Albuterol 0.083%(2.5mg/3ml) 30x3ml

Manufacturer RITEDOSE 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 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' medicine that you inhale into your lungs to quickly open up your airways. It helps relieve sudden symptoms like wheezing, shortness of breath, and chest tightness caused by asthma or COPD. It works by relaxing the muscles around your airways, making it easier to breathe. It's important to use it only when needed for quick relief, not for daily prevention.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is for inhalation only, using a special machine called a nebulizer that delivers the liquid solution directly into your lungs.

Important Usage Instructions

Do not use the solution if it appears cloudy, is leaking, or contains particles.
Do not use the solution if it has changed color.
Never mix other medications in the nebulizer with this solution.

Storing and Disposing of Your Medication

Store the medication at room temperature, protected from light.
Keep it in a dry place, avoiding storage in a bathroom.
Store 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.
Keep all medications in a safe location, out of the reach of children and pets.

Missing 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 return to your normal 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.
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Lifestyle & Tips

  • Always carry your albuterol rescue inhaler with you.
  • Understand and avoid your asthma/COPD triggers (e.g., allergens, smoke, cold air).
  • Learn and practice proper nebulizer technique to ensure the medicine reaches your lungs effectively.
  • Do not exceed the prescribed dose or frequency. If you need to use it more often than prescribed, contact your doctor immediately as this indicates worsening control.
  • Maintain good hydration to help thin mucus.
  • Consider smoking cessation if applicable.

Dosing & Administration

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Adult Dosing

Standard Dose: 2.5 mg (one 3 mL vial) administered by nebulization 3 to 4 times daily, as needed.
Dose Range: 2.5 - 5 mg

Condition-Specific Dosing:

acute_bronchospasm: 2.5 mg every 4-8 hours as needed.
severe_exacerbation: May be given more frequently (e.g., every 20 minutes for 3 doses) or continuously (e.g., 10-15 mg/hour) under medical supervision.
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Pediatric Dosing

Neonatal: Not established (use with extreme caution, often off-label and individualized by specialist)
Infant: For children 2-12 years: 1.25 mg or 2.5 mg (one 3 mL vial) administered by nebulization 3 to 4 times daily, as needed. Dose individualized based on response and tolerability.
Child: For children >12 years: 2.5 mg (one 3 mL vial) administered by nebulization 3 to 4 times daily, as needed.
Adolescent: 2.5 mg (one 3 mL vial) administered by nebulization 3 to 4 times daily, as needed.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended, but monitor for increased systemic effects due to potential for reduced clearance.
Severe: No specific dose adjustment recommended, but monitor for increased systemic effects due to potential for reduced clearance.
Dialysis: Consider monitoring for increased systemic effects; albuterol is not significantly removed by hemodialysis.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Albuterol is a selective short-acting beta2-adrenergic agonist. It acts by stimulating beta2-receptors on the smooth muscle cells of the bronchi, leading to activation of adenyl cyclase, which increases intracellular cyclic-3',5'-adenosine monophosphate (cAMP). Increased cAMP levels cause relaxation of bronchial smooth muscle, resulting in bronchodilation. It also inhibits the release of mediators from mast cells in the airways.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 10-20% (oral bioavailability due to first-pass metabolism; inhaled bioavailability is direct to lungs)
Tmax: 0.5 - 2 hours (for bronchodilation effect)
FoodEffect: Not relevant for inhaled administration.

Distribution:

Vd: Approximately 300 L
ProteinBinding: Approximately 10%
CnssPenetration: Limited

Elimination:

HalfLife: 3.8 - 5 hours (systemic)
Clearance: Not readily available for inhaled route, but primarily renal excretion.
ExcretionRoute: Renal (urine)
Unchanged: Approximately 60% of an inhaled dose is excreted unchanged in urine within 24 hours.
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Pharmacodynamics

OnsetOfAction: 5 - 15 minutes
PeakEffect: 60 - 90 minutes
DurationOfAction: 4 - 6 hours

Safety & Warnings

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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 immediately after 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

As with any medication, you may experience side effects. While many people have no side effects or only mild ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:

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, 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.
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Seek Immediate Medical Attention If You Experience:

  • Worsening shortness of breath or wheezing despite using albuterol.
  • Chest pain or severe palpitations.
  • Dizziness or lightheadedness.
  • Signs of an allergic reaction (e.g., rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing).
  • Persistent tremor or nervousness.
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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 to determine if the medications are similar.

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 medical conditions or concerns

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. 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 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 outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Tachycardia (rapid heart rate)
  • Palpitations (pounding heart)
  • Tremor (shaking)
  • Headache
  • Nausea and vomiting
  • Hypokalemia (low potassium levels)
  • Hyperglycemia (high blood sugar)
  • Metabolic acidosis
  • Chest pain
  • Agitation or restlessness

What to Do:

If you suspect an overdose, seek immediate medical attention. Call your local emergency number (e.g., 911 in the US) or Poison Control (1-800-222-1222). Treatment is supportive and may include monitoring cardiac function (ECG), electrolyte levels (especially potassium), and managing symptoms.

Drug Interactions

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Major Interactions

  • Beta-blockers (non-selective, e.g., propranolol): 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; consider alternative bronchodilators.
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Moderate Interactions

  • Diuretics (e.g., loop or thiazide diuretics): May potentiate the hypokalemic effect of albuterol, especially with high doses. Monitor potassium levels.
  • Digoxin: Albuterol may decrease serum digoxin levels. Monitor digoxin levels.
  • Other sympathomimetics: Additive cardiovascular effects. Use with caution.

Monitoring

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Baseline Monitoring

Pulmonary Function Tests (e.g., FEV1)

Rationale: To establish baseline lung function and assess severity of airway obstruction.

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

Heart Rate and Blood Pressure

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

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

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Routine Monitoring

Symptom Control (wheezing, shortness of breath, cough)

Frequency: Daily, or as needed with each use

Target: Reduction or resolution of symptoms

Action Threshold: Increased frequency of albuterol use (e.g., >2 days/week for symptom relief, not exercise-induced) indicates worsening asthma control and requires medical re-evaluation.

Heart Rate and Blood Pressure

Frequency: Periodically, or if patient reports palpitations/tremor

Target: Within patient's normal range

Action Threshold: Persistent tachycardia (>100 bpm) or significant hypertension; consider dose reduction or alternative.

Serum Potassium

Frequency: Periodically, especially with high doses, severe exacerbations, or concomitant diuretics/corticosteroids

Target: 3.5-5.0 mEq/L

Action Threshold: Hypokalemia (<3.5 mEq/L); may require potassium supplementation or dose adjustment.

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Symptom Monitoring

  • Worsening shortness of breath
  • Increased wheezing or chest tightness
  • Increased frequency of rescue inhaler use
  • Palpitations or rapid heart rate
  • Tremor or nervousness
  • Dizziness or lightheadedness
  • Chest pain

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. Untreated asthma can pose significant risks to both mother and fetus (e.g., pre-eclampsia, prematurity, low birth weight).

Trimester-Specific Risks:

First Trimester: Limited data, but generally considered acceptable if needed for asthma control.
Second Trimester: Generally considered acceptable if needed for asthma control.
Third Trimester: Generally considered acceptable if needed for asthma control. Monitor for potential maternal tachycardia or hyperglycemia, which could affect the fetus.
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Lactation

Albuterol is excreted in human milk. However, systemic absorption following inhalation is low, and the amount transferred to breast milk is likely small. The American Academy of Pediatrics considers albuterol compatible with breastfeeding. Monitor the infant for potential adverse effects such as irritability or tremor.

Infant Risk: Low risk, generally considered compatible with breastfeeding.
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Pediatric Use

Albuterol inhalation solution is approved for use in children 2 years of age and older. Dosing should be carefully individualized based on age, weight, and clinical response. Younger children may require lower doses (e.g., 1.25 mg). Proper nebulizer technique is crucial for effective delivery.

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Geriatric Use

No specific dose adjustment is generally required for elderly patients. However, elderly patients may be more sensitive to the cardiovascular effects of beta-agonists (e.g., tachycardia, tremor, hypertension). Use with caution and monitor for adverse effects, especially in those with pre-existing cardiovascular disease.

Clinical Information

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Clinical Pearls

  • Albuterol is a 'rescue' medication for acute symptoms; it is not for daily maintenance therapy. Overuse indicates poor asthma control and warrants re-evaluation by a healthcare provider.
  • Proper nebulizer technique is essential for effective drug delivery to the lungs. Patients should be instructed on how to use the nebulizer correctly.
  • Patients should be advised to seek immediate medical attention if their symptoms worsen or if they need to use albuterol more frequently than usual.
  • Can cause transient hypokalemia and hyperglycemia, especially with high doses or in susceptible individuals. Monitor electrolytes in severe exacerbations or with concomitant medications that affect potassium.
  • Paradoxical bronchospasm can occur, though rare. If it happens, discontinue albuterol immediately and use an alternative bronchodilator.
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Alternative Therapies

  • Other short-acting beta-agonists (SABAs): Levalbuterol (Xopenex) - the R-isomer of albuterol, potentially with fewer side effects.
  • Long-acting beta-agonists (LABAs): Formoterol, Salmeterol (used for maintenance, not acute relief, often in combination with inhaled corticosteroids).
  • Inhaled Corticosteroids (ICS): Beclomethasone, Budesonide, Fluticasone (for long-term asthma control and prevention of exacerbations).
  • Systemic Corticosteroids: Prednisone, Methylprednisolone (for acute severe exacerbations).
  • Anticholinergics: Ipratropium (Atrovent) - a short-acting anticholinergic bronchodilator.
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Cost & Coverage

Average Cost: $15 - $50 per 30 x 3mL vials (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 this medication, don't hesitate to discuss them with 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, including the amount taken and the time it happened, to facilitate prompt and effective treatment.