Maxair Autohaler (Inhalation)

Pirbuterol is used by itself or with other medicines to prevent bronchospasm in patients aged 12 years and older who have asthma, bronchitis, emphysema, and other lung diseases.

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

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

It is very important for your doctor to check your progress or your child's progress during regular visits. This helps your doctor see if the medicine is working well and to look for any side effects caused by the medicine.

This medicine may cause paradoxical bronchospasm, which can be life-threatening. Contact your doctor immediately if you have a cough, trouble breathing, shortness of breath, or wheezing.

Call your doctor right away if you have trouble breathing that continues after using a dose of this medicine or if your condition worsens.

You may also be using 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 to improve, unless your doctor tells you to.

Hypokalemia may occur while you are using this medicine. Contact your doctor immediately 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 consulting your doctor first.

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

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine versus the benefits it will provide. For this medicine, keep the following in mind:

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 if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

The use of pirbuterol in children younger than 12 years old is not recommended.

Geriatric

There is no information available about how age affects the effects of pirbuterol in older patients.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor might adjust the dose or take other precautions. When using this medicine, it is particularly important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been identified based on their potential significance and are not necessarily a complete list.

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

• Methacholine
• Sotalol

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may impact the use of this medicine. Make sure to inform your doctor if you have any other medical issues, 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. This medicine may worsen these conditions.

Along with its needed effects, Maxair Autohaler (Inhalation) may cause some unwanted effects. Although not all of these side effects may occur, if they do, 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 Maxair Autohaler. 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.

In the U.S.

• Maxair
• Maxair Autohaler

Pharmacologic Class: Beta-2 Adrenergic Agonist

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.