Albuterol 0.083%(2.5mg/3ml) 25x3ml

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 used to quickly open up the airways in your lungs 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 with a nebulizer, which turns the liquid medicine into a fine mist that you breathe in.
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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.

Important Administration 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 the medication 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 resume 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 with you, as it is a rescue medication for sudden breathing problems.
  • Use albuterol only as directed by your doctor. Do not use it more often than prescribed, as overuse can lead to serious side effects and may indicate your asthma is not well-controlled.
  • If you find yourself needing albuterol more frequently, contact your doctor. This is a sign that your underlying condition may be worsening and your maintenance therapy needs adjustment.
  • Learn proper nebulizer technique to ensure effective delivery of the medication.
  • Avoid triggers that worsen your breathing problems (e.g., allergens, smoke, cold air).

Dosing & Administration

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Adult Dosing

Standard Dose: 2.5 mg (one 3 mL vial of 0.083% solution) administered 3 to 4 times daily via nebulization
Dose Range: 2.5 - 5 mg

Condition-Specific Dosing:

acute_bronchospasm: 2.5 mg every 4-8 hours as needed
severe_exacerbation: May increase frequency to every 1-4 hours or continuous nebulization (10-15 mg/hour) under medical supervision
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Pediatric Dosing

Neonatal: Not established (use with extreme caution, often 0.63-1.25 mg per dose if used)
Infant: Not established (use with extreme caution, often 0.63-1.25 mg per dose if used)
Child: 2-12 years: 2.5 mg (one 3 mL vial of 0.083% solution) administered 3 to 4 times daily via nebulization. For children 2-5 years, 1.25 mg or 2.5 mg 3-4 times daily may be used.
Adolescent: 12 years and older: 2.5 mg (one 3 mL vial of 0.083% solution) administered 3 to 4 times daily via nebulization
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended for inhaled albuterol
Moderate: No specific adjustment recommended for inhaled albuterol
Severe: No specific adjustment recommended for inhaled albuterol, but monitor for increased systemic effects due to potential accumulation of metabolites
Dialysis: Considerations: Albuterol is not significantly removed by dialysis. Monitor for systemic effects.

Hepatic Impairment:

Mild: No specific adjustment recommended for inhaled albuterol
Moderate: No specific adjustment recommended for inhaled albuterol
Severe: No specific adjustment recommended for inhaled albuterol, 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, resulting in bronchodilation.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 10-20% (oral bioavailability of swallowed portion), rapid absorption from lungs
Tmax: Plasma: 2-3 hours (after inhalation)
FoodEffect: Not applicable for inhaled formulation

Distribution:

Vd: Approximately 156 L
ProteinBinding: Approximately 10%
CnssPenetration: Limited

Elimination:

HalfLife: 3.8-5 hours (inhaled)
Clearance: Not readily available for inhaled route, but systemic clearance is rapid
ExcretionRoute: Renal (primarily)
Unchanged: Approximately 60% (of systemically absorbed drug) excreted unchanged in urine
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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

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 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. 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 any other symptoms that 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 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.
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Seek Immediate Medical Attention If You Experience:

  • Worsening shortness of breath or wheezing after using albuterol
  • Chest pain or discomfort
  • Severe or persistent palpitations (fast or pounding heartbeat)
  • Severe tremor or nervousness
  • Signs of an allergic reaction (rash, hives, swelling of face/lips/tongue, difficulty breathing/swallowing)
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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 drugs, foods, or substances. 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.

Please note that this is not an exhaustive list of all potential interactions with this medication. To ensure your safety, it is crucial to discuss the following with your doctor and pharmacist:

All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Any existing health problems you have

Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm that it is safe to do so in conjunction with 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 this medication to both you and your baby, allowing you to make an informed decision.
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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. Treatment is supportive and symptomatic, often involving monitoring vital signs, ECG, and serum potassium levels.

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, especially in patients with asthma. Concurrent use is generally contraindicated.
  • Monoamine Oxidase Inhibitors (MAOIs) and Tricyclic Antidepressants (TCAs): May potentiate the cardiovascular effects of albuterol (e.g., increased heart rate, blood pressure). Use with extreme caution or avoid within 14 days of MAOI/TCA discontinuation.
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Moderate Interactions

  • Diuretics (e.g., Thiazide diuretics, Loop diuretics): May potentiate the hypokalemic effect of albuterol, especially at high doses. Monitor potassium levels.
  • Digoxin: Albuterol may decrease serum digoxin levels. Monitor digoxin levels.
  • Other sympathomimetics (e.g., Epinephrine, Pseudoephedrine): 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 asthma/COPD diagnosis.

Heart Rate and Blood Pressure

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

Timing: Prior to initiation of therapy.

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Routine Monitoring

Frequency of Albuterol Use

Frequency: Each visit or as part of patient self-monitoring

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

Action Threshold: Increased frequency (e.g., daily use, >2 times/week) indicates worsening asthma control and need for reassessment of maintenance therapy.

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

Frequency: Each visit, patient self-assessment daily

Target: Minimal or no symptoms

Action Threshold: Persistent or worsening symptoms despite regular use of albuterol indicates inadequate control.

Heart Rate and Blood Pressure

Frequency: Periodically, especially if patient reports palpitations or tremor

Target: Within normal limits for patient

Action Threshold: Persistent tachycardia (>100 bpm) or significant hypertension.

Serum Potassium (if high doses or concomitant diuretics)

Frequency: As clinically indicated

Target: 3.5-5.0 mEq/L

Action Threshold: Hypokalemia (<3.5 mEq/L).

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Symptom Monitoring

  • Wheezing
  • Shortness of breath (dyspnea)
  • Chest tightness
  • Cough
  • Palpitations
  • Tremor
  • Nervousness

Special Patient Groups

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Pregnancy

Albuterol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. While animal studies have shown some adverse effects, human data are limited. It is often considered a necessary medication for acute asthma exacerbations during pregnancy.

Trimester-Specific Risks:

First Trimester: Limited data, but generally considered if clinically indicated for maternal health.
Second Trimester: Generally considered safe for use if clinically indicated.
Third Trimester: May inhibit uterine contractions (tocolytic effect) at high doses, but this is generally not clinically significant at therapeutic inhaled doses. Monitor for maternal tachycardia.
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Lactation

Albuterol is excreted into human milk, but at low levels. The amount ingested by the infant is likely to be small and unlikely to cause adverse effects. Generally considered compatible with breastfeeding.

Infant Risk: Low risk of adverse effects to the breastfed infant.
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Pediatric Use

Albuterol inhalation solution is widely used and effective in children aged 2 years and older for the treatment of bronchospasm. Dosing is weight-based or age-based. For children under 2 years, use is off-label and requires careful consideration and supervision by a specialist.

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Geriatric Use

Elderly patients may be more sensitive to the effects of sympathomimetic amines, particularly cardiovascular effects (e.g., tachycardia, palpitations, hypertension). Use with caution, starting with the lowest effective dose and monitoring for adverse effects.

Clinical Information

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Clinical Pearls

  • Albuterol is a 'rescue' medication for acute symptoms, not a maintenance therapy for daily control of asthma or COPD.
  • Increased use of albuterol (e.g., needing it more than twice a week, or waking up at night due to symptoms) is a key indicator of worsening asthma control and necessitates a re-evaluation of the patient's long-term controller therapy.
  • Educate patients on the difference between rescue inhalers (albuterol) and controller medications (e.g., inhaled corticosteroids).
  • Proper nebulizer technique is crucial for effective drug delivery. Ensure patients understand how to use and clean their nebulizer.
  • Patients should be advised to seek immediate medical attention if their symptoms worsen after using albuterol or if they experience severe side effects.
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Alternative Therapies

  • Levalbuterol (Xopenex): R-isomer of albuterol, may have fewer side effects (e.g., less tachycardia, tremor) in some patients.
  • Other Short-Acting Beta2-Agonists (SABAs): e.g., Metaproterenol (less common).
  • Anticholinergics (e.g., Ipratropium bromide): Can be used alone or in combination with albuterol for acute bronchospasm, particularly in COPD.
  • Systemic Corticosteroids: For severe acute exacerbations.
  • Long-Acting Beta2-Agonists (LABAs): Used for maintenance therapy, not acute relief (e.g., Salmeterol, Formoterol).
  • Inhaled Corticosteroids (ICS): Used for maintenance therapy to reduce inflammation (e.g., Fluticasone, Budesonide).
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 25 x 3mL vials
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.