Generic Name: arformoterol (Inhalation route)

ar-for-MOE-ter-ol

Inhalation route(Solution)

Long-acting beta(2)-adrenergic agonists increase the risk of asthma-related deaths. This finding was obtained from data from a large placebo-controlled United States study that showed an increase in asthma-related deaths in patients receiving salmeterol (another long-acting beta(2)-adrenergic agonist). Safety and efficacy of arformoterol in patients with asthma have not been established. All LABA, including arformoterol, are contraindicated in patients with asthma without use of a long-term asthma control medication .

Commonly used brand name(s)

In the U.S.

  • Brovana

Available Dosage Forms:

  • Solution

Therapeutic Class: Bronchodilator

Pharmacologic Class: Sympathomimetic

Uses For Brovana

Arformoterol is used to treat symptoms of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. COPD is a long-term lung disease that causes bronchospasm (wheezing or difficulty with breathing).

Slideshow: Flashback: FDA Drug Approvals 2013

Arformoterol belongs to the family of medicines known as bronchodilators. Bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs. It is taken by inhalation (an inhaler) to help decrease coughing, wheezing, shortness of breath, and troubled breathing by increasing the flow of air into the lungs.

When used regularly everyday, inhaled arformoterol decreases the number and severity of COPD. However, it will not relieve symptoms of a COPD attack that has already started.

This medicine is available only with your doctor's prescription.

Before Using Brovana

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of arformoterol inhalation in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of arformoterol inhalation in the elderly. However, elderly patients are more likely to be sensitive to some side effects of this medicine than younger adults.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acebutolol
  • Atenolol
  • Befunolol
  • Betaxolol
  • Bevantolol
  • Bisoprolol
  • Bopindolol
  • Carteolol
  • Carvedilol
  • Celiprolol
  • Esmolol
  • Furazolidone
  • Iproniazid
  • Isocarboxazid
  • Labetalol
  • Landiolol
  • Levobetaxolol
  • Levobunolol
  • Linezolid
  • Mepindolol
  • Methylene Blue
  • Metipranolol
  • Metoprolol
  • Moclobemide
  • Nadolol
  • Nebivolol
  • Nipradilol
  • Oxprenolol
  • Pargyline
  • Penbutolol
  • Phenelzine
  • Pindolol
  • Procarbazine
  • Propranolol
  • Rasagiline
  • Selegiline
  • Sotalol
  • Talinolol
  • Tertatolol
  • Timolol
  • Tranylcypromine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Asthma or
  • Diabetes or
  • Electrolyte imbalance (e.g., low potassium in the blood) or
  • Heart or blood vessel disease or
  • Heart rhythm problems (e.g., arrhythmia) or
  • Hypertension (high blood pressure) or
  • Ketoacidosis (acids in the blood) or
  • Liver disease or
  • Overactive thyroid or
  • Seizures—Use with caution. May make these conditions worse.
  • COPD attack, severe—Should not be used if you are having a severe COPD attack, or if symptoms of COPD attack has already started. Your doctor may prescribe another medicine for you to use in case of an acute COPD attack.

Proper Use of Brovana

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than recommended on the label, unless otherwise directed by your doctor. Using the medicine more often may increase the chance of serious unwanted effects.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the medication guide if you do not have one. Your doctor might ask you to sign some forms to show that you understand this information.

You will use this medicine with an inhaler device called a nebulizer. The nebulizer turns the medicine into a fine mist that you breathe in through your mouth and to your lungs. Your caregiver will show you how to use your nebulizer.

This medicine is inhaled and must not be swallowed or injected.

To use the inhalation solution in the nebulizer:

  • Use the medicine immediately after opening the foil pouch. Do not use if the solution turns pinkish to brownish in color or if it becomes cloudy.
  • Place the inhalation solution in the medicine reservoir or nebulizer cup on the machine.
  • Connect the nebulizer to the face mask or mouthpiece.
  • Use the face mask or mouthpiece to breathe in the medicine.
  • Use the nebulizer for about 5 to 10 minutes, or until the medicine in the nebulizer cup is gone.
  • Clean all the parts of the nebulizer after each use.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral inhalation dosage form (nebulization):
    • For chronic obstructive pulmonary disease (COPD):
      • Adults—15 micrograms (mcg) two times a day (morning and evening) by nebulization.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store unopened vials of this medicine in the refrigerator. Do not freeze. An open vial of medicine must be used right away.

Unopened foil pouches of this medicine can also be stored at room temperature, away from heat and direct light, for up to six weeks.

Precautions While Using Brovana

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

Tell your doctor if you are also using other medicines for your COPD. Your doctor may want you to stop using the medicine and use it only during a severe COPD attack. Follow your doctor's instructions on how you should take your medicine.

This medicine should not be used if you are having a severe COPD attack, or if symptoms of COPD attack has already started. Your doctor may prescribe another medicine for you to use in case of an acute COPD attack. If the other medicine does not work as well, tell your doctor right away.

Tell your doctor if you have asthma. Some people with asthma have had more severe asthma attacks when they used this medicine. Talk to your doctor about any questions or concerns you may have.

This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Stop using this medicine and check with your doctor right away if you have coughing, difficulty breathing, shortness of breath, or wheezing after using this medicine.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

Brovana Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Back pain
  • chest pain
  • diarrhea
  • pain
Less common
  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • chills
  • cough
  • difficult or labored breathing
  • fever
  • general feeling of discomfort or illness
  • headache
  • joint pain
  • leg cramps
  • loss of appetite
  • muscle aches and pains
  • nausea
  • pain or tenderness around the eyes and cheekbones
  • rapid weight gain
  • rash
  • shivering
  • shortness of breath
  • sore throat
  • stuffy or runny nose
  • sweating
  • tightness of the chest
  • tingling of the hands or feet
  • trouble with sleeping
  • troubled breathing
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • vomiting
  • wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose
  • Arm, back, or jaw pain
  • blurred vision
  • chest discomfort
  • chest tightness or heaviness
  • confusion
  • convulsions
  • decreased urine
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • drowsiness
  • dry mouth
  • fast, pounding, or irregular heartbeat or pulse
  • increased thirst
  • mood changes
  • muscle pain or cramps
  • muscle tremors
  • nervousness
  • no blood pressure or pulse
  • numbness or tingling in the hands, feet, or lips
  • pounding in the ears
  • rapid, deep breathing
  • restlessness
  • slow heartbeat
  • stomach cramps
  • stopping of the heart
  • tremor
  • unconsciousness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

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