formoterol Inhalation, oral/nebulization

for-MOE-ter-ol

Commonly used brand name(s)

In the U.S.

• Foradil Aerolizer


• Perforomist

Available Dosage Forms:

• Aerosol Powder


• Solution


• Capsule

Therapeutic Class: Bronchodilator

Pharmacologic Class: Sympathomimetic

Uses For formoterol

Formoterol is used together with other medicines (such as inhaled corticosteroids) to treat asthma and prevent bronchospasm in patients with asthma. When used regularly every day, inhaled formoterol decreases the number and severity of asthma attacks. However, it will not relieve an asthma attack that has already started.

Formoterol is also used to treat symptoms of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Formoterol belongs to the family of medicines known as adrenergic bronchodilators. Adrenergic bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs. They relieve cough, wheezing, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes.

Formoterol is also used to prevent wheezing caused by exercise (exercise-induced bronchospasm or EIB).

formoterol is available only with your doctor's prescription.

Before Using formoterol

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 formoterol, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to formoterol 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of formoterol inhalation powder in children 5 years of age and older. Safety and efficacy have not been established for children younger than 5 years of age.

Appropriate studies have not been performed on the relationship of age to the effects of formoterol inhalation solution 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 formoterol in the elderly. However, elderly patients are more likely to have age-related heart or blood vessel disease, which may require caution in patients receiving formoterol.

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 formoterol, 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 formoterol 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


• Alprenolol


• Arotinolol


• Atenolol


• Befunolol


• Betaxolol


• Bevantolol


• Bisoprolol


• Bopindolol


• Brofaromine


• Bucindolol


• Bupranolol


• Carteolol


• Carvedilol


• Celiprolol


• Clorgyline


• Dilevalol


• Esmolol


• Furazolidone


• Iproniazid


• Isocarboxazid


• Labetalol


• Landiolol


• Lazabemide


• Levobetaxolol


• Levobunolol


• Linezolid


• Mepindolol


• Metipranolol


• Metoprolol


• Moclobemide


• Nadolol


• Nebivolol


• Nialamide


• Nipradilol


• Oxprenolol


• Pargyline


• Penbutolol


• Phenelzine


• Pindolol


• Procarbazine


• Propranolol


• Rasagiline


• Selegiline


• Sotalol


• Talinolol


• Tertatolol


• Timolol


• Toloxatone


• 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 formoterol. 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 (e.g., arrhythmia) or


• Hypertension (high blood pressure) or


• Hypokalemia (low potassium in the blood) or


• Ketoacidosis (acids in the blood) 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.

• Lactose intolerance—Use with caution. The capsule form of formoterol contains lactose.

Proper Use of formoterol

Use formoterol 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.

Inhaled formoterol is used to prevent asthma or COPD attacks. It is not used to relieve an attack that has already started. For relief of an asthma or COPD attack that has already started, you should use another medicine. If you do not have another medicine to use, or if you have any questions about this, check with your doctor.

In order for formoterol to help prevent asthma or COPD attacks, it must be used every day in regularly spaced doses, as ordered by your doctor.

Do not stop using formoterol or other asthma or COPD medicines that your doctor has prescribed for you unless you have discussed this with your doctor.

The formoterol inhalation solution should be used with a jet nebulizer that is connected to an air compressor with good air flow. The inhalation solution comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

To use the inhalation solution in the nebulizer:

• Use the medicine immediately after opening the foil pouch.


• Twist the cap off the vial and squeeze all the medicine in the nebulizer medicine cup.


• Do not mix Perforomist® inhalation solution with other medicines in the nebulizing 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 9 minutes, or until the medicine in the nebulizer cup is gone.


• Clean all the parts of the nebulizer after each use.

Formoterol inhalation powder is used with a special inhaler and usually comes with patient directions. Read the directions carefully before using formoterol. If you do not understand the directions or you are not sure how to use the inhaler, 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.

To use the formoterol inhalation powder:

• Dry your hands before handling formoterol.


• Open the foil pouch containing a blister card of capsules. Do not remove a capsule until you are ready for a dose.


• Place the capsule only in the capsule-chamber in the base of the inhaler. Do not swallow the capsule and do not place a capsule directly into the mouthpiece.


• Hold the mouthpiece of the inhaler upright and press both buttons at the same time. Press the buttons only once. You should hear a click as the capsule is being pierced.


• Breathe out fully. Do not exhale into the mouthpiece.


• Tilt your head slightly backwards. Keep the inhaler level, with the blue buttons to the left and right. Place the mouthpiece in your mouth then close your lips around the mouthpiece.


• Breathe in quickly and deeply.


• Remove the inhaler from your mouth. Hold your breath as long as you can and then exhale.


• Open the inhaler after using it, and remove and discard the empty capsule. Do not leave the used capsule inside the chamber.


• Close the mouthpiece and then replace the cover.


• Do not wash the inhaler. Keep it dry.


• Do not use a spacer with formoterol.


• You may reuse your inhaler. But use a new inhaler with each refill of your medicine.


• Do not use the inhaler for formoterol with any other medicine.

Dosing

The dose of formoterol 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 formoterol. 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 inhalation powder dosage form (used with Foradil® aerolizer):
  
  • For preventing an asthma attack:
    
    • Adults, teenagers, and children 5 years of age and older—12 micrograms (mcg) (1 capsule) by oral inhalation every 12 hours.
    
    
    • Children younger than 5 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For preventing exercise-induced bronchospasm (EIB):
    
    • Adults, teenagers, and children 5 years of age and older—12 micrograms (mcg) (1 capsule) by oral inhalation at least 15 minutes before exercise, as needed. Doses should be at least 12 hours apart.
    
    
    • Children younger than 5 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For maintenance treatment of COPD:
    
    • Adults, teenagers, and children 5 years of age and older—12 micrograms (mcg) (1 capsule) by oral inhalation every 12 hours.
    
    
    • Children younger than 5 years of age—Use and dose must be determined by your doctor.
    
    
  
  


• For inhalation solution dosage form (used with a nebulizer):
  
  • For COPD:
    
    • Adults—20 micrograms (mcg) (1 vial) in the nebulizer two times a day (morning and evening).
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of formoterol, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

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.

Precautions While Using formoterol

If you will be taking formoterol for a long time, it is very important that your doctor check you at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.

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.

formoterol 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.

formoterol should only be used as an additional treatment for patients who cannot be treated with other asthma medicines (such as inhaled corticosteroids) or for asthma patients that require two medicines, including formoterol. Ask your doctor if you have any questions.

Talk to your doctor or get medical care right away:

• Your or your child's symptoms do not improve after using formoterol for 1 week 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 (e.g., you use 1 whole canister of your short-acting inhaler in 8 weeks time, or you need to use 4 or more inhalations of your short-acting inhaler for 2 or more days in a row).


• You have a significant decrease in your peak flow when measured as directed by your doctor.

You or your child may also be taking an anti-inflammatory medicine, such as steroid, together with formoterol. Do not stop taking the anti-inflammatory medicine even if your asthma seems better, unless you are told to do so by your doctor.

Although formoterol decreases the number of asthma episodes, formoterol may increase the chances of a severe asthma episode when they do occur. Be sure to read about these risks in the Medication Guide and talk to your doctor or pharmacist about any questions or concerns that you have.

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

formoterol 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 formoterol.

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

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

formoterol 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

• Body aches or pain


• chills


• cold or flu-like symptoms


• cough or hoarseness


• difficulty with breathing


• ear congestion


• fever


• headache


• loss of voice


• nasal congestion


• runny nose


• sneezing


• sore throat


• unusual tiredness or weakness

Less common

• Chest pain or discomfort


• cough-producing mucous


• dry throat


• labored breathing


• pain or tenderness around the eyes and cheekbones


• shortness of breath


• stuffy nose


• tender, swollen glands in the neck


• tightness in the chest


• trauma


• trouble with swallowing


• voice changes


• wheezing

Rare

• Convulsions


• decreased urine


• dry mouth


• fainting


• fast, pounding, or irregular heartbeat or pulse


• increased thirst


• loss of appetite


• noisy breathing


• palpitations

Incidence not known

• Blurred vision


• confusion


• difficulty with swallowing


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• hives


• itching


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• skin rash


• sweating

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

Symptoms of overdose

• Arm, back, or jaw pain


• chest tightness or heaviness


• general feeling or discomfort or illness


• increased hunger or thirst


• increased urination


• mood changes


• muscle pain


• muscle spasm or jerking of all extremities


• nausea


• no blood pressure or pulse


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


• palpitations or pounding in the ears


• pounding or racing heartbeat or pulse


• sleeplessness


• slow heartbeat


• stopping of heart


• sudden loss of consciousness


• unconsciousness


• vomiting

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:

Less common

• Agitation


• back pain


• fear or nervousness


• increased mucous in the throat and lungs


• leg cramps


• muscle cramps


• redness of the skin


• restlessness


• shakiness in the legs, arms, hands, or feet


• trembling or shaking of the hands or feet


• trouble sleeping


• unable to sleep

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: formoterol Inhalation,/nebulization side effects (in more detail)

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