* MAXAIR Inhaler 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.
* Dosing Information
:* Dosage
=====Condition2=====
* Dosing Information
:* Dosage
=====Condition3=====
* Dosing Information
:* Dosage
=====Condition4=====
* Dosing Information
:* Dosage
<!--Off-Label Use and Dosage (Adult)-->
<!--Guideline-Supported Use (Adult)-->
|offLabelAdultGuideSupport======Condition1=====
* Developed by:
* Class of Recommendation:
====Dosage====
* 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.
* Strength of Evidence:
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.
* Dosing Information
As with all aerosol medications, it is recommended to prime (test) MAXAIR Inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks. Prime by releasing three “test sprays” into the air away from yourself and other people.
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
<!--Non–Guideline-Supported Use (Adult)-->
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport======Condition1=====
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
<!--Pediatric Indications and Dosage-->
<!--Pediatric Indications and Dosage-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed======Condition1=====
|fdaLIADPed=There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
<!--Off-Label Use and Dosage (Pediatric)-->
<!--Off-Label Use and Dosage (Pediatric)-->
<!--Guideline-Supported Use (Pediatric)-->
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport======Condition1=====
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
* Developed by:
* Class of Recommendation:
* Strength of Evidence:
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
<!--Non–Guideline-Supported Use (Pediatric)-->
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport======Condition1=====
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
* Dosing Information
<!--Contraindications-->
|contraindications=* MAXAIR Inhaler is contraindicated in patients with a history of hypersensitivity to pirbuterol or any of its ingredients.
:* Dosage
<!--Warnings-->
|warnings=* Cardiovascular: MAXAIR Inhaler, 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 Inhaler 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 Inhaler, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
=====Condition2=====
Paradoxical Bronchospasm: MAXAIR Inhaler can produce paradoxical bronchospasm, which can be life threatening. If paradoxical bronchospasm occurs, MAXAIR Inhaler 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.
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
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 anti-inflammatory agents, e.g., corticosteroids.
<!--Contraindications-->
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 Inhaler 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.
|contraindications=* Condition1
<!--Warnings-->
====Precautions====
|warnings=* Description
====Precautions====
General: Since pirbuterol is a sympathomimetic amine, it should be used with caution in patients with cardiovascular disorders, including ischemic heart disease, hypertension, or cardiac arrhythmias, in patients with hyperthyroidism or diabetes mellitus, and in patients who are unusually responsive to sympathomimetic amines or who have convulsive disorders. Significant changes in systolic and diastolic blood pressure could be expected to occur in some patients after use of any beta adrenergic aerosol bronchodilator.
* Description
Beta adrenergic agonist medications may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. The decrease is usually transient, not requiring supplementation.
<!--Adverse Reactions-->
<!--Adverse Reactions-->
<!--Clinical Trials Experience-->
<!--Clinical Trials Experience-->
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
|clinicalTrials=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).
=====Body as a Whole=====
The following were the adverse reactions reported more frequently than 1 in 100 patients:
Ear, Nose and Throat: smell/taste changes, sore throat.
Dermatological: rash, pruritus.
Other: numbness in extremities, alopecia, bruising, fatigue, edema, weight gain, flushing.
=====Endocrine=====
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.
: [[File:Pirbuterol Adv Eff.png|none|500px]]
Electrocardiograms: Electrocardiograms, obtained during a randomized, double-blind, cross-over 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.
=====Hematologic and Lymphatic=====
=====Metabolic and Nutritional=====
=====Musculoskeletal=====
=====Neurologic=====
=====Respiratory=====
=====Skin and Hypersensitivy Reactions=====
=====Special Senses=====
=====Urogenital=====
=====Miscellaneous=====
<!--Postmarketing Experience-->
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
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<!--Drug Interactions-->
<!--Drug Interactions-->
|drugInteractions=* Drug
|drugInteractions=Drug Interactions: Other short-acting beta adrenergic aerosol bronchodilators should not be used concomitantly with MAXAIR Inhaler because they may have additive effects.
:* Description
Monoamine Oxidase Inhibitors or Tricyclic Antidepressants: Pirbuterol should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of pirbuterol on the vascular system may be potentiated.
Beta Blockers: Beta adrenergic receptor blocking agents not only block the pulmonary effect of beta-agonists, such as MAXAIR Inhaler, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta blockers. However, under certain circumstances, e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta adrenergic blocking agents in patients with asthma. In this setting, cardioselective beta blockers could be considered, although they should be administered with caution.
Diuretics: The ECG changes and/or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of beta-agonists with non-potassium sparing diuretics.
<!--Use in Specific Populations-->
<!--Use in Specific Populations-->
|useInPregnancyFDA=* '''Pregnancy Category'''
|FDAPregCat=C
|useInPregnancyFDA=* Pirbuterol was not teratogenic in rats administered oral doses of 30, 100, and 300 mg/kg (approximately 100, 340, and 1000 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis). Pirbuterol was not teratogenic in rabbits administered oral doses of 30 and 100 mg/kg (approximately 200 and 680 times the maximum recommended inhalation dose for adults on a mg/m2 basis). However, pirbuterol at an oral dose of 300 mg/kg (approximately 2000 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis) caused abortions and fetal death.
There are no adequate and well-controlled studies in pregnant women. Pirbuterol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInLaborDelivery=* Because of the potential for beta-agonist interference with uterine contractility, use of MAXAIR Inhaler for relief of bronchospasm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk.
|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|useInNursing=* It is not known whether pirbuterol is excreted in human milk. Therefore, MAXAIR Inhaler should be used during nursing only if the potential benefit justifies the possible risk to the newborn.
|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInPed=* MAXAIR Inhaler is not recommended for patients under the age of 12 years because of insufficient clinical data to establish safety and effectiveness.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
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<!--Administration and Monitoring-->
<!--Administration and Monitoring-->
|administration=* Oral
|administration=* Inhalation
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
* Intravenous
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
* Description
<!--IV Compatibility-->
<!--IV Compatibility-->
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<!--Overdosage-->
<!--Overdosage-->
|overdose====Acute Overdose===
|overdose=The expected symptoms with overdosage are those of excessive beta-stimulation and/or any of the symptoms listed under ADVERSE REACTIONS, e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats per minute, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and insomnia. Hypokalemia may also occur. As with all sympathomimetic aerosol medication, cardiac arrest and even death may be associated with abuse of MAXAIR Inhaler.
====Signs and Symptoms====
* Description
====Management====
* Description
===Chronic Overdose===
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
<!--Pharmacology-->
Treatment consists of discontinuation of pirbuterol together with appropriate symptomatic therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage.
<!--Drug box 2-->
The oral median lethal dose of pirbuterol dihydrochloride in mice and rats is greater than 2000 mg/kg (approximately 3400 and 6800 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis).
|drugBox=<!--Mechanism of Action-->
|drugBox=<!--Mechanism of Action-->
|mechAction=*
|mechAction=*
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<!--Nonclinical Toxicology-->
<!--Nonclinical Toxicology-->
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
|nonClinToxic=Carcinogenicity, Mutagenesis and Impairment of Fertility: In a 2-year study in Sprague-Dawley rats, pirbuterol hydrochloride administered at dietary doses of 1.0, 3.0, and 10 mg/kg (approximately 3, 10, and 35 times the maximum recommended daily inhalation dose for adults and children on a mg/m2 basis) showed no evidence of carcinogenicity. In an 18-month study in mice at dietary doses of 1.0, 3.0, and 10 mg/kg (approximately 2, 5, and 15 times the maximum recommended daily inhalation dose for adults and children on a mg/m2 basis) no evidence of tumorigenicity was seen. Reproduction studies in rats administered pirbuterol hydrochloride at oral doses of 1, 3, and 10 mg/kg (approximately 3, 10, and 35 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis) revealed no evidence of impaired fertility.
Pirbuterol dihydrochloride showed no evidence of mutagenicity in in vitro assays and host-mediated microbial (Ames) assays for point mutations and in vivo tests for somatic or germ cell effects following acute and subchronic treatment in mice (cytogenicity assays).
<!--Clinical Studies-->
<!--Clinical Studies-->
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|howSupplied=*
|howSupplied=*
|packLabel=<!--Patient Counseling Information-->
|packLabel=<!--Patient Counseling Information-->
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
|fdaPatientInfo=* Information for Patients: The action of MAXAIR Inhaler should last up to five hours or longer. MAXAIR Inhaler should not be used more frequently than recommended. Do not increase the dose or frequency of MAXAIR Inhaler without consulting your physician. If you find that treatment with MAXAIR Inhaler 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 Inhaler, other inhaled drugs and asthma medications should be taken only as directed by your physician. 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 Inhaler. Effective and safe use includes an understanding of the way the medication should be administered. As with all aerosol medications, it is recommended to prime (test) MAXAIR Inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks. Prime by releasing three “test sprays” into the air away from yourself and other people.
<!--Precautions with Alcohol-->
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
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Overview
Pirbuterol is a Beta-2 Adrenergic Agonist that is FDA approved for the treatment of of bronchospasm in patients 12 years of age and older with reversible bronchospasm including asthma.. Common adverse reactions include nervousness, tremor.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
MAXAIR Inhaler 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.
Dosage
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.
As with all aerosol medications, it is recommended to prime (test) MAXAIR Inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks. Prime by releasing three “test sprays” into the air away from yourself and other people.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Pirbuterol in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Pirbuterol in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Pirbuterol in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Pirbuterol in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Pirbuterol in pediatric patients.
Contraindications
MAXAIR Inhaler is contraindicated in patients with a history of hypersensitivity to pirbuterol or any of its ingredients.
Warnings
Cardiovascular: MAXAIR Inhaler, 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 Inhaler 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 Inhaler, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
Paradoxical Bronchospasm: MAXAIR Inhaler can produce paradoxical bronchospasm, which can be life threatening. If paradoxical bronchospasm occurs, MAXAIR Inhaler 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 anti-inflammatory 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 Inhaler 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.
Precautions
General: Since pirbuterol is a sympathomimetic amine, it should be used with caution in patients with cardiovascular disorders, including ischemic heart disease, hypertension, or cardiac arrhythmias, in patients with hyperthyroidism or diabetes mellitus, and in patients who are unusually responsive to sympathomimetic amines or who have convulsive disorders. Significant changes in systolic and diastolic blood pressure could be expected to occur in some patients after use of any beta adrenergic aerosol bronchodilator.
Beta adrenergic agonist medications may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. The decrease is usually transient, not requiring supplementation.
Adverse Reactions
Clinical Trials Experience
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:
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.
Electrocardiograms: Electrocardiograms, obtained during a randomized, double-blind, cross-over 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.
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Pirbuterol in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Drug Interactions
Drug Interactions: Other short-acting beta adrenergic aerosol bronchodilators should not be used concomitantly with MAXAIR Inhaler because they may have additive effects.
Monoamine Oxidase Inhibitors or Tricyclic Antidepressants: Pirbuterol should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of pirbuterol on the vascular system may be potentiated.
Beta Blockers: Beta adrenergic receptor blocking agents not only block the pulmonary effect of beta-agonists, such as MAXAIR Inhaler, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta blockers. However, under certain circumstances, e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta adrenergic blocking agents in patients with asthma. In this setting, cardioselective beta blockers could be considered, although they should be administered with caution.
Diuretics: The ECG changes and/or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of beta-agonists with non-potassium sparing diuretics.
Pirbuterol was not teratogenic in rats administered oral doses of 30, 100, and 300 mg/kg (approximately 100, 340, and 1000 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis). Pirbuterol was not teratogenic in rabbits administered oral doses of 30 and 100 mg/kg (approximately 200 and 680 times the maximum recommended inhalation dose for adults on a mg/m2 basis). However, pirbuterol at an oral dose of 300 mg/kg (approximately 2000 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis) caused abortions and fetal death.
There are no adequate and well-controlled studies in pregnant women. Pirbuterol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pregnancy Category (AUS):
Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Pirbuterol in women who are pregnant.
Labor and Delivery
Because of the potential for beta-agonist interference with uterine contractility, use of MAXAIR Inhaler for relief of bronchospasm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk.
Nursing Mothers
It is not known whether pirbuterol is excreted in human milk. Therefore, MAXAIR Inhaler should be used during nursing only if the potential benefit justifies the possible risk to the newborn.
Pediatric Use
MAXAIR Inhaler is not recommended for patients under the age of 12 years because of insufficient clinical data to establish safety and effectiveness.
Geriatic Use
There is no FDA guidance on the use of Pirbuterol with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Pirbuterol with respect to specific gender populations.
Race
There is no FDA guidance on the use of Pirbuterol with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Pirbuterol in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Pirbuterol in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Pirbuterol in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Pirbuterol in patients who are immunocompromised.
Administration and Monitoring
Administration
Inhalation
Monitoring
There is limited information regarding Monitoring of Pirbuterol in the drug label.
IV Compatibility
There is limited information regarding IV Compatibility of Pirbuterol in the drug label.
Overdosage
The expected symptoms with overdosage are those of excessive beta-stimulation and/or any of the symptoms listed under ADVERSE REACTIONS, e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats per minute, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and insomnia. Hypokalemia may also occur. As with all sympathomimetic aerosol medication, cardiac arrest and even death may be associated with abuse of MAXAIR Inhaler.
Treatment consists of discontinuation of pirbuterol together with appropriate symptomatic therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage.
The oral median lethal dose of pirbuterol dihydrochloride in mice and rats is greater than 2000 mg/kg (approximately 3400 and 6800 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis).
Pharmacology
There is limited information regarding Pirbuterol Pharmacology in the drug label.
There is limited information regarding Pharmacodynamics of Pirbuterol in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Pirbuterol in the drug label.
Nonclinical Toxicology
Carcinogenicity, Mutagenesis and Impairment of Fertility: In a 2-year study in Sprague-Dawley rats, pirbuterol hydrochloride administered at dietary doses of 1.0, 3.0, and 10 mg/kg (approximately 3, 10, and 35 times the maximum recommended daily inhalation dose for adults and children on a mg/m2 basis) showed no evidence of carcinogenicity. In an 18-month study in mice at dietary doses of 1.0, 3.0, and 10 mg/kg (approximately 2, 5, and 15 times the maximum recommended daily inhalation dose for adults and children on a mg/m2 basis) no evidence of tumorigenicity was seen. Reproduction studies in rats administered pirbuterol hydrochloride at oral doses of 1, 3, and 10 mg/kg (approximately 3, 10, and 35 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis) revealed no evidence of impaired fertility.
Pirbuterol dihydrochloride showed no evidence of mutagenicity in in vitro assays and host-mediated microbial (Ames) assays for point mutations and in vivo tests for somatic or germ cell effects following acute and subchronic treatment in mice (cytogenicity assays).
Clinical Studies
There is limited information regarding Clinical Studies of Pirbuterol in the drug label.
How Supplied
Storage
There is limited information regarding Pirbuterol Storage in the drug label.
Images
Drug Images
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|?Drug Author
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Information for Patients: The action of MAXAIR Inhaler should last up to five hours or longer. MAXAIR Inhaler should not be used more frequently than recommended. Do not increase the dose or frequency of MAXAIR Inhaler without consulting your physician. If you find that treatment with MAXAIR Inhaler 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 Inhaler, other inhaled drugs and asthma medications should be taken only as directed by your physician. 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 Inhaler. Effective and safe use includes an understanding of the way the medication should be administered. As with all aerosol medications, it is recommended to prime (test) MAXAIR Inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks. Prime by releasing three “test sprays” into the air away from yourself and other people.
Precautions with Alcohol
Alcohol-Pirbuterol interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
