ProAir RespiClick Albuterol Sulfate 90 ug Powder, Metered
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🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
Albuterol is used to prevent and treat difficulty breathing, wheezing, shortness of breath, coughing, and chest tightness caused by lung diseases such as asthma and chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways). Albuterol inhalation aerosol and powder for oral inhalation is also used to prevent breathing difficulties during exercise. Albuterol inhalation aerosol (Proair HFA, Proventil HFA, Ventolin HFA) is used in adults and children 4 years of age and older. Albuterol powder for oral inhalation (Proair Respiclick) is used in children 12 ye...
Read the full MedlinePlus article ↗- Albuterol quickly relaxes the muscles around your airways, opening them up so you can breathe more easily. Think of it as a fast-acting rescue medicine — you use it when you feel y...
- What exactly does albuterol do, and when should I use it?
- That depends on which inhaler you have. If you have a standard HFA inhaler (like Ventolin HFA or Albuterol Sulfate HFA), shake it well before every puff and prime it with a few tes...
- The most common side effects are pretty mild — a scratchy throat, cough, or upper respiratory irritation, and sometimes a slightly faster heartbeat, shakiness, or headache. Those u...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Albuterol Sulfate — tap one for details:
Albuterol Sulfate may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $67.177 | $13,435.32 / 200 powders |
| Medicaid paysCMS SDUD · 12 mo | $111.14 | $22,227.80 / 200 powders |
| Medicare drug plans payPart D · Q2 2026 | $67.20 | $13,440.16 / 200 powders |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| ProAir RespiClick 90 ugthis 59310-0580-20 | Teva | 1 inhaler | $67.177 | — | Availability likely | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 59310-0580-20 You're viewing this | 1 INHALER in 1 BOX (59310-580-20) / 200 POWDER, METERED in 1 INHALER | $67.18 / ea | $13,435.32 | 2015-05-11 | Active |
| 59310-0580-21 | 1 INHALER in 1 BOX (59310-580-21) / 200 POWDER, METERED in 1 INHALER | — | — | 2015-04-23 | Discontinued by firm |
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 59310-0580-20?
What NDC number is used to bill for this package of ProAir RespiClick Albuterol Sulfate 90 ug Powder, Metered?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE PROAIR RESPICLICK is a beta 2 -adrenergic agonist indicated for: Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. ( 1.1 ) Prevention of exercise-induced bronchospasm in patients 4 years of age and older. ( 1.2 )
1.1Bronchospasm PROAIR RESPICLICK is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease.
1.2Exercise-Induced Bronchospasm PROAIR RESPICLICK is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION For oral inhalation only Treatment or prevention of bronchospasm in adults and children 4 years of age and older: 2 inhalations every 4 to 6 hours by oral inhalation. In some patients, 1 inhalation every 4 hours may be sufficient. ( 2.1 ) Prevention of exercise-induced bronchospasm in adults and children 4 years of age and older: 2 inhalations 15 to 30 minutes before exercise by oral inhalation.
(2.2) PROAIR RESPICLICK does not require priming. ( 2.3 ) Do not use with a spacer or volume holding chamber. ( 2.3 ) Keep the inhaler clean and dry at all times.
Routine maintenance is not required. If the mouthpiece needs cleaning, gently wipe the mouthpiece with a dry cloth or tissue as needed. Never wash or put any part of the inhaler in water.
( 2.3 ) Discard 13 months after opening the foil pouch, when the dose counter displays 0, or after the expiration date on the product, whichever comes first. ( 2.3 )
2.1Recommended Dosage for Bronchospasm The recommended dosage is 2 inhalations every 4 to 6 hours by oral inhalation. More frequent administration or a larger number of inhalations is not recommended. In some patients, 1 inhalation every 4 hours may be sufficient.
2.2Recommended Dosage for Exercise-Induced Bronchospasm The recommended dosage is 2 inhalations 15 to 30 minutes before exercise by oral inhalation.
2.3Administration and Maintenance Information Administer PROAIR RESPICLICK by oral inhalation only. PROAIR RESPICLICK inhaler does not require priming. Do not use PROAIR RESPICLICK with a spacer or volume holding chamber. Keep the inhaler clean and dry at all times. Never wash or put any part of your inhaler in water. Routine maintenance is not required. If the mouthpiece needs cleaning, gently wipe the mouthpiece with a dry cloth or tissue as needed.
2.4Dose Counter The PROAIR RESPICLICK inhaler has a dose counter attached to the actuator. When the patient receives the inhaler, the number 200 will be displayed. The dose counter will count down each time the inhaler is actuated.
When the dose counter reaches 20, the color of the numbers will change to red to remind the patient to contact their pharmacist for a refill of medication or consult their physician for a prescription refill. When the dose counter reaches 0, the background will change to solid red. Discard PROAIR RESPICLICK 13 months after opening the foil pouch, when the dose counter displays 0 or after the expiration date on the product, whichever comes first [see Patient Counseling Information (17)].
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Inhalation powder: a multi-dose breath-actuated dry powder inhaler that delivers 108 mcg of albuterol sulfate (equivalent to 90 mcg of albuterol base) from the mouth piece per actuation. Each inhaler is supplied for 200 inhalations. Inhalation powder: dry powder inhaler that delivers 108 mcg of albuterol sulfate (equivalent to 90 mcg of albuterol base) from the mouthpiece per actuation.
The inhaler is supplied for 200 inhalation doses. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS PROAIR RESPICLICK is contraindicated in patients with a history of hypersensitivity to albuterol and/or severe hypersensitivity to milk proteins. Rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate. There have been reports of anaphylactic reactions in patients using inhalation therapies containing lactose [see Warnings and Precautions ( 5.6 )] .
Patients with hypersensitivity to albuterol. ( 4 ) Patients with severe hypersensitivity to milk proteins. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Life-threatening paradoxical bronchospasm may occur. Discontinue PROAIR RESPICLICK immediately and treat with alternative therapy. ( 5.1 ) Need for more doses of PROAIR RESPICLICK than usual may be a sign of deterioration of asthma and requires reevaluation of treatment.
( 5.2 ) PROAIR RESPICLICK is not a substitute for corticosteroids. ( 5.3 ) Cardiovascular effects may occur. Use with caution in patients sensitive to sympathomimetic drugs and patients with cardiovascular or convulsive disorders.
( 5.4 , 5.7 ) Excessive use may be fatal. Do not exceed recommended dose. ( 5.5 ) Immediate hypersensitivity reactions may occur.
Discontinue PROAIR RESPICLICK immediately. ( 5.6 ) Hypokalemia and changes in blood glucose may occur. ( 5.7 , 5.8 )
5.1Paradoxical Bronchospasm PROAIR RESPICLICK can produce paradoxical bronchospasm that may be life threatening. If paradoxical bronchospasm occurs, PROAIR RESPICLICK should be discontinued immediately and alternative therapy instituted.
5.2Deterioration 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 PROAIR RESPICLICK, this may be a marker of destabilization of asthma and requires re-evaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, eg, corticosteroids.
5.3Use 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, to the therapeutic regimen.
5.4Cardiovascular Effects PROAIR RESPICLICK, like other beta-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of PROAIR RESPICLICK 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, PROAIR RESPICLICK, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
5.5Do Not Exceed Recommended Dose Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma. The exact cause of death is unknown, but cardiac arrest following an unexpected development of a severe acute asthmatic crisis and subsequent hypoxia is suspected.
5.6Hypersensitivity Reactions including Anaphylaxis Immediate hypersensitivity reactions may occur after administration of albuterol sulfate, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. PROAIR RESPICLICK contains small amounts of lactose, which may contain trace levels of milk proteins. Hypersensitivity reactions including anaphylaxis, angioedema, pruritus, and rash have been reported with the use of therapies containing lactose (lactose is an inactive ingredient in PROAIR RESPICLICK).
The potential for hypersensitivity must be considered in the clinical evaluation of patients who experience immediate hypersensitivity reactions while receiving PROAIR RESPICLICK.
5.7Coexisting Conditions PROAIR RESPICLICK, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines. Clinically significant changes in systolic and diastolic blood pressure have b…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Use of PROAIR RESPICLICK may be associated with the following: Paradoxical bronchospasm [see Warnings and Precautions ( 5.1 )] Cardiovascular Effects [see Warnings and Precautions ( 5.4 )] Immediate hypersensitivity reactions [see Warnings and Precautions ( 5.6 )] Hypokalemia [see Warnings and Precautions ( 5.8 ) Most common adverse reactions (≥1% and >placebo) are back pain, pain, gastroenteritis viral, sinus headache, urinary tract infection, nasopharyngitis, oropharyngeal pain and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Respiratory, LLC at 1-888-482-9522 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience A total of 1289 subjects were treated with PROAIR RESPICLICK during the clinical development program. The most common adverse reactions (≥1% and > placebo) were back pain, pain, gastroenteritis viral, sinus headache, and urinary tract infection. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adults and Adolescents 12 years of Age and Older : The adverse reaction information presented in Table 1 below concerning PROAIR RESPICLICK is derived from the 12-week blinded treatment period of three studies which compared PROAIR RESPICLICK 180 mcg four times daily with a double-blinded matched placebo in 653 asthmatic patients 12 to 76 years of age. Table 1: Adverse Reactions Experienced by Greater Than or Equal to 1.0% of Adult and Adolescent Patients in the PROAIR RESPICLICK Group and Greater Than Placebo in three 12-Week Clinical Trials 1 Preferred Term Number (%) of patients PROAIR RESPICLICK 180 mcg QID N=321 Placebo N=333 Back pain 6 (2%) 4 (1%) Pain 5 (2%) 2 (<1%) Gastroenteritis viral 4 (1%) 3 (<1%) Sinus headache 4 (1%) 3 (<1%) Urinary tract infection 4 (1%) 3 (<1%) 1.
This table includes all adverse events (whether considered by the investigator drug related or unrelated to drug) which occurred at an incidence rate of greater than or equal to 1.0% in the PROAIR RESPICLICK group and greater than placebo. In a long-term study of 168 patients treated with PROAIR RESPICLICK for up to 52 weeks (including a 12-week double-blind period), the most commonly reported adverse events greater than or equal to 5% were upper respiratory infection, nasopharyngitis, sinusitis, bronchitis, cough, oropharyngeal pain, headache, and pyrexia.
In a small cumulative dose study, tremor, palpitations, and headache were the most frequently occurring (≥5%) adverse events. Pediatric Patients 4 to 11 Years of Age : The adverse reaction information presented in Table 2 below concerning PROAIR RESPICLICK is derived from a 3‑week pediatric clinical trial which compared PROAIR RESPICLICK 180 mcg albuterol 4 times daily with a double‑blinded matched placebo in 185 asthmatic patients 4 to 11 years of age. Table 2: Adverse Reactions Experienced by Greater Than or Equal to 2.0% of Patients 4 to 11 Years of Age in the PROAIR RESPICLICK Group and Greater Than Placebo in the 3 Week Trial Preferred Term Number (%) of patients PROAIR RESPICLICK 180 mcg QID N=93 Placebo N=92 Nasopharyngitis 2 (2%) 1 (1%) Oropharyngeal pain 2 (2%) 1 (1%) Vomiting 3 (3%) 1 (1%)
6.2Postmarketing Experience In addition to the adverse reactions reported from clinical trials with PROAIR RESPICLICK, the following adverse events have been reported during use of other inhaled albuterol sulfate products: Urticaria, angioedema, rash, bronchospasm, hoarseness, oropharyngeal edema, and arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles), rare cases of aggravated bronchospasm, lack of efficacy, asthma exacerbation (potentially fatal), muscle cramps, and various oropharyngeal side-effects such as throat irritation, altered taste, glossitis, tongue ulceration, and gaggin…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Other short-acting sympathomimetic bronchodilators should not be used concomitantly with PROAIR RESPICLICK. If additional adrenergic drugs are to be administered by any route, they should be used with caution to avoid deleterious cardiovascular effects. Other short-acting sympathomimetic aerosol bronchodilators and adrenergic drugs: May potentiate effect.
( 7 ) Beta-blockers: May decrease effectiveness of PROAIR RESPICLICK and produce severe bronchospasm. Patients with asthma should not normally be treated with beta-blockers. ( 7.1 ) Diuretics, or non-potassium sparing diuretics: May potentiate hypokalemia or ECG changes.
Consider monitoring potassium levels. ( 7.2 ) Digoxin: May decrease serum digoxin levels. Consider monitoring digoxin levels.
( 7.3 ) Monoamine oxidase (MAO) inhibitors and tricyclic antidepressants: May potentiate effect of albuterol on the cardiovascular system. Consider alternative therapy in patients taking MAOs or tricyclic antidepressants. ( 7.4 )
7.1Beta-Blockers Beta-adrenergic-receptor blocking agents not only block the pulmonary effect of beta-agonists, such as PROAIR RESPICLICK, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances, eg, 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, consider cardioselective beta-blockers, although they should be administered with caution.
7.2Diuretics The ECG changes and/or hypokalemia which 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. Consider monitoring potassium levels.
7.3Digoxin Mean decreases of 16% and 22% in serum digoxin levels were demonstrated after single dose intravenous and oral administration of albuterol, respectively, to normal volunteers who had received digoxin for 10 days. The clinical significance of these findings for patients with obstructive airway disease who are receiving albuterol and digoxin on a chronic basis is unclear. Nevertheless, it would be prudent to carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and PROAIR RESPICLICK.
7.4Monoamine Oxidase Inhibitors or Tricyclic Antidepressants PROAIR RESPICLICK 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 albuterol on the cardiovascular system may be potentiated. Consider alternative therapy in patients taking MAO inhibitors or tricyclic antidepressants.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no randomized clinical studies of use of albuterol during pregnancy. Available data from published epidemiological studies and postmarketing case reports of pregnancy outcomes following inhaled albuterol use do not consistently demonstrate a risk of major birth defects or miscarriage. There are clinical considerations with use of albuterol in pregnant women [see Clinical Considerations].
In animal reproduction studies, when albuterol sulfate was administered subcutaneously to pregnant mice there was evidence of cleft palate at less than and up to 9 times the maximum recommended human daily inhalation dose (MRHDID) [see Data]. The estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk In women with poorly or moderately controlled asthma, there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. Pregnant women should be closely monitored and medication adjusted as necessary to maintain optimal control. Labor or Delivery Because of the potential for beta-agonist interference with uterine contractility, use of PROAIR RESPICLICK for relief of bronchospasm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk.
PROAIR RESPICLICK has not been approved for the management of pre-term labor. Serious adverse reactions, including pulmonary edema, have been reported during or following treatment of premature labor with beta 2 -agonists, including albuterol. Data Animal Data In a mouse reproduction study, subcutaneously administered albuterol sulfate produced cleft palate formation in 5 of 111 (4.5%) fetuses at an exposure nine-tenths the maximum recommended human dose (MRHDID) for adults (on a mg/m 2 basis at a maternal dose of 0.25 mg/kg) and in 10 of 108 (9.3%) fetuses at approximately 9 times the MRHDID (on a mg/m 2 basis at a maternal dose of 2.5 mg/kg).
Similar effects were not observed at approximately one-eleventh the MRHDID for adults (on a mg/m 2 basis at a maternal dose of 0.025 mg/kg). Cleft palate also occurred in 22 of 72 (30.5%) fetuses from females treated subcutaneously with isoproterenol (positive control). In a rabbit reproduction study, orally administered albuterol sulfate induced cranioschisis in 7 of 19 fetuses (37%) at approximately 750 times the MRHDID (on a mg/m 2 basis at a maternal dose of 50 mg/kg).
In a rat reproduction study, an albuterol sulfate/HFA-134a formulation administered by inhalation did not produce any teratogenic effects at exposures approximately 80 times the MRHDID (on a mg/m 2 basis at a maternal dose of 10.5 mg/kg). A study in which pregnant rats were dosed with radiolabeled albuterol sulfate demonstrated that drug-related material is transferred from the maternal circulation to the fetus.
8.2Lactation Risk Summary There are no available data on the presence of albuterol in human milk, the effects on the breastfed child, or the effects on milk production. However, plasma levels of albuterol after inhaled therapeutic doses are low in humans, and if present in breast milk, albuterol has a low oral bioavailability [see Clinical Pharmacology ( 12.3 )]. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for albuterol and any potential adverse effects on the breastfed child from albuterol or from the underlying maternal condition.
8.4Pediatric Use The safety and effectiveness of PROAIR RESPICLICK for the treatment or prevention of bronchospasm with reversible obstructive airway disease have been established in pediatric patients 12 to 17 years of age. Use…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no randomized clinical studies of use of albuterol during pregnancy. Available data from published epidemiological studies and postmarketing case reports of pregnancy outcomes following inhaled albuterol use do not consistently demonstrate a risk of major birth defects or miscarriage. There are clinical considerations with use of albuterol in pregnant women [see Clinical Considerations].
In animal reproduction studies, when albuterol sulfate was administered subcutaneously to pregnant mice there was evidence of cleft palate at less than and up to 9 times the maximum recommended human daily inhalation dose (MRHDID) [see Data]. The estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk In women with poorly or moderately controlled asthma, there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. Pregnant women should be closely monitored and medication adjusted as necessary to maintain optimal control. Labor or Delivery Because of the potential for beta-agonist interference with uterine contractility, use of PROAIR RESPICLICK for relief of bronchospasm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk.
PROAIR RESPICLICK has not been approved for the management of pre-term labor. Serious adverse reactions, including pulmonary edema, have been reported during or following treatment of premature labor with beta 2 -agonists, including albuterol. Data Animal Data In a mouse reproduction study, subcutaneously administered albuterol sulfate produced cleft palate formation in 5 of 111 (4.5%) fetuses at an exposure nine-tenths the maximum recommended human dose (MRHDID) for adults (on a mg/m 2 basis at a maternal dose of 0.25 mg/kg) and in 10 of 108 (9.3%) fetuses at approximately 9 times the MRHDID (on a mg/m 2 basis at a maternal dose of 2.5 mg/kg).
Similar effects were not observed at approximately one-eleventh the MRHDID for adults (on a mg/m 2 basis at a maternal dose of 0.025 mg/kg). Cleft palate also occurred in 22 of 72 (30.5%) fetuses from females treated subcutaneously with isoproterenol (positive control). In a rabbit reproduction study, orally administered albuterol sulfate induced cranioschisis in 7 of 19 fetuses (37%) at approximately 750 times the MRHDID (on a mg/m 2 basis at a maternal dose of 50 mg/kg).
In a rat reproduction study, an albuterol sulfate/HFA-134a formulation administered by inhalation did not produce any teratogenic effects at exposures approximately 80 times the MRHDID (on a mg/m 2 basis at a maternal dose of 10.5 mg/kg). A study in which pregnant rats were dosed with radiolabeled albuterol sulfate demonstrated that drug-related material is transferred from the maternal circulation to the fetus.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of PROAIR RESPICLICK for the treatment or prevention of bronchospasm with reversible obstructive airway disease have been established in pediatric patients 12 to 17 years of age. Use of PROAIR RESPICLICK for this indication is supported by evidence from two 12-week clinical trials in 318 patients 12 years of age and older with asthma comparing doses of 180 mcg four times daily with placebo, one long-term safety study in children 12 years of age and older, and one single-dose crossover study comparing doses of 90 and 180 mcg with albuterol sulfate inhalation aerosol (ProAir ® HFA) in 71 patients [see Clinical Studies ( 14.1 )].
The safety and effectiveness of PROAIR RESPICLICK for treatment of exercise-induced bronchospasm have been established in children 12 years of age and older. Use of PROAIR RESPICLICK for this indication is supported by evidence from one single-dose crossover study in 38 patients age 16 and older with exercise-induced bronchospasm comparing doses of 180 mcg with placebo [see Clinical Studies (14.2)] . The safety profile for patients ages 12 to 17 was consistent with the overall safety profile seen in these studies.
The safety of PROAIR RESPICLICK in children 4 to 11 years of age is based on two single-dose, controlled, crossover studies: one with 61 patients comparing doses of 90 and 180 mcg with matched placebo and albuterol HFA MDI and one with 15 patients comparing a dose of 180 mcg with matched albuterol HFA MDI; and one 3-week clinical trial in 185 patients 4 to 11 years of age with asthma comparing a dose of 180 mcg four times daily with matched albuterol HFA MDI. The effectiveness of PROAIR RESPICLICK in children 4 to 11 years with exercise-induced bronchospasm is extrapolated from clinical trials in patients 12 years of age and older with asthma and exercise-induced bronchospasm, based on data from a single-dose study comparing the bronchodilatory effect of PROAIR RESPICLICK 90 mcg and 180 mcg with placebo in 61 patients with asthma, and data from a 3-week clinical trial in 185 asthmatic children 4 to 11 years of age comparing a dose of 180 mcg albuterol 4 times daily with placebo [see Clinical Studies ( 14.1 )] .
The safety and effectiveness of PROAIR RESPICLICK in pediatric patients below the age of 4 years have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of PROAIR RESPICLICK did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see Warnings and Precautions ( 5.4 , 5.7 )].
All beta 2 -adrenergic agonists, including albuterol, are known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
🆘 Overdosage ▾
10 OVERDOSAGE The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the symptoms listed under ADVERSE REACTIONS, eg, 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 medications, cardiac arrest and even death may be associated with abuse of PROAIR RESPICLICK.
Treatment consists of discontinuation of PROAIR RESPICLICK 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 of PROAIR RESPICLICK.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Albuterol sulfate is a beta 2 -adrenergic agonist. The pharmacologic effects of albuterol sulfate are attributable to activation of beta 2 -adrenergic receptors on airway smooth muscle. Activation of beta 2 -adrenergic receptors leads to the activation of adenylcyclase and to an increase in the intracellular concentration of cyclic-3',5’‑adenosine monophosphate (cyclic AMP).
This increase of cyclic AMP is associated with the activation of protein kinase A, which in turn inhibits the phosphorylation of myosin and lowers intracellular ionic calcium concentrations, resulting in muscle relaxation. Albuterol relaxes the smooth muscle of all airways, from the trachea to the terminal bronchioles. Albuterol acts as a functional antagonist to relax the airway irrespective of the spasmogen involved, thus protecting against all bronchoconstrictor challenges.
Increased cyclic AMP concentrations are also associated with the inhibition of release of mediators from mast cells in the airway. While it is recognized that beta 2 -adrenergic receptors are the predominant receptors on bronchial smooth muscle, data indicate that there are beta-receptors in the human heart, 10% to 50% of which are cardiac beta 2 -adrenergic receptors. The precise function of these receptors has not been established [see Warnings and Precautions ( 5.4 )] .
Albuterol has been shown in most controlled clinical trials to have more effect on the respiratory tract, in the form of bronchial smooth muscle relaxation, than isoproterenol at comparable doses while producing fewer cardiovascular effects. However, inhaled albuterol, like other beta-adrenergic agonist drugs, can produce a significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, symptoms, and/or electrocardiographic changes [ see Warnings and Precautions ( 5.4 )].
12.2Pharmacodynamics In a pharmacodynamic (PD) trial conducted in 47 patients, the PD and safety profiles were similar for PROAIR RESPICLICK and ProAir HFA. Comparable changes from baseline in the PD measures (serum glucose and potassium concentrations, QTcB, QTcF, heart rate, systolic blood pressure, and diastolic blood pressure) were observed following cumulative dose administration up to 1440 mcg of both PROAIR RESPICLICK and ProAir HFA. The overall safety, efficacy and PD profile of PROAIR RESPICLICK and ProAir HFA were comparable.
Following 90 or 180 mcg single-dose inhalation, the bronchodilatory effect of PROAIR RESPICLICK was significantly greater than placebo and comparable to that of ProAir HFA in patients 12 years of age and older (N=71) and pediatric patients 4 to 11 years of age (N=61) with persistent asthma. Cardiac Electrophysiology As with other beta 2 -adrenergic agonists, PROAIR RESPICLICK prolonged QT intervals following a 1440 mcg cumulative dose. The prolongation was comparable to that of ProAir HFA.
12.3Pharmacokinetics Absorption Albuterol was rapidly absorbed into the systemic circulation with peak plasma concentrations occurring at half an hour following single- or multiple-dose oral inhalation(s) of PROAIR RESPICLICK. In a cumulative dose study, the AUC 0-t was comparable between PROAIR RESPICLICK group and ProAir HFA group; C max value was approximately one-third higher in PROAIR RESPICLICK group than ProAir HFA group. Distribution The volume of distribution has not been determined for PROAIR RESPICLICK.
Published literature suggests that albuterol exhibits low in vitro plasma protein binding (10%). Elimination The accumulation ratio (~1.6 fold) was observed following one week QID dosing. The corresponding effective half-life was approximately 5 hours, which was consistent with the elimination half-life following both single- or multiple-dose administration.
Metabolism Information available in the published literature suggests that the primary enzyme responsible for the metabolism of albuterol in humans is SULTIA3 (sulfotransferase). When…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Albuterol sulfate is a beta 2 -adrenergic agonist. The pharmacologic effects of albuterol sulfate are attributable to activation of beta 2 -adrenergic receptors on airway smooth muscle. Activation of beta 2 -adrenergic receptors leads to the activation of adenylcyclase and to an increase in the intracellular concentration of cyclic-3',5’‑adenosine monophosphate (cyclic AMP).
This increase of cyclic AMP is associated with the activation of protein kinase A, which in turn inhibits the phosphorylation of myosin and lowers intracellular ionic calcium concentrations, resulting in muscle relaxation. Albuterol relaxes the smooth muscle of all airways, from the trachea to the terminal bronchioles. Albuterol acts as a functional antagonist to relax the airway irrespective of the spasmogen involved, thus protecting against all bronchoconstrictor challenges.
Increased cyclic AMP concentrations are also associated with the inhibition of release of mediators from mast cells in the airway. While it is recognized that beta 2 -adrenergic receptors are the predominant receptors on bronchial smooth muscle, data indicate that there are beta-receptors in the human heart, 10% to 50% of which are cardiac beta 2 -adrenergic receptors. The precise function of these receptors has not been established [see Warnings and Precautions ( 5.4 )] .
Albuterol has been shown in most controlled clinical trials to have more effect on the respiratory tract, in the form of bronchial smooth muscle relaxation, than isoproterenol at comparable doses while producing fewer cardiovascular effects. However, inhaled albuterol, like other beta-adrenergic agonist drugs, can produce a significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, symptoms, and/or electrocardiographic changes [ see Warnings and Precautions ( 5.4 )].
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING PROAIR RESPICLICK inhalation powder is supplied as a white inhaler with a red cap, in a sealed foil pouch, one pouch per carton. Actuations Net Contents NDC 200 0.65 g 59310-580-20 Store at room temperature (between 15°C and 25°C; 59°F and 77°F). Avoid exposure to extreme heat, cold, or humidity.
Keep out of reach of children. PROAIR RESPICLICK inhaler has a dose counter. Patients should never try to alter the numbers for the dose counter.
Discard the inhaler 13 months after opening the foil pouch, when the counter displays 0, or after the expiration date on the product, whichever comes first. The labeled amount of medication in each actuation cannot be assured after the counter displays 0, even though the inhaler is not completely empty and will continue to operate [see Dosage and Administration (2.4), Patient Counseling Information (17)].
📋 Description ▾
11 DESCRIPTION The active ingredient of PROAIR RESPICLICK inhalation powder is albuterol sulfate, a racemic salt of albuterol. Albuterol sulfate is a beta 2 -adrenergic agonist. It has the chemical name α 1 -[( tert -butylamino) methyl]-4-hydroxy- m -xylene-α,α'-diol sulfate (2:1) (salt), and the following chemical structure: The molecular weight of albuterol sulfate is 576.7, and the empirical formula is (C 13 H 21 NO 3 ) 2 •H 2 SO 4 .
Albuterol sulfate is a white to off-white crystalline powder. It is soluble in water and slightly soluble in ethanol. Albuterol sulfate is the official U.S.
Adopted Name in the United States, and salbutamol sulfate is the recommended World Health Organization international nonproprietary name. PROAIR RESPICLICK is an inhalation-driven, multi-dose inhalation powder (dry powder inhaler) for oral inhalation only. It contains a formulation blend of albuterol sulfate with alpha-lactose monohydrate.
Each actuation provides a metered dose of 2.6 mg of the formulation containing 117 mcg of albuterol sulfate (equivalent to 97 mcg of albuterol base) and lactose from the device reservoir. Under standardized in vitro test conditions with fixed flow rates ranging from 58 to 71 L/min, and with a total air volume of 2 L, the PROAIR RESPICLICK inhaler delivers 108 mcg of albuterol sulfate (equivalent to 90 mcg of albuterol base) with lactose from the mouthpiece. The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.
In a study that investigated the peak inspiratory flow rate (PIFR) in asthma (n=27, ages 12 to 17 years old and n=50, ages 18 to 45 years old) and COPD (n=50, over 50 years old) patients, the mean PIFR achieved by subjects was >60 L/min (range = 31 to 110 L/min.), indicating that patients would be able to achieve the required inspiratory flow to operate the MDPI device correctly. The inhaler is provided for 200 actuations (inhalations). structural formula
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Patients should be given the following information: Frequency of Use The action of PROAIR RESPICLICK should last for 4 to 6 hours. Instruct patients to not use PROAIR RESPICLICK more frequently than recommended.
Instruct patients to not increase the dose or frequency of doses of PROAIR RESPICLICK without consulting the physician. If patients find that treatment with PROAIR RESPICLICK becomes less effective for symptomatic relief, symptoms become worse, and/or they need to use the product more frequently than usual, they should seek medical attention immediately [see Warnings and Precautions (5.2)]. Caring for and Storing the Inhaler Instruct patients to not open their inhaler unless they are taking a dose.
Repeated opening and closing the cover without taking medication will waste medication and may damage the inhaler. Advise patients to keep their inhaler dry and clean at all times. Never wash or put any part of the inhaler in water.
Patient should replace inhaler if washed or placed in water. Routine maintenance is not required. If the mouthpiece needs cleaning, instruct patients to gently wipe the mouthpiece with a dry cloth or tissue as needed.
Instruct patients to store the inhaler at room temperature and to avoid exposure to extreme heat, cold, or humidity. Instruct patients to never take the inhaler apart. Inform patients that PROAIR RESPICLICK has a dose counter.
When the patient receives the inhaler, the number 200 will be displayed. The dose counter will count down each time the mouthpiece cap is opened and closed. The dose counter window displays the number of actuations left in the inhaler in units of two (eg, 200, 198, 196, etc).
When the counter displays 20, the color of the numbers will change to red to remind the patient to contact their pharmacist for a refill of medication or consult their physician for a prescription refill. When the dose counter reaches 0, the background will change to solid red. Inform patients to discard PROAIR RESPICLICK when the dose counter displays 0 or after the expiration date on the product, whichever comes first [see Dosage and Administration (2.3), (2.4)].
Paradoxical Bronchospasm Inform patients that PROAIR RESPICLICK can produce paradoxical bronchospasm. Instruct patients to discontinue PROAIR RESPICLICK if paradoxical bronchospasm occurs [see Warnings and Precautions (5.1)]. Concomitant Drug Use Inform patients that, while they are taking PROAIR RESPICLICK, they should take other inhaled drugs and asthma medications only as directed by a physician [see Drug Interactions (7)].
Common Adverse Events Common adverse effects of treatment with inhaled albuterol include palpitations, chest pain, rapid heart rate, tremor, and nervousness. Pregnancy Inform patients who are pregnant or nursing that they should contact their physician about the use of PROAIR RESPICLICK [see Use in Specific Populations (8.1)]. General Information on Use Effective and safe use of PROAIR RESPICLICK includes an understanding of the way that it should be administered.
Do not use a spacer or volume holding chamber with PROAIR RESPICLICK. Patients should be instructed on the proper use of the inhaler. See the FDA-approved Patient Information and Patient Instructions for Use.
Discard PROAIR RESPICLICK 13 months after opening the foil pouch, when the dose counter displays 0 or after the expiration date on the product, whichever comes first. In general, the technique for administering PROAIR RESPICLICK to children is similar to that for adults. Children should use PROAIR RESPICLICK under adult supervision, as instructed by the patient’s physician.
Distributed by: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054 ©2020, Teva Respiratory, LLC. All rights reserved.
United States Patent Nos. 6701917, 6718972, 6748947, 6871646, 7540282, 8006690, 8651103, 8978966, 9216260, 9463…