Pronunciation:

lee-val-BUE-ter-ol

Brand Names:

• Xopenex
• Xopenex HFA
• Xopenex Pediatric

Dosage Forms:

• Aerosol Powder
• Solution

Classifications:

Therapeutic—

Bronchodilator

Pharmacologic—

Beta-2 Adrenergic Agonist

Uses of This Medicine:

Levalbuterol is used to prevent or treat bronchospasm in patients with asthma and other lung diseases.

Levalbuterol 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 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.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. 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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of levalbuterol solution and solution concentrate 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.

Older adults—

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.

Breast-feeding—

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.

Other medicines—

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.

• Acebutolol
• Albuterol
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amphetamine
• Arotinolol
• Atenolol
• Befunolol
• Betaxolol
• Bevantolol
• Bisoprolol
• Bopindolol
• Bucindolol
• Bupranolol
• Butriptyline
• Carteolol
• Carvedilol
• Celiprolol
• Clomipramine
• Desipramine
• Dextroamphetamine
• Dibenzepin
• Dilevalol
• Dothiepin
• Doxepin
• Epinephrine
• Esmolol
• Fenoterol
• Hexoprenaline
• Imipramine
• Iprindole
• Labetalol
• Landiolol
• Levobunolol
• Lisdexamfetamine
• Lofepramine
• Melitracen
• Mepindolol
• Methacholine
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Nortriptyline
• Opipramol
• Oxprenolol
• Penbutolol
• Pindolol
• Practolol
• Propizepine
• Propranolol
• Protriptyline
• Sotalol
• Talinolol
• Tertatolol
• Tianeptine
• Timolol
• 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:

• Diabetes or
• Heart disease or
• Heart rhythm problems (eg, arrhythmia, QT prolongation) or
• Hypertension (high blood pressure) or
• Hyperthyroidism (overactive thyroid) or
• Seizures, history of—Use with caution. May make these conditions worse.

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

Proper Use of This Medicine:

Use this medicine only as directed by your doctor. 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 other asthma medicine that you are taking without telling your doctor. To do so may increase the chance for breathing problems.

The levalbuterol inhalation solution and inhalation solution concentrate 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 or solution concentrate in the nebulizer:

• Open the pouch and remove one vial.
• Check the liquid in the vial. It should be clear or colorless. Do not use it if is discolored.
• Open the vial and place the inhalation solution in the medicine reservoir or nebulizer cup on the machine. If you are using the solution concentrate, mix it first with sterile normal saline before placing it on the reservoir.
• 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 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. Test or prime the inhaler before using it.
• 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 in the air, away from your face. The inhaler will now be ready to provide the right amount of medicine when you use it.
• 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.
• Wash the actuator through the top and bottom with warm running water for 30 seconds at least once a week.

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 3 times a day, every 6 to 8 hours per day. Some patients may need to start at 1.25 mg in the nebulizer 3 times a day.
    • Children 6 to 11 years of age—0.31 mg in the nebulizer 3 times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 0.63 mg 3 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.

Use the inhalation solution concentrate vial right away after opening the foil pouch.

Throw away the canister after either 200 sprays have been used. Ask your pharmacist if you are not sure. Do not place the canister in water to see if the canister is full (float test).

Precautions While Using This Medicine:

If you will be using this medicine for a long time, it is important that your doctor check 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 similar inhaled medicines, such as albuterol (Accuneb®), isoproterenol (Isuprel®), metaproterenol (Alupent®), pirbuterol (Maxair®), or terbutaline (Brethaire®).

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, which 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 or swallowing, or 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 (seizures), 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, trouble breathing, 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.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted 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

Chest pain or tightness

dizziness

feeling “faint”

lightheadedness

troubled breathing

Incidence not known

Confusion

cough

difficult or labored breathing

difficulty swallowing

drowsiness

extra heartbeat

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 genitals

nausea

noisy breathing

rapid, deep breathing

redness of the skin

restlessness

stomach cramps

unusual tiredness or weakness

vomiting

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

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

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

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

stomach pain

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.