Albuterol 0.083%(2.5mg/3ml) Inh Sol

Manufacturer SUN PHARMACEUTICALS 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
Not available
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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 helps open up your airways quickly when you have trouble breathing, like during an asthma attack or flare-up. 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 for you to inhale.
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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 intended 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 with this solution in the nebulizer.

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.

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 return to 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 use it more frequently than directed by your doctor.
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Lifestyle & Tips

  • Always carry your rescue inhaler with you.
  • Use albuterol only as needed for sudden breathing problems, not for daily prevention.
  • If you find yourself using albuterol more often than usual (e.g., more than twice a week for symptoms, or more than twice a month for nighttime symptoms), contact your doctor. This could mean your asthma is not well-controlled and your regular maintenance medication may need adjustment.
  • Do not stop or change your other asthma medications unless directed by your doctor.
  • Avoid triggers that worsen your asthma (e.g., smoke, allergens, cold air).
  • Practice proper nebulizer technique as instructed by your healthcare provider or pharmacist.

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

severe_bronchospasm: May increase frequency to every 4 hours or increase dose to 5 mg (two 3 mL vials of 0.083%) 3-4 times daily under medical supervision.
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Pediatric Dosing

Neonatal: Not established for routine use; use with extreme caution and individualized dosing if clinically necessary.
Infant: Not established for routine use; use with extreme caution and individualized dosing if clinically necessary. For children 2-12 years, 1.25 mg or 2.5 mg 3-4 times daily.
Child: 2 to 12 years: 1.25 mg or 2.5 mg (one 3 mL vial of 0.083%) administered 3 to 4 times daily by nebulization. Dosing may be individualized based on response.
Adolescent: 12 years and older: 2.5 mg (one 3 mL vial of 0.083%) administered 3 to 4 times daily by nebulization.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended, but monitor for increased systemic effects.
Severe: Use with caution; monitor for increased systemic effects due to potential for reduced clearance.
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.
Severe: Use with caution; monitor for increased systemic effects as hepatic metabolism may be impaired.

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 bronchial smooth muscle, 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% of an inhaled dose reaches the lower airways; the remainder is deposited in the oropharynx and swallowed. The swallowed portion is absorbed from the GI tract.
Tmax: Systemic Tmax is approximately 2-5 hours after oral inhalation.
FoodEffect: Not applicable for inhaled solution.

Distribution:

Vd: Approximately 300 L (in adults).
ProteinBinding: Approximately 10% protein bound.
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 3.8 to 5 hours (systemic).
Clearance: Not readily available for inhaled route, but primarily renal.
ExcretionRoute: Renal (urine).
Unchanged: Approximately 60% of an orally administered dose is excreted unchanged in urine within 24 hours; for inhaled dose, a significant portion of the systemically absorbed drug is excreted unchanged.
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Pharmacodynamics

OnsetOfAction: 5 to 15 minutes
PeakEffect: 60 to 90 minutes
DurationOfAction: 4 to 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 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 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. While many people may not experience any side effects or only minor 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 bother you or persist:

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.
  • Fast or irregular heartbeat (palpitations).
  • Severe dizziness or lightheadedness.
  • Signs of an allergic reaction (rash, hives, swelling of face/lips/tongue, severe difficulty 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 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 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, contact your doctor immediately.

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 breastfeeding. 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:

  • Exaggerated beta-adrenergic stimulation: tachycardia, palpitations, tremor, headache, nervousness, nausea, dizziness, fatigue, malaise, insomnia.
  • Metabolic effects: hypokalemia, hyperglycemia, lactic acidosis.
  • Cardiovascular effects: angina, hypertension, hypotension, arrhythmias (including supraventricular tachycardia and premature ventricular contractions).

What to Do:

Seek immediate medical attention or call Poison Control (1-800-222-1222). Treatment is supportive and symptomatic. Consider a cardioselective beta-blocker if severe cardiac symptoms are present, but use with extreme caution in patients with a history of bronchospasm.

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 or avoid use within 14 days of discontinuing MAOIs/TCAs.
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Moderate Interactions

  • Diuretics (loop or thiazide): 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 extreme caution.

Monitoring

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Baseline Monitoring

Baseline lung function (e.g., FEV1, peak flow)

Rationale: To assess severity of asthma/COPD and establish a baseline for treatment efficacy.

Timing: Prior to initiation of therapy.

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: Regularly, at each visit or as reported by patient

Target: As needed, typically not more than 4 times daily for chronic use. Increased use indicates worsening asthma control.

Action Threshold: Increased frequency of use (e.g., >2 days/week for symptom relief, or >2 times/month for nocturnal symptoms) suggests inadequate asthma control and warrants re-evaluation of maintenance therapy.

Symptoms of asthma/COPD (e.g., wheezing, shortness of breath, cough)

Frequency: Regularly, at each visit or as reported by patient

Target: Minimal to no symptoms.

Action Threshold: Persistent or worsening symptoms, or increased nocturnal awakenings, indicate need for treatment adjustment.

Heart rate and blood pressure

Frequency: Periodically, especially if patient reports palpitations or tremor, or has cardiovascular comorbidities.

Target: Within normal limits for the patient.

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

Serum potassium (if high doses or concomitant diuretics)

Frequency: Periodically, as clinically indicated.

Target: 3.5-5.0 mEq/L

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

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Symptom Monitoring

  • Increased wheezing or shortness of breath
  • Increased cough
  • Chest tightness
  • Increased need for rescue inhaler
  • Nocturnal awakenings due to asthma symptoms
  • Palpitations or rapid heart rate
  • Tremor or nervousness
  • Dizziness

Special Patient Groups

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Pregnancy

Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Albuterol has been shown to be teratogenic in animal studies at high doses, but human data are reassuring. It is a commonly used medication for asthma exacerbations during pregnancy.

Trimester-Specific Risks:

First Trimester: Animal studies show teratogenicity at high doses; human data do not suggest increased risk of major birth defects.
Second Trimester: Generally considered safe for use if clinically indicated.
Third Trimester: May inhibit uterine contractions and cause transient maternal tachycardia or hyperglycemia. Neonatal hypoglycemia has been reported rarely.
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Lactation

Albuterol is excreted in human milk. However, due to its low oral bioavailability and short half-life, systemic exposure to the infant is expected to be low. Generally considered compatible with breastfeeding, but monitor infant for irritability or tremor.

Infant Risk: Low risk; monitor for signs of beta-adrenergic effects (e.g., irritability, tremor, tachycardia).
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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 be more sensitive to systemic effects. Proper nebulizer technique is crucial.

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Geriatric Use

Use with caution in elderly patients, as they may be more susceptible to the cardiovascular and central nervous system effects of sympathomimetics. Start with the lowest effective dose and titrate slowly. Monitor for tremor, palpitations, and blood pressure changes.

Clinical Information

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Clinical Pearls

  • Albuterol is a rescue medication for acute bronchospasm; it is not for daily maintenance therapy.
  • Increased use of albuterol (e.g., more than twice a week for symptoms) indicates worsening asthma control and warrants re-evaluation of maintenance therapy.
  • Educate patients on proper nebulizer technique to ensure effective drug delivery.
  • Patients should be advised to seek immediate medical attention if their symptoms worsen or if they experience severe side effects after using albuterol.
  • Paradoxical bronchospasm can occur with any inhaled bronchodilator; if it occurs, discontinue albuterol immediately and institute alternative therapy.
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Alternative Therapies

  • Levalbuterol (Xopenex) - R-isomer of albuterol, may have fewer side effects in some patients.
  • Other short-acting beta-agonists (SABAs) in different formulations (e.g., metered-dose inhalers).
  • Long-acting beta-agonists (LABAs) - for maintenance therapy, not acute relief.
  • Inhaled corticosteroids (ICS) - for maintenance therapy, not acute relief.
  • Systemic corticosteroids - for severe acute exacerbations.
  • Anticholinergics (e.g., ipratropium) - may be used alone or in combination with albuterol for acute exacerbations.
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Cost & Coverage

Average Cost: $15 - $50 per 25-30 vials (3 mL, 0.083%)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (preferred 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 occurred.