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Arformoterol Tartrate Nebulizer solution

It helps to open up the airways of your lungs

Generic Name: arformoterol

Brand Names: Brovana

There is an FDA Alert for this drug. Click here to view it.

Special Alerts:

[Posted 02/18/2010] FDA notified healthcare professionals and consumers that, due to safety concerns, FDA is requiring a risk management strategy (REMS) and class-labeling changes for all Long-Acting Beta-Agonists (LABAs). The REMS will require a revised Medication Guide written specifically for patients, and a plan to educate healthcare professionals about the appropriate use of LABAs. These changes are based on FDA's analyses of studies showing an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations in pediatric and adult patients as well as death in some patients using LABAs for the treatment of asthma.

Healthcare professionals are reminded that to ensure the safe use of these products:

  • Single-ingredient LABAs should only be used in combination with an asthma controller medication; they should not be used alone.
  • LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications.
  • LABAs should be used for the shortest duration of time required to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved. Patients should then be maintained on an asthma controller medication.
  • Pediatric and adolescent patients who require the addition of a LABA to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA, to ensure compliance with both medications.

FDA has determined that the benefits of LABAs in improving asthma symptoms outweigh the potential risks when used appropriately with an asthma controller medication in patients who need the addition of LABAs. FDA believes the safety measures recommended will improve the safe use of these drugs. For more information visit the FDA website at: [Web] and [Web].

REMS:

FDA approved a REMS for arformoterol tartrate to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of arformoterol tartrate and consists of the following: medication guide and communication plan. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).

What is this medicine?

ARFORMOTEROL (AR for MOE ter ol) is a slow-acting bronchodilator. It helps to open up the airways of your lungs. This medicine is used to treat COPD. It should not be used alone for asthma. Do NOT use for an acute asthma attack. Do NOT use for a COPD attack.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of the following conditions:
  • diabetes
  • have asthma and are not taking any other asthma medicine
  • heart disease or irregular heartbeat
  • high blood pressure
  • pheochromocytoma
  • seizures
  • thyroid disease
  • worsening asthma
  • an unusual or allergic reaction to arformoterol, other medicines, food, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

This medicine is used in a nebulizer. Nebulizers make a liquid into an aerosol so that you can breathe it in through your mouth and nose into your lungs. You will be taught how to use your nebulizer. Follow the directions on your prescription label. Take your medicine at regular intervals. Do not use more often than directed.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:
  • MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
  • procarbazine

This medicine may also interact with the following medications:

  • caffeine
  • diuretics
  • formoterol
  • medicines for colds
  • medicines for depression, anxiety, or psychotic disturbances
  • medicines for weight loss including some herbal products
  • methadone
  • salmeterol
  • some antibiotics like clarithromycin, erythromycin, levofloxacin, and linezolid
  • some heart medicines
  • steroid hormones like dexamethasone, cortisone, hydrocortisone
  • theophylline

What should I watch for while using this medicine?

Visit your doctor for regular check ups. Tell your doctor or health care professional if your symptoms do not get better. This medicine may increase the possibility of dying from breathing problems. If your symptoms get worse or if you need your short-acting inhalers more often, call your doctor right away. Do not use this medicine more than every 12 hours. NEVER use this medicine for an acute bronchospasm.

If you are going to have surgery tell your doctor or health care professional that you are using this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:
  • allergic reactions such as skin rash or itching, hives, swelling of the face, lips or tongue
  • chest pain
  • difficulty breathing or wheezing that increases or does not go away
  • dizziness or fainting
  • fever
  • high blood pressure
  • irregular heartbeat
  • nervousness
  • tremors
  • unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • cough
  • headache
  • nausea, vomiting
  • sore throat
  • stuffy nose
  • upset stomach


Last Updated: July 22, 2010
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