Albuterol davis drug guide

Combivent

SIDE EFFECTS

Adverse reaction information concerning Combivent® (ipratropium bromide and albuterol sulfate) Inhalation Aerosol is derived from two 12-week controlled clinical trials (N=358 for COMBIVENT Inhalation Aerosol) as seen in Table 1.

Table 1 : All Adverse Events (in percentages), from Two Large Double-blind, Parallel, 12-Week Studies of Patients with COPD*

COMBIVENT Ipratropium Bromide 36 mcg/Albuterol Sulfate 206 mcg QID
N = 358
Ipratropium Bromide 36 mcg QID
N = 362
Albuterol Sulfate 206 mcg QID
N = 347
Body as a Whole-General Disorders
Headache 5.6 3.9 6.6
Pain 2.5 1.9 1.2
Influenza 1.4 2.2 2.9
Chest Pain 0.3 1.4 2.9
Gastrointestinal System Disorders
Nausea 2.0 2.5 2.6
Respiratory System Disorders (Lower)
Bronchitis 12.3 12.4 17.9
Dyspnea 4.5 3.9 4
Coughing 4.2 2.8 2.6
Respiratory Disorders 2.5 1.7 2.3
Pneumonia 1.4 2.5 0.6
Bronchospasm 0.3 3.9 1.7
Respiratory System Disorders (Upper)
Upper Respiratory Tract Infection 10.9 12.7 13
Pharyngitis 2.2 3.3 2.3
Sinusitis 2.3 1.9 0.9
Rhinitis 1.1 2.5 2.3
*All adverse events, regardless of drug relationship, reported by two percent or more patients in one or more treatment group in the 12-week controlled clinical trials.

Additional adverse reactions, reported in less than two percent of the patients in the COMBIVENT Inhalation Aerosol treatment group include edema, fatigue, hypertension, dizziness, nervousness, paresthesia, tremor, dysphonia, insomnia, diarrhea, dry mouth, dyspepsia, vomiting, arrhythmia, palpitation, tachycardia, arthralgia, angina, increased sputum, taste perversion, and urinary tract infection/dysuria.

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 been reported with Combivent® (ipratropium bromide and albuterol sulfate) Inhalation Aerosol, with positive rechallenge in some cases. Many of these patients had a history of allergies to other drugs and/or foods including soybean (see CONTRAINDICATIONS).

Post-Marketing Experience

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 Atrovent® (ipratropium bromide) Inhalation Aerosol CFC.

Additional side effects identified from the published literature and/or post-marketing surveillance on the use of ipratropium bromide-containing products (singly or in combination with albuterol), include: hypersensitivity, pharyngeal edema, mouth edema, urinary retention, mydriasis, bronchospasm (including paradoxical bronchospasm), cases of precipitation or worsening of narrow-angle glaucoma, glaucoma, intraocular pressure increased, acute eye pain, halo vision, blurred vision, accommodation disorder, ocular irritation, corneal edema, conjunctival hyperaemia, nasal congestion, drying of secretions, mucosal ulcers, stomatitis, irritation from aerosol, throat irritation, dry throat, wheezing, exacerbation of COPD symptoms, hoarseness, palpitations, heartburn, drowsiness, CNS stimulation, coordination difficulty, flushing, alopecia, hypotension, edema, gastrointestinal distress (diarrhea, nausea, vomiting), gastrointestinal motility disorder, constipation, hypokalemia, mental disorder, hyperhidrosis, muscle spasms, muscular weakness, myalgia, asthenia, myocardial ischemia, diastolic blood pressure decreased, and systolic blood pressure increased.

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

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

Albuterol and Ipratropium Oral Inhalation

The combination of albuterol and ipratropium comes as a solution (liquid) to inhale by mouth using a nebulizer (machine that turns medication into a mist that can be inhaled) and as a spray to inhale by mouth using an inhaler. It is usually inhaled four times a day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use albuterol and ipratropium exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Your doctor may tell you to use additional doses of albuterol and ipratropium inhalation if you experience symptoms such as wheezing, difficulty breathing, or chest tightness. Follow these directions carefully, and do not use extra doses of medication unless your doctor tells you that you should. Do not use more than 2 extra doses of the nebulizer solution per day. Do not use the inhalation spray more than six times in 24 hours.

Call your doctor if your symptoms worsen, if you feel that albuterol and ipratropium inhalation no longer controls your symptoms, or if you find that you need to use extra doses of the medication more often.

If you are using the inhaler, your medication will come in cartridges. Each cartridge of albuterol and ipratropium inhalation spray is designed to provide 120 inhalations. This is enough medication to last one month if you use one inhalation four times a day. After you use all 120 doses, the inhaler will lock and will not release any more medication, There is a dose indicator on the side of the inhaler that keeps track of how much medication is left in the cartridge. Check the dose indicator from time to time to see how much medication is left. When the pointer on the dose indicator enters the red area, the cartridge contains enough medication for 7 days and it is time to refill your prescription so that you will not run out of medication.

Be careful not to get albuterol and ipratropium inhalation into your eyes. If you get albuterol and ipratropium in your eyes, you may develop narrow angle glaucoma (a serious eye condition that may cause loss of vision). If you already have narrow angle glaucoma, your condition may worsen. You may experience widened pupils (black circles in the center of the eyes), eye pain or redness, blurred vision, and vision changes such as seeing halos around lights, or seeing unusual colors Call your doctor if you get albuterol and ipratropium into your eyes or if you develop these symptoms.

The inhaler that comes with albuterol and ipratropium spray is designed for use only with a cartridge of albuterol and ipratropium. Never use it to inhale any other medication, and do not use any other inhaler to inhale the medication in a cartridge of albuterol and ipratropium.

Before you use albuterol and ipratropium inhalation for the first time, read the written instructions that come with the inhaler or nebulizer. Ask your doctor, pharmacist, or respiratory therapist to show you how to use it. Practice using the inhaler or nebulizer while he or she watches.

To prepare the inhaler for use, follow these steps:

  1. Put the inhaler together before you use it for the first time. To start, take the inhaler out of the box, and keep the orange cap closed. Press the safety catch and pull off the clear base of the inhaler. Be careful not to touch the piercing element inside of the base
  2. The inhaler must be discarded three months after you put it together. Write this date on the label of the inhaler so you will not forget when you need to discard your inhaler.
  3. Take the cartridge out of the box and insert the narrow end into the inhaler. You can press the inhaler against a hard surface to be sure it is inserted correctly. Replace the clear plastic base on the inhaler.
  4. Hold the inhaler upright with the orange cap closed. Turn the clear base in the direction of the white arrows until it clicks.
  5. Flip the orange cap so that it is fully open. Point the inhaler toward the ground.
  6. Press the dose release button. Close the orange cap.
  7. Repeat steps 4-6 until you see a spray coming out of the inhaler. Then repeat these steps three more times.
  8. The inhaler is now primed and ready for use. You will not need to prime your inhaler again unless you do not use it for longer than 3 days. If you do not use your inhaler for more than 3 days, you will need to release one spray toward the ground before you start to use it again. If you do not use your inhaler for more than 21 days, you will need to follow steps 4-7 to prime the inhaler again.

To inhale the spray using the inhaler, follow these steps:

  1. Hold the inhaler upright with the orange cap closed. Turn the clear base in the direction of the white arrows until it clicks.
  2. Open the orange cap.
  3. Breathe out slowly and completely.
  4. Place the mouthpiece in your mouth and close your lips around it. Be careful not to cover the air vents with your lips.
  5. Point the inhaler toward the back of your throat and breathe in slowly and deeply.
  6. While you are breathing in, press the dose release button. Continue to breathe in as the spray is released into your mouth.
  7. Hold your breath for 10 seconds or as long as you comfortably can.
  8. Take the inhaler out of your mouth and close the orange cap. Keep the cap closed until you are ready to use the inhaler again.

To inhale the solution using a nebulizer, follow these steps:

  1. Remove one vial of medication from the foil pouch. Put the rest of the vials back into the pouch until you are ready to use them.
  2. Twist off the top of the vial and squeeze all of the liquid into the reservoir of the nebulizer.
  3. Connect the nebulizer reservoir to the mouthpiece or face mask.
  4. Connect the nebulizer reservoir to the compressor.
  5. Put the mouthpiece in your mouth or put on the face mask. Sit in a comfortable, upright position and turn on the compressor.
  6. Breathe in calmly, deeply, and evenly through your mouth for about 5 to 15 minutes until mist stops forming in the nebulizer chamber.

Clean your inhaler or nebulizer regularly. Follow the manufacturer’s directions carefully and ask your doctor or pharmacist if you have any questions about cleaning your inhaler or nebulizer.

General Information

DuoNeb Inhalation Solution has been approved for the treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) in patients who require more than one bronchodilator. This product combines two respiratory solutions, ipratropium bromide and albuterol sulfate, in a premixed, premeasured, unit-dose vial for nebulization. With this formulation, there is no need for patients to dilute or mix solutions, and advantages may include faster treatment time and a reduced chance of medication error.

COPD includes emphysema and chronic bronchitis — diseases that are characterized by airflow obstruction. According to the World Health Organization, COPD will be the third most common cause of death worldwide by 2020. The quality of life for a person suffering from COPD diminishes as the disease progresses. Current treatment is tailored to the severity of the disease and may include bronchodilators, antibiotics and exercise to strengthen muscles.

Clinical Results

Results of an 863-subject trial demonstrated that DuoNeb improved bronchodilation over albuterol alone by 24% and over ipratropium alone by 37%, with no increased safety risk.

Side Effects

Adverse reactions reported with DuoNeb include (but are not limited to) the following:

  • Chest pain
  • Pharyngitis
  • Diarrhea
  • Bronchitis
  • Nausea
  • Leg cramps

Caution is advised for patients with the following conditions:

  • Convulsive disorders
  • Hyperthyroidism
  • Diabetes Mellitus
  • Narrow-angle glaucoma
  • Prostatic hypertrophy
  • Bladder-neck obstruction

Albuterol sulfate administration, as well as the co-administration of DuoNeb and other sympathomimetic agents, may result in significant cardiovascular effects.

Mechanism of Action

Albuterol is a beta2-adrenergic bronchodilator. Ipratropium bromide, also a bronchodilator, blocks the physiologic action of acetylcholine.

Additional Information

If you would like further information on COPD, please visit the National Library of Medicine.

Albuterol-Ipratropium

Follow the directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Albuterol and ipratropium inhalation is usually used 4 times per day. Follow your doctor’s dosing instructions very carefully.

Overuse of this medicine may increase the risk of death. It is critical that you use only the prescribed dose of this medicine.

Albuterol and ipratropium inhalation comes with patient instructions for safe and effective use, and directions for priming the inhaler device. Duoneb and Combivent Respimat have different patient instructions. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

To use the inhaler (Combivent Respimat):

  • You do not need to shake Combivent Respimat before use.
  • Uncap the mouthpiece of the inhaler. Breathe out fully. Put the mouthpiece into your mouth and close your lips. Keep your eyes closed to prevent spraying any medicine into your eyes. Breathe in slowly while pressing the dose-release button on the inhaler. Hold your breath for 10 seconds, then breathe out slowly.
  • Close the cap until you use your inhaler again.
  • Carefully follow all directions for cleaning your specific inhaler device once per week.

Keep track of the number of sprays you have used. Throw away the Combivent Respimat inhaler canister after 3 months or 120 sprays, whichever comes first.

To use the solution with a nebulizer (Duoneb):

  • Open the foil pouch and remove one vial. Squeeze all of the medicine out into the chamber of the nebulizer. Attach the mouthpiece or face mask, then attach the drug chamber to the compressor.
  • Sit upright in a comfortable position. Place the mouthpiece into your mouth or put on the face mask, covering your nose and mouth. Turn on the compressor.
  • Breathe in slowly and evenly until no more mist is formed by the nebulizer and the drug chamber is empty.
  • Clean the nebulizer after each use. Follow the cleaning directions that came with your nebulizer.

Use albuterol and ipratropium regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Seek medical attention if you think this medication is not working as well as usual.

While using albuterol and ipratropium, you may need medical tests.

Store at room temperature away from moisture, heat, and light. Keep each Duoneb vial in its foil pouch until you are ready to use it. Do not store Combivent Respimat in your car on hot days. Extreme heat can cause the medicine canister to burst. Do not throw an empty canister into open flame.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of albuterol and ipratropium can be fatal. Overdose symptoms may include chest pain, fast or pounding heartbeats, tremors, dry mouth, extreme thirst, muscle weakness or limp feeling, severe headache, pounding in your neck or ears, or feeling like you might pass out.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Do not use more than 6 inhalations in a 24-hour period.

Copyright 1996-2020 Cerner Multum, Inc.

Latest Update: 11/9/2018, Version: 7.01

Ipratropium Therapy in Adults with Acute Asthma

Approximately 14 million persons in the United States have asthma. Of note, the prevalence of self-reported disease doubled from 1980 to 1994. Current treatment guidelines for patients with asthma recommend the regular use of anti-inflammatory agents, including inhaled steroids, mast cell stabilizers and leukotriene modifiers, to prevent chronic airway inflammation. In patients with acute asthma exacerbations, the treatment guidelines advocate nebulized therapy with a beta2-adrenergic receptor agonist combined with ipratropium. This treatment plan makes sense in theory because these two agents have different mechanisms of action by which they produce more bronchodilation in combination than beta-agonist monotherapy. However, the use of ipratropium in the treatment of patients with acute asthma remains controversial. Herner and colleagues reviewed data from several clinical trials to assess the safety, tolerability, effectiveness and price of the combined use of ipratropium with a beta-agonist in the treatment of patients with acute asthma.

Adverse effects reported by the manufacturer of ipratropium bromide solution for inhalation are from 12-week active-controlled clinical trials. The most common adverse events included tremor, agitation, vomiting, increase in pulse, dry mouth, palpitations, chest pain, back pain, nervousness, headache, nausea and dizziness. However, many of the reported side effects were minor and occurred during administration of ipratropium for more than 12 weeks; thus, these side effects may not correlate with acute asthma exacerbations. In the trials reviewed for this article, patient dropout resulting from the side effects of combined therapy did not differ from the dropout rate in the control group that received only beta-agonist therapy. In a pooled analysis including 10 trials investigating ipratropium as adjunctive therapy with beta-agonist in adults with acute asthma, no serious adverse effects were associated with any therapy, and patients who took ipratropium did not experience more side effects compared with those who took placebo. Most trials did not report adverse effect rates. The safety and efficacy of ipratropium in children younger than 12 years have not been established. Ipratropium solution for inhalation is rated as a pregnancy category B drug, and none of the other asthma medications for pregnancy has a higher safety rating.

The authors reviewed a number of clinical trials that used a variety of combined and monotherapy approaches using ipratropium and albuterol (e.g., nebulized treatments of albuterol-placebo compared with albuterolipratropium, ipratropium-albuterol compared with albuterol alone), in the treatment of adults with acute asthma. Primary and secondary end points varied among these studies and included hospital admission rates, admission-discharge ratios, length of stay in the emergency department, and changes in forced expiratory volume (FEV1) and peak expiratory flow rate (PEFR). One study evaluated the efficacy of a single nebulizer treatment of ipratropium and albuterol compared with albuterol alone. The results revealed a trend toward fewer hospitalizations in the ipratropium-albuterol group, but the difference was not statistically significant. One pooled analysis of three of the trials that evaluated the efficacy of combined ipratropium and albuterol revealed a 20 percent decrease in hospitalization rate, a 16 percent decrease in the risk of asthma exacerbation and an 8 percent decrease in the need for further asthma therapy. However, only the last outcome was statistically significant.

The authors reference the 1998 Drug Topics Red Book in evaluating cost. A single adult dose of ipratropium (2.5 mL of the 0.02 percent solution) has an average wholesale price of $1.75. In addition, mixing ipratropium solution with albuterol solution does not add to the cost of administration.

The authors conclude that, based on evidence from the reviewed clinical trials, the benefit of adding nebulized ipratropium to a beta-agonist in the treatment of adults with acute asthma remains unclear. Further studies are needed to assess subjective parameters (e.g., symptom improvement, the patient’s perception of clinical benefit). In addition, further trials are needed that include patients with a PEFR/FEV1 of less than 50 percent because most cases of adult asthma that have been studied in clinical trials to date were not defined as severe.

Ipratropium and Albuterol Inhalation Solution

Generic Name: Ipratropium and Albuterol Inhalation Solution (i pra TROE pee um & al BYOO ter ole)
Brand Name: DuoNeb

Medically reviewed by Drugs.com. Last updated on Sep 1, 2019.

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Uses of Ipratropium and Albuterol Inhalation Solution:

  • It is used to open the airways in lung diseases where spasm may cause breathing problems.

What do I need to tell my doctor BEFORE I take Ipratropium and Albuterol Inhalation Solution?

  • If you have an allergy to ipratropium, albuterol, or any other part of ipratropium and albuterol inhalation solution.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you take other drugs called anticholinergics, like ipratropium or oxybutynin. Ask your doctor if you are not sure if any of your drugs are anticholinergic.
  • If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with ipratropium and albuterol inhalation solution.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take ipratropium and albuterol inhalation solution with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Ipratropium and Albuterol Inhalation Solution?

  • Tell all of your health care providers that you take ipratropium and albuterol inhalation solution. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how ipratropium and albuterol inhalation solution affects you.
  • Do not take more of ipratropium and albuterol inhalation solution or use it more often than you have been told. Deaths have happened when too much of ipratropium and albuterol inhalation solution was taken. Talk with your doctor.
  • Call your doctor right away if your normal dose does not work well, if your signs get worse, or if you need to use ipratropium and albuterol inhalation solution more often than normal.
  • If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
  • Do not get ipratropium and albuterol inhalation solution in the eyes.
  • If ipratropium and albuterol inhalation solution gets in the eyes, rinse with water right away. Call the doctor right away if ipratropium and albuterol inhalation solution gets in the eyes and blurred eyesight, worsened glaucoma, or eye pain happens.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using ipratropium and albuterol inhalation solution while you are pregnant.

How is this medicine (Ipratropium and Albuterol Inhalation Solution) best taken?

Use ipratropium and albuterol inhalation solution as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • For breathing in only as a liquid (solution) by a special machine (nebulizer) into the lungs.
  • Do not use if the solution is cloudy, leaking, or has particles.
  • Do not use if solution changes color.
  • Do not mix other drugs in nebulizer.

What do I do if I miss a dose?

  • If you use ipratropium and albuterol inhalation solution on a regular basis, use a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not use 2 doses at the same time or extra doses.
  • Many times ipratropium and albuterol inhalation solution is used on an as needed basis. Do not use more often than told by the doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Chest pain or pressure or a fast heartbeat.
  • A heartbeat that does not feel normal.
  • Change in eyesight, eye pain, or very bad eye irritation.
  • Seeing halos or bright colors around lights.
  • Red eyes.
  • Trouble passing urine, pain when passing urine, passing urine in a weak stream or drips, or passing urine more often.
  • Very bad dizziness or passing out.
  • This medicine can cause very bad breathing problems right after you take a dose. Sometimes, this may be life-threatening. If you have trouble breathing, breathing that is worse, wheezing, or coughing after using ipratropium and albuterol inhalation solution, use a rescue inhaler and get medical help right away.

What are some other side effects of Ipratropium and Albuterol Inhalation Solution?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Feeling nervous and excitable.
  • Headache.
  • Shakiness.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Ipratropium and Albuterol Inhalation Solution?

  • Store at room temperature. Do not freeze.
  • Protect from light.
  • Store unused containers in foil pouch until use.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer information use

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about ipratropium and albuterol inhalation solution, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

More about albuterol / ipratropium

  • Side Effects
  • During Pregnancy
  • Dosage Information
  • Drug Interactions
  • Pricing & Coupons
  • En Español
  • 37 Reviews
  • Drug class: bronchodilator combinations

Consumer resources

  • Albuterol and ipratropium inhalation
  • Ipratropium and Albuterol Inhalation Spray
  • Ipratropium and albuterol Inhalation, oral/nebulization (Advanced Reading)

Other brands: DuoNeb, Combivent, Combivent Respimat

Professional resources

  • Ipratropium and Albuterol (Wolters Kluwer)
  • … +1 more

Related treatment guides

  • COPD, Maintenance

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