Arformoterol

Arformoterol is a prescription medication used to used to control wheezing, shortness of breath, coughing, and chest tightness caused by chronic obstructive pulmonary disease, or COPD. Arformoterol belongs to a group of drugs called long-acting beta agonists (LABAs). These work by relaxing and opening air passages in the lungs, making it easier to breathe.

This medication comes in oral inhalational form and is taken twice a day, 12 hours apart, with a nebulizer machine.

Common side effects of arformoterol include chest or back pain, diarrhea, and sinus congestion.

Arformoterol is eliminated from the body when it is broken down by several enzymes. Two of the major enzymes that break down arformoterol are UGT and CYP2D6.

Testing for these two enzymes can be done to determine whether you are considered a "poor metabolizer." Patients who are poor metabolizers have less of these enzymes available to break down the drug, which could lead to higher levels of the drug in the blood. Having a higher level of arformoterol in the blood could lead to increased side effects. Some patients have a lesser amount of UGT or CYP2D6 available in their bodies to break down arformoterol.

In studies of arformoterol, healthy patients who were considered poor metabolizers did not experience higher drug levels.

Arformoterol is a prescription medication used to used to control wheezing, shortness of breath, coughing, and chest tightness caused by chronic obstructive pulmonary disease, or COPD.

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

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

• Brovana

Common side effects of arformoterol include:

• chest or back pain
• diarrhea
• sinus congestion
• headache
• tremor
• nervousness
• leg cramps
• high blood potassium
• shortness of breath
• rash
• fever
• increased white blood cells
• vomiting
• tiredness
• leg swelling
• chest congestion or bronchitis

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

These are not all the side effects with arformoterol. Ask your healthcare provider or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to 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:

• theophylline (Theocron, Theolair)
• diuretics such as
  • acetazolamide (Diamox)
  • amiloride (Midamor)
  • bumetanide (Bumex)
  • chlorothiazide (Diuril)
  • chlorthalidone (Thalitone)
  • ethacrynic acid (Edecrin)
  • furosemide (Lasix)
  • hydrochlorothiazide (Microzide, HCTZ)
  • metolazone (Zaroxolyn)
  • torsemide (Demadex)
  • triamterene (Dyrenium, Dyazide, Maxzide)
• steroids such as prednisone (Cortan, Deltasone, Orasone, Sterapred), budesonide (Entocort), dexamethasone (Decadron), triamcinolone (Kenacort, Aristocort), flunisolide (AeroBid, Aerospan), ciclesonide (Alvesco), mometasone (Asmanex, Dulera), fluticasone (Flovent), methylprednisolone (Medrol, Solu-Medrol), fludrocortisone (Florinef), and hydrocortisone (Cortef, Hydrocortone)
• tricyclic antidepressants such as trimipramine (Surmontil), amitriptyline (Elavil), nortriptyline (Pamelor, Aventyl), protriptyline (Vivactil), and clomipramine (Anafranil)
• beta blockers such as
  • metoprolol (Toprol XL, Lopressor)
  • carvedilol (Coreg)
  • bisoprolol (Zebeta)
  • betaxolol (Kerlone)
  • nebivolol (Bystolic)
  • propranolol (Inderal)
• Monoamine oxidase inhibitors such as
  • isocarboxazid (Marplan)
  • phenelzine (Nardil)
  • tranylcypromine (Parnate)
  • selegiline (Emsam, Eldepryl, Zelapar)
  • rasagiline (Azilect)

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

What is the most important information I should know about arformoterol?

• People with asthma, who take long-acting beta2-adrenergic agonist (LABA) medicines, such as arformoterol, have an increased risk of death from asthma problems.
• It is not known if LABA medicines, such as arformoterol, increase the risk of death in people with chronic obstructive pulmonary disease (COPD).
• Get emergency medical care if:
  • breathing problems worsen quickly
  • you use your rescue inhaler medicine, but it does not relieve your breathing problems
  • You experience a sudden shortness of breath immediately after use of arformoterol
• If your COPD symptoms worsen over time, do not increase your dose of arformoterol; instead, call your healthcare provider.

Arformoterol can cause serious side effects, including:

• increased blood pressure
• fast or irregular heartbeat
• 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.

Call your healthcare provider or get emergency medical care right away if:

• your breathing problems worsen with arformoterol
• 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

Do not use arformoterol if you:

• have had a serious allergic reaction to arformoterol, formoterol, or any of the ingredients in arformoterol. Ask your healthcare provider if you are not sure.
• have asthma without using a long-term asthma control medicine.

Arformoterol should not be used in children. It is not known if arformoterol is safe and effective in children.

It is not known if arformoterol is safe and effective in people with asthma.

Medications 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 arformoterol, 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
• have liver problems
• are pregnant or planning to become pregnant. It is not known if arformoterol can harm your unborn baby.
• are breastfeeding. It is not known if arformoterol passes into your milk and if it can harm your baby.

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements. Arformoterol and certain other medicines may interact with each other. This may cause serious side effects.

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.

This medication 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. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if arformoterol 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 arformoterol.

• Use arformoterol exactly as prescribed. One ready-to-use vial of arformoterol is one dose. The usual dose of arformoterol is 1 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 ready-to-use vials of arformoterol a day.
• Do not swallow or inject arformoterol
• Arformoterol is for use with a standard jet nebulizer machine connected to an air compressor.
• Do not mix other medicines with arformoterol in your nebulizer machine.
• If you miss a dose of arformoterol, just skip that dose. Take your next dose at your usual time. Do not take 2 doses at one time.
• While you are using arformoterol 2 times each day:
  • do not use other medicines that contain a long-acting beta2-agonist (LABA) for any reason.
  • do not use your short-acting beta2-agonist medicine on a regular basis (four times a day).
• Arformoterol 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 arformoterol 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 arformoterol:
  • more often than prescribed
  • more medicine than prescribed to you
  • with other LABA medicines

Take arformoterol exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose of arformoterol is one 15 mcg unit-dose vial taken twice daily (morning and evening) with a nebulizer. A total daily dose of greater than 30 mcg (15 mcg twice daily) is not recommended.

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

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Long-acting beta2-adrenergic agonists (LABA) increase the risk of asthma-related death. Data from a large placebo-controlled US study that compared the safety of another long-acting beta2-adrenergic agonist (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 arformoterol, the active ingredient in arformoterol. The 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.