What is Perforomist?

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, 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).

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

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.

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 this medicine 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 this medicine 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 a Medication Guide and patient directions. Read the directions carefully before using this medicine. 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 this medicine.
• 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 this medicine.
• You may reuse your inhaler. But use a new inhaler with each refill of your medicine.
• Do not use the inhaler for this medicine with any other medicine.

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 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.
    • 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).

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

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

Store Foradil® capsules at room temperature, away from heat, light, or moisture. Keep capsules stored in the blister packaging, and do not remove from blister until immediately before use.

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:

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.

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.

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.

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.

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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amifampridine
• Amisulpride
• Bepridil
• Cisapride
• Dronedarone
• Mesoridazine
• Pimozide
• Piperaquine
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

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.

• Amiodarone
• Anagrelide
• Aripiprazole
• Aripiprazole Lauroxil
• Buprenorphine
• Buserelin
• Clozapine
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Deslorelin
• Deutetrabenazine
• Domperidone
• Donepezil
• Efavirenz
• Encorafenib
• Escitalopram
• Fingolimod
• Fluconazole
• Fluoxetine
• Foscarnet
• Gonadorelin
• Goserelin
• Histrelin
• Hydroxychloroquine
• Hydroxyzine
• Inotuzumab Ozogamicin
• Ivabradine
• Ivosidenib
• Ketoconazole
• Leuprolide
• Levofloxacin
• Lofexidine
• Macimorelin
• Methadone
• Metronidazole
• Nafarelin
• Nilotinib
• Osimertinib
• Panobinostat
• Pasireotide
• Pimavanserin
• Pitolisant
• Posaconazole
• Quetiapine
• Ribociclib
• Sertraline
• Sotalol
• Sulpiride
• Tacrolimus
• Triptorelin
• Vemurafenib
• Vinflunine
• Zuclopenthixol

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.

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:

• Acute asthma attack or
• COPD attack, severe—Should not be used if you are having an acute asthma attack, severe COPD attack, or if symptoms of an asthma or COPD attack has already started. Your doctor may prescribe another medicine for you to use in case of an acute asthma or COPD attack.

• Angina (severe chest pain) or
• Diabetes or
• Heart or blood vessel disease (e.g., aneurysm) or
• Heart rhythm problems (e.g., arrhythmia) or
• Hypertension (high blood pressure) or
• Hyperthyroidism (an overactive thyroid) or
• Hypokalemia (low potassium in the blood) or
• Ketoacidosis (acids in the blood) or
• Pheochromocytoma (adrenal gland problem) or
• Seizures—Use with caution. May make these conditions worse.

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

If you will be taking this medicine 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.

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

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.

This medicine 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 this medicine 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 this medicine. 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 this medicine decreases the number of asthma episodes, this medicine 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.

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 or your child has a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

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: 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.

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.