Proventil HFA In W/dos Ctr 200puffs

Manufacturer SANDOZ 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
C
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FDA Approved
Aug 2005
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Albuterol is a 'rescue inhaler' medication used to quickly open up the airways in your lungs. It helps relieve symptoms like wheezing, shortness of breath, and coughing caused by asthma or COPD. It works by relaxing the muscles around your airways, making it easier to breathe.
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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.

Pre-Exercise Use

If you are using this medication to prevent breathing problems that occur with exercise, use it 15 to 30 minutes before exercising. Be sure to follow the cleaning instructions carefully.

Preparing Your Inhaler

Before using your inhaler, shake it well. You will need to prime the inhaler before the first use and also if it has not been used for a while. Make sure you understand when and how to prime the inhaler. If you have questions, consult your doctor or pharmacist. Some inhalers may need to be primed if they are dropped, so check with your doctor or pharmacist if you are unsure.

Using a Spacer

A spacer can be used with the inhaler to make it easier to use.

Tracking Your Doses

If your inhaler has a dose counter, use it to keep track of the number of doses left. When the counter reaches "0", discard the inhaler.

Storing and Disposing of Your Medication

Store your medication at room temperature, protected from light and moisture. Do not store it in a bathroom. If the inhaler comes in a foil pouch, store it in the pouch until you are ready to use it. Protect the inhaler from cold, 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, exhale fully, then inhale slowly and deeply while pressing down on the canister, hold your breath for 5-10 seconds, and exhale slowly.
  • Rinse your mouth with water and spit after each use to minimize potential side effects like dry mouth or throat irritation.
  • Do not use this medication more often than prescribed. Increased use may indicate worsening asthma and requires medical attention.
  • Identify and avoid triggers that worsen your breathing (e.g., allergens, smoke, cold air, exercise if not pre-treated).

Dosing & Administration

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Adult Dosing

Standard Dose: 2 inhalations (180 mcg) every 4 to 6 hours as needed for bronchospasm. For exercise-induced bronchospasm, 2 inhalations 15 to 30 minutes before exercise.

Condition-Specific Dosing:

exerciseInducedBronchospasm: 2 inhalations 15 to 30 minutes before exercise.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (typically nebulized albuterol is used for this age group)
Child: 4 years and older: 2 inhalations (180 mcg) every 4 to 6 hours as needed for bronchospasm. For exercise-induced bronchospasm, 2 inhalations 15 to 30 minutes before exercise.
Adolescent: Same as adult
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended due to low systemic absorption.
Moderate: No specific adjustment recommended due to low systemic absorption.
Severe: Use with caution; monitor for adverse effects, though systemic absorption is low.
Dialysis: No specific recommendations; low systemic absorption suggests minimal impact.

Hepatic Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended.
Severe: No specific adjustment recommended; albuterol is primarily metabolized by sulfate conjugation, not extensively by CYP450.

Pharmacology

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Mechanism of Action

Albuterol is a selective beta-2 adrenergic agonist. It acts by stimulating beta-2 receptors in the smooth muscle of the bronchi, leading to relaxation of the bronchial smooth muscle and bronchodilation. This action is mediated by activation of adenyl cyclase, which increases intracellular cyclic AMP (cAMP) levels.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 10-20% of an inhaled dose reaches the lungs; the remainder is swallowed and absorbed from the GI tract. Systemic bioavailability from the swallowed portion is about 50%.
Tmax: Inhalation: 0.5-2 hours (for bronchodilation effect); Oral: 2-3 hours (for systemic absorption).
FoodEffect: Not clinically significant for inhaled albuterol.

Distribution:

Vd: Approximately 156 L (in adults).
ProteinBinding: 10%
CnssPenetration: Limited

Elimination:

HalfLife: 3.8-5 hours (after inhalation).
Clearance: Not precisely quantified for inhaled route, but rapidly cleared.
ExcretionRoute: Renal (primarily as metabolite and unchanged drug).
Unchanged: Approximately 40% of the systemically absorbed dose is excreted unchanged in urine.
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Pharmacodynamics

OnsetOfAction: 5-15 minutes
PeakEffect: 60-90 minutes
DurationOfAction: 4-6 hours
Confidence: Medium

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 or excitable
Dizziness or headache
Upset stomach or vomiting
Shakiness
Throat irritation
Runny nose

This list is not exhaustive, and you may experience other 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 (paradoxical bronchospasm).
  • Increased need for your rescue inhaler (e.g., using it more than 2 days a week, or needing a refill more than once a month).
  • Chest pain or discomfort.
  • Fast or pounding heartbeat (palpitations).
  • Severe headache or dizziness.
  • Tremor or nervousness that is bothersome.
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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, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are currently using a similar medication. 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 disclose all your medications, including:

Prescription and over-the-counter (OTC) medications
Natural products
* Vitamins

Additionally, inform your doctor about any existing health problems. This information will help your doctor determine if it is safe for you to take this medication in conjunction with your other medications and health conditions.

Remember, do not start, stop, or modify the dosage of any medication without first consulting your doctor to ensure your safety.
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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, discuss your pregnancy status or plans to become pregnant or breastfeed with your doctor. This will enable you to weigh the benefits and risks of the medication for both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Tachycardia (fast heart rate)
  • Palpitations
  • Tremor
  • Nervousness
  • Headache
  • Dizziness
  • Nausea
  • Vomiting
  • Hyperglycemia (high blood sugar)
  • Hypokalemia (low potassium levels)
  • Metabolic acidosis

What to Do:

Seek immediate medical attention or call 911. Contact Poison Control at 1-800-222-1222. Management is supportive and symptomatic. Monitor cardiac function (ECG), serum potassium, and blood glucose levels. Beta-blockers should be used with extreme caution due to the risk of inducing 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 or avoid within 14 days of discontinuing MAOIs/TCAs.
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Moderate Interactions

  • Diuretics (loop or thiazide): May potentiate ECG changes and/or hypokalemia resulting from beta-agonists, especially at higher doses.
  • Digoxin: Albuterol may decrease serum digoxin levels. Monitor digoxin levels.
  • Other sympathomimetics: Concomitant use may potentiate adverse cardiovascular effects.
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Confidence Interactions

Monitoring

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Baseline Monitoring

Pulmonary Function Tests (e.g., FEV1)

Rationale: To establish baseline lung function and assess severity of respiratory condition.

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

Heart Rate and Blood Pressure

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

Timing: Prior to initiation.

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Routine Monitoring

Frequency of Albuterol Use

Frequency: At each follow-up visit (e.g., every 3-6 months)

Target: As needed, typically not more than 2 days a week for symptom control (excluding EIB). Increased use indicates worsening asthma control.

Action Threshold: Use more than 2 days a week (excluding EIB) or more than one canister per month suggests inadequate asthma control and requires re-evaluation of therapy.

Symptom Control (wheezing, shortness of breath, cough, chest tightness)

Frequency: Daily by patient, reviewed at each visit.

Target: Minimal to no symptoms.

Action Threshold: Persistent or worsening symptoms, nocturnal awakenings, or limitation of activity.

Heart Rate and Blood Pressure

Frequency: Periodically, especially in patients with cardiovascular comorbidities.

Target: Within normal limits for the patient.

Action Threshold: Significant or persistent tachycardia, palpitations, or 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

  • Shortness of breath
  • Wheezing
  • Cough
  • Chest tightness
  • Palpitations
  • Tremor
  • Nervousness
  • Dizziness
  • Headache
  • Paradoxical bronchospasm (worsening of breathing immediately after use)

Special Patient Groups

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Pregnancy

Albuterol is Pregnancy Category C. Use 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. It has been used clinically for preterm labor, but this is an off-label use.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity based on animal studies, but human data are limited and generally reassuring for therapeutic doses.
Second Trimester: Generally considered safer than first trimester, but still use only if clearly needed.
Third Trimester: May inhibit uterine contractions and cause maternal tachycardia, hyperglycemia, and hypokalemia. Fetal effects may include tachycardia and hypoglycemia.
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Lactation

Albuterol is excreted in human milk. However, due to low systemic absorption after inhalation, the amount transferred to breast milk is likely small, and systemic effects on the breastfed infant are not expected. Use with caution, weighing the benefits of breastfeeding against potential risks.

Infant Risk: Low risk of adverse effects on the infant due to low systemic exposure.
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Pediatric Use

Safe and effective for children 4 years of age and older. For children younger than 4 years, nebulized albuterol is generally preferred due to challenges with inhaler technique and lack of specific HFA device studies in this age group.

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Geriatric Use

Use with caution in elderly patients, especially those with cardiovascular disease, due to increased susceptibility to beta-adrenergic adverse effects (e.g., tachycardia, palpitations, tremor). Start with the lowest effective dose and monitor closely.

Clinical Information

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Clinical Pearls

  • Albuterol is a 'rescue' medication, not a maintenance therapy. Increased use (more than 2 days/week, excluding EIB) indicates poor asthma control and warrants re-evaluation of the patient's long-term asthma management plan.
  • Proper inhaler technique is critical for effective drug delivery. Patients should be regularly re-educated and their technique checked.
  • Patients should be advised to carry their rescue inhaler at all times.
  • Paradoxical bronchospasm is a rare but serious adverse effect; if it occurs, discontinue albuterol immediately and use an alternative bronchodilator.
  • While less common with HFA formulations, rinsing the mouth after use can help prevent local side effects like dry mouth or throat irritation.
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Alternative Therapies

  • Levalbuterol (Xopenex HFA): R-isomer of albuterol, may have fewer side effects (e.g., less tachycardia, tremor) in some patients.
  • Other short-acting beta-agonists (SABAs) in nebulized form (e.g., albuterol sulfate solution for nebulization).
  • Anticholinergics (e.g., ipratropium bromide): Can be used as an alternative or in combination with SABAs, particularly for COPD exacerbations.
  • Systemic corticosteroids: For acute severe exacerbations, often used in conjunction with SABAs.
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Cost & Coverage

Average Cost: Highly variable, typically $30-$70 per 200-puff inhaler
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred brand/generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is 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 it is a good idea to check with your pharmacist for more information. 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 details about the overdose, including the medication taken, the amount, and the time it occurred.