Proair Respiclick

Drug overview for PROAIR RESPICLICK (albuterol sulfate):

Generic name: ALBUTEROL SULFATE (al-BUE-ter-ol/sal-BUE-ta-mol)
Drug class: Beta-Adrenergic Agents Short-Acting (Inhaled)
Therapeutic class: Respiratory Therapy Agents

Albuterol (a racemic mixture) and levalbuterol (the R-enantiomer) are synthetic sympathomimetic amines that stimulate beta-adrenergic receptors. The drugs are relatively selective, short-acting beta2-adrenergic agonists.

No enhanced Uses information available for this drug.

DRUG IMAGES

PROAIR RESPICLICK 90 MCG INHLR

The following indications for PROAIR RESPICLICK (albuterol sulfate) have been approved by the FDA:

Indications:
Acute asthma attack
Bronchospasm prevention
Exercise-induced bronchospasm prevention

Professional Synonyms:
Acute asthma exacerbation
Acute asthma
Bronchial spasm prophylaxis
Bronchospasm prophylaxis
Exercise-induced bronchospasm prophylaxis

The following dosing information is available for PROAIR RESPICLICK (albuterol sulfate):

Dosing
Administration
PROAIR RESPICLICK
Generic

Dosage of albuterol sulfate is expressed in terms of albuterol. Dosage of levalbuterol hydrochloride or tartrate is expressed in terms of levalbuterol. Dosage of albuterol sulfate and levalbuterol must be carefully adjusted according to individual requirements and response.

The albuterol oral aerosol inhalers deliver 90 mcg of albuterol from the mouthpiece per metered spray. The levalbuterol tartrate oral aerosol inhaler delivers 45 mcg of levalbuterol from the mouthpiece per metered spray. The oral aerosol inhaler containing albuterol sulfate and ipratropium bromide delivers 18 mcg of ipratropium bromide and 103 mcg of albuterol sulfate (equivalent to 90 mcg of albuterol) from the mouthpiece per metered spray.

Using in vitro testing at an average flow rate of 3.6 L/minute for an average of 15 minutes, the Pari-LC Plus(R) nebulizer delivered at the mouthpiece approximately 46 or 42% of the original dosage of albuterol or ipratropium bromide, respectively. Using in vitro testing at an average flow rate of 3.6

L/minute for an average of 15 minutes or less, the Pari-LC Plus(R) nebulizer delivered at the mouthpiece approximately 43 or 39% of the original dosage of albuterol at the 1.25- or 0. 63-mg strength, respectively.

Commercially available albuterol sulfate aerosol with a hydrofluoroalkane (HFA) propellant delivers at least 200 metered sprays per 18-g (Ventolin(R) HFA), 6.7-g (Proventil(R) HFA), or 8.5-g (ProAir(R) HFA) canister, respectively.

The commercially available aerosol inhaler containing albuterol sulfate in fixed combination with ipratropium bromide delivers 200 metered sprays per 14.7-g canister. The commercially available levalbuterol aerosol inhaler delivers 200 metered sprays per 15-g canister. The canister should be discarded after the labeled number of actuations have been used.

Albuterol sulfate is administered orally or by oral inhalation via a metered-dose inhaler or nebulization. Albuterol sulfate is administered in fixed combination with ipratropium bromide via a metered-dose aerosol inhaler or via nebulization. Levalbuterol hydrochloride is administered by oral inhalation via nebulization.

Levalbuterol tartrate with hydrofluoroalkane (HFA) propellant is administered by oral inhalation via a metered-dose inhaler. To avoid microbial contamination, proper aseptic technique should be used when albuterol or levalbuterol is administered via nebulization. Albuterol sulfate extended-release tablets should not be chewed or crushed.

Dosing information for PROAIR RESPICLICK
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
PROAIR RESPICLICK 90 MCG INHLR	Maintenance	Adults inhale 2 puffs (180 mcg) by inhalation route every 4-6 hours as needed

No generic dosing information available.

The following drug interaction information is available for PROAIR RESPICLICK (albuterol sulfate):

Contraindicated
Severe
Moderate

There are 0 contraindications.

There are 4 severe interactions. These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.

Drug Interaction	Drug Names
Ergot Alkaloids/Sympathomimetics SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Concurrent use of ergot alkaloids and sympathomimetics may result in additive or synergistic effect on peripheral blood vessels. CLINICAL EFFECTS: Concurrent use of ergot alkaloids and sympathomimetics may result in increased blood pressure due to peripheral vasoconstriction. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: When possible, avoid the concurrent use of ergot alkaloids and sympathomimetics. If concurrent use is warranted, monitor blood pressure and for signs of vasoconstriction. Decreasing the dose of one or both drugs may be necessary. DISCUSSION: There have been reports of severe vasoconstriction resulting in gangrene in patients receiving intravenous ergonovine with dopamine or norepinephrine.	DIHYDROERGOTAMINE MESYLATE, ERGOLOID MESYLATES, ERGOMAR, ERGOTAMINE TARTRATE, ERGOTAMINE-CAFFEINE, METHYLERGONOVINE MALEATE, METHYSERGIDE MALEATE, MIGERGOT, MIGRANAL, TRUDHESA
Selected Inhalation Anesthetic Agents/Sympathomimetics SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: The exact mechanism is unknown. The anesthetics produce conduction changes that increase impulse re-entry into the myocardial tissue.(1) The anesthetics' ability to precipitate arrhythmias is enhanced by elevated arterial blood pressure, tachycardia, hypercapnia, and/or hypoxia, events that stimulate the release of endogenous catecholamines.(1) CLINICAL EFFECTS: Concurrent use of inhalation anesthetic agents and sympathomimetics may result in ventricular arrhythmias or sudden blood pressure and heart rate increase during surgery.(2) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Monitor blood pressure and avoid use of sympathomimetics in patients being treated with anesthetics on the day of surgery.(2) Intravenous use of epinephrine during surgery with halothane and related halogenated general anesthetics should be strongly discouraged. When intravenous epinephrine is necessary, nitrous oxide anesthesia supplemented with ether, muscle relaxants, or opioids should be used instead of halothane.(3,4) Epinephrine may safely be used subcutaneously with the following precautions: the patient is adequately ventilated to prevent hypoxia or respiratory acidosis; the total dose of epinephrine is limited to 100 mcg/10 minute period or 300 mcg/hour in adults, 3.5 mcg/Kg in infants, 2.5 mcg/Kg in children up to two years of age, and 1.45 mcg/Kg in children over two years of age; a minimum effective concentration of anesthetic is maintained; the drugs are not co-administered in patients with hypertension or other cardiovascular disorders; and the cardiac rhythm is continuously monitored during and after injection.(3-10) If arrhythmias occur after the administration of the epinephrine, the drugs of choice are lidocaine or propranolol, depending on the type of arrhythmia.(1) DISCUSSION: Administration of epinephrine during halothane anesthesia may may lead to serious ventricular arrhythmias.(3-6,11-18) This has occurred when epinephrine was administered intravenously,(6) when it was administered with lidocaine as a dental block,(11,14) or when it was administered supraperiosteally.(5) Norepinephrine has been shown to interact with halothane in a manner similar to epinephrine.(1) In two case reports, patients were given terbutaline (0.25 to 0.35 mg) for wheezing following induction of anesthesia with halothane. One patient's heart rate increased from 68 to 100 beats/minute, and the ECG showed premature ventricular contractions and bigeminy, while the other patient developed multiple unifocal premature ventricular contractions and bigeminy. The arrhythmias resolved in both patients following lidocaine administration.(19) Although not documented, isoproterenol causes effects on the heart similar to terbutaline(20) and would probably interact with halothane in a similar manner. Other inhalation anesthetics that increase the incidence of arrhythmias with epinephrine include chloroform,(20) methoxyflurane,(20) and enflurane.(12) A similar interaction may be expected between the other inhalation anesthetics and sympathomimetics.	DESFLURANE, FORANE, ISOFLURANE, SEVOFLURANE, SUPRANE, TERRELL, ULTANE
Beta-2 Agonists/Non-Cardioselective Beta-Blockers SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Non-cardioselective beta-blockers and beta-2 agonists may antagonize the effects of each other. CLINICAL EFFECTS: Diminished response to either the beta-agonist, beta-blocker, or both may occur. Beta-blockers may also induce bronchospasm. PREDISPOSING FACTORS: Patients receiving beta-2 agonists for the treatment of asthma may be more at risk for bronchospasm. PATIENT MANAGEMENT: If possible, avoid beta-blocker therapy in asthmatic patients requiring beta-2 agonist therapy. If beta-blocker therapy is required, use a cardio-selective beta-blocker. For timolol ophthalmic drops, counsel patients to apply pressure to the inner corner of the eye after administration to prevent systemic absorption. Monitor patients for decreased effects of either agent, such as increased need for/use of beta-2 agonists or increased heart rate or blood pressure. DISCUSSION: Many patients with asymptomatic or mild reactive airways disease tolerate beta-blockers well. Most patients with COPD do not have bronchospastic component to their illness and may be given beta-blockers. Heart failure treatment guidelines recommend beta-blockers in the presence of COPD. Non-selective beta-blockers have been shown to have a negative effect on lung function (FEV1) and airway hyperresponsiveness (AHR) in patients with asthma and COPD.(1) An open-label study using the nonselective beta blocker nadolol showed no effect on salbutamol in 10 patients with mild asthma not on controller therapy.(2) A study in 8 healthy men showed that long acting propranolol (160 mg) only effected airway dilation at the 200 mcg salbutamol dose. The 800 mcg and 1600 mcg dose were unaffected. However, penbutolol prevented any significant airway dilation with all doses of salbutamol.(3) In a double blind, three-way, crossover study, 44% (7/16 patients) of patients taking metoprolol showed a greater than 20% decrease in FEV1 compared to 19% (3 patients) after dilevalol and 6% (1 patient) after placebo. Dilevalol and metoprolol significantly inhibited isoproterenol response compared to placebo.(4) A double-blind, randomized, crossover study in 10 asthmatic patients showed that intravenous propranolol produced marked symptomatic bronchoconstriction. Only a slight but significant inhibition of bronchomotor sensitivity to isoproterenol was noted during esmolol infusion.(5) In 18 patients with reversible bronchial asthma, labetalol caused a significant increase in FEV1 and metoprolol caused a significant decrease in FEV1. Concurrent administration of isoproterenol and labetalol caused a further increase in FEV1. The effect of isoproterenol was decreased by metoprolol (100, 200mg).(6) In one study propranolol (0.06mg/kg IV) was shown to almost completely block the effects of isoproterenol in asthmatics. Metoprolol (0.12mg/kg IV) did not affect isoproterenol.(7) Studies have shown that cardioselective beta-blockers are safe for patients with asthma and COPD.(8,9,10) Nebivolol and celiprolol significantly decreased FEV1. Inhalation of albuterol (up to 800mcg) significantly improved FEV1, but the values after nebivolol and celiprolol administration were lower than the initial values.(11) Administration of metoprolol did not cause any respiratory problems in 9 asthmatic patients. There was no significant difference between the metoprolol and placebo groups in the respiratory response to an isoproterenol aerosol in 24 asthmatic patients.(12) Eight male asthmatic patients were given 10 mg bisoprolol, 20 mg bisoprolol, and 100 mg metoprolol. Both bisoprolol and metoprolol caused bronchoconstriction measured by a significant fall in PEFR (peak expiratory flow rate). Terbutaline was able to reverse bronchoconstriction in all patients.(13) A double blind, placebo-controlled study analyzed the use of atenolol 100mg, metoprolol 100mg, or acebutolol 400 mg in 8 asthmatic patients before and after exercise. All three drugs reduced significantly FEV1 and PEFR. Administration of terbutaline improved all respiratory indices.(14) A double-blind crossover trial in 10 asthmatic patients showed that a single IV dose of atenolol 3mg caused slight impairment of ventilatory function. A dose of salbutamol by inhalation was able to reverse the bronchial effect of atenolol.(15) Propranolol (80mg/day), oxprenolol (80mg/day), atenolol (100mg/day), and celiprolol 200mg/day were given to 10 asthmatic patients in a randomized, crossover design with a two week washout period between each drug. The non-beta 1 selective beta blockers (propranolol, oxprenolol) caused a significant reduction in FEV1 and inhibited the bronchodilator response to inhaled salbutamol. Atenolol and celiprolol (beta1 selective beta blockers) did not significantly affect respiratory function or antagonize salbutamol effects.(16) A double blind, randomized, within patient, placebo-controlled study compared the cardioselective beta-blocker atenolol to the non-selective propranolol. Atenolol caused a significantly less drop in FEV1 compared to propranolol. The effect of isoprenaline plus the beta blockers were also studied. Both atenolol and propranolol effected isoprenaline FEV1 dose response curves but the greatest displacement was seen with propranolol.(17) The pulmonary effects of celiprolol 200 mg, celiprolol 400mg, propranolol 40mg, atenolol 100 mg were evaluated in 34 asthmatic patients. Propranolol and atenolol caused significant reductions in pulmonary function. Propranolol pretreatment caused a significant reduction in the effect of the bronchodilator. Celiprolol did not antagonize the bronchodilators.(18) A double-blind, placebo controlled, randomized, crossover design study studied the effects of propranolol 80mg or celiprolol 200 or 400mg on pulmonary function. Propranolol produced a significant decrease in FEV1 and FVC. Celiprolol and placebo had similar results. The effect of aerosolized terbutaline was also measured. Even at supratherapeutic doses, terbutaline was unable to restore pulmonary function parameters to baseline levels after treatment with propranolol. Terbutaline caused further bronchodilation after administration of celiprolol.(19) Eleven asthmatic patients showed significant bronchoconstriction in small airways after propranolol 40mg and pindolol 2.5mg in a double blind, randomized trial. Large airways only showed bronchoconstriction with propranolol. Terbutaline 0.5mg subcutaneous was given after pretreatment with propranolol and pindolol. The bronchodilator effect of terbutaline on large airways was diminished after both propranolol and timolol.(20)	BETAPACE, BETAPACE AF, BETIMOL, BRIMONIDINE TARTRATE-TIMOLOL, CARVEDILOL, CARVEDILOL ER, COMBIGAN, COREG, COREG CR, CORGARD, COSOPT, COSOPT PF, DORZOLAMIDE-TIMOLOL, HEMANGEOL, INDERAL LA, INDERAL XL, INNOPRAN XL, ISTALOL, LABETALOL HCL, LABETALOL HCL-WATER, NADOLOL, PINDOLOL, PROPRANOLOL HCL, PROPRANOLOL HCL ER, PROPRANOLOL-HYDROCHLOROTHIAZID, SOTALOL, SOTALOL AF, SOTALOL HCL, SOTYLIZE, TIMOLOL, TIMOLOL MALEATE, TIMOLOL-BIMATOPROST, TIMOLOL-BRIMONI-DORZOL-BIMATOP, TIMOLOL-BRIMONIDIN-DORZOLAMIDE, TIMOLOL-DORZOLAMIDE-BIMATOPRST, TIMOPTIC OCUDOSE
Iobenguane I 123/Agents that Affect Catecholamines SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Many compounds that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells.(1) CLINICAL EFFECTS: Compounds that reduce catecholamine uptake or that deplete catecholamine stores may interfere with imaging completed with iobenguane.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Discuss the use of agents that affect catecholamines. Discontinue drugs that reduce catecholamine uptake or deplete catecholamine stores prior to imaging with iobenguane. Before imaging with iobenguane, discontinue agents that affect catecholamines for at least 5 biological half-lives, as clinically tolerated.(1) DISCUSSION: Many agents may reduce catecholamine uptake or deplete catecholamine stores.(1) Examples include: - CNS stimulants or amphetamines (e.g. cocaine, methylphenidate, dextroamphetamine) - norepinephrine and dopamine reuptake inhibitors (e.g. phentermine) - norepinephrine and serotonin reuptake inhibitors (e.g. tramadol) - monoamine oxidase inhibitors (e.g. phenelzine, linezolid) - central monoamine depleting drugs (e.g. reserpine) - non-select beta adrenergic blocking drugs (e.g. labetalol) - alpha agonists or alpha/beta agonists (e.g. pseudoephedrine, phenylephrine, ephedrine, phenylpropanolamine, naphazoline) - tricyclic antidepressants or norepinephrine reuptake inhibitors (e.g. amitriptyline, bupropion, duloxetine, mirtazapine, venlafaxine) - botanicals that may inhibit reuptake of norepinephrine, serotonin or dopamine (e.g. ephedra, ma huang, St. John's Wort, yohimbine)	ADREVIEW

There are 2 moderate interactions. The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.

Drug Interaction	Drug Names
Inhaled Direct-Acting Sympathomimetics/Tricyclic Compounds SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Unknown. However, it is speculated that direct-acting sympathomimetic amines have an enhanced effect due to tricyclic blockage of norepinephrine reuptake. CLINICAL EFFECTS: Increased effect of direct acting sympathomimetics. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The concurrent use of inhaled sympathomimetics and tricyclic compounds or the use of these agents within 14 days of each other should be approached with extreme caution. DISCUSSION: Epinephrine and other direct-acting sympathomimetic amines exert enhanced cardiovascular effects (e.g., arrhythmias, hypertension, and tachycardia) in individuals concurrently receiving or previously treated with tricyclic antidepressants. Protriptyline, amitriptyline, and desipramine have also been reported to interact with direct-acting sympathomimetics. Similarity between cyclobenzaprine and the tricyclic antidepressants consideration of tricyclic antidepressant interactions for cyclobenzaprine.	AMITRIPTYLINE HCL, AMOXAPINE, AMRIX, ANAFRANIL, CHLORDIAZEPOXIDE-AMITRIPTYLINE, CLOMIPRAMINE HCL, CYCLOBENZAPRINE HCL, CYCLOBENZAPRINE HCL ER, CYCLOPAK, CYCLOTENS, DESIPRAMINE HCL, DOXEPIN HCL, FEXMID, IMIPRAMINE HCL, IMIPRAMINE PAMOATE, NORPRAMIN, NORTRIPTYLINE HCL, PAMELOR, PERPHENAZINE-AMITRIPTYLINE, PROTRIPTYLINE HCL, SILENOR, TRIMIPRAMINE MALEATE
Methacholine/Beta-Agonists; Anticholinergics; Theophylline SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Beta-agonists, anticholinergics, and theophylline may inhibit the action of methacholine on the airway.(1) CLINICAL EFFECTS: The result of the methacholine challenge test may not be accurate.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The following drugs should be held before a methacholine challenge for the the duration indicated:(1) - short-acting beta-agonists: 6 hours - long-acting beta-agonists: 36 hours - short-acting anti-cholinergics: 12 hours - long-acting anti-cholinergics: at least 168 hours (7 days) - oral theophylline: 12-48 hours DISCUSSION: Beta-agonists, anticholinergics, and theophylline may inhibit the action of methacholine on the airway and cause inaccurate test results.	METHACHOLINE CHLORIDE, PROVOCHOLINE

Drug Interaction

Drug Names

Inhaled Direct-Acting Sympathomimetics/Tricyclic Compounds

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Unknown. However, it is speculated that direct-acting sympathomimetic amines have an enhanced effect due to tricyclic blockage of norepinephrine reuptake.

CLINICAL EFFECTS: Increased effect of direct acting sympathomimetics.

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The concurrent use of inhaled sympathomimetics and tricyclic compounds or the use of these agents within 14 days of each other should be approached with extreme caution.

DISCUSSION: Epinephrine and other direct-acting sympathomimetic amines exert enhanced cardiovascular effects (e.g., arrhythmias, hypertension, and tachycardia) in individuals concurrently receiving or previously treated with tricyclic antidepressants. Protriptyline, amitriptyline, and desipramine have also been reported to interact with direct-acting sympathomimetics. Similarity between cyclobenzaprine and the tricyclic antidepressants consideration of tricyclic antidepressant interactions for cyclobenzaprine.

AMITRIPTYLINE HCL, AMOXAPINE, AMRIX, ANAFRANIL, CHLORDIAZEPOXIDE-AMITRIPTYLINE, CLOMIPRAMINE HCL, CYCLOBENZAPRINE HCL, CYCLOBENZAPRINE HCL ER, CYCLOPAK, CYCLOTENS, DESIPRAMINE HCL, DOXEPIN HCL, FEXMID, IMIPRAMINE HCL, IMIPRAMINE PAMOATE, NORPRAMIN, NORTRIPTYLINE HCL, PAMELOR, PERPHENAZINE-AMITRIPTYLINE, PROTRIPTYLINE HCL, SILENOR, TRIMIPRAMINE MALEATE

Methacholine/Beta-Agonists; Anticholinergics; Theophylline

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Beta-agonists, anticholinergics, and theophylline may inhibit the action of methacholine on the airway.(1)

CLINICAL EFFECTS: The result of the methacholine challenge test may not be accurate.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The following drugs should be held before a methacholine challenge for the the duration indicated:(1) - short-acting beta-agonists: 6 hours - long-acting beta-agonists: 36 hours - short-acting anti-cholinergics: 12 hours - long-acting anti-cholinergics: at least 168 hours (7 days) - oral theophylline: 12-48 hours

DISCUSSION: Beta-agonists, anticholinergics, and theophylline may inhibit the action of methacholine on the airway and cause inaccurate test results.

METHACHOLINE CHLORIDE, PROVOCHOLINE

The following contraindication information is available for PROAIR RESPICLICK (albuterol sulfate):

Overview
Contraindicated
Severe
Moderate

Drug contraindication overview.

No enhanced Contraindications information available for this drug.

There are 0 contraindications.

There are 0 severe contraindications.

There are 12 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Cardiac arrhythmia
Chronic myocardial ischemia
Congenital long QT syndrome
Diabetes mellitus
Hypertension
Hyperthyroidism
Hypokalemia
Ketoacidosis
Metabolic acidosis
Myocardial ischemia
Prolonged QT interval
Seizure disorder

The following adverse reaction information is available for PROAIR RESPICLICK (albuterol sulfate):

Overview
Severe
Less Severe

Adverse reaction overview.

No enhanced Common Adverse Effects information available for this drug.

There are 11 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Abnormal ECG Anaphylaxis Angina Angioedema Hypokalemia Hypotension Metabolic acidosis Myocardial ischemia Paradoxical bronchospasm Pharyngeal edema Urticaria

There are 45 less severe adverse reactions.

More Frequent	Less Frequent
Back pain Nausea Nervousness Pain Pain in oropharynx Pharyngitis Rhinitis Tachycardia Tremor Upper respiratory infection Urinary tract infection Viral gastroenteritis Vomiting	Ataxia Chills Cough Cramps in legs Depression Dizziness Drowsy Dry throat Dysgeusia Edema Eructation Fever Flatulence Headache disorder Hyperhidrosis Hyperkinesis Hypertension Insomnia Migraine Mouth irritation Sore throat Symptoms of anxiety Tinnitus Voice change Xerostomia

Rare/Very Rare
Chest pain Cramps Hyperglycemia Palpitations Skin rash Sleep disorder Vertigo

The following precautions are available for PROAIR RESPICLICK (albuterol sulfate):

Pediatric
Pregnant
Lactation
Geriatric

No enhanced Pediatric Use information available for this drug.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Experts from the National Asthma Education and Prevention Program (NAEPP) state that maintaining adequate control of asthma during pregnancy is important for the health and well-being of the mother and the fetus. Because of the risks associated with asthma symptoms and exacerbations (e.g., increased perinatal mortality, preeclampsia, preterm birth, low birth weight during pregnancy, such experts consider use of antiasthmatic agents to be safer than the complications of inadequately controlled asthma. Albuterol is the preferred short-acting inhaled beta2-agonist because more data are available on use of albuterol in pregnant women than on use of other short-acting inhaled beta2-agonists, and such data indicate an excellent safety profile. The manufacturers of albuterol or levalbuterol state that the drugs should be used during pregnancy only if the possible benefits outweigh the potential risks. During marketing experience with the drug, various congenital anomalies, including cleft palate and limb defects, have been reported in the children of patients being treated with albuterol; however, some women were receiving multiple medications during their pregnancies. Because no consistent pattern of congenital abnormality development can be discerned, a relationship between albuterol use and the development of congenital anomalies cannot be established. Large IV doses of albuterol have reportedly inhibited uterine contractions, and the drug has reportedly delayed preterm labor following oral administration. Serious adverse effects, including maternal pulmonary edema, have been reported during or following treatment of premature labor with beta2-agonists, including albuterol. There are currently no well-controlled studies to show that albuterol will stop preterm labor or prevent labor at term, and the risks versus benefits of tocolytic therapy with levalbuterol or albuterol have not been established. Albuterol or orally inhaled levalbuterol should be used with caution in pregnant women when needed for relief of bronchospasm during labor and only when the potential benefits are expected to clearly outweigh the possible risks, since the drugs may interfere with uterine contractility. Albuterol has been shown to be teratogenic in mice and rabbits. Reproduction studies in mice given subcutaneous albuterol doses of 0.025, 0.25, or 2.5 mg/kg (approximately 0.003, 0.03, or 0.3 times, respectively, the maximum recommended daily oral dosage for adults; 0.125, 1.25, and 12.5 times the maximum recommended human albuterol single-use inhalation solution via nebulization; less than the maximum recommended adult daily inhalation solution dosage on a mg/m2 basis; and up to 8 times the maximum recommended daily inhalation aerosol dosage on a mg/m2 basis) showed cleft palate formation in 4.5% of fetuses at 0.25

mg/kg and in 9.3% of fetuses at 2.5 mg/kg (approximately equal to the maximum daily nebulized levalbuterol, albuterol sulfate, or albuterol sulfate/ipratropium bromide dosage in adults on a mg/m2 basis); cleft palate did not occur in mice receiving 0.025

mg/kg of albuterol (representing less than the maximum daily adult inhalation dosage of albuterol sulfate alone via metered-dose inhalation or nebulization or in fixed combination with ipratropium bromide via nebulization on a mg/m2 basis). Cleft palate also occurred in 30.5% of fetuses treated with 2.5

mg/kg of isoproterenol (positive control). A reproduction study with oral albuterol in rabbits revealed cranioschisis in 37% of fetuses at 50 mg/kg (approximately 25, 55, 60 or 80 times the maximum recommended daily adult oral albuterol sulfate dosage, albuterol sulfate/ipratropium bromide nebulized adult dosage, nebulized pediatric albuterol dosage or nebulized albuterol sulfate adult dosage, respectively, on a mg/m2 basis; 630-680 times the maximum daily adult inhalation aerosol dosage; or 250 times the maximum albuterol inhalation solution dosage via nebulization for a 50-kg human). In a reproduction study in rats given albuterol sulfate aerosol containing a hydrofluoroalkane propellant by oral inhalation, the drug did not exhibit any teratogenic effects at 10.5

mg/kg daily (approximately 60-65 times the maximum recommended human daily inhalation dosage on a mg/m2 basis). Safe use of the drug in pregnant women has not been established. A reproduction study in rabbits given oral levalbuterol dosages of up to 25 mg/kg (approximately 110 times the maximum recommended daily adult oral inhalation dosage on a mg/m2 basis) revealed no evidence of teratogenicity.

It is not known whether albuterol, albuterol sulfate, or levalbuterol is distributed into milk. Because of the potential for tumorigenicity shown for albuterol in animal studies, a decision should be made whether to discontinue nursing or albuterol or levalbuterol, taking into account the importance of the drug to the woman.

No enhanced Geriatric Use information available for this drug.

The following icd codes are available for PROAIR RESPICLICK (albuterol sulfate)'s list of indications:

Acute asthma attack
J45.21	Mild intermittent asthma with (acute) exacerbation
J45.22	Mild intermittent asthma with status asthmaticus
J45.31	Mild persistent asthma with (acute) exacerbation
J45.32	Mild persistent asthma with status asthmaticus
J45.41	Moderate persistent asthma with (acute) exacerbation
J45.42	Moderate persistent asthma with status asthmaticus
J45.51	Severe persistent asthma with (acute) exacerbation
J45.52	Severe persistent asthma with status asthmaticus
J45.901	Unspecified asthma with (acute) exacerbation
J45.902	Unspecified asthma with status asthmaticus
J98.01	Acute bronchospasm
Bronchospasm prevention
J44.8	Other specified chronic obstructive pulmonary disease
J44.81	Bronchiolitis obliterans and bronchiolitis obliterans syndrome
J44.89	Other specified chronic obstructive pulmonary disease
J44.9	Chronic obstructive pulmonary disease, unspecified
J45.20	Mild intermittent asthma, uncomplicated
J45.30	Mild persistent asthma, uncomplicated
J45.40	Moderate persistent asthma, uncomplicated
J45.50	Severe persistent asthma, uncomplicated
J45.909	Unspecified asthma, uncomplicated
J45.990	Exercise induced bronchospasm
J45.998	Other asthma
Exercise-induced bronchospasm prevention
J45.990	Exercise induced bronchospasm