Proventil 0.083% Inh Soln 25 X 3ml
It is used to open the airways in lung diseases where spasm may cause breathing problems.
Drug Class
Bronchodilator
Pharmacologic Class
Selective beta-2 adrenergic agonist
Pregnancy Category
Category C
FDA Approved
Sep 1981
DEA Schedule
Not Controlled
Overview
What is this medicine?
Albuterol is a 'rescue' medicine that helps open up your airways quickly when you have trouble breathing due to asthma or other lung conditions. It works by relaxing the muscles around your airways, making it easier to breathe. It's used for quick relief of symptoms like wheezing, shortness of breath, and chest tightness.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. This medication is for inhalation only, using a special machine called a nebulizer, which delivers the liquid solution directly into your lungs.
Before using the medication, check the solution for any signs of damage or contamination. Do not use the solution if it appears cloudy, is leaking, or contains particles. Additionally, do not use the solution if it has changed color. It is also important not to mix any other medications with this solution in the nebulizer.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep unused containers in their original foil pouch until you are ready to use them. Check the packaging for information on how long the vials can be stored after the pouch has been opened. Always keep your medications in a safe and secure location, out of the reach of children and pets.
What to Do If You Miss a Dose
If you take this medication on a regular schedule, use the missed dose 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 dosing schedule. Do not take two doses at the same time or take extra doses. If you use this medication as needed, do not use it more frequently than directed by your doctor.
To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. This medication is for inhalation only, using a special machine called a nebulizer, which delivers the liquid solution directly into your lungs.
Before using the medication, check the solution for any signs of damage or contamination. Do not use the solution if it appears cloudy, is leaking, or contains particles. Additionally, do not use the solution if it has changed color. It is also important not to mix any other medications with this solution in the nebulizer.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep unused containers in their original foil pouch until you are ready to use them. Check the packaging for information on how long the vials can be stored after the pouch has been opened. Always keep your medications in a safe and secure location, out of the reach of children and pets.
What to Do If You Miss a Dose
If you take this medication on a regular schedule, use the missed dose 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 dosing schedule. Do not take two doses at the same time or take extra doses. If you use this medication as needed, do not use it more frequently than directed by your doctor.
Lifestyle & Tips
- Use only as directed by your doctor. Do not use more often than prescribed.
- Understand how to properly use your nebulizer machine and the inhalation solution.
- Keep track of how often you use your rescue inhaler. If you need to use it more frequently than usual, or if it's not working as well, contact your doctor immediately as this may indicate worsening asthma.
- Avoid known triggers for your asthma or lung condition.
- Do not stop other asthma medications unless advised by your doctor.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
2.5 mg (one 3 mL vial of 0.083% solution) administered 3 to 4 times daily by nebulization
Dose Range:
2.5 - 2.5 mg
Condition-Specific Dosing:
acute_bronchospasm:
May be administered every 4-6 hours as needed. More frequent administration is not recommended.
Pediatric Dosing
Neonatal:
Not established (often used off-label with lower doses)
Infant:
Not established (often used off-label with lower doses)
Child:
2.5 mg (one 3 mL vial of 0.083% solution) administered 3 to 4 times daily by nebulization (for children 2-12 years of age)
Adolescent:
2.5 mg (one 3 mL vial of 0.083% solution) administered 3 to 4 times daily by nebulization
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended
Moderate:
No specific adjustment recommended
Severe:
Use with caution; monitor for increased systemic effects due to potential accumulation of albuterol and its metabolite
Dialysis:
Consider monitoring for systemic effects; albuterol is not significantly removed by hemodialysis
Hepatic Impairment:
Mild:
No specific adjustment recommended
Moderate:
No specific adjustment recommended
Severe:
No specific adjustment recommended; use with caution due to potential altered metabolism
Pharmacology
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 bronchial tree, leading to activation of adenyl cyclase and an increase in intracellular cyclic-3',5'-adenosine monophosphate (cAMP). Increased cAMP levels cause relaxation of bronchial smooth muscle, inhibition of mediator release from mast cells, and some inhibition of histamine release from basophils, resulting in bronchodilation.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 10-20% of an inhaled dose reaches the lower airways; systemic bioavailability of the orally absorbed portion is about 50%.
Tmax:
Approximately 2 hours (for systemic absorption after inhalation)
FoodEffect:
Not applicable for inhalation solution
Distribution:
Vd:
Not available (systemic volume of distribution is large)
ProteinBinding:
Approximately 10%
CnssPenetration:
Limited
Elimination:
HalfLife:
3.8 to 5 hours (systemic)
Clearance:
Not available
ExcretionRoute:
Renal (primarily)
Unchanged:
Approximately 60% of the systemically absorbed dose is excreted unchanged in urine within 24 hours
Pharmacodynamics
OnsetOfAction:
5-15 minutes
PeakEffect:
60-90 minutes
DurationOfAction:
4-6 hours
Safety & Warnings
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
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 notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
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, 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.
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
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 notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
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, 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:
- Worsening of breathing problems or asthma symptoms after using the medication.
- Chest pain or discomfort.
- Fast or irregular heartbeat (palpitations).
- Severe dizziness or lightheadedness.
- Severe tremor or nervousness.
- Signs of an allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing).
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, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are currently taking another medication similar to this one. If you are unsure, consult your doctor or pharmacist for clarification.
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. They will help determine whether it is safe to take this medication in conjunction with your other medications and health issues.
Remember, do not start, stop, or modify the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are currently taking another medication similar to this one. If you are unsure, consult your doctor or pharmacist for clarification.
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. They will help determine whether it is safe to take this medication in conjunction with your other medications and health issues.
Remember, do not start, stop, or modify the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Adhering to the prescribed dosage and usage frequency is crucial, as taking more of this drug or using it more often than directed can be fatal. If you have any concerns or questions, consult your doctor.
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 normal, contact your doctor immediately.
If you have diabetes (high blood sugar), it is vital 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.
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 normal, contact your doctor immediately.
If you have diabetes (high blood sugar), it is vital 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.
Overdose Information
Overdose Symptoms:
- Tachycardia (rapid heart rate)
- Palpitations
- Tremor
- Nervousness
- Headache
- Dizziness
- Nausea
- Vomiting
- Hypokalemia (low potassium levels)
- Hyperglycemia (high blood sugar)
- Metabolic acidosis
What to Do:
Seek immediate medical attention or call Poison Control (1-800-222-1222). Treatment is supportive and symptomatic. Beta-adrenergic blocking agents (e.g., a cardioselective beta-blocker) may be considered, but only with extreme caution due to the risk of inducing bronchospasm.
Drug Interactions
Major Interactions
- Beta-adrenergic blocking agents (e.g., propranolol, carvedilol): May block the bronchodilatory effect of albuterol and produce severe bronchospasm in asthmatic patients. Generally, beta-blockers and albuterol should not be used concomitantly.
- Monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants (TCAs): May potentiate the vascular effects of albuterol. Use with extreme caution in patients receiving these agents or within 2 weeks of discontinuation.
Moderate Interactions
- Diuretics (e.g., loop or thiazide diuretics): ECG changes and/or hypokalemia may result from beta-agonists, especially at higher doses. The hypokalemic effect of diuretics may be acutely worsened by beta-agonists.
- Digoxin: Albuterol may decrease serum digoxin levels. Monitor digoxin levels.
Monitoring
Baseline Monitoring
Pulmonary function tests (e.g., FEV1, peak flow)
Rationale: To assess baseline lung function and severity of airway obstruction.
Timing: Prior to initiation of therapy and periodically thereafter.
Heart rate and blood pressure
Rationale: To establish baseline cardiovascular status, as albuterol can cause tachycardia and blood pressure changes.
Timing: Prior to initiation of therapy.
Routine Monitoring
Symptom control (e.g., wheezing, shortness of breath, cough)
Frequency: Daily, or as needed with each dose
Target: Improvement or resolution of symptoms
Action Threshold: Worsening symptoms, increased frequency of use, or lack of response to usual dose indicates need for medical re-evaluation.
Peak expiratory flow (PEF)
Frequency: Daily, or as recommended by clinician
Target: Individualized based on personal best and asthma action plan
Action Threshold: Significant drop in PEF (e.g., <80% of personal best) or entry into 'yellow' or 'red' zone of asthma action plan.
Heart rate
Frequency: Periodically, especially during acute exacerbations or if cardiovascular symptoms occur
Target: Within normal limits for age, or patient's baseline
Action Threshold: Persistent tachycardia or palpitations.
Serum potassium
Frequency: Periodically, especially in patients at risk for hypokalemia (e.g., concomitant diuretic use, severe asthma exacerbation)
Target: 3.5-5.0 mEq/L
Action Threshold: Hypokalemia (<3.5 mEq/L).
Symptom Monitoring
- Worsening shortness of breath
- Increased wheezing
- Chest tightness
- Increased cough
- Paradoxical bronchospasm (worsening of breathing immediately after dose)
- Palpitations or rapid heart rate
- Tremor
- Dizziness
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 animal studies at high doses. Clinical experience with albuterol in pregnant women is limited.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity observed in animal studies at high doses; human data are insufficient to rule out risk.
Second Trimester:
Generally considered safer than in the first trimester, but use only if clearly needed.
Third Trimester:
May inhibit uterine contractions and increase risk of maternal and fetal tachycardia. Use with caution during labor and delivery.
Lactation
Albuterol is excreted in human milk. While the amount is likely small and systemic effects on the infant are not expected, caution should be exercised when albuterol is administered to a nursing mother. The benefits of breastfeeding should be weighed against the potential risks.
Infant Risk:
Low risk of adverse effects on the breastfed infant due to low systemic absorption and excretion into milk.
Pediatric Use
Albuterol inhalation solution is approved for use in children 2 years of age and older. Dosing for children under 2 years is not officially established for the 0.083% solution but is often used off-label with careful dose titration and monitoring. Children may be more susceptible to systemic effects at higher doses.
Geriatric Use
Elderly patients may be more susceptible to the cardiovascular effects of sympathomimetic amines (e.g., tachycardia, palpitations, blood pressure changes). Use with caution and monitor for adverse effects, especially in those with underlying cardiovascular disease.
Clinical Information
Clinical Pearls
- Albuterol is a short-acting beta-agonist (SABA) and should be used as a 'rescue' medication for acute bronchospasm, not for daily maintenance therapy.
- Increased frequency of albuterol use (e.g., needing it more than twice a week for symptom control, excluding exercise-induced bronchospasm) indicates poorly controlled asthma and warrants medical re-evaluation and adjustment of maintenance therapy.
- Paradoxical bronchospasm (worsening of wheezing or shortness of breath immediately after a dose) is a rare but serious adverse effect; discontinue the drug immediately and seek medical attention.
- Patients should be educated on proper nebulizer technique to ensure effective drug delivery.
- Monitor for signs of hypokalemia, especially in patients receiving concomitant diuretics or corticosteroids, or during severe asthma exacerbations.
Alternative Therapies
- Levalbuterol (Xopenex) - another SABA, R-isomer of albuterol
- Ipratropium bromide (Atrovent) - short-acting anticholinergic bronchodilator (often used in combination with albuterol for severe exacerbations)
- Long-acting beta-agonists (LABAs) - e.g., salmeterol, formoterol (for maintenance, not rescue)
- Inhaled corticosteroids (ICS) - e.g., fluticasone, budesonide (for maintenance, not rescue)
- Leukotriene receptor antagonists (LTRAs) - e.g., montelukast (for maintenance)
- Systemic corticosteroids - for acute severe exacerbations
Cost & Coverage
Average Cost:
$15 - $50 per 25 x 3ml vials (generic)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic)
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.