Brovana

DRUG DESCRIPTION

BROVANA (arformoterol tartrate) Inhalation Solution is a sterile, clear, colorless, aqueous solution of the tartrate salt of arformoterol, the (R,R)-enantiomer of formoterol. Arformoterol is a selective beta2-adrenergic bronchodilator. The chemical name for arformoterol tartrate is formamide, N-[2-hydroxy-5-[(1R)-1-hydroxy-2-[[(1R)-2(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]-, (2R,3R)-2,3dihydroxybutanedioate (1:1 salt), and its established structural formula is as follows:

BROVANA® (arformoterol tartrate) Structural Formula Illustration

The molecular weight of arformoterol tartrate is 494.5 g/mol, and its empirical formula is C19H24N2O4•C4H6O6 (1:1 salt). It is a white to off-white solid that is slightly soluble in water.

Arformoterol tartrate is the United States Adopted Name (USAN) for (R,R)formoterol L-tartrate.

BROVANA (arformoterol tartrate) Inhalation Solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate.

BROVANA Inhalation Solution requires no dilution before administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend upon patient factors, the nebulizer used, and compressor performance. Using the PARI LC® PLUS nebulizer (with mouthpiece) connected to a PARI DURA NEB™3000 compressor under in vitro conditions, the mean delivered dose from the mouthpiece (% nominal) was approximately 4.1 mcg (27.6%) at a mean flow rate of 3.3 L/min. The mean nebulization time was 6 minutes or less. BROVANA Inhalation Solution should be administered from a standard jet nebulizer at adequate flow rates via face mask or mouthpiece.

Patients should be carefully instructed on the correct use of this drug product (please refer to the accompanying Medication Guide).

What are the possible side effects of arformoterol inhalation (Brovana)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • bronchospasm (wheezing, chest tightness, trouble breathing);
  • chest pain, fast or pounding heart beats, restless feeling, tremor;
  • feeling short of breath, even with mild exertion;
  • swelling, rapid weight gain;
  • white patches or sores inside...

Read All Potential Side Effects and See Pictures of Brovana »

What are the precautions when taking arformoterol tartrate inhalation solution (Brovana)?

Before using arformoterol, tell your doctor or pharmacist if you are allergic to it; or to formoterol; or to sympathomimetic drugs (e.g., phenylephrine, pseudoephedrine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (e.g., irregular heartbeat, angina), high blood pressure, overactive thyroid (hyperthyroidism), seizures, diabetes, liver problems, certain metabolic problem (ketoacidosis).

Arformoterol may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely...

Read All Potential Precautions of Brovana »


Brovana Consumer (continued)

SIDE EFFECTS: Shakiness (tremor), nausea, headache, nervousness, dizziness, dry mouth, or trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fast/pounding/irregular/slow heartbeat, muscle weakness/cramps, increased thirst/urination.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, severe dizziness, fainting.

Rarely, this medication has caused severe (possibly fatal), sudden worsening of breathing problems (paradoxical bronchospasm). If you have trouble breathing or experience sudden wheezing, use your quick-relief inhaler and seek immediate medical attention.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using arformoterol, tell your doctor or pharmacist if you are allergic to it; or to formoterol; or to sympathomimetic drugs (e.g., phenylephrine, pseudoephedrine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (e.g., irregular heartbeat, angina), high blood pressure, overactive thyroid (hyperthyroidism), seizures, diabetes, liver problems, certain metabolic problem (ketoacidosis).

Arformoterol may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using arformoterol, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using arformoterol safely.

Before having surgery, tell your doctor or dentist that you are using this medication.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this drug passes into breast milk. Consult your doctor before breast-feeding.


Brovana Patient Information Including Side Effects

Brand Names: Brovana

Generic Name: arformoterol inhalation (Pronunciation: ar for MOE ter ole)

  • What is arformoterol inhalation (Brovana)?
  • What are the possible side effects of arformoterol inhalation (Brovana)?
  • What is the most important information I should know about arformoterol inhalation (Brovana)?
  • What should I discuss with my healthcare provider before using arformoterol inhalation (Brovana)?
  • How should I use arformoterol inhalation (Brovana)?
  • What happens if I miss a dose (Brovana)?
  • What happens if I overdose (Brovana)?
  • What should I avoid while using arformoterol inhalation (Brovana)?
  • What other drugs will affect arformoterol inhalation (Brovana)?
  • Where can I get more information?

What is arformoterol inhalation (Brovana)?

Arformoterol is a bronchodilator. It works by relaxing muscles in the airways to improve breathing.

Arformoterol inhalation is used to prevent bronchoconstriction in people with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Arformoterol will not treat a bronchospasm attack that has already begun.

Arformoterol may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of arformoterol inhalation (Brovana)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • bronchospasm (wheezing, chest tightness, trouble breathing);
  • chest pain, fast or pounding heart beats, restless feeling, tremor;
  • feeling short of breath, even with mild exertion;
  • swelling, rapid weight gain;
  • white patches or sores inside your mouth or on your lips; or
  • dry mouth, increased thirst, drowsiness, restless feeling, confusion, nausea, vomiting, increased urination, muscle pain or weakness, fast heart rate, feeling light-headed, or fainting.

Other, less serious side effects may be more likely to occur, such as:

  • weakness; headache, sleep problems (insomnia);
  • nausea, vomiting, diarrhea;
  • leg cramps;
  • fever;
  • stuffy nose, dry mouth; or
  • hoarseness or deepened voice.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about arformoterol inhalation (Brovana)?

Do not use this medication to treat a sudden bronchospasm attack. It will not work fast enough to reverse your symptoms. Use another, faster-acting inhalation medication to treat sudden attacks of bronchospasm.

Call your doctor right away if you feel that this medicine is not working as well as usual, or if you think you need to use more than usual. An increased need for medication could be an early sign that your condition is getting worse.

Salmeterol, a medicine similar to arformoterol, has been shown to increase the risk of asthma-related death. It is not known whether arformoterol could cause this same effect in people with chronic obstructive pulmonary disease. It is critical that you use only the prescribed dose of this medicine and follow all patient instructions for safe use of the medication. Talk with your doctor about your individual risks and benefits in using arformoterol.

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