Pronunciation:

pir-BUE-ter-ol

Brand Names:

• Maxair
• Maxair Autohaler

Classifications:

Pharmacologic—

Beta-2 Adrenergic Agonist

Uses of This Medicine:

Pirbuterol is used alone or together with other medicines, to prevent bronchospasm in patients 12 years of age and older with asthma, bronchitis, emphysema, and other lung diseases.

Pirbuterol 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—

Use of pirbuterol in children younger than 12 years of age is not recommended.

Older adults—

No information is available on the relationship of age to the effects of pirbuterol in geriatric patients.

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.

• Methacholine
• Sotalol

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 or blood vessel disease or
• Heart rhythm problems (e.g., arrhythmia) or
• Hypertension (high blood pressure) or
• Hyperthyroidism (overactive thyroid) or
• Hypokalemia (low potassium in the blood) or
• Seizures—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Inhaled pirbuterol is used with a special inhaler that comes with patient instructions. Read the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the inhaler, ask your doctor to show you what to do. Also, ask your doctor to check regularly how you use the inhaler 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 your doctor ordered. Also, do not stop taking this medicine without telling your doctor. To do so may increase the chance of side effects.

Do not stop using this medicine or other asthma medicines that your doctor has prescribed for you unless you have discussed this with your doctor.

When you use the inhaler for the first time, or if you have not used it for more than 48 hours, the inhaler may not give the right amount of medicine with the first puff. Therefore, before using the inhaler, prime it by spraying the medicine two times into the air away from the face, and shaking it well before each spray.

Do not use the inhaler for this medicine with any other medicine.

Dosing—

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.

• For inhalation dosage form (aerosol):
  • For prevention of bronchospasm:
    • Adults and children 12 years of age and older—Two puffs every 4 to 6 hours as needed, up to a total of 12 puffs per day. Each puff contains 200 micrograms (mcg) of pirbuterol.
    • Children younger than 12 years of age—Use is not recommended.

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.

Storage—

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress 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 caused by the medicine.

This medicine may cause paradoxical bronchospasm, which may be life-threatening. Check with your doctor right away if you are having a cough, difficulty with breathing, shortness of breath, or wheezing.

Check with your doctor at once if difficulty with breathing continues after using a dose of this medicine or if your condition gets worse.

You may also be taking an anti-inflammatory medicine (e.g., corticosteroids) for asthma along with this medicine. Do not stop taking the anti-inflammatory medicine even if your asthma seems better, unless you are told to do so by your doctor.

Hypokalemia may occur while you are using this medicine. Check with your doctor right away if you 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 change your dose or stop using this medicine without asking your doctor first.

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

Shakiness in the legs, arms, hands, or feet

trembling or shaking of the hands or feet

Less common

Fast, pounding, or irregular heartbeat or pulse

Rare

Blurred vision

bruising

chest pain

confusion

dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly

fainting

feeling of warmth

numbness in the arms or legs

redness of the face, neck, arms, and occasionally, upper chest

sweating

swelling

unusual tiredness or weakness

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

Symptoms of overdose

Arm, back, or jaw pain

chest tightness or heaviness

confusion

convulsions

decreased urine

dry mouth

general feeling of discomfort or illness

headache

increased thirst

loss of appetite

mood changes

muscle pain or cramps

nausea or vomiting

nervousness

numbness or tingling in the hands, feet, or lips

pounding in the ears

shortness of breath

sleeplessness

slow or fast heartbeat

trouble sleeping

unable to sleep

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:

Less common

Cough

dizziness

Rare

Abdominal or stomach cramps

anxiety

bad, unusual, or unpleasant (after) taste

change in taste

depression

hair loss

increase in body movements

itching skin

redness, swelling, or soreness of the tongue

swelling or inflammation of the mouth

thinning of the hair

weakness

weight gain

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.