Xopenex HFA

DRUG DESCRIPTION

The active component of XOPENEX HFA (levalbuterol tartrate) Inhalation Aerosol is levalbuterol tartrate, the (R)-enantiomer of albuterol. Levalbuterol tartrate is a relatively selective beta2-adrenergic receptor agonist (see CLINICAL PHARMACOLOGY). Levalbuterol tartrate has the chemical name (R)-?1-[[(1,1-dimethylethyl)amino]methyl]- 4-hydroxy-1,3-benzenedimethanol L-tartrate (2:1 salt), and it has the following chemical structure:

XOPENEX HFA  (levalbuterol tartrate) structural formula illustration

The molecular weight of levalbuterol tartrate is 628.71, and its empirical formula is (C13H21NO3)2 C4H6O6. It is a white to light-yellow solid, freely soluble in water and very slightly soluble in ethanol.

Levalbuterol tartrate is the generic name for (R)-albuterol tartrate in the United States. XOPENEX HFA (levalbuterol tartrate inhalation aerosol) Inhalation Aerosol is a pressurized metered-dose aerosol inhaler (MDI), which produces an aerosol for oral inhalation. It contains a suspension of micronized levalbuterol tartrate, propellant HFA-134a (1,1,1,2-tetrafluoroethane), Dehydrated Alcohol USP, and Oleic Acid NF.

The inhaler should be primed by releasing 4 sprays into the air, away from the face, before using it for the first time and when the inhaler has not been used for more than 3 days. After priming with 4 actuations, each actuation delivers 59 mcg of levalbuterol tartrate (equivalent to 45 mcg of levalbuterol free base) from the actuator (or mouthpiece). Each 15 g canister provides 200 actuations (or inhalations) and each 8.4 g canister provides 80 actuations (or inhalations).

This product does not contain chlorofluorocarbons (CFCs).

What are the possible side effects of levalbuterol inhalation (Xopenex, Xopenex Concentrate, Xopenex HFA)?

Stop using levalbuterol inhalation and seek emergency medical attention if you experience any of the following serious side effects:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • worsening of respiratory symptoms (shortness of breath, wheezing); or
  • chest pain or irregular heartbeats.

Other, less serious side effects may be more likely to occur. Continue to use levalbuterol...

Read All Potential Side Effects and See Pictures of Xopenex HFA

What are the precautions when taking levalbuterol tartrate inhalation aerosol (Xopenex HFA)?

Before taking levalbuterol, tell your doctor or pharmacist if you are allergic to it; or to similar bronchodilators (e.g., albuterol, metaproterenol, salmeterol); or to sympathomimetic drugs (e.g., epinephrine, 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 disease (e.g., high blood pressure, abnormal heart rhythm, coronary insufficiency), seizures, overactive thyroid (hyperthyroidism), diabetes, kidney disease, low blood potassium level (hypokalemia).

This drug may make you dizzy. Do not drive, use machinery, or do any...

Read All Potential Precautions of Xopenex HFA


Xopenex HFA Consumer (continued)

SIDE EFFECTS: Headache, nausea, nervousness, dizziness, shaking (tremor), trouble sleeping, dry mouth, cough, sore throat, or runny nose may occur. If any of these effects persist or worsen, notify 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 heartbeat, muscle cramps, weakness.

Seek immediate medical attention if this unlikely but serious side effect occurs: chest pain.

Rarely, this medication has caused severe (rarely fatal), sudden worsening of breathing problems/asthma (paradoxical bronchospasm). If you experience sudden wheezing, seek immediate medical attention.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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 taking levalbuterol, tell your doctor or pharmacist if you are allergic to it; or to similar bronchodilators (e.g., albuterol, metaproterenol, salmeterol); or to sympathomimetic drugs (e.g., epinephrine, 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 disease (e.g., high blood pressure, abnormal heart rhythm, coronary insufficiency), seizures, overactive thyroid (hyperthyroidism), diabetes, kidney disease, low blood potassium level (hypokalemia).

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.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

The elderly may be at greater risk for the effects on the heart while using this drug.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.


Xopenex HFA Patient Information Including Side Effects

Brand Names: Xopenex, Xopenex Concentrate, Xopenex HFA

Generic Name: levalbuterol (Pronunciation: leh val BYOO ter all)

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

What is levalbuterol inhalation (Xopenex HFA)?

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

Levalbuterol inhalation is used to treat reversible obstructive airway conditions such as asthma, bronchitis, and emphysema.

Levalbuterol inhalation may also be used for conditions other than those listed in this medication guide.

What are the possible side effects of levalbuterol inhalation (Xopenex HFA)?

Stop using levalbuterol inhalation and seek emergency medical attention if you experience any of the following serious side effects:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • worsening of respiratory symptoms (shortness of breath, wheezing); or
  • chest pain or irregular heartbeats.

Other, less serious side effects may be more likely to occur. Continue to use levalbuterol inhalation and talk to your doctor if you experience

  • dizziness;
  • tremor or nervousness;
  • anxiety;
  • headache;
  • cough or runny nose;
  • upset stomach; or
  • leg cramps.

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 levalbuterol inhalation (Xopenex HFA)?

Do not use more of this medication, or use doses more frequently, than directed by your doctor. Seek medical attention if you notice that you require more than your usual or more than the maximum amount of any asthma medication in a 24-hour period. An increased need for medication could be an early sign of a serious asthma attack.

It is very important that you use nebulized levalbuterol properly, so that the medicine gets into the lungs. Talk to your doctor about proper nebulizer use.

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