Proventil 2mg Tablets

Manufacturer SCHERING Active Ingredient Albuterol Tablets(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
Category C
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FDA Approved
Jun 1981
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Albuterol tablets are a medicine used to open up the airways in your lungs, making it easier to breathe. It's often used for conditions like asthma or COPD. It works by relaxing the muscles around your airways. Take it exactly as prescribed, usually several times a day.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food.

Storing and Disposing of Your Medication

Store your medication at room temperature, away from light and moisture. Keep it in a dry place, avoiding storage in a bathroom. Ensure that all medications are kept in a safe location, out of reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult your pharmacist for guidance on proper disposal. You may also want to check if there are drug take-back programs available in your area.

Missing a Dose

If you take this medication regularly, take a missed dose as soon as you remember. However, if it's 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 take extra doses. If you use this medication as needed, do not take it more frequently than directed by your doctor.
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Lifestyle & Tips

  • Do not exceed the prescribed dose, as this can increase side effects.
  • Report any worsening of breathing or symptoms immediately to your doctor.
  • Avoid smoking, as it can worsen respiratory conditions and reduce the effectiveness of the medication.
  • Maintain good hydration to help thin mucus in the airways.

Dosing & Administration

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Adult Dosing

Standard Dose: 2 mg to 4 mg three or four times daily
Dose Range: 2 - 4 mg

Condition-Specific Dosing:

elderly_or_sensitive: Initially 2 mg three or four times daily, then cautiously increased.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: 6-12 years: 2 mg three or four times daily. May increase to 4 mg three or four times daily if needed. Max 24 mg/day.
Adolescent: Over 12 years: Same as adult dosing (2 mg to 4 mg three or four times daily).
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, monitor for increased side effects.
Moderate: Consider starting at lower end of dosing range (e.g., 2 mg three times daily) and titrate based on response and tolerability.
Severe: Reduce dose significantly (e.g., 2 mg twice daily or less) and monitor closely due to primary renal excretion.
Dialysis: Not well studied; consider significant dose reduction and monitor for adverse effects. Albuterol is dialyzable.

Hepatic Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended, as hepatic metabolism is minor.
Severe: No specific adjustment recommended, as hepatic metabolism is minor.

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 relaxation of bronchial smooth muscle. This relaxation results in bronchodilation, which helps to relieve bronchospasm in conditions like asthma and COPD. The activation of beta-2 receptors also leads to an increase in intracellular cyclic AMP (cAMP), which inhibits the release of mediators from mast cells in the airways.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 50% (oral)
Tmax: 2-3 hours
FoodEffect: Food may delay absorption but does not significantly affect the extent of absorption.

Distribution:

Vd: Approximately 3.1 L/kg
ProteinBinding: 10% (low)
CnssPenetration: Limited

Elimination:

HalfLife: 4-6 hours
Clearance: Not readily available for oral form, but primarily renal.
ExcretionRoute: Renal (urine)
Unchanged: Approximately 60% of an oral dose is excreted unchanged in urine within 24 hours.
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Pharmacodynamics

OnsetOfAction: 30-60 minutes
PeakEffect: 2-3 hours
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
Signs of a severe skin reaction (Stevens-Johnson syndrome, erythema multiforme), including:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Skin reaction that resembles rings
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
Chest pain or pressure
Rapid or irregular heartbeat

This medication may also cause severe breathing problems, which can be life-threatening. If you experience trouble breathing, worsening breathing, wheezing, or coughing, especially after using an inhaler or liquid for breathing in, 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 notice 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

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:

  • Severe or worsening shortness of breath
  • Chest pain or discomfort
  • Fast or irregular heartbeat (palpitations)
  • Severe dizziness or lightheadedness
  • Unusual muscle weakness or cramps (signs of low potassium)
  • Allergic reaction symptoms (rash, itching, swelling, severe dizziness, trouble 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 there are any potential interactions.

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 existing health problems

This information will help your doctor determine if it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose 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 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 using this medication during pregnancy or breastfeeding to ensure the best possible outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Tachycardia (fast heart rate)
  • Palpitations
  • Arrhythmias
  • Tremor
  • Nervousness
  • Headache
  • Nausea
  • Vomiting
  • Hypokalemia
  • Hyperglycemia
  • Metabolic acidosis

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic, including careful monitoring of cardiac function, serum potassium, and blood glucose.

Drug Interactions

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Major Interactions

  • Non-selective beta-blockers (e.g., propranolol, nadolol)
  • MAO inhibitors (MAOIs)
  • Tricyclic antidepressants (TCAs)
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Moderate Interactions

  • Diuretics (loop or thiazide)
  • Digoxin
  • Other sympathomimetics

Monitoring

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Baseline Monitoring

Pulmonary Function Tests (e.g., FEV1)

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

Timing: Prior to initiation of therapy.

Heart Rate and Blood Pressure

Rationale: Albuterol can cause cardiovascular stimulation.

Timing: Prior to initiation of therapy.

Serum Potassium

Rationale: Albuterol can cause transient hypokalemia.

Timing: Prior to initiation, especially in patients at risk (e.g., on diuretics).

Blood Glucose

Rationale: Albuterol can cause transient hyperglycemia, especially in diabetic patients.

Timing: Prior to initiation, especially in diabetic patients.

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Routine Monitoring

Pulmonary Function Tests (e.g., FEV1)

Frequency: Periodically, as clinically indicated (e.g., every 3-6 months for stable patients, more frequently for unstable).

Target: Improvement from baseline, individualized.

Action Threshold: Lack of improvement or worsening indicates need for re-evaluation of therapy.

Heart Rate and Blood Pressure

Frequency: Periodically, especially during dose titration or if symptoms of cardiovascular stimulation occur.

Target: Within normal limits or patient's baseline.

Action Threshold: Persistent tachycardia (>100 bpm) or significant hypertension may require dose adjustment or discontinuation.

Serum Potassium

Frequency: Periodically, especially in patients at risk for hypokalemia (e.g., concomitant diuretic use, severe asthma exacerbation).

Target: 3.5-5.0 mEq/L.

Action Threshold: Hypokalemia (<3.5 mEq/L) may require potassium supplementation or dose adjustment.

Blood Glucose

Frequency: Periodically, especially in diabetic patients.

Target: Individualized glycemic targets.

Action Threshold: Persistent hyperglycemia may require adjustment of diabetes medication or albuterol dose.

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Symptom Monitoring

  • Tremor
  • Nervousness
  • Palpitations
  • Headache
  • Dizziness
  • Muscle cramps
  • Chest pain
  • Worsening shortness of breath (paradoxical bronchospasm)

Special Patient Groups

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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. Oral albuterol may inhibit uterine contractions.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though human data are limited and conflicting.
Second Trimester: Risk of maternal cardiovascular effects (tachycardia, hyperglycemia) and potential for fetal effects.
Third Trimester: May inhibit uterine contractions and delay labor. Risk of maternal and fetal tachycardia, hypokalemia, and hyperglycemia.
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Lactation

Albuterol is excreted in human milk. While the amount is likely small, caution should be exercised when albuterol is administered to a nursing mother. Monitor the infant for signs of beta-adrenergic effects (e.g., irritability, poor feeding, tremor).

Infant Risk: Low risk, but potential for mild beta-adrenergic effects in the infant.
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Pediatric Use

Oral albuterol is approved for children 6 years and older. Dosing must be carefully adjusted based on age and weight. Younger children may be more susceptible to systemic side effects. Inhaled albuterol is generally preferred for acute bronchospasm in children due to faster onset and fewer systemic effects.

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Geriatric Use

Elderly patients may be more sensitive to the effects of sympathomimetics, particularly cardiovascular effects (e.g., tachycardia, arrhythmias, hypertension). Start with the lower end of the dosing range (e.g., 2 mg three or four times daily) and titrate cautiously based on response and tolerability. Monitor closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Oral albuterol has a slower onset and longer duration of action compared to inhaled albuterol, and is associated with more systemic side effects (e.g., tremor, nervousness, tachycardia).
  • It is generally reserved for patients who cannot use inhaled formulations or for whom inhaled therapy is insufficient.
  • Patients should be advised not to use oral albuterol for acute relief of bronchospasm; inhaled short-acting beta-agonists (SABAs) are the preferred rescue medication.
  • Paradoxical bronchospasm, though rare with oral forms, can occur and requires immediate discontinuation.
  • Educate patients on the difference between oral and inhaled albuterol and their respective roles in asthma/COPD management.
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Alternative Therapies

  • Inhaled short-acting beta-agonists (e.g., albuterol HFA, levalbuterol HFA)
  • Inhaled long-acting beta-agonists (LABAs) (e.g., salmeterol, formoterol)
  • Inhaled corticosteroids (ICS)
  • Combination ICS/LABA inhalers
  • Long-acting muscarinic antagonists (LAMAs) (e.g., tiotropium)
  • Oral corticosteroids (for acute exacerbations)
  • Methylxanthines (e.g., theophylline - less common due to narrow therapeutic index)
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Cost & Coverage

Average Cost: $10 - $30 per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.