Albuterol 0.021%(0.63mg/3ml) 25x3ml

Manufacturer MYLAN Active Ingredient Albuterol Inhalation Solution(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.
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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
Sep 1981
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Albuterol is a medicine that helps open up the airways in your lungs, making it easier to breathe. It's often called a 'rescue inhaler' because it works quickly to relieve symptoms like wheezing, shortness of breath, and chest tightness during an asthma attack or flare-up. It works by relaxing the muscles around your airways.
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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. 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.

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 schedule. Do not take two doses at the same time or take 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

  • Identify and avoid asthma triggers (e.g., allergens, smoke, cold air, exercise if not pre-treated).
  • Follow your asthma action plan provided by your doctor.
  • Do not exceed the prescribed dose or frequency of albuterol.
  • Always carry your rescue inhaler with you.
  • Rinse your mouth after use if you experience a dry mouth or unpleasant taste, though this is less common with nebulized solution than with inhaled corticosteroids.
  • Store medication at room temperature, away from light and moisture.

Dosing & Administration

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Adult Dosing

Standard Dose: 2.5 mg (0.5 mL of 0.5% solution or 3 mL of 0.083% solution) via nebulizer 3-4 times daily as needed. The 0.021% (0.63mg/3ml) concentration is a lower dose, often used for continuous nebulization (e.g., 0.63mg/hour) or in specific low-dose protocols, rather than a standard single dose for acute bronchospasm.
Dose Range: 0.63 - 5 mg

Condition-Specific Dosing:

acute_bronchospasm: 2.5 mg (0.083% solution) 3-4 times daily. For severe cases, continuous nebulization at 10-15 mg/hour may be used, often starting with higher concentrations and adjusting flow. The 0.63mg/3ml concentration would be used in specific continuous nebulization protocols or as a very low single dose.
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Pediatric Dosing

Neonatal: Not established for routine use; use with extreme caution and under specialist guidance. Dosing is highly individualized, often starting at 0.05-0.1 mg/kg/dose.
Infant: For children 2-12 years: 1.25 mg (0.042% solution) or 2.5 mg (0.083% solution) 3-4 times daily. The 0.021% (0.63mg/3ml) concentration may be used for very young infants or for continuous nebulization in specific protocols.
Child: For children 2-12 years: 1.25 mg (0.042% solution) or 2.5 mg (0.083% solution) 3-4 times daily. The 0.021% (0.63mg/3ml) concentration may be used for continuous nebulization or as a very low single dose in specific protocols.
Adolescent: For children >12 years: 2.5 mg (0.083% solution) 3-4 times daily. The 0.021% (0.63mg/3ml) concentration is a lower dose, typically not used as a standard single dose for acute bronchospasm in this age group, but may be part of continuous nebulization protocols.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed, but monitor for increased systemic effects due to potential accumulation of metabolites.
Dialysis: Considerations: Not significantly removed by hemodialysis. No specific dose adjustment, but monitor for adverse effects.

Hepatic Impairment:

Mild: No specific adjustment.
Moderate: No specific adjustment.
Severe: No specific adjustment, but monitor for increased systemic effects due to potential altered metabolism.

Pharmacology

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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). Increased cAMP levels cause 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, due to first-pass metabolism); for inhalation, systemic bioavailability is variable but a significant portion of the inhaled dose is swallowed and absorbed from the GI tract.
Tmax: Inhalation: 0.5-2 hours (for bronchodilation effect).
FoodEffect: Not applicable for inhaled administration.

Distribution:

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

Elimination:

HalfLife: Inhalation: 3.8-5 hours (systemic).
Clearance: Approximately 270 mL/min (renal).
ExcretionRoute: Renal (primarily as unchanged drug and sulfate conjugate), fecal (minor).
Unchanged: Approximately 60% (renal excretion of unchanged drug after oral administration).
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Pharmacodynamics

OnsetOfAction: 5-15 minutes (inhalation).
PeakEffect: 60-90 minutes (inhalation).
DurationOfAction: 4-6 hours (inhalation).

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 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. 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 if they bother you or persist, contact your doctor:

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

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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 shortness of breath or wheezing despite using albuterol.
  • Needing to use albuterol more often than prescribed (e.g., more than 2 days a week for symptom control, not including exercise-induced bronchospasm).
  • Symptoms not improving within 15-20 minutes after use.
  • Experiencing chest pain, rapid heart rate, or severe tremor after using the medication.
  • Signs of an allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing).
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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, 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 to determine if there are any potential interactions.

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. They will help you determine if it is safe to take this medication with your existing medications and health conditions.

Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
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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 have 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 prescribed, immediately contact your doctor.

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 breastfeeding. Your doctor will discuss the potential benefits and risks of using this medication during these situations to ensure the best outcome for both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Tachycardia (rapid heart rate)
  • Palpitations
  • Tremor (shakiness)
  • Nervousness
  • Headache
  • Dizziness
  • Nausea
  • Vomiting
  • Hypokalemia (low potassium levels, potentially leading to muscle weakness or arrhythmias)
  • Hyperglycemia (high blood sugar)
  • Metabolic acidosis

What to Do:

Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is generally supportive and symptomatic. Beta-adrenergic blocking agents (e.g., cardioselective beta-blockers) may be considered in severe cases, but should be used with extreme caution due to the risk of inducing bronchospasm.

Drug Interactions

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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, leading to severe cardiovascular adverse effects. Use with extreme caution or avoid within 14 days of MAOI/TCA discontinuation.
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Moderate Interactions

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

Monitoring

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Baseline Monitoring

Pulmonary function tests (FEV1, FVC)

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

Timing: Prior to initiation of therapy and periodically.

Vital signs (heart rate, blood pressure)

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

Timing: Prior to initiation.

Serum potassium

Rationale: To establish baseline, especially in patients at risk for hypokalemia or on concomitant diuretics.

Timing: Prior to initiation, if indicated.

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Routine Monitoring

Symptom control (wheezing, shortness of breath, cough)

Frequency: Daily, or as needed with each dose.

Target: Reduction or resolution of symptoms.

Action Threshold: Increased frequency of use, worsening symptoms, or lack of response indicates need for medical re-evaluation.

Peak expiratory flow (PEF)

Frequency: Daily, or as per asthma action plan.

Target: Individualized based on personal best and asthma action plan zones.

Action Threshold: Decreased PEF below personal best or yellow/red zone indicates need for intervention.

Heart rate and rhythm

Frequency: Periodically, or if patient reports palpitations/tremor.

Target: Within normal limits for patient.

Action Threshold: Persistent tachycardia, arrhythmias, or significant palpitations.

Serum potassium

Frequency: Periodically, especially with high doses, frequent use, or concomitant diuretics.

Target: 3.5-5.0 mEq/L.

Action Threshold: <3.5 mEq/L.

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Symptom Monitoring

  • Worsening shortness of breath
  • Increased wheezing
  • Chest tightness
  • Increased cough
  • Need for more frequent use of rescue inhaler
  • Palpitations
  • Tremor
  • Nervousness

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 it is generally safe when used as directed for asthma control, which is crucial during pregnancy.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity observed in animal studies at high doses; human data are reassuring but limited. Use only if clearly needed.
Second Trimester: Generally considered safer than in the first trimester, but still use only if benefits outweigh risks.
Third Trimester: May inhibit uterine contractions (tocolytic effect) and cause transient maternal and fetal tachycardia, hyperglycemia, and hypokalemia. Use with caution, especially close to term.
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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. The American Academy of Pediatrics considers albuterol compatible with breastfeeding. Use with caution and monitor the infant for adverse effects (e.g., irritability, tremor).

Infant Risk: Low risk.
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Pediatric Use

Albuterol is widely used and effective in pediatric patients for the treatment of bronchospasm associated with asthma and other reversible obstructive airway diseases. Dosing is weight- or age-based. The 0.021% (0.63mg/3ml) concentration may be particularly useful for very young children or for continuous nebulization protocols where lower doses are required.

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Geriatric Use

Use with caution in elderly patients, as they may be more susceptible to the cardiovascular effects of sympathomimetic amines (e.g., tachycardia, palpitations, hypertension). Consider starting with lower doses and titrating up based on response and tolerability. Monitor for cardiac adverse effects and hypokalemia.

Clinical Information

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Clinical Pearls

  • Albuterol is a rescue medication; it should not be used for daily maintenance unless specifically prescribed for exercise-induced bronchospasm or as part of a specific continuous nebulization regimen.
  • Increased use of albuterol (e.g., more than 2 days a week for symptom control, not including exercise-induced bronchospasm) indicates worsening asthma control and necessitates re-evaluation of the patient's maintenance therapy (e.g., inhaled corticosteroids).
  • Paradoxical bronchospasm can occur with inhaled albuterol, though rare. If it occurs, discontinue immediately and institute alternative therapy.
  • Patients should be educated on the proper technique for using their nebulizer to ensure optimal drug delivery.
  • Hypokalemia can occur, especially with high doses or concomitant use of diuretics. Monitor potassium levels in at-risk patients.
  • The 0.021% (0.63mg/3ml) concentration is a lower dose than the standard 2.5mg/3ml (0.083%) and is often used for continuous nebulization or in specific pediatric protocols, rather than as a typical single dose for acute exacerbations in adults.
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Alternative Therapies

  • Other Short-Acting Beta-Agonists (SABAs): Levalbuterol (Xopenex) - R-isomer of albuterol, potentially fewer side effects.
  • Long-Acting Beta-Agonists (LABAs): Salmeterol, Formoterol (used for maintenance, never monotherapy in asthma).
  • Inhaled Corticosteroids (ICS): Budesonide, Fluticasone (first-line for asthma maintenance).
  • Systemic Corticosteroids: Prednisone, Methylprednisolone (for acute severe exacerbations).
  • Anticholinergics: Ipratropium (for COPD, sometimes adjunct in asthma).
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Cost & Coverage

Average Cost: $10 - $50 per 25 x 3ml vials (0.083% solution, generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred generic)
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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.