Albuterol 0.042%(1.25mg/3ml) 25x3ml

Manufacturer MYLAN Active Ingredient Albuterol Inhalation Solution(al BYOO ter ole) Pronunciation al-BYOO-ter-ol
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 Beta2-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 'rescue' inhaler that helps open up your airways quickly when you have trouble breathing due to asthma or COPD. It works by relaxing the muscles around your airways, making it easier to breathe. It's used for sudden breathing problems, not for daily prevention.
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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 carefully. Read all the information provided with your medication and follow the instructions closely. This medication is for inhalation only, using a special machine called a nebulizer, which delivers the medication directly into your lungs as a liquid solution.

Before using the medication, check the solution for any signs of damage or contamination. Do not use the medication if the solution 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 one 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 the medication in a bathroom. If you have unused containers, keep them in the 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. 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 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 take it more frequently than directed by your doctor.
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Lifestyle & Tips

  • Always carry your rescue inhaler with you.
  • Understand and avoid your asthma triggers (e.g., allergens, smoke, cold air).
  • Follow your asthma action plan provided by your doctor.
  • Do not use more often than prescribed, as overuse can be harmful and indicates poorly controlled asthma.
  • Proper nebulizer technique is crucial for effective delivery of the medication. Ensure the nebulizer is clean and maintained as per instructions.

Dosing & Administration

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Adult Dosing

Standard Dose: 2.5 mg (equivalent to two 1.25 mg/3 mL vials) administered 3 to 4 times daily by nebulization, as needed.
Dose Range: 1.25 - 5 mg

Condition-Specific Dosing:

acute_bronchospasm: 2.5 mg (two 1.25 mg/3 mL vials) every 20 minutes for 3 doses, then 2.5 mg every 1 to 4 hours as needed, or 10-15 mg/hour continuously.
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Pediatric Dosing

Neonatal: Not established (use with extreme caution, often off-label for specific conditions)
Infant: 1.25 mg (one 1.25 mg/3 mL vial) 3 to 4 times daily by nebulization, as needed. Dosing may be individualized based on response and tolerance.
Child: 1.25 mg (one 1.25 mg/3 mL vial) 3 to 4 times daily by nebulization, as needed. For children 2-12 years, 2.5 mg (two 1.25 mg/3 mL vials) 3 to 4 times daily is also common.
Adolescent: 2.5 mg (two 1.25 mg/3 mL vials) 3 to 4 times daily by nebulization, as needed.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended.
Severe: No specific adjustment recommended, but monitor for increased systemic effects due to potential accumulation of metabolites.
Dialysis: No specific adjustment recommended, but monitor for increased systemic effects.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Albuterol is a selective beta2-adrenergic agonist. It acts by stimulating beta2-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 some inhibition of microvascular leakage.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 10-20% (oral, due to first-pass metabolism); significant local pulmonary absorption after inhalation.
Tmax: Approximately 0.5-2 hours (inhalation).
FoodEffect: Not clinically significant for inhaled albuterol.

Distribution:

Vd: Approximately 3.1 L/kg.
ProteinBinding: Approximately 10%.
CnssPenetration: Limited.

Elimination:

HalfLife: Approximately 3.8-5 hours (systemic).
Clearance: Approximately 0.27 L/min/kg.
ExcretionRoute: Renal (primarily as unchanged drug and sulfate conjugate).
Unchanged: Approximately 69% (of inhaled dose excreted in urine as unchanged drug).
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Pharmacodynamics

OnsetOfAction: Within 5-15 minutes (inhalation).
PeakEffect: Approximately 60-90 minutes (inhalation).
DurationOfAction: Approximately 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 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
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 right after a dose or when using a new canister or vial of this medication for the first time. 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 if they bother you or do not go away:

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, 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 after using the medication.
  • Increased need for your rescue inhaler (e.g., using it more than twice a week for symptoms, not exercise-induced).
  • Chest pain or rapid, pounding heartbeat.
  • Severe dizziness or lightheadedness.
  • Muscle cramps or weakness (signs of low potassium).
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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 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.

This list is not exhaustive, and it is crucial to discuss all your medications and health conditions with your doctor. Provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your health problems, including any pre-existing conditions

Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to ensure your safety. It is vital to verify that it is safe to take this medication with all your other medications and health conditions.
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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. Adhering to the prescribed dosage and usage frequency is crucial, as taking more than the recommended amount or using it too often 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 prescribed, 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 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 (rapid heart rate)
  • Palpitations (pounding heart)
  • Tremor (shakiness)
  • Nervousness
  • Headache
  • Dizziness
  • Nausea
  • Vomiting
  • Hyperglycemia (high blood sugar)
  • Hypokalemia (low potassium)
  • Metabolic acidosis

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic, often involving beta-blockers (cardioselective) for severe cardiovascular effects, and potassium supplementation for hypokalemia.

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 cardiovascular effects of albuterol. Use with extreme caution or avoid within 14 days of discontinuing MAOIs/TCAs.
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Moderate Interactions

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

Monitoring

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Baseline Monitoring

Pulmonary Function Tests (e.g., FEV1, Peak Expiratory Flow)

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

Timing: Prior to initiation of therapy, especially for new diagnoses or significant changes in symptoms.

Heart Rate and Blood Pressure

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

Timing: Prior to initiation of therapy.

Serum Potassium

Rationale: High doses of beta-agonists can cause transient hypokalemia.

Timing: Consider in patients at risk for hypokalemia (e.g., on diuretics, severe asthma exacerbation).

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Routine Monitoring

Symptom Control (e.g., wheezing, shortness of breath, cough)

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

Target: Improved or resolved symptoms.

Action Threshold: Worsening symptoms, increased frequency of use, or lack of response indicates need for re-evaluation.

Peak Expiratory Flow (PEF)

Frequency: Daily (patient self-monitoring) for moderate to severe asthma.

Target: Patient's personal best or >80% of predicted.

Action Threshold: Significant drop from personal best or predicted values, indicating worsening asthma.

Frequency of Albuterol Use

Frequency: At each clinical visit.

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

Action Threshold: Use more than twice a week (excluding exercise-induced bronchospasm) suggests inadequate control and need for step-up in controller therapy.

Heart Rate and Blood Pressure

Frequency: Periodically, especially in patients with cardiovascular comorbidities or those on high doses.

Target: Within normal limits or patient's baseline.

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

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Symptom Monitoring

  • Wheezing
  • Shortness of breath
  • Cough
  • Chest tightness
  • Palpitations
  • Tremor
  • Nervousness
  • Dizziness

Special Patient Groups

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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. Clinical experience suggests it is generally safe when needed for asthma control, as uncontrolled asthma poses greater risks to both mother and fetus.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity (animal studies), but human data are reassuring for inhaled use.
Second Trimester: Generally considered safer than in the first trimester, but still use only if clearly needed.
Third Trimester: May inhibit uterine contractions (tocolytic effect) and cause transient maternal/fetal tachycardia or hyperglycemia. Use with caution near 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. Generally considered compatible with breastfeeding, but monitor the infant for signs of agitation or tremor.

Infant Risk: Low risk. Monitor for irritability, tremor, or poor feeding.
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Pediatric Use

Widely used and generally safe and effective in children 2 years of age and older. Dosing must be carefully individualized based on age, weight, and clinical response. Infants under 2 years may be treated off-label under close medical supervision for specific conditions (e.g., bronchiolitis).

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Geriatric Use

Use with caution in elderly patients, especially those with cardiovascular disease (e.g., ischemic heart disease, arrhythmias, hypertension), diabetes, or hyperthyroidism, due to increased susceptibility to adverse effects such as tachycardia, palpitations, and tremor. Start with lower doses and titrate based on response and tolerability.

Clinical Information

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Clinical Pearls

  • Albuterol is a 'rescue' medication for acute symptoms; it is not a controller medication for daily asthma management. Increased use indicates worsening asthma control.
  • Proper nebulizer technique is essential for effective drug delivery. Patients should be instructed on how to use and clean their nebulizer.
  • Patients should be advised to seek immediate medical attention if they experience paradoxical bronchospasm (worsening of breathing immediately after using the inhaler).
  • Educate patients on the difference between rescue inhalers and controller medications to prevent misuse and ensure optimal asthma management.
  • Monitor for hypokalemia, especially in patients receiving high doses, concomitant diuretics, or corticosteroids.
  • Advise patients to report any cardiovascular symptoms (e.g., palpitations, chest pain) to their healthcare provider.
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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 as controller medications, often in combination with inhaled corticosteroids).
  • Inhaled Corticosteroids (ICS): Budesonide, Fluticasone (controller medications for inflammation in asthma).
  • Systemic Corticosteroids: Prednisone (for acute severe exacerbations).
  • Anticholinergics: Ipratropium (Atrovent) - for COPD or as an alternative bronchodilator.
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Cost & Coverage

Average Cost: Varies widely, typically $20-$100+ per 25 x 3mL vials
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred generic) for most insurance plans.
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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 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.