Albuterol 0.021%(0.63mg/3ml) 30x3ml
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
C
FDA Approved
Aug 1981
DEA Schedule
Not Controlled
Overview
What is this medicine?
Albuterol is a medicine that helps open up your airways when you have trouble breathing due to asthma or COPD. It works quickly to relax the muscles around your airways, making it easier to breathe. It's often called a 'rescue inhaler' because it's used for quick relief of breathing problems.
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 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. Unused containers should be kept in their original foil pouch until use. After opening the pouch, check the packaging for information on how long the vials can be stored. Keep all medications in a safe and secure location, out of the reach of children and pets.
Missing a Dose
If you take this medication on a regular basis and miss a dose, use it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and continue with 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 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. Unused containers should be kept in their original foil pouch until use. After opening the pouch, check the packaging for information on how long the vials can be stored. Keep all medications in a safe and secure location, out of the reach of children and pets.
Missing a Dose
If you take this medication on a regular basis and miss a dose, use it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and continue with 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 as directed by your doctor, typically for quick relief of symptoms, not for daily maintenance.
- Do not use more often than prescribed, as overuse can lead to side effects and may indicate worsening asthma/COPD.
- Always have your albuterol with you for emergencies.
- If you need to use your albuterol more frequently than usual, contact your doctor as this may signal a need to adjust your long-term treatment plan.
- Learn proper nebulizer technique to ensure the medicine reaches your lungs effectively.
Available Forms & Alternatives
Available Strengths:
- Albuterol 2mg Tablets
- Albuterol 4mg Tablets
- Albuterol 0.5% Conc(2.5mg/0.5ml)
- Albuterol 0.021%(0.63mg/3ml) 30x3ml
- Albuterol 0.083%(2.5mg/3ml) 25x3ml
- Albuterol 0.083%(2.5mg/3ml) Inh Sol
- Albuterol 0.083%(2.5mg/3ml) 30x3ml
- Albuterol Sulfate 2mg Tablets
- Albuterol Sulfate 4mg Tablets
- Albuterol HFA Inh (200 Puffs) 18gm
- Albuterol HFA Inh (200 Puffs) 8.5gm
- Albuterol Sulfate Syrup (2mg/5ml)
- Albuterol Sulfate 2mg Tablets
- Albuterol Sulfate 4mg Tablets
- Albuterol HFA Inh (200 Puffs) 6.7gm
- Albuterol 0.083%(2.5mg/3ml) Inh Sol
- Albuterol 0.021%(0.63mg/3ml) 25x3ml
- Albuterol 0.042%(1.25mg/3ml) 25x3ml
Dosing & Administration
Adult Dosing
Standard Dose:
0.63 mg (one 3 mL vial of 0.021% solution) administered 3 to 4 times daily by nebulization, as needed.
Dose Range:
0.63 - 1.25 mg
Condition-Specific Dosing:
acute_bronchospasm:
0.63 mg or 1.25 mg (one 3 mL vial of 0.021% or 0.042% solution) administered 3 to 4 times daily by nebulization, as needed. Higher doses (2.5 mg) may be used if clinically indicated and tolerated.
Pediatric Dosing
Neonatal:
Not established for routine use; use with extreme caution and under specialist guidance.
Infant:
Not established for routine use; use with extreme caution and under specialist guidance. For children <2 years, 0.63 mg or 1.25 mg may be considered based on weight and clinical response, but 0.021% is less common for this age group.
Child:
For children 2-12 years: 0.63 mg (one 3 mL vial of 0.021% solution) administered 3 to 4 times daily by nebulization, as needed. Some guidelines suggest 1.25 mg or 2.5 mg for children >2 years depending on severity and response.
Adolescent:
Same as adult dosing: 0.63 mg (one 3 mL vial of 0.021% solution) administered 3 to 4 times daily by nebulization, as needed.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended, but monitor for increased systemic effects.
Severe:
No specific adjustment recommended, but monitor for increased systemic effects due to potential accumulation of metabolites.
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, but monitor for increased systemic effects.
Severe:
No specific adjustment recommended, but monitor for increased systemic effects 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 relaxation of the bronchial smooth muscle and bronchodilation. This action is mediated by activation of adenyl cyclase, which increases intracellular cyclic-3',5'-adenosine monophosphate (cAMP) levels. Increased cAMP levels lead to relaxation of bronchial smooth muscle and inhibition of mediator release from mast cells.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 20% (oral bioavailability, after inhalation much is swallowed and absorbed systemically)
Tmax:
0.5-2 hours (systemic absorption after inhalation)
FoodEffect:
Not applicable for inhaled formulation.
Distribution:
Vd:
Not readily available for inhaled albuterol, but widely distributed.
ProteinBinding:
10%
CnssPenetration:
Limited
Elimination:
HalfLife:
3.8-6 hours (systemic)
Clearance:
Not readily available, primarily renal excretion.
ExcretionRoute:
Renal (urine)
Unchanged:
Approximately 69% of a dose is excreted in urine as unchanged drug and metabolites 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 medical attention immediately:
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 after the first use of a new canister or vial of this medication, or right after a dose. 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. Many people may not experience any side effects or only have minor ones. If you notice any of the following side effects, or if they bother you or do not go away, contact your doctor:
Feeling nervous and excitable
Dizziness or headache
Upset stomach or vomiting
Shakiness
Throat irritation
Runny nose
This is not a comprehensive list of all 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.
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 medical attention immediately:
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 after the first use of a new canister or vial of this medication, or right after a dose. 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. Many people may not experience any side effects or only have minor ones. If you notice any of the following side effects, or if they bother you or do not go away, contact your doctor:
Feeling nervous and excitable
Dizziness or headache
Upset stomach or vomiting
Shakiness
Throat irritation
Runny nose
This is not a comprehensive list of all 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.
Seek Immediate Medical Attention If You Experience:
- Worsening shortness of breath after using the medication
- Chest pain or discomfort
- Severe or persistent palpitations (fast or irregular heartbeat)
- Severe tremor or nervousness
- Dizziness or lightheadedness
- Signs of an allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, severe dizziness, trouble 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 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 for clarification.
To ensure your safety, it is crucial to disclose all of your medications, including:
Prescription and over-the-counter (OTC) medications
Natural products
* Vitamins
Additionally, inform your doctor about any existing health problems. This information will help your doctor determine whether it is safe for you 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. This will help prevent potential interactions and ensure your safety while taking this medication.
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 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 for clarification.
To ensure your safety, it is crucial to disclose all of your medications, including:
Prescription and over-the-counter (OTC) medications
Natural products
* Vitamins
Additionally, inform your doctor about any existing health problems. This information will help your doctor determine whether it is safe for you 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. This will help prevent potential interactions and ensure your safety while taking this medication.
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 monitor your blood sugar levels closely 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 prescribed, notify your doctor right away.
If you have diabetes (high blood sugar), it is crucial to monitor your blood sugar levels closely 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 (fast heart rate)
- Palpitations
- Tremor
- Nervousness
- Headache
- Dizziness
- Nausea
- Vomiting
- Hypokalemia (low potassium)
- Hyperglycemia (high blood sugar)
- Metabolic acidosis
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Non-selective beta-blockers (e.g., propranolol, carvedilol): May block the bronchodilatory effect of albuterol and produce severe bronchospasm in asthmatic patients.
Major Interactions
- Diuretics (loop or thiazide): May exacerbate ECG changes and/or hypokalemia associated with albuterol, especially at high doses.
- Digoxin: Albuterol may decrease serum digoxin levels.
- Monoamine Oxidase Inhibitors (MAOIs) and Tricyclic Antidepressants (TCAs): May potentiate the cardiovascular effects of albuterol (e.g., increased heart rate, blood pressure).
Moderate Interactions
- Other sympathomimetic agents: Additive cardiovascular effects; use with caution.
- Theophylline: Increased risk of adverse cardiovascular effects and hypokalemia.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Pulmonary function tests (e.g., FEV1, peak expiratory flow)
Rationale: To assess baseline lung function and severity of airway obstruction.
Timing: Prior to initiation of therapy, especially for new diagnoses or significant changes in condition.
Heart rate and rhythm
Rationale: Albuterol can cause tachycardia and palpitations.
Timing: Prior to initiation, especially in patients with pre-existing cardiovascular conditions.
Blood pressure
Rationale: Albuterol can cause transient increases in blood pressure.
Timing: Prior to initiation, especially in patients with hypertension.
Routine Monitoring
Symptoms of bronchospasm (e.g., wheezing, shortness of breath, cough)
Frequency: Daily, as needed
Target: Resolution or improvement of symptoms
Action Threshold: Persistent or worsening symptoms, increased frequency of use (e.g., >2 days/week for rescue) indicates inadequate control and need for re-evaluation.
Peak expiratory flow (PEF) or FEV1 (if home spirometry available)
Frequency: Daily (for moderate-severe asthma) or as needed
Target: Patient's personal best or >80% predicted
Action Threshold: Significant drop from personal best or predicted values, or increased variability.
Heart rate
Frequency: As needed, especially during acute exacerbations or if patient reports palpitations
Target: Within normal limits for patient
Action Threshold: Persistent tachycardia (>100 bpm at rest) or significant palpitations.
Serum potassium (K+)
Frequency: Periodically, especially with high doses, concomitant diuretics, or cardiac conditions
Target: 3.5-5.0 mEq/L
Action Threshold: Hypokalemia (<3.5 mEq/L).
Symptom Monitoring
- Wheezing
- Shortness of breath (dyspnea)
- Cough
- Chest tightness
- Increased work of breathing
- Palpitations
- Tremor
- Nervousness
- Dizziness
Special Patient Groups
Pregnancy
Category C. Use 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. Albuterol has been widely used in pregnancy for asthma management, and uncontrolled asthma poses greater risks to both mother and fetus.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity based on animal studies, but human data do not show a consistent pattern of major birth defects.
Second Trimester:
Generally considered safer than in the first trimester, but still use with caution.
Third Trimester:
May inhibit uterine contractions and cause transient maternal and fetal tachycardia and hyperglycemia. Use with caution during labor and delivery.
Lactation
L3 (Moderately safe). Albuterol is excreted in human milk, but systemic absorption by the infant is likely to be low due to poor oral bioavailability. Monitor the infant for signs of agitation, tremor, or tachycardia.
Infant Risk:
Low risk of adverse effects to the breastfed infant, but theoretical risk of tremor, irritability, or tachycardia. Observe infant for these effects.
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 this concentration but may be used off-label under specialist guidance. Children may be more susceptible to systemic side effects.
Geriatric Use
Use with caution in elderly patients, especially those with cardiovascular disease (e.g., ischemic heart disease, hypertension, arrhythmias), diabetes, or hyperthyroidism, due to increased risk of systemic adverse effects. Start with the lowest effective dose and monitor closely.
Clinical Information
Clinical Pearls
- Albuterol is a rescue medication for acute bronchospasm; it is not for daily maintenance therapy.
- Overuse (e.g., needing to use it more than twice a week, excluding exercise-induced bronchospasm) indicates poorly controlled asthma and warrants re-evaluation of the patient's long-term control therapy.
- Educate patients on the difference between rescue (albuterol) and controller medications.
- Proper nebulizer technique is crucial for effective drug delivery to the lungs.
- Patients should be advised to rinse their mouth after use to minimize local side effects and systemic absorption of swallowed drug.
Alternative Therapies
- Levalbuterol (Xopenex): R-isomer of albuterol, may have fewer side effects (e.g., less tachycardia, tremor) in some patients.
- Other short-acting beta-agonists (SABAs) in different formulations (e.g., metered-dose inhalers like Ventolin HFA, ProAir HFA, Proventil HFA).
- Short-acting anticholinergics (e.g., ipratropium bromide): Used for COPD, less effective for asthma.
- Systemic corticosteroids: For acute severe exacerbations.
- Long-term control medications (e.g., inhaled corticosteroids, LABAs, LTRAs) are used for maintenance therapy, not as alternatives for acute relief.
Cost & Coverage
Average Cost:
$15 - $40 per 30 x 3mL vials (0.021%)
Generic Available:
Yes
Insurance Coverage:
Tier 1 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this 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.