Pirbuterol

The action of MAXAIR (pirbuterol) AUTOHALER should last up to five hours or longer. MAXAIR (pirbuterol) AUTOHALER should not be used more frequently than recommended. Do not increase the dose or frequency of MAXAIR (pirbuterol) AUTOHALER without consulting your physician. If you find that treatment with MAXAIR (pirbuterol) AUTOHALER becomes less effective for symptomatic relief, or your symptoms become worse, and/or you need to use the product more frequently than usual, you should seek medical attention immediately. While you are using MAXAIR (pirbuterol) AUTOHALER, other inhaled drugs and asthma medications should betaken only as directed by yourphysician. Common adverse effects include palpitations, chest pain, rapid heart rate, tremor or nervousness. If you are pregnant or nursing, contact your physician about use of MAXAIR (pirbuterol) AUTOHALER. Effective and safe use includes an understanding of the way themedication should be administered. As with all aerosol medications, it is recommended to prime (test) MAXAIR (pirbuterol) AUTOHALER before using for the first time. MAXAIR (pirbuterol) 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.) The MAXAIR (pirbuterol) AUTOHALER actuator should notbe used with anyother inhalation aerosol canister. In addition, canisters for use with MAXAIR (pirbuterol) AUTOHALER should not be utilized with any other actuator.

Pirbuterol may cause serious side effects, including:

• worsening trouble breathing, coughing and wheezing (paradoxical bronchospasm). If this happens stop using pirbuterol and call your doctor or get emergency help right away. Paradoxical bronchospasm is more likely to happen with your first use of a new canister of medicine.
• heart problems including faster heart rate and higher blood pressure
• possible death in people with asthma who use too much pirbuterol
• worsening of other medical problems in people who also use pirbuterol including increases in blood sugar

Do not use pirbuterol if you are allergic to any of the ingredients in it. 

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of pirbuterol there are no specific foods that you must exclude from your diet when receiving this medication.

Before you use pirbuterol, tell your doctor if you:

• have heart problems
• have high blood pressure (hypertension)
• have convulsions (seizures)
• have thyroid problems
• have diabetes
• are pregnant or breastfeeding

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

Tell your doctor if you are pregnant or plan to become pregnant. 

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Pirbuterol falls into category C. There are no good studies that have been done in humans with pirbuterol. But in animal studies, pregnant animals were given pirbuterol, and the babies did not show any medical issues related to this medication.

Use pirbuterol as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Follow how to take this medicine as you have been told by your doctor. Do not use more than you were told to use.
• Keep out of your eyes.
• For breathing in only.
• Prepare puffer (inhaler) before first use or when puffer has not been used for 2 days. Spray 2 test sprays into the air.
• Shake well before use.
• A spacer may be used with the puffer (inhaler) for easy use.
• Put the cap back on after you are done using your dose.
• Have your puffer (inhaler) use checked with your doctor at each visit. Read and follow facts on how to use the puffer. Make sure you use the puffer the right way.
• If using more than 1 type of puffer (inhaler), ask the doctor which puffer to use first.
• Follow how to clean carefully.
• This medicine may catch on fire. Do not use near an open flame or while smoking.

What do I do if I miss a dose?

• If you take pirbuterol on a regular basis, take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not breathe in 2 doses or extra doses.
• Many times this medicine is taken on an as needed basis. Do not take more often than told by the doctor.

• Store at room temperature.
• Throw away the puffer (inhaler) after the most number of sprays have been used, even if it feels like there is more drug in the can.
• Protect from heat and sunlight. Do not puncture or burn even if it seems empty.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

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Hypersensitivity to pirbuterol or any component of the formulation

Store between 15°C and 30°C (59°F and 86°F).

AtoMOXetine: May enhance the tachycardic effect of Beta2-Agonists. Monitor therapy

AtoMOXetine: May enhance the hypertensive effect of Sympathomimetics. AtoMOXetine may enhance the tachycardic effect of Sympathomimetics. Monitor therapy

Atosiban: Beta2-Agonists may enhance the adverse/toxic effect of Atosiban. Specifically, there may be an increased risk for pulmonary edema and/or dyspnea. Monitor therapy

Beta-Blockers (Beta1 Selective): May diminish the bronchodilatory effect of Beta2-Agonists. Of particular concern with nonselective beta-blockers or higher doses of the beta1 selective beta-blockers. Monitor therapy

Beta-Blockers (Nonselective): May diminish the bronchodilatory effect of Beta2-Agonists. Avoid combination

Betahistine: May diminish the therapeutic effect of Beta2-Agonists. Monitor therapy

Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Exceptions: Cannabidiol. Monitor therapy

Cocaine: May enhance the hypertensive effect of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Consider therapy modification

Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Monitor therapy

Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Monitor therapy

Iobenguane I 123: Sympathomimetics may diminish the therapeutic effect of Iobenguane I 123. Avoid combination

Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Reduce initial doses of sympathomimetic agents, and closely monitor for enhanced pressor response, in patients receiving linezolid. Specific dose adjustment recommendations are not presently available. Consider therapy modification

Loop Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Loop Diuretics. Monitor therapy

Loxapine: Agents to Treat Airway Disease may enhance the adverse/toxic effect of Loxapine. More specifically, the use of Agents to Treat Airway Disease is likely a marker of patients who are likely at a greater risk for experiencing significant bronchospasm from use of inhaled loxapine. Management: This is specific to the Adasuve brand of loxapine, which is an inhaled formulation. This does not apply to non-inhaled formulations of loxapine. Avoid combination

MAO Inhibitors: May enhance the adverse/toxic effect of Beta2-Agonists. Monitor therapy

Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Monitor therapy

Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Monitor therapy

Thiazide and Thiazide-Like Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Monitor therapy

Tricyclic Antidepressants: May enhance the adverse/toxic effect of Beta2-Agonists. Monitor therapy

Concerns related to adverse effects:

• Bronchospasm: Rarely, paradoxical bronchospasm may occur with use of inhaled bronchodilating agents (may occur more frequently with the first use of a new canister); this should be distinguished from inadequate response.

Disease-related concerns:

• Asthma: Appropriate use: Optimize anti-inflammatory treatment before initiating maintenance treatment with pirbuterol. Do not use as a component of chronic therapy without an anti-inflammatory agent. Only the mildest forms of asthma (Step 1 and/or exercise-induced) would not require concurrent use based upon asthma guidelines.

• Cardiovascular disease: Use with caution in patients with cardiovascular disease (arrhythmia or hypertension or heart failure); beta-agonists may cause elevation in blood pressure, heart rate and result in CNS stimulation/excitation. Beta2-agonists may also increase risk of arrhythmias.

• Diabetes: Use with caution in patients with diabetes mellitus; beta2-agonists may increase serum glucose.

• Glaucoma: Use with caution in patients with glaucoma; may elevate intraocular pressure.

• Hyperthyroidism: Use with caution in hyperthyroidism; may stimulate thyroid activity.

• Hypokalemia: Use with caution in patients with hypokalemia; beta2-agonists may decrease serum potassium.

• Seizures: Use with caution in patients with seizure disorders; beta-agonists may result in CNS stimulation/excitation.

Other warnings/precautions:

• Appropriate use: Do not exceed recommended dose; serious adverse events, including fatalities, have been associated with excessive use of inhaled sympathomimetics.

• Patient information: Patients must be instructed to seek medical attention in cases where acute symptoms are not relieved or a previous level of response is diminished. The need to increase frequency of use may indicate deterioration of asthma, and treatment must not be delayed. All patients should utilize a spacer device when using a metered-dose inhaler.