Pronunciation:

ar-for-MOE-ter-ol

Brand Names:

• Brovana

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Bronchodilator

Pharmacologic—

Sympathomimetic

Uses of This Medicine:

Arformoterol is used for the long-term maintenance treatment of air flow blockage in patients with 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). When used regularly, inhaled arformoterol decreases the number and severity of COPD attacks. However, it will not relieve symptoms of a COPD attack that has already started.

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. They relieve coughing, wheezing, shortness of breath, and troubled breathing by increasing the flow of air into the lungs.

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

Before Using This Medicine:

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.

Children—

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.

Older adults—

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.

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.

Other 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.

• Methacholine
• Sotalol

Other interactions—

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
• Heart or blood vessel disease or
• Heart rhythm problems (eg, arrhythmia, QT prolongation) or
• Hypertension (high blood pressure) or
• Hyperthyroidism (overactive thyroid) or
• Hypokalemia (low potassium in the blood) or
• Ketoacidosis (high ketones in the blood) 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 a COPD attack has already started. Your doctor may prescribe another medicine for you to use in case of an acute COPD attack.

• Liver disease—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

Proper Use of This Medicine:

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 patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. If you do not understand the directions or you are not sure how to use the nebulizer, ask your doctor to show you what to do. Also, ask your doctor to check how you use the inhaler to make sure you are using it properly.

You will use this medicine with an inhaler device called a nebulizer connected to an air compressor. 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 and compressor.

Do not swallow or inject the solution.

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. Connect the nebulizer to the compressor.
• To inhale the medicine, place the mouthpiece in your mouth, then turn on the compressor. Breathe in deeply and steadily until no more mist is formed in the nebulizer reservoir.
• 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 (solution):
  • For maintenance treatment of COPD:
    • Adults—15 micrograms (mcg) 2 times a day (morning and evening) by nebulization. The total dose should not be more than 30 mcg per day.
    • 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.

You may also store the unopened foil pouches of this medicine can also be stored at room temperature, away from heat and direct light, for up to 6 weeks. Throw away any unused medicine after 6 weeks.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure the medicine is working properly and to decide if you should continue to take it. Blood tests may also be needed to check for unwanted effects.

Tell your doctor if you are also using any other medicine for your COPD. Your doctor may want you to 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 a 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.

Talk to your doctor or get medical care right away if:

• Your symptoms do not improve after using this medicine within a few days or if they become worse.
• Your short-acting inhaler does not seem to be working as well as usual and you need to use it more often.

This medicine should not be used together with similar inhaled medicines such as budesonide/formoterol (Symbicort®), formoterol (Foradil®, Perforomist™), indacaterol (Arcapta® Neohaler®), salmeterol (Serevent®), or salmeterol/fluticasone (Advair®).

This medicine may increase the risk of worsening asthma, which may lead to hospitalization, intubation, and death in patients with asthma who take this medicine without an inhaled steroid 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. Check with your doctor right away if you have coughing, difficulty breathing, shortness of breath, or wheezing after using this medicine.

Arformoterol may cause heart or blood vessel problems, including heart rhythm problems. Check with your doctor right away if you have chest pain or tightness, decreased urine output, dilated neck veins, extreme fatigue, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, troubled breathing, or weight gain.

Hypokalemia (low potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have more than one of the following symptoms: decreased urine, dry mouth, increased thirst, loss of appetite, mood changes, muscle pain or cramps, nausea or vomiting, numbness or tingling in the hands, feet, or lips, seizures, uneven heartbeat, or unusual tiredness or weakness.

This medicine may affect blood sugar levels. If you are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor.

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

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

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

Chest pain

Less common

Anxiety

blistering, crusting, irritation, itching, or reddening of the skin

bloating or swelling of the face, arms, hands, lower legs, or feet

bloody or cloudy urine

blurred vision

chest discomfort or tightness

chills

cold sweats

confusion

cool, pale skin

cough

decreased urination

depression

difficult or labored breathing

difficult, burning, or painful urination

difficulty swallowing

dilated neck veins

dizziness

dry mouth

extreme tiredness or weakness

fainting

fast heartbeat

fever

flushed, dry skin

frequent urge to urinate

fruit-like breath odor

headache

hives, itching, skin rash

increase in heart rate

increased hunger

increased thirst

increased urination

irregular breathing

irregular heartbeat, recurrent

lightheadedness

loss of appetite

loss of consciousness

mood changes

muscle aches and pains

nausea

nervousness

nightmares numbness or tingling in the hands, feet, or lips

pain or discomfort in the arms, jaw, back, or neck

pain or tenderness around the eyes and cheekbones

pounding, slow heartbeat

rapid breathing

rapid weight gain

seizures

shakiness

slurred speech

sore throat

stomach pain

stuffy or runny nose

sunken eyes

sweating

unusual tiredness or weakness

unusual weight gain or loss

vomiting

wrinkled skin

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, tightness, or heaviness

confusion

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

loss of consciousness

mood changes

muscle pain, cramps, or tremors

nervousness

numbness or tingling in the hands, feet, or lips

pounding in the ears

rapid, deep breathing

restlessness

seizures

slow heartbeat

stomach cramps

tremor

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Diarrhea

Less common

Blindness

bloody, black, or tarry stools

blurred vision

burning feeling in the chest or stomach

change in vision

change in voice

constipation

decreased vision

difficulty in moving

dry skin

eye pain

indigestion

leg cramps

muscle stiffness

pain, swelling, or redness in the joints

pelvic pain

skin color changes

stomach upset

tearing

tenderness in the stomach area

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.