Pronunciation:

lev-al-BYOO-ter-ol

Brand Names:

• Xopenex
• Xopenex HFA
• Xopenex Pediatric

Dosage Forms:

• Solution
• Aerosol Powder

Classifications:

Therapeutic—

Bronchodilator

Pharmacologic—

Sympathomimetic

Uses of This Medicine:

Levalbuterol belongs to the family of adrenergic bronchodilators. Levalbuterol is used to prevent or treat chest tightness, shortness of breath, troubled breathing and wheezing associated with bronchospasm.

This medicine is breathed in through the mouth by using a nebulizer and compressor or by using an inhaler. Levalbuterol opens up the bronchial tubes (air passages) of the lungs.

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—

The inhalation solution has been tested in children 12 years of age and older. The inhalation aerosol has been tested in children 4 years of age and older. In effective doses, this medicine has not been shown to cause different side effects or problems than it does in other age groups.

Older adults—

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same as they do in young adults. Although there is limited information comparing the use of levalbuterol in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults. Your doctor may want to begin with a lesser dose and increase the dosage as tolerated.

Pregnancy—

	Pregnancy 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.

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—

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
• Alprenolol
• Arotinolol
• Atenolol
• Befunolol
• Betaxolol
• Bevantolol
• Bisoprolol
• Bopindolol
• Bucindolol
• Bupranolol
• Carteolol
• Carvedilol
• Celiprolol
• Clorgyline
• Dilevalol
• Esmolol
• Iproniazid
• Isocarboxazid
• Labetalol
• Landiolol
• Levobetaxolol
• Levobunolol
• Mepindolol
• Metipranolol
• Metoprolol
• Moclobemide
• Nadolol
• Nebivolol
• Nialamide
• Nipradilol
• Oxprenolol
• Pargyline
• Penbutolol
• Phenelzine
• Pindolol
• Procarbazine
• Propranolol
• Selegiline
• Sotalol
• Talinolol
• Tertatolol
• Timolol
• Toloxatone
• Tranylcypromine

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:

• Heart disease (irregular heartbeat or decreased blood flow through the heart) or
• High blood pressure—Use of levalbuterol may worsen these conditions

• Diabetes mellitus (sugar diabetes)—Levalbuterol may worsen blood glucose control

• Hyperthyroidism (overactive thyroid)

• Seizures—Concurrent use may worsen this condition

Proper Use of This Medicine:

These medicines come with patient directions. Read them carefully before using the medicine. If you do not understand the directions or if you are not sure how to use the medicine, ask your health care professional to show you what to do. Also, ask your health care professional to check regularly how you use the medicine to make sure you are using it properly.

Use this medicine only as directed. Do not use more of it and do not use it more often than recommended on the label, unless otherwise directed by your doctor. Using the medicine more often may increase the chance of serious unwanted effects. Deaths have occurred when too much of an inhalation bronchodilator medicine was used.

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 in 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.

For patients using levalbuterol inhalation solution dosage form:

• If you are using this medicine in a nebulizer, make sure you understand exactly how to use it. If you have any questions about this, check with your health care professional.
• 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 health care professional.

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 inhalation aerosol dosage form:
  • For preventing or treating bronchospasm:
    • Adults and children 4 years of age and older—This medicine is used in an aerosol inhaler The usual dose is 2 inhalations (puffs) every 4 to 6 hours. In some patients 1 inhalation (puff) every 4 hours may be enough.
    • Children up to 4 years of age—Use and dose must be determined by your doctor.

• For inhalation solution dosage form:
  • For preventing or treating bronchospasm:
    • Adults and children 12 years of age and older—This medicine is used in a nebulizer and is taken by inhalation over a period of five to fifteen minutes. The usual dose is 0.63 milligrams (mg) to 1.25 mg three times a day, every six to eight hours.
    • Children up to 12 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—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine:

It is important that your doctor check your progress at regular intervals to make sure that your medicine is working properly.

If you still have trouble breathing after using this medicine, if your condition becomes worse, or if you are using more medicine than the amount prescribed, check with your doctor at once.

Do not add or stop taking inhaled or other asthma medicines without first checking with your doctor.

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 as soon as possible if any of the following side effects occur:

More common

Fast heartbeat

Less common or rare

Chest pain or tightness

dizziness

feeling “faint”

high or low blood pressure

hives

light-headedness

shortness of breath

troubled breathing

wheezing

Incidence not known

Cough

Difficult or labored breathing

difficulty swallowing

extra heartbeats

fainting

fast, pounding, slow, or irregular heartbeat or pulse

hives or welts

itching

large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs

noisy breathing

palpitations

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

rash

redness of skin

tightness in chest

unusual tiredness or weakness

Symptoms of overdose

Chest pain

dizziness

dry mouth

fatigue

general feeling of discomfort or illness

headache

high blood pressure

impaired consciousness

irregular or fast heartbeat

light-headedness

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 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 urine

bloody nose

burning, dry or itching eyes

burning or stinging of skin

cough producing mucus

cramps

diarrhea

difficulty breathing

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

nausea

night sweats

numbness or decreased sensitivity of the hand

pain

painful cold sores or blisters on lips, nose, eyes, or genitals

pimples

redness, pain, swelling of eye, eyelid, or inner lining of eyelid

sleeplessness

tingling sensation in extremities

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.