Maxair Autohaler

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.

Pediatric

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

Geriatric

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

Pregnancy

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.

Interactions with 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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.

This section provides information on the proper use of a number of products that contain pirbuterol. It may not be specific to Maxair Autohaler. Please read with care.

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.

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:

• Shakiness in the legs, arms, hands, or feet
• trembling or shaking of the hands or feet

• Fast, pounding, or irregular heartbeat or pulse

• 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:

• 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:

• Cough
• dizziness

• 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.

• It is used to open the airways in lung diseases where spasm may cause breathing problems.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how Maxair Autohaler affects you.
• Wear disease medical alert ID (identification).
• Call your doctor right away if your normal dose does not work well, if your signs get worse, or if you need to use this medicine more often than normal.
• If you have high blood sugar (diabetes), Maxair Autohaler may sometimes raise blood sugar. Talk with your doctor about how to keep your blood sugar under control.
• Do not give to a child younger than 12 years of age.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

The active component of Maxair Autohaler (pirbuterol acetate) is (R,S)α6-{[(1,1-dimethylethyl)amino]methyl}-3-hydroxy-2,6-pyridinedimethanol monoacetate salt, a beta-2 adrenergic bronchodilator, having the following chemical structure:

Pirbuterol acetate is a white, crystalline racemic mixture of two optically active isomers. It is a powder, freely soluble in water, with a molecular weight of 300.3 and empirical formula of C12H20N2O3•C2H4O2.

Maxair Autohaler is a pressurized metered-dose aerosol unit for oral inhalation. It provides a fine-particle suspension of pirbuterol acetate in the propellant mixture of trichloromonofluoromethane and dichlorodifluoromethane, with sorbitan trioleate. Each actuation delivers 253 mcg of pirbuterol (as pirbuterol acetate) from the valve and 200 mcg of pirbuterol (as pirbuterol acetate) from the mouthpiece. The unit is breath-actuated such that the medication is delivered automatically during inspiration without the need for the patient to coordinate actuation with inspiration. Each 14.0 g canister provides 400 inhalations and each 2.8 g canister provides 80 inhalations.

As with all aerosol medications, it is recommended to prime (test) Maxair Autohaler before using for the first time. Maxair Autohaler should also be primed if it has not been used in 48 hours. As described in the priming procedure, use the test fire slide to release two priming sprays into the air away from yourself and other people. (See "Patient's Instructions For Use" portion of this package insert.)

Maxair Autohaler is indicated for the prevention and reversal of bronchospasm in patients 12 years of age and older with reversible bronchospasm including asthma. It may be used with or without concurrent theophylline and/or corticosteroid therapy.

Maxair Autohaler is contraindicated in patients with a history of hypersensitivity to pirbuterol or any of its ingredients.

Cardiovascular

Maxair Autohaler, like other inhaled beta adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure and/or symptoms. Although such effects are uncommon after administration of Maxair Autohaler at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, Maxair Autohaler, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

Paradoxical Bronchospasm

Maxair Autohaler can produce paradoxical bronchospasm, which can be life threatening. If paradoxical bronchospasm occurs, Maxair Autohaler should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister or vial.

Use of Anti-Inflammatory Agents

The use of beta adrenergic agonist bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding antiinflammatory agents, e.g., corticosteroids.

Deterioration of Asthma

Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of Maxair Autohaler than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and the treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.

Applies to pirbuterol: inhalation aerosol

Cardiovascular

Cardiovascular side effects have included palpitations and peripheral vasodilation, commonly resulting in reflex tachycardia. Blood pressure may increase or decrease. Higher doses may rarely aggravate angina, myocardial ischemia, or cause atrial or ventricular arrhythmias.[Ref]

Although most studies have not revealed a significant effect of pirbuterol on blood pressure or heart rate, anecdotally significant increases have been noted. Aggravation of angina may be due to tachycardia produced by pirbuterol. Supraventricular premature beats and ventricular tachycardia have also been reported. Higher doses of pirbuterol should be used with caution in patients with cardiac disease, arrhythmias, or hypertension. All of these effects are dose-related and lower doses may be tolerated.[Ref]

Musculoskeletal

Musculoskeletal side effects have included tremors, especially at higher doses.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea, dry mouth, and diarrhea.[Ref]

Metabolic

Metabolic side effects have included hypokalemia and, less commonly, hyperglycemia.[Ref]

Nervous system

Nervous system side effects have included nervousness, dizziness, insomnia, and headache.[Ref]

Respiratory

Respiratory side effects have included cough. Rare instances of paradoxical bronchoconstriction have been associated with the use of pirbuterol (the active ingredient contained in Maxair Autohaler) [Ref]

Some side effects of Maxair Autohaler may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.