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 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.

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.

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.

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.

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.

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.

Arformoterol does not relieve sudden symptoms of COPD. Always have a rescue inhaler medicine with you to treat sudden symptoms. 

Use arformoterol exactly as prescribed. Arformoterol should not be diluted or mixed with other drugs in the nebulizer.

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.