Proair Digihaler 90mcg (200 Doses)

Manufacturer TEVA Active Ingredient Albuterol Digital 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.
đŸˇī¸
Drug Class
Bronchodilator
đŸ§Ŧ
Pharmacologic Class
Selective beta-2 adrenergic agonist
🤰
Pregnancy Category
Category C
✅
FDA Approved
Dec 2018
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

Proair Digihaler is a quick-relief inhaler used to open up the airways in your lungs. It helps you breathe easier when you have asthma or COPD symptoms like wheezing, shortness of breath, or chest tightness. It can also be used before exercise to prevent breathing problems.
📋

How to Use This Medicine

Using 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 device as directed. If you are taking multiple inhaled medications, consult your doctor about which one to use first.

When using this medication to prevent exercise-induced breathing problems, inhale 15 to 30 minutes before exercising. Follow the cleaning instructions carefully. After each use, replace the cap and close the device. Only open the device when taking a dose, and do not take it apart or wash it. Do not use a spacer with this device, and avoid breathing out into it.

To clean the mouthpiece, gently wipe it with a dry tissue or cloth. Do not wash or submerge it in water. The inhaler has a built-in dose counter to track 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.

This product also tracks inhaler event information and can be used with a smartphone app. However, it can function independently without the app. Ensure you understand how to use the product and the app, and follow your doctor's guidance. Refer to the package insert for detailed instructions, and consult your doctor if you have any questions.

Storing and Disposing of Your Medication

Store the inhaler at room temperature, protected from light and moisture. Avoid storing it in a bathroom, and keep it 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.

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 resume your regular schedule. Do not take two doses at the same time or extra doses. If you use this medication as needed, do not take it more frequently than directed by your doctor.
💡

Lifestyle & Tips

  • Always carry your Proair Digihaler with you.
  • Use it only as directed by your doctor; do not use more often than prescribed.
  • Understand and follow your asthma action plan.
  • Avoid known asthma triggers (e.g., smoke, allergens, cold air).
  • Practice proper inhaler technique as demonstrated by your healthcare provider. The Digihaler has a built-in sensor to help track usage.
  • Rinse your mouth with water after each use to prevent dry mouth or throat irritation.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: 2 inhalations (180 mcg) orally every 4 to 6 hours as needed for bronchospasm, or 15 minutes before exercise for exercise-induced bronchospasm.
Dose Range: 90 - 180 mg

Condition-Specific Dosing:

Exercise-Induced Bronchospasm: 2 inhalations (180 mcg) orally 15 minutes before exercise.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: 4 years and older: 2 inhalations (180 mcg) orally every 4 to 6 hours as needed for bronchospasm, or 15 minutes before exercise for exercise-induced bronchospasm.
Adolescent: 2 inhalations (180 mcg) orally every 4 to 6 hours as needed for bronchospasm, or 15 minutes before exercise for exercise-induced bronchospasm.
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended.
Severe: Use with caution; albuterol is primarily renally excreted. Monitor for increased adverse effects.
Dialysis: Not available

Hepatic Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended.
Severe: Use with caution; monitor for increased adverse effects.
Confidence: Medium

Pharmacology

đŸ”Ŧ

Mechanism of Action

Albuterol is a selective 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 and an increase in intracellular cyclic-3',5'-adenosine monophosphate (cAMP). The increase in cAMP levels leads to 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.
📊

Pharmacokinetics

Absorption:

Bioavailability: Approximately 20% (oral bioavailability of swallowed dose); inhaled portion acts locally.
Tmax: Approximately 30 minutes (for systemic absorption after inhalation).
FoodEffect: Not clinically significant for inhaled albuterol.

Distribution:

Vd: Approximately 3.1 L/kg (systemic).
ProteinBinding: 10% to 20%.
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 4.6 to 6 hours (systemic).
Clearance: Not readily available for inhaled route, but primarily renal.
ExcretionRoute: Renal (80-100% of inhaled dose excreted in urine within 24 hours, with 60% as unchanged drug and 20% as metabolite).
Unchanged: Approximately 60% (of systemically absorbed dose).
âąī¸

Pharmacodynamics

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

Safety & Warnings

âš ī¸

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
Painful urination
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 shortly 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, although many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:

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

This is not an exhaustive list of possible 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.
🚨

Seek Immediate Medical Attention If You Experience:

  • Your symptoms get worse or do not improve after using the inhaler.
  • You need to use your inhaler more often than usual (e.g., daily or more than twice a week for symptoms, not exercise).
  • You experience severe chest pain, fast heart rate, or dizziness after using the inhaler.
  • You develop paradoxical bronchospasm (sudden worsening of breathing after using the inhaler).
📋

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, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any 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 discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure that it is safe to take this medication in conjunction with your other treatments and health conditions.

Remember, do not start, stop, or change the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
âš ī¸

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 drug.

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 outcome for you and your baby.
🆘

Overdose Information

Overdose Symptoms:

  • Chest pain
  • Fast or irregular heartbeat (palpitations)
  • Severe tremor or shakiness
  • Nervousness or anxiety
  • Headache
  • Dizziness
  • Nausea
  • Vomiting
  • Dry mouth
  • Muscle cramps
  • Hypokalemia (low potassium, may cause muscle weakness or abnormal heart rhythm)

What to Do:

If you suspect an overdose, seek immediate medical attention or call Poison Control at 1-800-222-1222.

Drug Interactions

🔴

Major Interactions

  • Beta-blockers (e.g., propranolol, carvedilol): May block the bronchodilatory effect of albuterol and produce severe bronchospasm in asthmatic patients. Avoid concomitant use.
  • Monoamine Oxidase Inhibitors (MAOIs) and Tricyclic Antidepressants (TCAs): May potentiate the vascular effects of albuterol. Use with extreme caution or avoid within 2 weeks of discontinuing MAOIs/TCAs.
🟡

Moderate Interactions

  • Diuretics (e.g., furosemide, hydrochlorothiazide): May worsen ECG changes and/or hypokalemia associated with albuterol, especially at higher doses.
  • Digoxin: Albuterol may decrease serum digoxin levels. Monitor digoxin levels.

Monitoring

đŸ”Ŧ

Baseline Monitoring

Pulmonary function tests (e.g., FEV1)

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

Timing: Prior to initiation of therapy.

Heart rate and rhythm

Rationale: Albuterol can cause cardiovascular effects.

Timing: Prior to initiation, especially in patients with pre-existing cardiac conditions.

📊

Routine Monitoring

Frequency of albuterol use

Frequency: Regularly (e.g., at each visit, or patient self-monitoring)

Target: As needed, typically not more than 2 days a week for symptom control (excluding exercise-induced bronchospasm).

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

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

Frequency: Daily (patient self-monitoring) and at each clinical visit.

Target: Minimal or no symptoms.

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

Adverse effects (e.g., tremor, palpitations, nervousness)

Frequency: At each clinical visit and as reported by patient.

Target: Absence or mild, tolerable effects.

Action Threshold: Intolerable or severe adverse effects.

Peak expiratory flow (PEF) readings (if patient uses a peak flow meter)

Frequency: Daily (patient self-monitoring) as per asthma action plan.

Target: Within patient's personal best or green zone.

Action Threshold: Readings consistently in yellow or red zone, or significant drop from personal best.

đŸ‘ī¸

Symptom Monitoring

  • Worsening shortness of breath
  • Increased wheezing
  • Chest tightness
  • Increased cough
  • Need for more frequent use of rescue inhaler
  • Difficulty sleeping due to asthma symptoms
  • Decreased exercise tolerance

Special Patient Groups

🤰

Pregnancy

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Albuterol has been shown to be teratogenic in mice and rabbits at doses much higher than the human therapeutic dose.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity observed in animal studies at high doses.
Second Trimester: Generally considered safer than first trimester, but still use with caution.
Third Trimester: May inhibit uterine contractions and increase risk of maternal hyperglycemia and fetal tachycardia. Use with caution during labor and delivery.
🤱

Lactation

Albuterol is excreted in human milk. The amount is likely small, and adverse effects on the infant are not expected at typical inhaled doses. Use with caution.

Infant Risk: Low risk of adverse effects; monitor infant for irritability, tremor, or feeding difficulties.
đŸ‘ļ

Pediatric Use

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.

👴

Geriatric Use

Use with caution in elderly patients, especially those with cardiovascular disease, hypertension, or diabetes, due to potential for adrenergic side effects. Start with the lowest effective dose and monitor closely.

Clinical Information

💎

Clinical Pearls

  • Proair Digihaler is a rescue inhaler, not a maintenance medication. It should be used for acute symptom relief or prevention of exercise-induced bronchospasm.
  • Increased frequency of use (e.g., more than twice a week for symptoms, excluding exercise-induced bronchospasm) indicates worsening asthma control and necessitates re-evaluation of the patient's asthma management plan, potentially requiring initiation or adjustment of controller therapy (e.g., inhaled corticosteroids).
  • Proper inhaler technique is critical for effective drug delivery. The Digihaler has a built-in sensor to help track usage and provide data to the patient and healthcare provider.
  • Patients should be advised to rinse their mouth after use to minimize local side effects like dry mouth or throat irritation.
  • Paradoxical bronchospasm can occur; if it happens, discontinue the product immediately and use an alternative bronchodilator.
🔄

Alternative Therapies

  • Levalbuterol (Xopenex HFA) - another SABA, R-isomer of albuterol.
  • Other albuterol formulations (e.g., Proair HFA, Ventolin HFA, Proventil HFA, Proair Respiclick).
  • Long-acting beta-agonists (LABAs) for maintenance therapy (e.g., salmeterol, formoterol), often in combination with inhaled corticosteroids.
  • Inhaled corticosteroids (ICS) for maintenance therapy (e.g., fluticasone, budesonide).
  • Oral corticosteroids for severe exacerbations.
💰

Cost & Coverage

Average Cost: Check current pricing (typically $100-$200+) per 200-dose inhaler
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (for brand-name products)
📚

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.