Albuterol Sulfate 2mg Tablets

Manufacturer AMNEAL PHARMACEUTICALS 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
C
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FDA Approved
Sep 1981
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Albuterol is a medication used to open up the airways in your lungs, making it easier to breathe. It's often used to treat conditions like asthma and COPD. This tablet form works over several hours to help prevent breathing problems.
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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, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a safe location, out of the 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 the best disposal method. 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

  • Take this medication exactly as prescribed by your doctor. Do not take more or less than directed.
  • Do not stop taking other asthma or COPD medications unless advised by your doctor.
  • Avoid triggers that worsen your breathing problems (e.g., smoke, allergens, cold air).
  • Carry an inhaled rescue bronchodilator (if prescribed) for sudden breathing difficulties, as oral albuterol is not for acute attacks.
  • Report any worsening of symptoms or increased need for rescue inhaler use to your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: 2 mg to 4 mg three or four times daily
Dose Range: 2 - 8 mg

Condition-Specific Dosing:

extendedRelease: 4 mg to 8 mg every 12 hours, not to exceed 32 mg/day
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: 2-6 years: 0.1 mg/kg three times daily, not to exceed 2 mg three times daily. 6-12 years: 2 mg three or four times daily. May increase to 4 mg three or four times daily if needed.
Adolescent: 12 years and older: 2 mg to 4 mg three or four times daily. May increase to 8 mg four times daily if needed, not to exceed 32 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended
Moderate: No specific adjustment recommended, monitor for adverse effects
Severe: Use with caution; consider lower initial doses and monitor for adverse effects due to potential accumulation of albuterol and its metabolite.
Dialysis: Not well studied; albuterol is dialyzable, but clinical significance for oral form is low given its half-life and metabolism.

Hepatic Impairment:

Mild: No specific adjustment recommended
Moderate: No specific adjustment recommended
Severe: No specific adjustment recommended, as hepatic metabolism is not the primary elimination pathway for the active drug.

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 bronchi, leading to activation of adenyl cyclase and an increase in intracellular cyclic-3',5'-adenosine monophosphate (cAMP). The increased cAMP levels cause relaxation of bronchial smooth muscle, inhibition of the release of mediators from mast cells, and increased ciliary activity, resulting in bronchodilation.
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Pharmacokinetics

Absorption:

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

Distribution:

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

Elimination:

HalfLife: 4-6 hours (oral)
Clearance: Approximately 0.27 L/hr/kg
ExcretionRoute: Renal (primarily as metabolites)
Unchanged: Approximately 20% (oral dose)
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Pharmacodynamics

OnsetOfAction: Within 30 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 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. Many people may not experience any side effects or only minor ones. 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 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 or wheezing despite taking the medication.
  • Chest pain or discomfort.
  • Fast or irregular heartbeat (palpitations).
  • Severe dizziness or lightheadedness.
  • Muscle weakness or cramps (signs of low potassium).
  • Allergic reaction symptoms (rash, itching, swelling of face/tongue/throat, 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 the medications are similar.

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

It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Do not initiate, discontinue, or modify the dosage 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 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, immediately contact your doctor.

If you have diabetes (high blood sugar), it is crucial to closely monitor your blood sugar levels while taking this drug.

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 for both you and your baby, allowing you to make an informed decision.
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Overdose Information

Overdose Symptoms:

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

What to Do:

Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive and symptomatic. Beta-adrenergic blocking agents (e.g., cardioselective beta-blockers) may be considered, but use with extreme caution due to risk of bronchospasm.

Drug Interactions

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Contraindicated Interactions

  • Non-selective beta-blockers (e.g., propranolol, carvedilol) - may block the bronchodilatory effect of albuterol and produce severe bronchospasm.
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Major Interactions

  • Diuretics (thiazide or loop diuretics) - may potentiate ECG changes and/or hypokalemia associated with beta-agonists.
  • Digoxin - may decrease serum digoxin levels.
  • Monoamine Oxidase Inhibitors (MAOIs) and Tricyclic Antidepressants (TCAs) - may potentiate the vascular effects of albuterol, increasing risk of cardiovascular adverse effects.
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Moderate Interactions

  • Other sympathomimetics - additive cardiovascular effects.
  • Theophylline - increased risk of adverse cardiovascular effects and hypokalemia.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Heart Rate and Blood Pressure

Rationale: To establish baseline and monitor for cardiovascular adverse effects (tachycardia, palpitations, hypertension).

Timing: Prior to initiation of therapy.

Serum Potassium

Rationale: To establish baseline, especially in patients at risk for hypokalemia (e.g., concomitant diuretic use).

Timing: Prior to initiation of therapy.

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Routine Monitoring

Respiratory Symptoms (e.g., wheezing, shortness of breath)

Frequency: Regularly, as clinically indicated

Target: Improvement or resolution of symptoms

Action Threshold: Worsening symptoms, increased frequency of use, or lack of response may indicate inadequate control or worsening asthma/COPD and require re-evaluation.

Heart Rate and Blood Pressure

Frequency: Periodically, or if symptoms of cardiovascular effects occur

Target: Within normal limits or patient's baseline

Action Threshold: Persistent tachycardia, palpitations, or significant hypertension may require dose adjustment or discontinuation.

Serum Potassium

Frequency: Periodically, especially in patients at risk for hypokalemia or with high doses

Target: 3.5-5.0 mEq/L

Action Threshold: Potassium < 3.5 mEq/L, especially with symptoms (e.g., muscle weakness, cramps, arrhythmias).

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Symptom Monitoring

  • Increased shortness of breath
  • Increased wheezing
  • Chest tightness
  • Cough
  • Palpitations
  • Tremor
  • Nervousness
  • Dizziness
  • Muscle cramps

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. Untreated asthma poses a greater risk to both mother and fetus than albuterol use.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity observed in animal studies at high doses; human data are limited but generally reassuring.
Second Trimester: Generally considered safer than in the first trimester, but continued monitoring is advised.
Third Trimester: May inhibit uterine contractions (tocolytic effect) and cause maternal tachycardia or hyperglycemia. Neonatal hypoglycemia has been reported rarely.
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Lactation

Albuterol is excreted in human milk. However, due to its short half-life and low oral bioavailability, the amount transferred to breast milk is likely small. Generally considered compatible with breastfeeding, but monitor the infant for signs of agitation, tremor, or tachycardia.

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

Oral albuterol is generally not preferred for acute bronchospasm in children due to slower onset and higher systemic side effects compared to inhaled forms. Dosing must be carefully calculated by weight for younger children. Monitor closely for adverse effects, especially cardiovascular and CNS effects.

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Geriatric Use

Use with caution in elderly patients, particularly those with underlying cardiovascular disease, hypertension, or diabetes. Start with lower doses and titrate slowly due to increased sensitivity to beta-adrenergic effects. Monitor for tremor, tachycardia, and hypokalemia.

Clinical Information

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Clinical Pearls

  • Oral albuterol is generally reserved for patients who cannot use inhaled forms or for chronic management where sustained bronchodilation is needed, but it has largely been replaced by inhaled long-acting beta-agonists (LABAs) or inhaled corticosteroids (ICS)/LABA combinations for chronic control.
  • It is NOT a rescue medication for acute asthma attacks due to its slower onset of action compared to inhaled albuterol.
  • Patients should be educated on the difference between oral and inhaled albuterol and when to use each.
  • Monitor for hypokalemia, especially in patients on diuretics or corticosteroids, as albuterol can cause a transient decrease in serum potassium.
  • Advise patients to report any signs of worsening asthma or increased need for rescue inhaler use, as this may indicate inadequate disease control.
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Alternative Therapies

  • Inhaled short-acting beta-agonists (SABAs) e.g., albuterol HFA, levalbuterol (for rescue)
  • Inhaled long-acting beta-agonists (LABAs) e.g., salmeterol, formoterol (for maintenance)
  • Inhaled corticosteroids (ICS) e.g., fluticasone, budesonide (for maintenance)
  • ICS/LABA combinations e.g., fluticasone/salmeterol, budesonide/formoterol (for maintenance)
  • Leukotriene receptor antagonists (LTRAs) e.g., montelukast
  • Methylxanthines e.g., theophylline (less common due to narrow therapeutic index)
  • Anticholinergics e.g., ipratropium, tiotropium
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (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 evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication. It's also important to note that some medications may come with additional patient information leaflets, so be sure to check with your pharmacist for more details. 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 for guidance. 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 information about the medication taken, the amount, and the time it was taken, as this will help healthcare professionals provide the best possible care.