Maxair

Pirbuterol is a bronchodilator that relaxes muscles in the airways and increases air flow to the lungs.

Pirbuterol inhalation is used to treat or prevent bronchospasm in people with reversible obstructive airway disease. Pirbuterol is sometimes used with another medication such as theophylline or a steroid.

Pirbuterol inhalation may also be used for conditions not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not use this medication if you are allergic to pirbuterol.

To make sure you can safely use pirbuterol, tell your doctor if you have any of these other conditions:

• heart disease, high blood pressure, or congestive heart failure;
• a heart rhythm disorder;
• a seizure disorder such as epilepsy;
• diabetes; or
• overactive thyroid.

FDA pregnancy category C. It is not known whether pirbuterol will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether pirbuterol passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Pirbuterol should not be given to a child younger than 12 years old.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Maxair and other medicines may affect each other and cause side effects. Especially tell your doctor if you take:

• other inhaled medicines or asthma medicines
• beta blocker medicines
• diuretics
• digoxin
• monoamine oxidase inhibitors
• tricyclic antidepressants

This is not a complete list of Maxair drug interactions. Ask your doctor or pharmacist for more information.

Take Maxair exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you.

The usual dose for adults and children 12 years and older is two inhalations (400 mcg) repeated every 4-6 hours. One inhalation (200 mcg) repeated every 4-6 hours may be sufficient for some patients.

A total daily dose of 12 inhalations should not be exceeded.

Do not increase your dose or take extra doses of Maxair without first talking to your doctor.

If you take too much Maxair, call your local Poison Control Center or seek emergency medical attention right away.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

The following rates of adverse reactions to pirbuterol are based on single- and multiple-dose clinical trials involving 761 patients, 400 of whom received multiple doses (mean duration of treatment was 2.5 months and maximum was 19 months).

The following were the adverse reactions reported more frequently than 1 in 100 patients:

CNS: nervousness (6.9%), tremor (6.0%), headache (2.0%), dizziness (1.2%).

Cardiovascular: palpitations (1.7%), tachycardia (1.2%).

Respiratory: cough (1.2%).

Gastrointestinal: nausea (1.7%).

The following adverse reactions occurred less frequently than 1 in 100 patients and there may be a causal relationship with pirbuterol:

CNS: depression, anxiety, confusion, insomnia, weakness, hyperkinesia, syncope.

Cardiovascular: hypotension, skipped beats, chest pain.

Gastrointestinal: dry mouth, glossitis, abdominal pain/cramps, anorexia, diarrhea, stomatitis, nausea and vomiting.

Ear, Nose and Throat: smell/taste changes, sore throat.

Dermatological: rash, pruritus.

Other:numbness in extremities, alopecia, bruising, fatigue, edema, weight gain, flushing.

Other adverse reactions were reported with a frequency of less than 1 in 100 patients but a causal relationship between pirbuterol and the reaction could not be determined: migraine, productive cough, wheezing, and dermatitis.

The following rates of adverse reactions during three-month controlled clinical trials involving 310 patients are noted. The table does not include mild reactions.

PERCENT OF PATIENTS WITH MODERATE TO SEVERE ADVERSE REACTIONS

Electrocardiograms: Electrocardiograms, obtained during a randomized, double-blind, crossover study in 57 patients, showed no observations or findings considered clinically significant, or related to drug administration. Most electrocardiographic observations, obtained during a randomized, double-blind, cross-over study in 40 patients, were judged not clinically significant or related to drug administration. One patient was noted to have some changes on the one hour postdose electrocardiogram consisting of ST and T wave abnormality suggesting possible inferior ischemia. This abnormality was not observed on the predose or the six hours postdose ECG. A treadmill was subsequently performed and all the findings were normal.

Read the entire FDA prescribing information for Maxair (Pirbuterol)

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.

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.

The usual dose for adults and children 12 years and older is two inhalations (400 mcg) repeated every 4-6 hours. One inhalation (200 mcg) repeated every 4-6 hours may be sufficient for some patients.

A total daily dose of 12 inhalations should not be exceeded.

If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately as this is often a sign of seriously worsening asthma which would require reassessment of therapy.

Applies to pirbuterol: inhalation aerosol powder

Along with its needed effects, pirbuterol (the active ingredient contained in Maxair) 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 while taking pirbuterol:

• 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 while taking pirbuterol:

• 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 of pirbuterol 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