Formoterol

Formoterol is a prescription medication used to treat breathing difficulties caused by asthma, exercise induced bronchospasm (EIB), and chronic obstructive pulmonary disease (COPD). Formoterol belongs to a group of medications called long acting beta agonists. It works by helping the muscles in your lungs to stay relaxed. This opens up the airways and makes it easier to breathe.

Formoterol comes in the form of a powder filled capsule that is inhaled by mouth (never swallowed) using an Aerolizer inhaler. For asthma and COPD the usual dose is one capsule inhaled twice daily.

Formoterol is also available as a solution to be inhaled via a nebulizer to treat COPD. It is usually inhaled every 12 hours. 

Common side effects include headache, chest pain, and trouble sleeping. 

Formoterol is a prescription medicine used to treat breathing difficulties caused by asthma, exercise induced bronchospasm (EIB), and chronic obstructive pulmonary disease (COPD).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Formoterol may be found in some form under the following brand names:

• Dulera

• Foradil

• Perforomist

• Symbicort

Formoterol may cause serious side effects, including:

• See "Formoterol Precautions."
• Sudden breathing problems immediately after inhaling your medicine (wheezing or coughing and difficulty breathing)
• Fast or irregular heart beat (palpitations)
• Serious allergic reactions including rash, hives, swelling of the face, mouth, and tongue, and breathing problems. Call your healthcare provider or get emergency medical care if you get any symptoms of a serious allergic reaction. 
• Low blood potassium (which may cause symptoms of muscle spasm, muscle weakness or abnormal heart rhythm)
• Increases in blood sugar levels (hyperglycemia)
• Using too much of a LABA medicine may cause:
  • chest pain
  • increased blood pressure
  • a fast or irregular heart beat
  • headache
  • tremor
  • nervousness
  • dizziness
  • weakness 
  • trouble sleeping
  • electrocardiogram (ECG) changes
  • seizures

Common side effects with formoterol include:

Asthma in Adults and Adolescents:

• headache
• tremor
• chest infection
• chest pain
• trouble sleeping

Asthma in Children 5-12 Years of Age:

• viral infections
• runny nose
• tonsillitis
• gastroenteritis
• abdominal pain
• nausea
• dyspepsia

COPD:

• respiratory infection
• throat infection
• chest pain
• sinus infection 
• fever
• leg cramps
• muscle cramps

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the side effects with formoterol. Ask your healthcare provider or pharmacist for more information.

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

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• aminophylline (Truphylline)
• amiodarone (Cordarone)
• antidepressants such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil)
• beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), propranolol (Inderal), and sotalol (Betapace, Betapace AF)
• clonidine (Catapres)
• diet pills
• digoxin (Lanoxin, Digitek)
• disopyramide (Norpace)
• diuretics ('water pills') such as bumetanide (Bumex), chlorothiazide (Diuril), chlorthalidone (Thalitone), ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (Esidrix, Hydrodiuril, Microzide, Oretic), metolazone (Zaroxolyn), torsemide (Demadex).
• dofetilide (Tikosyn)
• dyphylline (Dilor, Lufyllin)
• erythromycin (E.E.S., E-Mycin, Erythrocin)
• guanabenz
• medications for colds
• monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl), and tranylcypromine (Parnate)
• midodrine (Orvaten)
• moxifloxacin (Avelox)
• oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone); pimozide (Orap)
• procainamide (Procanbid, Pronestyl)
• quinidine (Quinidex)
• salmeterol (Serevent) or salmeterol and fluticasone (Advair)
• sparfloxacin (Zagam)
• theophylline (Theo-Chron, Theolair)
• thioridazine (Mellaril)

This is not a complete list of formoterol drug interactions. Ask your doctor or pharmacist for more information.

Formoterol can cause serious side effects, including:

1. People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as formoterol, have an increased risk of death from asthma problems.

• Call your healthcare provider if breathing problems worsen over time while using formoterol. You may need a different treatment.
• Get emergency medical care if:
  • breathing problems worsen quickly, and
  • you use your rescue inhaler medicine, but it does not relieve your breathing problems.

2. Do not use formoterol as your only asthma medicine. Formoterol must only be used with a long-term asthma control medicine, such as an inhaled corticosteroid.

3. When your asthma is well controlled, your healthcare provider may tell you to stop taking formoterol. Your healthcare provider will decide if you can stop formoterol without loss of asthma control. You will continue taking your long-term asthma control medicine, such as an inhaled corticosteroid.

4. Children and adolescents who take LABA medicines may have an increased risk of being hospitalized for asthma problems.

Do not take formoterol:

• to treat your asthma without a long-term asthma control medicine, such as an inhaled corticosteroid 
• to treat sudden symptoms of asthma or COPD
• if you are allergic to formoterol fumarate or any of the ingredients in it. Ask your healthcare provider if you are not sure. 

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of formoterol there are no specific foods that you must exclude from your diet when receiving this medication.

Tell your healthcare provider about all of your health conditions, including if you:

• have heart problems
• have high blood pressure
• have seizures
• have thyroid problems
• have diabetes
• are pregnant or breastfeeding 
• are allergic to formoterol or any other medications

Formoterol contains lactose (milk sugar) and a small amount of milk proteins. It is possible that allergic reactions may happen in patients who have a severe milk protein allergy.

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. 

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Formoterol falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans, though. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

It is not known if formoterol crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using formoterol.

See the step-by-step instructions for using the inhaler in the leaflet that comes with this medicine. Do not use formoterol unless your healthcare provider has taught you and you understand everything. Ask your healthcare provider or pharmacist if you have any questions.

• Children should use formoterol with an adult’s help, as instructed by the child’s healthcare provider.
• Use formoterol exactly as prescribed. Do not use formoterol more often than prescribed.
• If you miss a dose of formoterol, just skip that dose. Take your next dose at your usual time. Never take 2 doses at one time.
• Do not use a spacer device.
• Do not breathe into the device.
• While you are using formoterol 2 times each day, do not use other medicines that contain a long-acting beta2-agonist (LABA) for any reason. Ask your healthcare provider or pharmacist for a list of these medicines. 
• Do not stop using formoterol or any of your asthma medicines unless told to do so by your healthcare provider because your symptoms might get worse. Your healthcare provider will change your medicines as needed.
• Formoterol does not relieve sudden symptoms. Always have a rescue inhaler medicine with you to treat sudden symptoms. If you do not have an inhaled, short-acting bronchodilator, contact your healthcare provider to have one prescribed for you.

• Call your healthcare provider or get medical care right away if:
  • your breathing problems worsen with formoterol
  • you need to use your rescue inhaler medicine more often than usual
  • your rescue inhaler medicine does not work as well for you at relieving symptoms
  • you need to use 4 or more inhalations of your rescue inhaler medicine for 2 or more days in a row
  • you use 1 whole canister of your rescue inhaler medicine in 8 weeks time
  • your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you.
  • you have asthma and your symptoms do not improve after using formoterol regularly for 1 week.

Formoterol Inhalation Solution:

Formoterol is also available as a solution to be inhaled via a nebulizer to treat COPD. It is usually inhaled every 12 hours. 

• Use formoterol Inhalation Solution exactly as prescribed. One ready-to-use vial of formoterol Inhalation Solution is one dose.

• The usual dose of formoterol Inhalation Solution is one ready-to-use vial, twice a day (morning and evening) breathed in through your nebulizer machine. The 2 doses should be about 12 hours apart. Do not use more than 2 vials of formoterol Inhalation Solution a day.

• Do not mix other medicines with formoterol Inhalation Solution in your nebulizer machine.

• If you miss a dose of formoterol Inhalation Solution, just skip that dose. Take your next dose at your usual time. Do not take 2 doses at one time.

While you are using formoterol Inhalation Solution 2 times each day:

• do not use other medicines that contain a long-acting beta 2-agonist (LABA) for any reason.
• do not use your short-acting beta 2-agonist medicine on a regular basis (four times a day).

Formoterol Inhalation Solution does not relieve sudden symptoms of COPD. Always have a rescue inhaler medicine with you to treat sudden symptoms. If you do not have a rescue inhaler medicine, call your healthcare provider to have one prescribed for you.

 

Do not stop using formoterol Inhalation Solution or other medicines to control or treat your COPD unless told to do so by your healthcare provider because your symptoms might get worse. Your healthcare provider will change your medicines as needed.

 

Do not use formoterol Inhalation Solution:

• more often than prescribed

• more medicine than prescribed for you

  with other LABA medicines

Take this medication exactly as prescribed. Follow the directions on your prescription label carefully.

• For asthma and COPD, the usual dose is 1 capsule inhaled through the inhaler 2 times each day (morning and evening). The 2 doses should be about 12 hours apart. 
• For preventing exercise-induced bronchospasm, the usual dose is 1 capsule inhaled through the inhaler at least 15 minutes before exercise, as needed. Do not use formoterol more often than every 12 hours. Do not use extra formoterol before exercise if you already use it 2 times each day.
• Perforomist: For COPD, the usual dose is 20 mcg unit-dose vial administered twice daily (morning and evening) by nebulization. A total daily dose greater than 40 mcg is not recommended.

If you take too much formoterol, call your local Poison Control Center or seek emergency medical attention right away.

• Store formoterol at room temperature between 68°F and 77°F (20°C to 25°C). 
• Protect formoterol from heat and moisture. 
• Do not remove formoterol capsules from their foil blister package until just before use. 
• Always discard the old inhaler by the “Use by” date and use the new one provided with each new prescription.
• Safely discard formoterol capsules and the inhaler if no longer needed or is out-of-date. 
• Keep formoterol and all medicines out of the reach of children.

WARNING: ASTHMA-RELATED DEATH

Long-acting beta2-adrenergic agonists (LABA), such as formoterol, increase the risk of asthma-related death. Data from a large placebo controlled US study that compared the safety of another LABA (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including formoterol.

Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA.

Because of this risk, use of formoterol for the treatment of asthma without a concomitant long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated. Use formoterol only as additional therapy for patients with asthma who are currently taking but are inadequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use formoterol for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.

Pediatric and Adolescent Patients

Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients. For pediatric and adolescent patients with asthma who require addition of a LABA to an inhaled corticosteroid, a fixed-dose combination product containing both an inhaled corticosteroid and LABA should ordinarily be considered to ensure adherence with both drugs. In cases where use of a separate long-term asthma control medication (e.g. inhaled corticosteroid) and LABA is clinically indicated, appropriate steps must be taken to ensure adherence with both treatment components. If adherence cannot be assured, a fixed-dose combination product containing both an inhaled corticosteroid and LABA is recommended.