Proair Respiclick Oral Pwd Inh(200)

Manufacturer TEVA RESPIRATORY Active Ingredient Albuterol Inhalation Powder(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 Beta-2 Adrenergic Agonist
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Pregnancy Category
Category C
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FDA Approved
Dec 2014
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Proair Respiclick is an inhaler that helps open up your airways to make breathing easier when you have asthma or COPD. It's a 'rescue' medicine, meaning you use it when you feel symptoms like wheezing or shortness of breath, or before exercise to prevent symptoms.
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How to Use This Medicine

Proper Use of This Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. For inhalation into the lungs, use 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 exercise-induced breathing problems, inhale 15 to 30 minutes before exercising. Be sure to follow the cleaning instructions carefully.

Using the Inhaler

Replace the cap after each use.
Close the device after each dose, and only open it when you are ready to take a dose.
Do not disassemble or wash the device.
Do not use the inhaler with a spacer.
Avoid breathing out into the device.
Clean the mouthpiece by wiping it with a dry tissue or cloth. Do not wash or submerge it in water.

Tracking Your Doses
The inhaler has a built-in dose counter to help you keep track of the number of doses remaining. Dispose of the inhaler when the counter reaches "0," 13 months after opening the foil pouch, or after the expiration date, whichever occurs first.

Storage and Disposal

Store the medication at room temperature, protected from light and moisture. Avoid storing it in a bathroom.
Keep the inhaler away from cold and heat.
If the inhaler comes in a foil pouch, store it in the pouch until you are ready to use it.

Missed Dose

If you use this medication regularly, take a missed dose as soon as you remember.
If it is almost time for your next dose, skip the missed dose and resume your regular schedule.
Do not take two doses at once or use extra doses.
* If you use this medication as needed, do not take it more frequently than directed by your doctor.
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Lifestyle & Tips

  • Always carry your rescue inhaler with you.
  • Use proper inhaler technique as demonstrated by your healthcare provider. Do not shake Proair Respiclick before use.
  • Do not use more often than prescribed. If you need to use it more frequently, contact your doctor as this may indicate worsening asthma control.
  • Avoid your known asthma triggers (e.g., allergens, smoke, cold air).
  • Rinse your mouth with water after each use to prevent dry mouth and reduce local side effects, although this is less critical for dry powder inhalers than for metered dose inhalers with propellants.

Dosing & Administration

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Adult Dosing

Standard Dose: 2 inhalations (180 mcg) every 4-6 hours as needed for bronchospasm. Some patients may find 1 inhalation (90 mcg) sufficient.
Dose Range: 90 - 180 mg

Condition-Specific Dosing:

exercise_induced_bronchospasm: 2 inhalations (180 mcg) 15-30 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 4-6 hours as needed for bronchospasm. Some patients may find 1 inhalation (90 mcg) sufficient. For exercise-induced bronchospasm: 2 inhalations (180 mcg) 15-30 minutes before exercise.
Adolescent: 2 inhalations (180 mcg) every 4-6 hours as needed for bronchospasm. Some patients may find 1 inhalation (90 mcg) sufficient. For exercise-induced bronchospasm: 2 inhalations (180 mcg) 15-30 minutes before exercise.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended.
Severe: Monitor for increased systemic effects; dose adjustment may be considered for severe impairment (CrCl < 30 mL/min) due to renal excretion of albuterol and its metabolite. Use with caution.
Dialysis: Monitor for increased systemic effects. Albuterol is dialyzable, but clinical significance for inhaled doses is low.

Hepatic Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended.
Severe: No specific adjustment recommended. Albuterol is primarily metabolized by sulfation, not extensively by the liver.

Pharmacology

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Mechanism of Action

Albuterol is a selective short-acting beta-2 adrenergic agonist. It acts by stimulating beta-2 adrenergic receptors in the smooth muscle of the bronchi, leading to activation of adenyl cyclase. This increases intracellular cyclic-3',5'-adenosine monophosphate (cAMP) levels, which in turn causes relaxation of bronchial smooth muscle, inhibition of mediator release from mast cells, and to a lesser extent, inhibition of microvascular leakage and enhancement of mucociliary clearance.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 20% (oral bioavailability of swallowed portion); inhaled portion acts locally.
Tmax: 0.5-2 hours (for systemic absorption after inhalation).
FoodEffect: Not clinically significant for inhaled product.

Distribution:

Vd: Approximately 3.1 L/kg (systemic).
ProteinBinding: 10% (low).
CnssPenetration: Limited

Elimination:

HalfLife: 3.8-5 hours (systemic).
Clearance: Not readily available for inhaled route, but systemic clearance is high.
ExcretionRoute: Renal (primarily as unchanged drug and sulfate conjugate).
Unchanged: Approximately 60% of an inhaled dose is excreted in urine as unchanged drug within 24 hours.
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Pharmacodynamics

OnsetOfAction: Within 5 minutes.
PeakEffect: 60-90 minutes.
DurationOfAction: 4-6 hours.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while 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
Pain while urinating
Difficulty urinating
Chest pain or pressure
Rapid or irregular heartbeat
Severe breathing problems, which can be life-threatening, especially when using an inhaler or liquid for breathing in. This may occur soon after taking 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor:

Feeling nervous or excitable
Dizziness or headache
Upset stomach or vomiting
Shakiness
Throat irritation
Runny nose
Back pain
Aches and pains (mild pain relievers may help)

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult 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 shortness of breath or wheezing immediately after using the inhaler (paradoxical bronchospasm). Seek immediate medical attention.
  • Chest pain or fast/irregular heartbeat.
  • Severe headache or dizziness.
  • Muscle cramps or weakness (may indicate low potassium).
  • Increased frequency of needing your rescue inhaler (e.g., more than twice a week, not including exercise-induced asthma) indicates your asthma is not well-controlled and requires medical review.
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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 medication, its components, or other substances. Be sure to describe the allergic reaction you experienced, including the symptoms that occurred.
If you have a milk allergy, as this may be relevant to your treatment.
If you are currently taking another medication similar to this one. If you are unsure, consult your doctor or pharmacist to determine the best course of action.

This list is not exhaustive, and it is crucial to disclose all medications and health conditions to your doctor and pharmacist. This includes:

All prescription and over-the-counter (OTC) medications
Natural products
Vitamins

Your doctor and pharmacist need this information to ensure safe treatment. Do not start, stop, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this medication and your individual health profile.
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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 using this medication during pregnancy or breast-feeding to ensure the best possible outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Tachycardia (fast heart rate)
  • Palpitations
  • Tremor (shakiness)
  • Nervousness
  • Headache
  • Nausea
  • Dizziness
  • Hypokalemia (low potassium, can cause muscle weakness or cramps)
  • Hyperglycemia (high blood sugar)
  • Metabolic acidosis

What to Do:

Seek immediate medical attention or call Poison Control (1-800-222-1222). Treatment is generally supportive and symptomatic. Beta-blockers may be used cautiously in severe cases of cardiac effects, but only under strict medical supervision due to the risk of inducing bronchospasm.

Drug Interactions

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Major Interactions

  • Beta-blockers (e.g., propranolol, carvedilol): May block the bronchodilator effect of albuterol and produce severe bronchospasm in asthmatic patients. Generally, patients with asthma should not be treated with beta-blockers.
  • Monoamine Oxidase Inhibitors (MAOIs) and Tricyclic Antidepressants (TCAs): May potentiate the vascular effects of albuterol, leading to severe hypertension or cardiovascular effects. Use with extreme caution or avoid within 14 days of discontinuing MAOIs/TCAs.
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Moderate Interactions

  • Diuretics (loop or thiazide): May potentiate ECG changes and/or hypokalemia resulting from beta-agonists, especially at higher doses. Monitor potassium levels.
  • Digoxin: Albuterol may decrease serum digoxin levels. Monitor digoxin levels.
  • Other sympathomimetic agents: Concomitant use may potentiate cardiovascular adverse effects. Use with caution.

Monitoring

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Baseline Monitoring

Pulmonary function tests (e.g., FEV1)

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

Timing: Before initiating therapy, especially for new diagnosis or significant change in control.

Vital signs (heart rate, blood pressure)

Rationale: Albuterol can cause cardiovascular effects (tachycardia, palpitations, hypertension).

Timing: Before initiation and periodically.

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Routine Monitoring

Frequency of albuterol use

Frequency: At each follow-up visit (e.g., every 3-6 months for stable patients).

Target: Less than 2 days per week (excluding exercise-induced bronchospasm) for well-controlled asthma.

Action Threshold: Increased frequency of use (e.g., daily or more than twice weekly) indicates worsening asthma control and necessitates re-evaluation of maintenance therapy.

Asthma/COPD symptoms (wheezing, shortness of breath, cough, chest tightness)

Frequency: Daily by patient, reviewed at each visit.

Target: Minimal or no symptoms.

Action Threshold: Persistent or worsening symptoms, nocturnal awakenings, or limitation of activity.

Inhaler technique

Frequency: At each follow-up visit.

Target: Correct technique demonstrated.

Action Threshold: Incorrect technique, leading to suboptimal drug delivery and poor symptom control.

Serum potassium (if high doses or concomitant diuretics)

Frequency: Periodically, as clinically indicated.

Target: 3.5-5.0 mEq/L.

Action Threshold: Hypokalemia (<3.5 mEq/L).

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Symptom Monitoring

  • Increased wheezing
  • Increased shortness of breath
  • Increased cough
  • Chest tightness
  • Decreased peak flow readings
  • Need for more frequent use of rescue inhaler
  • Waking at night due to asthma symptoms
  • Paradoxical bronchospasm (rare, but severe worsening of breathing immediately after use)

Special Patient Groups

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Pregnancy

Albuterol is classified as Pregnancy Category C. 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 that inhaled albuterol is generally safe during pregnancy when needed for asthma control, as uncontrolled asthma poses greater risks to both mother and fetus.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity observed in animal studies at high doses, but human data do not suggest a clear risk.
Second Trimester: Generally considered safe for use if clinically indicated for asthma control.
Third Trimester: May inhibit uterine contractions (tocolytic effect) at high systemic doses, but this is unlikely with usual inhaled doses. Monitor for maternal tachycardia.
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Lactation

Albuterol is excreted into human milk. However, due to its short half-life and extensive metabolism, amounts ingested by the infant are small and are not expected to cause adverse effects. Generally considered compatible with breastfeeding, but caution is advised.

Infant Risk: Low. Monitor breastfed infant for signs of agitation, tremor, or tachycardia, though these are rare.
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Pediatric Use

Approved for children 4 years of age and older. Dosing is similar to adults. Proper inhaler technique is crucial and should be regularly assessed. Younger children may require supervision for correct use.

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Geriatric Use

No specific dose adjustment is generally required. However, elderly patients may be more susceptible to the cardiovascular adverse effects of beta-agonists (e.g., tachycardia, palpitations, tremor). Use with caution and monitor for these effects, especially in those with pre-existing cardiovascular disease.

Clinical Information

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Clinical Pearls

  • Proair Respiclick is a dry powder inhaler (DPI) and does not require shaking before use or a spacer. Patients should be instructed to exhale fully before inhaling the dose and hold their breath for as long as comfortable after inhalation.
  • Unlike metered-dose inhalers (MDIs), DPIs are breath-actuated, meaning the patient's inspiratory effort draws the medication into the lungs. Ensure the patient has sufficient inspiratory flow.
  • Patients should be advised that if they need to use their rescue inhaler more than twice a week (excluding use for exercise-induced bronchospasm), their asthma may not be well-controlled, and they should contact their healthcare provider for re-evaluation of their maintenance therapy.
  • Paradoxical bronchospasm is a rare but serious adverse event where the patient's breathing worsens immediately after using the inhaler. If this occurs, the patient should discontinue the product and seek immediate medical attention.
  • Educate patients on the difference between their 'rescue' inhaler (albuterol) and their 'controller' inhalers (e.g., inhaled corticosteroids) to ensure appropriate use of each.
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Alternative Therapies

  • Long-acting beta-2 agonists (LABAs) for maintenance (e.g., salmeterol, formoterol).
  • Inhaled corticosteroids (ICS) for maintenance (e.g., fluticasone, budesonide).
  • Combination ICS/LABA inhalers (e.g., Advair, Symbicort, Dulera, Breo).
  • Leukotriene receptor antagonists (LTRAs) (e.g., montelukast).
  • Oral corticosteroids (for acute exacerbations or severe persistent asthma).
  • Anticholinergics (e.g., ipratropium, tiotropium) for COPD or severe asthma.
  • Biologic therapies (e.g., omalizumab, mepolizumab, dupilumab) for severe asthma.
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Cost & Coverage

Average Cost: $50 - $150 per 200-actuation inhaler
Generic Available: Yes
Insurance Coverage: Often Tier 2 or 3 for brand-name, Tier 1 for generic albuterol HFA.
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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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.