Albuterol HFA Inh (200 Puffs) 6.7gm

Manufacturer CIPLA USA 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
Short-acting beta2-adrenergic agonist (SABA)
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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 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 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 using it.
Before using the inhaler for the first time, or if it has not been used for a while, you will need to prime it. 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, you may need to prime it 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 resume 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 your inhaler exactly as prescribed by your doctor.
  • Do not use your rescue inhaler more often than prescribed, as this could be a sign that your asthma is not well-controlled and you may need a different daily medication.
  • Rinse your mouth with water after each use to prevent dry mouth and throat irritation.
  • Keep track of how many puffs you use and when you need a refill.
  • Avoid triggers that worsen your breathing problems (e.g., smoke, allergens, cold air).
  • Maintain good hydration.

Dosing & Administration

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Adult Dosing

Standard Dose: 2 inhalations every 4-6 hours as needed for bronchospasm; 2 inhalations 15-30 minutes before exercise for prevention of exercise-induced bronchospasm (EIB)
Dose Range: 1 - 2 mg

Condition-Specific Dosing:

acute_bronchospasm: 2 inhalations every 4-6 hours as needed
exercise_induced_bronchospasm_prevention: 2 inhalations 15-30 minutes before exercise
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Pediatric Dosing

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

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No specific recommendations; albuterol is minimally renally excreted unchanged.

Hepatic Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed

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). The increase in cAMP leads to relaxation of bronchial smooth muscle, inhibition of mediator release from mast cells, and to a lesser extent, inhibition of microvascular leakage and enhancement of mucociliary clearance.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 50% (oral bioavailability of swallowed dose)
Tmax: 0.5-2 hours (for bronchodilation effect, not plasma concentration)
FoodEffect: Not clinically significant for inhaled product

Distribution:

Vd: Not available (widely distributed)
ProteinBinding: 10%
CnssPenetration: Limited

Elimination:

HalfLife: 3.8-5 hours (inhaled)
Clearance: Not available
ExcretionRoute: Renal (primarily as metabolites, some unchanged drug)
Unchanged: Approximately 20% (of inhaled dose)
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Pharmacodynamics

OnsetOfAction: Within 5 minutes
PeakEffect: 30-60 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
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 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:

  • Increased need for your rescue inhaler (using it more than 2 days a week, not for exercise-induced symptoms)
  • Symptoms waking you up at night
  • Decreased effectiveness of the inhaler
  • Worsening shortness of breath or wheezing
  • Chest pain or rapid heart rate
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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. Please 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 existing health problems

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:

  • Exaggerated beta-adrenergic stimulation
  • Tachycardia
  • Palpitations
  • Tremor
  • Nervousness
  • Headache
  • Dizziness
  • Nausea
  • Vomiting
  • Hypokalemia
  • Hyperglycemia
  • Metabolic acidosis

What to Do:

Seek immediate medical attention or call 911. Call Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic. Consider a cardioselective beta-blocker in severe cases, but use with extreme caution due to risk of bronchospasm.

Drug Interactions

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Contraindicated Interactions

  • Beta-blockers (non-selective and cardioselective, e.g., Propranolol, Carvedilol, Metoprolol): May block the bronchodilator effect of albuterol and produce severe bronchospasm in asthmatic patients.
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Major Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) and Tricyclic Antidepressants (TCAs): May potentiate the vascular effects of albuterol, increasing risk of cardiovascular adverse effects. Use with extreme caution or avoid within 2 weeks of discontinuing MAOIs/TCAs.
  • Diuretics (loop or thiazide): May exacerbate ECG changes and/or hypokalemia associated with high doses of beta-agonists.
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Moderate Interactions

  • Digoxin: Albuterol may decrease serum digoxin levels. Monitor digoxin levels.
  • Other sympathomimetic agents: Concomitant use may potentiate adverse cardiovascular effects. Use with caution.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Pulmonary function tests (e.g., FEV1)

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

Timing: Prior to initiation of therapy and periodically.

Heart rate and blood pressure

Rationale: Albuterol can cause cardiovascular effects.

Timing: Prior to initiation.

Symptom assessment (frequency of rescue inhaler use, nocturnal symptoms)

Rationale: To establish baseline symptom control.

Timing: Prior to initiation.

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Routine Monitoring

Frequency of albuterol use

Frequency: Daily (patient self-monitoring)

Target: < 2 days/week (for asthma control, excluding EIB prevention)

Action Threshold: > 2 days/week use (excluding EIB) indicates inadequate asthma control and need for re-evaluation of maintenance therapy.

Symptom control (daytime/nighttime symptoms, activity limitation)

Frequency: Regularly (patient self-monitoring, clinician review at visits)

Target: Minimal to no symptoms

Action Threshold: Increased symptoms or activity limitation.

Peak expiratory flow (PEF) or FEV1

Frequency: Periodically (as clinically indicated)

Target: Patient's personal best or predicted normal

Action Threshold: Significant decrease from baseline.

Heart rate and blood pressure

Frequency: Periodically, especially if cardiovascular risk factors are present or symptoms occur.

Target: Within normal limits for patient

Action Threshold: Significant increase or sustained elevation.

Serum potassium (if high doses or concomitant diuretics)

Frequency: As clinically indicated

Target: 3.5-5.0 mEq/L

Action Threshold: Hypokalemia.

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Symptom Monitoring

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

Special Patient Groups

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Pregnancy

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Albuterol is a Category C drug. Untreated asthma poses a greater risk to the mother and fetus than albuterol use.

Trimester-Specific Risks:

First Trimester: Limited data, but generally considered low risk compared to uncontrolled asthma.
Second Trimester: Generally considered safe for use if needed for asthma control.
Third Trimester: Generally considered safe for use if needed for asthma control. May inhibit uterine contractions at high doses, but this is not typically a concern with standard inhaled doses.
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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. Use with caution, but generally considered compatible with breastfeeding.

Infant Risk: Low risk of adverse effects in breastfed infants. Monitor for irritability, tremor, or poor feeding.
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Pediatric Use

Approved for children 4 years and older. Dosing is similar to adults. Proper inhaler technique is crucial and may require supervision or use of a spacer with a mask for younger children.

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Geriatric Use

No specific dose adjustment is generally required. However, elderly patients may be more susceptible to the cardiovascular effects of beta-agonists (e.g., tachycardia, tremor). Use with caution in patients with underlying cardiovascular disease.

Clinical Information

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Clinical Pearls

  • Albuterol is a rescue medication, not a controller. Increased use indicates worsening asthma control and necessitates re-evaluation of maintenance therapy.
  • Proper inhaler technique is critical for efficacy. Patients should be instructed on how to use the HFA inhaler correctly, including shaking the canister, priming (if new or not used for a period), exhaling fully, inhaling slowly and deeply while actuating, holding breath, and rinsing mouth.
  • Patients should be advised to seek immediate medical attention if their symptoms worsen or if they experience severe side effects.
  • Patients with exercise-induced bronchospasm should use albuterol 15-30 minutes before exercise.
  • Paradoxical bronchospasm can occur, though rarely. If this happens, discontinue the product immediately and use an alternative therapy.
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Alternative Therapies

  • Other short-acting beta2-agonists (SABAs) in nebulized form (e.g., albuterol nebulizer solution)
  • Long-acting beta2-agonists (LABAs) for maintenance therapy (e.g., Salmeterol, Formoterol - always used with an inhaled corticosteroid for asthma)
  • Inhaled corticosteroids (ICS) for asthma control (e.g., Fluticasone, Budesonide)
  • Combination ICS/LABA inhalers for asthma control (e.g., Fluticasone/Salmeterol, Budesonide/Formoterol)
  • Systemic corticosteroids for acute exacerbations
  • Anticholinergics (e.g., Ipratropium) for COPD or as an add-on for severe asthma exacerbations.
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Cost & Coverage

Average Cost: Varies widely, typically $30-$70 per 6.7gm (200 puffs) inhaler
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 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 is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.