Levalbuterol (Inhalation)

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

Levalbuterol is part of a group of medicines called adrenergic bronchodilators. Adrenergic bronchodilators are medicines that you inhale through your mouth to open up the bronchial tubes (air passages) in your lungs. They help relieve cough, wheezing, shortness of breath, and difficulty breathing by increasing the flow of air through the bronchial tubes.

This medicine is available only with your doctor's prescription.

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.

In deciding to use a medicine, you and your doctor need to think about the risks of the medicine compared to the benefits it may provide. Here are some important points to consider:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, please read the label or package ingredients carefully.

Pediatric

Studies have not been done to understand how levalbuterol solution and solution concentrate affect children younger than 6 years old, and how levalbuterol aerosol affects children younger than 4 years old. Safety and effectiveness have not been proven for these age groups.

Geriatric

So far, studies have not shown any specific problems in older adults that would limit the use of levalbuterol. However, older patients may have kidney issues, which could require careful monitoring or adjustments in the dose for those taking levalbuterol.

Breast Feeding

There are not enough studies to determine the risk to infants when this medication is used by breastfeeding women. Consider the potential benefits and risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines might be used together even if an interaction could happen. In these situations, your doctor may need to adjust the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the following medicines while using this medicine. The interactions listed below are significant but may not include all possible interactions.

It is usually not recommended to use this medicine with any of the following medicines, but it may be necessary in some cases. If both medicines are prescribed, your doctor may change the dose or frequency for one or both medicines.

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

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around meal times or with specific types of food, as interactions may happen. Using alcohol or tobacco with certain medicines can also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how this medicine works. Be sure to inform your doctor if you have any other medical problems, especially:

• Diabetes or
• Heart disease or
• Heart rhythm problems (e.g., arrhythmia, QT prolongation) or
• Hypertension (high blood pressure) or
• Hyperthyroidism (overactive thyroid) or
• History of seizures—Use with caution. May worsen these conditions.

• Kidney disease—Use with caution. The effects may be stronger due to slower removal of the medicine from the body.

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.

In the U.S.

• Xopenex
• Xopenex HFA
• Xopenex Pediatric

Available Dosage Forms:

• Aerosol Powder
• Solution

Therapeutic Class: Bronchodilator

Pharmacologic Class: Beta-2 Adrenergic Agonist

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).

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