Proair HFA Oral Inh (200 Pfs) 8.5g

Manufacturer TEVA Active Ingredient Albuterol Inhalation Aerosol(al BYOO ter ole) Pronunciation al BYOO ter ole
It is used to open the airways in lung diseases where spasm may cause breathing problems. It is used to prevent breathing problems that happen with exercise.
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Drug Class
Bronchodilator
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Pharmacologic Class
Selective Beta2-Adrenergic Agonist
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Pregnancy Category
Category C
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FDA Approved
May 2008
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Proair HFA is an inhaler that contains albuterol, a medicine that helps open up the airways in your lungs. It's used to quickly relieve symptoms like wheezing, shortness of breath, and chest tightness during an asthma attack, or to prevent breathing problems before exercise. It works by relaxing the muscles around your airways, making it easier to breathe.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication effectively, follow your doctor's instructions and read all the information provided. For inhalation into the lungs, use the medication as directed. If you are taking multiple inhaled medications, consult your doctor about which one to use first.

Pre-Exercise Use

If you are using this medication to prevent breathing problems during exercise, inhale it 15 to 30 minutes before physical activity. Be sure to follow the cleaning instructions carefully and replace the cap after each use.

Preparing Your Inhaler

Before using your inhaler for the first time, or if it has not been used for a while, you will need to prime it. Your doctor or pharmacist can advise you on when and how to prime the inhaler. Some inhalers may require priming if they are dropped, so it's essential to check with your doctor or pharmacist if you are unsure.

Using a Spacer

A spacer can be used with the inhaler to make it easier to use. Additionally, some inhalers have a dose counter to track the number of doses remaining. If your inhaler has a dose counter, discard it when the counter reaches "0".

Storage and Disposal

Store your medication at room temperature, protected from light and moisture. Do not store it in a bathroom. If the inhaler comes in a foil pouch, keep it in the pouch until you are ready to use it. Protect the inhaler from cold, heat, and sunlight. Do not puncture or burn the inhaler, even if it seems empty.

Missing a Dose

If you use this medication regularly and miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and continue with your regular schedule. Do not take two doses at the same time or extra doses. If you are using this medication as needed, do not use it more frequently than directed by your doctor.
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Lifestyle & Tips

  • Always carry your Proair HFA inhaler with you.
  • Use proper inhaler technique as demonstrated by your healthcare provider. Shake the inhaler well before each use, prime it if it's new or hasn't been used for a while, and inhale slowly and deeply as you press down on the canister.
  • Rinse your mouth with water after each use to prevent dry mouth or throat irritation.
  • Keep track of how many puffs you use. The inhaler has a dose counter. Discard the inhaler when the counter reads zero.
  • Avoid your asthma triggers (e.g., smoke, pollen, pet dander).
  • Do not use this inhaler more often than prescribed. Increased use may indicate worsening asthma and requires medical attention.

Dosing & Administration

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Adult Dosing

Standard Dose: 2 inhalations (180 mcg) every 4 to 6 hours as needed for bronchospasm, or 2 inhalations 15 minutes before exercise.

Condition-Specific Dosing:

exercise-induced bronchospasm: 2 inhalations 15 minutes before exercise.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: 4 years and older: 2 inhalations (180 mcg) every 4 to 6 hours as needed for bronchospasm, or 2 inhalations 15 minutes before exercise.
Adolescent: Same as adult dosing.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended.
Severe: No specific adjustment recommended; use with caution due to renal excretion of albuterol and its metabolite.
Dialysis: Consideration for reduced frequency or dose in patients on dialysis due to potential for accumulation, though not well-studied.

Hepatic Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended.
Severe: No specific adjustment recommended; use with caution as albuterol is metabolized in the liver, though not a primary route of elimination for the parent drug.

Pharmacology

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Mechanism of Action

Albuterol is a selective beta2-adrenergic agonist. It acts by stimulating beta2-adrenergic receptors in the smooth muscle of the bronchi, leading to relaxation of bronchial smooth muscle and bronchodilation. This action is mediated by adenyl cyclase, an enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3',5'-adenosine monophosphate (cAMP). Increased cAMP levels are associated with relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 20% (oral bioavailability of inhaled dose due to swallowed portion)
Tmax: 0.5 to 2 hours (for systemic absorption)
FoodEffect: Not clinically significant for inhaled albuterol.

Distribution:

Vd: Approximately 156 L
ProteinBinding: Approximately 10%
CnssPenetration: Limited

Elimination:

HalfLife: 3.8 to 5 hours (systemic)
Clearance: Not readily available for inhaled route, but primarily renal excretion.
ExcretionRoute: Renal (urine)
Unchanged: Approximately 80-100% of the systemically absorbed dose is excreted in urine within 24 hours, with 60% as unchanged drug and 20% as the inactive metabolite.
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Pharmacodynamics

OnsetOfAction: 5 to 15 minutes
PeakEffect: 60 to 90 minutes
DurationOfAction: 4 to 6 hours

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Fainting
+ Changes in eyesight
Signs of low potassium levels, such as:
+ Muscle pain or weakness
+ Muscle cramps
+ Abnormal heartbeat
Chest pain or pressure
Fast or abnormal heartbeat
Severe breathing problems, which can be life-threatening, especially when using an inhaler or liquid for breathing in. This may occur right after a dose or when using a new canister or vial of this medication. If you experience trouble breathing, worsening breathing, wheezing, or coughing, seek medical help immediately.

Other Possible Side Effects

Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:

Feeling nervous or excitable
Dizziness or headache
Upset stomach or vomiting
Shakiness
Throat irritation
Runny nose

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Worsening asthma symptoms despite using the inhaler as directed.
  • Needing to use the inhaler more frequently than usual (e.g., more than twice a week for symptoms, not including exercise-induced bronchospasm).
  • Symptoms not improving or getting worse after using the inhaler.
  • Paradoxical bronchospasm (sudden worsening of breathing immediately after using the inhaler).
  • Severe chest pain, rapid or irregular heartbeat, or severe dizziness.
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this drug, any of its components, or other medications, foods, or substances. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking another medication similar to this one. If you are unsure, consult your doctor or pharmacist to determine if the medications are similar.

This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. This will help ensure that it is safe to take this medication in conjunction with your other medications and health conditions.

Remember, do not start, stop, or change the dosage of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all your other medications and health conditions before proceeding.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. To ensure safe use, do not exceed the prescribed dose or frequency, as overdoses have been fatal. If you experience any concerns, consult your doctor immediately.

If you find that your usual dose is not providing adequate relief, your symptoms are worsening, or you need to use this medication more frequently than prescribed, notify your doctor right away.

If you have diabetes (high blood sugar), it is crucial to closely monitor your blood sugar levels while taking this medication.

Before taking this medication, inform your doctor if you are pregnant, planning to become pregnant, or are breast-feeding. Your doctor will discuss the potential benefits and risks of this medication to both you and your baby, allowing you to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Exaggerated beta-adrenergic stimulation effects: tachycardia (rapid heart rate), palpitations, tremor, headache, nervousness, nausea, dizziness, fatigue, malaise, insomnia.
  • Metabolic effects: hypokalemia (low potassium), hyperglycemia (high blood sugar), lactic acidosis.

What to Do:

Seek immediate medical attention or call 911. Contact a poison control center (1-800-222-1222). Treatment is supportive and symptomatic. Consider a cardioselective beta-blocker if severe cardiac symptoms are present, but use with extreme caution due to potential for bronchospasm.

Drug Interactions

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Contraindicated Interactions

  • Non-selective beta-blockers (e.g., propranolol, carvedilol) due to antagonism of albuterol's effects and potential for severe bronchospasm.
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Major Interactions

  • Diuretics (loop or thiazide): May exacerbate ECG changes and/or hypokalemia associated with albuterol, especially at higher doses.
  • Monoamine Oxidase Inhibitors (MAOIs) and Tricyclic Antidepressants (TCAs): May potentiate the cardiovascular effects of albuterol (e.g., increased heart rate, blood pressure). Use with extreme caution or avoid within 14 days of discontinuing MAOIs/TCAs.
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Moderate Interactions

  • Other sympathomimetics: Additive cardiovascular effects; use with caution.
  • Digoxin: Albuterol may decrease serum digoxin levels.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Pulmonary function tests (e.g., FEV1)

Rationale: To assess baseline lung function and severity of asthma/COPD.

Timing: Prior to initiation of therapy and periodically.

Heart rate and blood pressure

Rationale: To establish baseline cardiovascular status, as albuterol can cause tachycardia and hypertension.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Frequency of albuterol use

Frequency: Daily/weekly

Target: As needed, ideally less than 2 days a week (excluding exercise-induced bronchospasm)

Action Threshold: Increased frequency (e.g., >2 days/week) indicates worsening asthma control and need for reassessment of maintenance therapy.

Symptoms of asthma/COPD (e.g., wheezing, shortness of breath, cough, chest tightness)

Frequency: Daily

Target: Minimal to no symptoms

Action Threshold: Worsening or persistent symptoms despite regular use of albuterol.

Heart rate and rhythm

Frequency: Periodically, or if patient reports palpitations/tachycardia

Target: Within normal limits for patient

Action Threshold: Persistent tachycardia, arrhythmias.

Serum potassium (especially in patients on diuretics or with comorbidities)

Frequency: Periodically, if clinically indicated

Target: 3.5-5.0 mEq/L

Action Threshold: Hypokalemia.

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Symptom Monitoring

  • Worsening shortness of breath
  • Increased wheezing
  • Increased cough
  • Chest tightness
  • Increased need for rescue inhaler
  • Palpitations or rapid heart rate
  • Tremor

Special Patient Groups

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Pregnancy

Albuterol is a Pregnancy Category C drug. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Studies in animals have shown adverse effects, but there are no adequate and well-controlled studies in pregnant women. Clinical experience suggests it is generally safe and effective for managing asthma during pregnancy, which is crucial for maternal and fetal health.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity observed in animal studies at high doses, but human data do not suggest increased risk of major birth defects.
Second Trimester: Generally considered safe for use to control asthma symptoms.
Third Trimester: May inhibit uterine contractions and should be used with caution during labor and delivery. Transient maternal and fetal tachycardia may occur.
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Lactation

Albuterol is excreted in human milk. However, due to its short half-life and low oral bioavailability, systemic exposure to the infant is expected to be low. Generally considered compatible with breastfeeding, but caution is advised.

Infant Risk: Low risk of adverse effects in breastfed infants. Monitor infant for signs of irritability, tremor, or tachycardia, though unlikely.
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Pediatric Use

Proair HFA is approved for use in children 4 years of age and older. Dosing is similar to adults. Proper inhaler technique is crucial and may require supervision or assistance for younger children.

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Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Use with caution in elderly patients with co-morbid conditions such as cardiovascular disease (e.g., ischemic heart disease, hypertension, arrhythmias), hyperthyroidism, or diabetes, as they may be more susceptible to the adverse effects of sympathomimetics.

Clinical Information

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Clinical Pearls

  • Proair HFA is a rescue inhaler, not a maintenance medication. Patients should have a separate controller medication if they have persistent asthma.
  • Proper inhaler technique is critical for efficacy. Educate patients on shaking the inhaler, priming (if needed), slow deep inhalation, and breath-holding.
  • Patients should be advised to seek medical attention if they need to use their rescue inhaler more than twice a week (excluding exercise-induced bronchospasm), as this indicates poor asthma control.
  • Paradoxical bronchospasm can occur; if it happens, discontinue the product immediately and use an alternative bronchodilator.
  • Counsel patients on potential side effects like tremor, nervousness, and palpitations, which are usually transient.
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Alternative Therapies

  • Other short-acting beta2-agonists (SABAs): Ventolin HFA, Proventil HFA, Xopenex HFA (levalbuterol)
  • Long-acting beta2-agonists (LABAs) for maintenance (e.g., salmeterol, formoterol)
  • Inhaled corticosteroids (ICS) for maintenance (e.g., fluticasone, budesonide)
  • Combination ICS/LABA inhalers for maintenance (e.g., Advair, Symbicort, Dulera, Breo)
  • Systemic corticosteroids for acute exacerbations
  • Anticholinergics (e.g., ipratropium) for COPD or as an add-on for asthma
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Cost & Coverage

Average Cost: $40 - $100 per 8.5g inhaler (200 actuations)
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (preferred brand or non-preferred brand, respectively). Generic albuterol is often Tier 1.
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.