Albuterol HFA Inh (200 Puffs) 18gm

Manufacturer PRASCO LABORATORIES Active Ingredient Albuterol Inhalation Aerosol(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. It is used to prevent breathing problems that happen with exercise.
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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
Apr 1996
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Albuterol HFA is a quick-relief inhaler, often called a 'rescue inhaler.' It helps open up your airways quickly when you have sudden breathing problems like wheezing, shortness of breath, or chest tightness due to asthma or COPD. It can also be used before exercise to prevent breathing problems.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication effectively, follow your doctor's instructions and read all the information provided. For inhalation into the lungs, use the medication as directed. If you are using multiple inhaled medications, consult your doctor about which one to use first.

Using the Inhaler

If you are using this medication to prevent exercise-induced breathing problems, use it 15 to 30 minutes before exercising.
Always follow the cleaning instructions carefully.
Replace the cap after each use.
Shake the inhaler well before use.
Before first use, you will need to prime the inhaler. You may also need to prime it if it has not been used for a while. Be sure to understand when and how to prime the inhaler. If you have questions, consult your doctor or pharmacist.
If you drop the inhaler, it may need to be primed again. Check with your doctor or pharmacist if you are unsure.
A spacer can be used with the inhaler to make it easier to use.
Some inhalers have a dose counter to track the number of doses remaining. If your inhaler has a dose counter, discard it when the counter reaches "0".

Storing and Disposing of Your Medication

Store the medication at room temperature, protected from light and moisture. Do not store it in a bathroom.
Keep the medication away from cold temperatures.
If the inhaler comes in a foil pouch, store it in the pouch until you are ready to use it.
Protect the medication from heat and sunlight. Do not puncture or burn the inhaler, even if it seems empty.

Missing a Dose

If you use this medication regularly, take a missed dose as soon as you remember.
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 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 proper inhaler technique as demonstrated by your healthcare provider. Shake the inhaler well before each use, prime it if it's new or hasn't been used for a while, exhale fully, inhale slowly and deeply while pressing down on the canister, hold your breath for 5-10 seconds, and then exhale slowly.
  • Clean your inhaler regularly as instructed in the package insert.
  • Avoid known asthma triggers (e.g., smoke, allergens, cold air).
  • Do not use this inhaler more often than prescribed. If you need to use it more frequently, it may indicate your condition is worsening, and you should contact your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: 2 inhalations every 4 to 6 hours as needed for bronchospasm
Dose Range: 2 - 2 mg

Condition-Specific Dosing:

exercise-induced bronchospasm: 2 inhalations 15 to 30 minutes before exercise
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (use nebulized albuterol often preferred)
Child: 4 years and older: 2 inhalations every 4 to 6 hours as needed for bronchospasm; 2 inhalations 15 to 30 minutes before exercise
Adolescent: 2 inhalations every 4 to 6 hours as needed for bronchospasm; 2 inhalations 15 to 30 minutes before exercise
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed
Moderate: No specific adjustment needed
Severe: Use with caution; monitor for increased systemic effects due to potential accumulation of renally excreted metabolites. No specific dose adjustment guidelines.
Dialysis: No specific adjustment needed, but monitor for systemic effects.

Hepatic Impairment:

Mild: No specific adjustment needed
Moderate: No specific adjustment needed
Severe: No specific adjustment needed, but use with caution as albuterol is metabolized in the liver.

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 relaxation of bronchial smooth muscle and bronchodilation. This action is mediated by activation of adenyl cyclase, which increases intracellular cyclic AMP (cAMP) levels. Increased cAMP levels lead to relaxation of smooth muscle and inhibition of release of mediators from mast cells in the airways.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 10-20% of the inhaled dose reaches the systemic circulation after absorption from the lungs. The remaining portion is swallowed and absorbed from the GI tract, undergoing first-pass metabolism.
Tmax: 0.5 to 2 hours (for systemic effects after inhalation)
FoodEffect: Not applicable for inhaled administration.

Distribution:

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

Elimination:

HalfLife: 3.8 to 5 hours (systemic)
Clearance: Approximately 270 mL/min
ExcretionRoute: Renal (primarily as unchanged drug and sulfate conjugate)
Unchanged: Approximately 69% of the intravenous dose is excreted unchanged in urine.
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Pharmacodynamics

OnsetOfAction: Within 5 minutes
PeakEffect: 30 to 60 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 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

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, 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 the inhaler.
  • Needing to use the inhaler more often than usual (e.g., more than twice a week for symptoms, not including exercise-induced).
  • Symptoms not improving or getting worse after using the inhaler.
  • Chest pain, rapid or irregular heartbeat, or severe tremor after use.
  • Signs of an allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, 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.

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

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

To ensure your safety, it is vital to verify that it is safe to take this medication with all of your other medications and health conditions. Do not start, stop, or change the dose of any medication without first consulting your doctor.
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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 (rapid heart rate)
  • Palpitations (pounding heart)
  • Tremor (shakiness)
  • Nervousness
  • Headache
  • Dizziness
  • Nausea
  • Vomiting
  • Hypokalemia (low potassium levels)
  • Hyperglycemia (high blood sugar)
  • Metabolic acidosis

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 at 1-800-222-1222.

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. Avoid concomitant use.
  • 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 discontinuing MAOIs/TCAs.
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Moderate Interactions

  • Diuretics (e.g., loop or thiazide diuretics): May worsen ECG changes and/or hypokalemia induced by beta-agonists, especially at high doses. Monitor serum potassium.
  • 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)

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

Timing: Prior to initiation of therapy, especially for new diagnoses.

Vital Signs (Heart Rate, Blood Pressure)

Rationale: To establish baseline and identify potential cardiovascular risks.

Timing: Prior to initiation.

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Routine Monitoring

Frequency of albuterol use

Frequency: At each follow-up visit

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

Action Threshold: Increased frequency of use (e.g., >2 days/week) indicates worsening asthma control and need for re-evaluation of maintenance therapy.

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

Frequency: Daily (patient self-monitoring) and at each follow-up visit

Target: Minimal or no symptoms

Action Threshold: Persistent or worsening symptoms despite regular use, or need for frequent rescue inhaler use.

Heart Rate and Blood Pressure

Frequency: Periodically, especially in patients with cardiovascular comorbidities or those reporting palpitations/tremor.

Target: Within normal limits for the patient

Action Threshold: Significant tachycardia, palpitations, or hypertension.

Serum Potassium

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

Target: 3.5-5.0 mEq/L

Action Threshold: Hypokalemia (<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 or rapid heart rate
  • Tremor

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 needed for asthma control, as uncontrolled asthma poses greater risks to both mother and fetus.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity observed in animal studies at high doses; human data are reassuring but limited.
Second Trimester: Generally considered safe for use if clinically indicated.
Third Trimester: May inhibit uterine contractions (tocolytic effect) and cause transient maternal/fetal tachycardia. Use with caution during labor and delivery.
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Lactation

Albuterol is excreted in human milk. However, due to its low systemic absorption and short half-life, the amount transferred to breast milk is likely small. It is generally considered compatible with breastfeeding, but caution is advised. Monitor the infant for signs of agitation or tremor.

Infant Risk: Low risk; monitor for irritability, tremor, or feeding difficulties.
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Pediatric Use

Albuterol HFA is approved for use in children 4 years of age and older. Dosing is similar to adults. Proper inhaler technique is crucial and may require supervision or use of a valved holding chamber (spacer) for younger children.

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Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Use with caution in elderly patients with co-morbid conditions such as cardiovascular disease (e.g., ischemic heart disease, hypertension, arrhythmias) or diabetes, due to potential for systemic beta-adrenergic effects.

Clinical Information

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Clinical Pearls

  • Albuterol HFA is a rescue inhaler for acute symptoms, not a maintenance medication for daily control (unless specifically prescribed for exercise-induced bronchospasm).
  • Patients should be instructed on proper inhaler technique, including shaking the inhaler, priming (if new or not used for a period), exhaling fully, inhaling slowly and deeply, holding breath, and cleaning the device.
  • Over-reliance on albuterol (e.g., using the inhaler more than twice a week for symptoms, excluding exercise-induced bronchospasm) indicates poorly controlled asthma and warrants re-evaluation of the patient's asthma action plan and maintenance therapy.
  • Paradoxical bronchospasm (worsening of wheezing or shortness of breath immediately after using the inhaler) is rare but can occur; if it happens, discontinue the drug immediately and use an alternative bronchodilator.
  • Patients should be advised to seek immediate medical attention if their symptoms worsen or if they experience severe side effects like chest pain or severe palpitations.
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Alternative Therapies

  • Other short-acting beta-agonists (SABAs) like levalbuterol (Xopenex HFA).
  • Long-acting beta-agonists (LABAs) for maintenance therapy (e.g., salmeterol, formoterol), often in combination with inhaled corticosteroids.
  • Inhaled corticosteroids (ICS) for asthma maintenance (e.g., fluticasone, budesonide).
  • Long-acting muscarinic antagonists (LAMAs) for COPD (e.g., tiotropium).
  • Systemic corticosteroids for acute exacerbations.
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Cost & Coverage

Average Cost: $30 - $70+ per 18gm inhaler (200 puffs)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred generic or brand)
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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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.