with Combivent Respimat?

Combivent Respimat may interact with bladder or urinary medicines, diuretics (water pills), heart or blood pressure medications, medications for Parkinson's disease or depression, other bronchodilators, stimulants, ADHD medications, diet pills, over-the-counter cold or allergy medicine, or medication to treat excess stomach acid, stomach ulcer, motion sickness, or irritable bowel syndrome. Tell your doctor all medications and supplements you use.

Combivent Respimat During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant during treatment with Combivent Respimat; it is unknown if it is harmful to a fetus. It is unknown if Combivent Respimat passes into breast milk or if it could harm a nursing baby. Breastfeeding while using Combivent Respimat is not recommended.

Additional Information

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

 

Combivent Respimat Consumer Information

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

Call your doctor at once if you have:

• wheezing, choking, or other breathing problems after using this medicine;
• chest pain;
• fast or pounding heartbeats, fluttering in your chest;
• tremors, nervousness;
• swelling of your ankles or feet;
• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• painful or difficult urination; or
• low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects may include:

• headache;
• trouble breathing; 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)

 

Combivent Respimat Professional Information

SIDE EFFECTS

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

• Paradoxical bronchospasm [see WARNINGS AND PRECAUTIONS]
• Cardiovascular effects [see WARNINGS AND PRECAUTIONS]
• Hypersensitivity reactions, including anaphylaxis [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS]
• Hypokalemia [see WARNINGS AND PRECAUTIONS]

Albuterol is a component of COMBIVENT RESPIMAT.

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

• Ocular effects [see WARNINGS AND PRECAUTIONS]
• Urinary retention [see WARNINGS AND PRECAUTIONS]

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)