Albuterol HFA Inh (200 Puffs) 8.5gm

Manufacturer TEVA PHARMACEUTICALS 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
Selective beta-2 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 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's used for sudden breathing problems or before exercise to prevent them.
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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 breathing problems during exercise, 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 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, 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, away from light and moisture. Do not store it in a bathroom.
Protect the medication 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 inhalation technique as demonstrated by your healthcare provider.
  • Do not use more often than prescribed. Increased use may indicate worsening asthma and requires medical attention.
  • Rinse your mouth with water after each use to prevent dry mouth and reduce local side effects, though this is more critical for inhaled corticosteroids.
  • Keep track of how many puffs you use to know when to get a refill (most inhalers have a dose counter).

Dosing & Administration

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Adult Dosing

Standard Dose: 2 inhalations (180 mcg) every 4 to 6 hours as needed for bronchospasm.
Dose Range: 90 - 180 mg

Condition-Specific Dosing:

exercise-induced bronchospasm: 2 inhalations (180 mcg) 15 to 30 minutes before exercise.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: For children 4 years of age and older: 2 inhalations (180 mcg) every 4 to 6 hours as needed for bronchospasm. For exercise-induced bronchospasm: 2 inhalations (180 mcg) 15 to 30 minutes before exercise.
Adolescent: 2 inhalations (180 mcg) every 4 to 6 hours as needed for bronchospasm. For exercise-induced bronchospasm: 2 inhalations (180 mcg) 15 to 30 minutes before exercise.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended, use with caution.
Severe: No specific adjustment recommended, use with caution and monitor for adverse effects.
Dialysis: Considerations: Albuterol is not significantly removed by hemodialysis. Monitor for adverse effects.

Hepatic Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended, use with caution.
Severe: No specific adjustment recommended, use with caution and monitor for adverse effects.

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 smooth muscle of the bronchial tree, 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 some inhibition of microvascular leakage, resulting in bronchodilation.
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Pharmacokinetics

Absorption:

Bioavailability: Not directly applicable for inhaled drug (local action), but systemic absorption occurs. Approximately 20% of a single albuterol dose reaches the lungs, with the remainder swallowed.
Tmax: 2-5 hours (for systemic absorption after inhalation)
FoodEffect: Not clinically significant for inhaled albuterol.

Distribution:

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

Elimination:

HalfLife: 3.8-5 hours (systemic)
Clearance: Approximately 27 L/hr (systemic)
ExcretionRoute: Renal (primarily as unchanged drug and sulfate conjugate)
Unchanged: Approximately 69% of the orally absorbed 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

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 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, although many people may not experience any or may only have mild symptoms. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

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 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 after using the inhaler
  • Increased need for the inhaler (e.g., more than 2 days a week, not for exercise)
  • Chest pain or discomfort
  • Severe dizziness or lightheadedness
  • Severe palpitations or rapid heart rate
  • Muscle cramps or weakness (signs of hypokalemia)
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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 medications, 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 to determine if there are any potential interactions.
Please note that this is not an exhaustive list of all medications or health conditions that may interact with this drug.

To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All medications you are taking, including prescription and over-the-counter medications, natural products, and vitamins.
* Any health problems you have.

It is vital to verify that it is safe to take this medication with all of your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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Precautions & Cautions

It is crucial to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Adhering to the prescribed dosage and frequency is essential, as taking more of this drug or using it more often than directed can be fatal. If you have any 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 normal, contact your doctor immediately.

If you have diabetes (high blood sugar), it is essential 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:

  • Exaggeration of common side effects: tachycardia (rapid heart rate), palpitations, tremor, nervousness, headache, dizziness, nausea, dry mouth, fatigue, malaise.
  • Severe symptoms: chest pain, arrhythmias, hypertension or hypotension, hypokalemia, metabolic acidosis, seizures.

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic. Consider a cardioselective beta-blocker for severe cardiac symptoms, but use with extreme caution in patients with 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.
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Moderate Interactions

  • Diuretics (loop or thiazide): May exacerbate ECG changes and/or hypokalemia associated with beta-agonists, especially at high doses.
  • Digoxin: Albuterol may decrease serum digoxin levels. Monitor digoxin levels.
  • Other sympathomimetics: Concomitant use may potentiate adverse cardiovascular effects. Use with caution.

Monitoring

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Baseline Monitoring

Pulmonary Function Tests (e.g., FEV1, Peak Expiratory Flow)

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

Timing: Before initiating therapy and periodically.

Heart Rate and Blood Pressure

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

Timing: Before initiating therapy.

Serum Potassium

Rationale: High doses of beta-agonists can cause transient hypokalemia.

Timing: Consider in patients at risk for hypokalemia or on concomitant diuretics.

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Routine Monitoring

Frequency of Albuterol Use

Frequency: At each visit

Target: <2 days/week (excluding exercise-induced bronchospasm)

Action Threshold: Increased use (e.g., >2 days/week) indicates inadequate asthma control and warrants reassessment of maintenance therapy.

Symptom Control (daytime/nighttime symptoms, activity limitation)

Frequency: At each visit

Target: Minimal to no symptoms

Action Threshold: Persistent symptoms indicate need for adjustment of maintenance therapy.

Peak Expiratory Flow (PEF) readings (if patient uses a peak flow meter)

Frequency: Daily (if indicated by asthma action plan)

Target: Patient's personal best or >80% of predicted

Action Threshold: Significant drop in PEF (e.g., <80% of personal best) indicates worsening asthma.

Heart Rate and Blood Pressure

Frequency: Periodically, especially if cardiovascular symptoms reported.

Target: Within normal limits for patient

Action Threshold: Persistent tachycardia, palpitations, or hypertension.

Serum Potassium

Frequency: Periodically, if patient is on high doses or concomitant diuretics.

Target: 3.5-5.0 mEq/L

Action Threshold: <3.5 mEq/L

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Symptom Monitoring

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

Special Patient Groups

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Pregnancy

Use during pregnancy 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. Human data are limited but do not suggest a clear association with major birth defects.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though human data are reassuring.
Second Trimester: Generally considered safer than first trimester, but still use with caution.
Third Trimester: May inhibit uterine contractions (tocolytic effect) and cause transient maternal/fetal tachycardia or hyperglycemia. Monitor for these effects.
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Lactation

Albuterol is excreted in human milk. While the amount is likely small and systemic effects on the infant are not expected, caution should be exercised. Monitor the infant for signs of agitation, tremor, or feeding difficulties.

Infant Risk: Low risk, but monitor for irritability, tremor, or poor feeding.
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Pediatric Use

Safe and effective for children 4 years of age and older. Proper inhalation technique is crucial; consider spacer devices for younger children. Dosing is similar to adults for this age group.

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Geriatric Use

No specific dose adjustment is generally needed, but elderly patients may be more sensitive to the cardiovascular effects of beta-agonists. Use with caution and monitor for adverse effects such as tremor, tachycardia, and nervousness. Start with the lowest effective dose.

Clinical Information

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Clinical Pearls

  • Albuterol is a 'rescue' medication for acute bronchospasm, not a maintenance therapy. Increased use indicates worsening asthma control.
  • Proper inhalation technique is critical for effective drug delivery. Patients should be regularly re-educated on technique.
  • Paradoxical bronchospasm (worsening wheezing immediately after use) can occur; discontinue use and seek immediate medical attention if this happens.
  • Patients should be advised to keep a dose counter on their inhaler or track puffs manually to ensure they do not run out unexpectedly.
  • Inform patients about common side effects like tremor, nervousness, and palpitations, which are usually transient.
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Alternative Therapies

  • Levalbuterol (Xopenex HFA): A single isomer of albuterol, potentially with fewer side effects (e.g., less tremor) but higher cost.
  • Formoterol (Perforomist, Foradil): A long-acting beta-agonist (LABA), used for maintenance, not rescue.
  • Salmeterol (Serevent Diskus): Another LABA, used for maintenance.
  • Ipratropium (Atrovent HFA): An anticholinergic bronchodilator, often used for COPD or in combination with albuterol (DuoNeb) for severe asthma.
  • Inhaled Corticosteroids (ICS) (e.g., fluticasone, budesonide): Maintenance therapy for asthma, reduce inflammation.
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Cost & Coverage

Average Cost: Varies widely, typically $30-$70 per 8.5gm (200 puffs) inhaler
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (for generic), Tier 2 or 3 (for 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 this 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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.