1 What is Xopenex?

Brand: Xopenex, Xopenex HFA, Xopenex Pediatric

Generic: Levalbuterol

Xopenex is used to prevent or treat bronchospasm in patients with asthma and other lung diseases. Xopenex belongs to the family of medicines known as adrenergic bronchodilators.

Adrenergic bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs.

They relieve a cough, wheezing, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes. This medicine is available only with your doctor's prescription. 

2 What to Know Before Using

Before using Xopenex, you must know all about the risks and complications associated with it. This is a decision you and your doctor will make.

For this medicine, the following should be considered:

Allergies: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric: Appropriate studies have not been performed on the relationship of age to the effects of levalbuterol solution in children younger than 6 years of age, and levalbuterol aerosol in children younger than 4 years of age. Safety and efficacy have not been established in these age groups.

Geriatric: Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of levalbuterol in the elderly. However, elderly patients are more likely to have kidney problems, which may require caution and an adjustment in the dose for patients receiving levalbuterol.

Pregnancy: Information about this levalbuterol-inhalation-routePregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding: There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions: Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose or other precautions may be necessary.

When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below.

The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Albuterol
  • Amineptine
  • Amitriptyline
  • Amitriptylinoxide
  • Amoxapine
  • Butriptyline
  • Clomipramine
  • Desipramine
  • Dibenzepin
  • Dothiepin
  • Doxepin
  • Epinephrine
  • Fenoterol
  • Hexoprenaline
  • Imipramine
  • Iprindole
  • Lofepramine
  • Melitracen
  • Nortriptyline
  • Opipramol
  • Propizepine
  • Protriptyline
  • Tianeptine
  • Trimipramine
  • Tulobuterol

Other Interactions: Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems: The presence of other medical problems may affect the use of this medicine.

Make sure you tell your doctor if you have any other medical problems, especially:

Use with caution. The effects may be increased because of slower removal of the medicine from the body.

3 Proper Usage

Proper usage of Xopenex requires strict adherence to your doctor’s orders. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop using this medicine or any asthma medicine without telling your doctor. To do so may increase the chance for breathing problems.

The levalbuterol inhalation solution should be used with a jet nebulizer that is connected to an air compressor with good air flow. The inhalation solution and nebulizer will come with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

To use the inhalation solution in the nebulizer:

Open the pouch and remove one vial. Open the vial and place the inhalation solution in the medicine reservoir or nebulizer cup on the machine. Connect the nebulizer to the face mask or mouthpiece.

Use the face mask or mouthpiece to breathe in the medicine. Use the nebulizer for about 5 to 15 minutes, or until the medicine in the nebulizer cup is gone. Clean all the parts of the nebulizer after each use.

Do not use if the solution becomes cloudy. Do not mix another inhalation medicine with levalbuterol in the nebulizer, unless told to do so by your doctor.

For patients using levalbuterol inhalation aerosol:

The levalbuterol aerosol canister provides about 200 inhalations, depending on the size of the canister your doctor ordered. You should try to keep a record of the number of inhalations you use so you will know when the canister is almost empty.

This canister, unlike some other aerosol canisters, cannot be floated in water to test its fullness. When you use the inhaler for the first time, or if you have not used it in a while, the inhaler may not deliver the right amount of medicine with the first puff. Therefore, before using the inhaler, test or prime it.

To test or prime the inhaler:

Shake the inhaler well immediately before each use. Take the cap off the actuator (or mouthpiece). Inspect the actuator for the presence of foreign objects and make sure that the canister is seated in the actuator before each use.

Prime the inhaler by releasing 4 test sprays into the air, away from your face. The inhaler will now be ready to provide the right amount of medicine when you use it.

To use the inhaler:

Shake the inhaler well. Breathe out fully through your mouth, expelling as much air from your lungs as possible. Place the mouthpiece fully into your mouth, holding the inhaler in the mouthpiece down position and closing your lips around it. While breathing in deeply and slowly through your mouth, fully depress the top of the metal canister with your middle finger.

Immediately after the puff is delivered, release your finger from the canister and remove the inhaler from your mouth. Hold your breath for 10 seconds, if possible.

If your doctor has prescribed more than a single inhalation/puff, wait 1 minute between inhalations. Then, shake the inhaler well and repeat. Replace the cap on the mouthpiece after each use. Clean the actuator or mouthpiece at least once a week.

To clean the inhaler:

To clean the blue plastic actuator (or mouthpiece), remove the canister and red mouthpiece cap. Wash the actuator through the top and bottom with warm running water for 30 seconds at least once a week.

Shake off the excess water and let the inhaler parts air dry completely before putting the inhaler back together. Do not clean the metal canister or allow the metal canister to become wet.

Never immerse the metal canister in water. To dry, shake off excess water and let the actuator air-dry thoroughly, such as overnight. When the actuator is dry, replace the canister and the mouthpiece cap.

Make sure the canister is fully and firmly inserted into the actuator. Blockage from medicine build-up is more likely to occur if the actuator is not allowed to air dry thoroughly. If your actuator becomes blocked (little or no medicine coming out of the mouthpiece), wash your actuator and air dry thoroughly.

If you need your inhaler before the plastic actuator is completely dry, shake excess water off the actuator, replace canister, shake well, and test spray twice into the air away from your face, to remove most of the water remaining in the actuator. Then take your dose as prescribed. After such use, rewash and air dry the actuator thoroughly.

Dosing: The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine.

If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For preventing or treating bronchospasm:

For inhalation aerosol dosage form:

  • Adults and children 4 years of age and older: Two puffs every 4 to 6 hours. In some patients, one puff every 4 hours may be enough.
  • Children younger than 4 years of age: Use and dose must be determined by your doctor.

For inhalation solution dosage form (used with a nebulizer):

  • Adults and children 12 years of age and older: At first, 0.63 milligrams (mg) in the nebulizer three times a day, every 6 to 8 hours per day. Some patients may need to start at 1.25 mg in the nebulizer three times a day.
  • Children 6 to 11 years of age and older: 0.31 mg in the nebulizer three times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 0.63 mg three times a day.
  • Children younger than 6 years of age: Use and dose must be determined by your doctor.

Missed Dose: If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Do not double doses. If your dosing schedule is different from all of the above and you miss a dose of this medicine, or if you have any questions about this, check with your doctor.

Storage: Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep the medicine in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze.

Keep the inhalation solution in the foil pouch until you are ready to use it. The rest of the vials in the pouch should be used within 2 weeks after the foil pouch has been opened.

4 Precautions to Take

Before using Xopenex, there are some precautions you must take. If you will be using this medicine for a long time, it is important that your doctor checks your or your child's progress at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.

This medicine should not be used together with other inhaled medicines that are similar, such as albuterol (AccunebВ®), isoproterenol (IsuprelВ®), metaproterenol (AlupentВ®), pirbuterol (MaxairВ®), or terbutaline (BrethaireВ®).

This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening.

Check with your doctor right away if you or your child have coughing, difficulty breathing, shortness of breath, or wheezing after using this medicine.

Talk to your doctor or get medical help right away if Your or your child's symptoms do not improve or they become worse after using this medicine. Your inhaler does not seem to be working as well as usual and you need to use it more often.

You or your child may also be taking an antiinflammatory medicine, such as a steroid (cortisone-like medicine), together with this medicine.

Do not stop taking the antiinflammatory medicine, even if your asthma seems better unless you are told to do so by your doctor.

Levalbuterol may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention.

Check with your doctor right away if you or your child develop:

  • a skin rash
  • hives
  • itching
  • trouble breathing
  • trouble swallowing
  • any swelling of your hands, face, or mouth while you are using this medicine

Hypokalemia (low potassium in the blood) may occur while you are using this medicine.

Check with your doctor right away if you or your child have more than one of the following symptoms:

  • convulsions
  • decreased urine
  • dry mouth
  • increased thirst
  • irregular heartbeat
  • loss of appetite
  • mood changes
  • muscle pain or cramps
  • nausea or vomiting
  • numbness or tingling in the hands, feet or lips
  • shortness of breath, or unusual tiredness or weakness

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, and herbal or vitamin supplements.

5 Potential side effects

Make sure you meet with your doctor in using Xopenex to avoid unwanted potential side effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common:

  • fast heartbeat

Less common or rare:

Incidence not known:

  • cough difficult or labored breathing difficulty
  • swallowing
  • extra heartbeats
  • fainting
  • fast, pounding, slow, or irregular heartbeat or pulse
  • hives, welts, itching, or rash large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • noisy breathing
  • redness of the skin
  • tightness in the chest
  • unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose:

  • chest pain
  • dizziness
  • dry mouth
  • general feeling of discomfort or illness
  • headache
  • impaired consciousness
  • irregular or fast heartbeat
  • lightheadedness
  • nausea
  • nervousness seizures
  • sleeplessness
  • sweating
  • tremor

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common:

  • accidental injury (in children 4 to 11 years of age)
  • anxiety body
  • aches or pain
  • chills
  • congestion
  • cough or hoarseness
  • dryness or soreness of the throat
  • fever
  • general aches and pains
  • headache
  • hoarseness
  • increased cough
  • leg cramps
  • loss of appetite
  • migraines or other headaches
  • muscle tightness
  • nervousness
  • runny or stuffy nose

Less common or rare:

  • abdominal or stomach pain
  • abnormal growth filled with fluid or semisolid material
  • blemishes on the skin
  • blood in the urine
  • bloody nose
  • burning, dry, or itching eyes
  • burning or stinging of the skin
  • cough producing mucus
  • cramps
  • diarrhea
  • difficulty having a bowel movement (stool)
  • discharge from the eye
  • dry mouth or throat
  • ear pain
  • excessive tearing eye
  • itch heavy menstrual bleeding
  • muscle pain
  • night sweats
  • numbness or decreased sensitivity of the hand pain
  • painful cold sores or blisters on the lips, nose, eyes, or genitals
  • pimples
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • sleeplessness
  • tingling sensation in the arms or legs
  • vaginal yeast infection
  • weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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