Albuterol 4mg Tablets

Manufacturer SUN 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 Beta2-Adrenergic Agonist
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Pregnancy Category
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 for conditions like asthma or COPD. This tablet form works throughout your body to help relax the muscles around your airways.
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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. It's essential to follow the dosage instructions carefully to ensure safe and effective use.

Storing and Disposing of Your Medication

Store this 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 by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method or explore local drug take-back programs.

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 normal 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 exactly as prescribed; do not take more often or in higher doses than recommended.
  • Do not stop taking other asthma medications unless advised by your doctor.
  • Avoid triggers that worsen your breathing (e.g., allergens, smoke, cold air).
  • Carry identification if you have asthma or COPD.
  • Report any worsening of symptoms or increased need for medication to your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: 2 mg to 4 mg orally 3 or 4 times a day
Dose Range: 2 - 4 mg

Condition-Specific Dosing:

elderly_or_sensitive: Start with 2 mg orally 3 or 4 times a day, then cautiously increase to 4 mg 3 or 4 times a day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: 2 to 5 years: 0.1 mg/kg orally 3 times a day, not to exceed 2 mg 3 times a day. 6 to 12 years: 2 mg orally 3 or 4 times a day. Over 12 years: 2 mg to 4 mg orally 3 or 4 times a day.
Adolescent: 2 mg to 4 mg orally 3 or 4 times a day
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, monitor for adverse effects.
Moderate: No specific adjustment recommended, monitor for adverse effects.
Severe: Consider dose reduction (e.g., 50%) and extend dosing interval due to primary renal excretion of unchanged drug and metabolites. Monitor for adverse effects.
Dialysis: Albuterol is dialyzable. Consider supplemental dose post-dialysis or adjust based on clinical response and adverse effects.

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, but monitor for increased systemic effects.

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 bronchial tree, leading to relaxation of bronchial smooth muscle, bronchodilation, and increased airflow. This action is mediated by activation of adenyl cyclase, which increases intracellular cyclic AMP (cAMP) levels. Increased cAMP levels lead to activation of protein kinase A, which inhibits phosphorylation of myosin and lowers intracellular ionic calcium concentrations, resulting in muscle relaxation.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 50% (due to significant first-pass metabolism)
Tmax: 2 to 3 hours
FoodEffect: Food may delay Tmax but does not significantly affect bioavailability.

Distribution:

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

Elimination:

HalfLife: Approximately 4 to 6 hours (for oral tablets)
Clearance: Approximately 0.4 L/hr/kg
ExcretionRoute: Primarily renal (80-100% of dose excreted in urine within 72 hours)
Unchanged: Approximately 60% of an oral dose is excreted unchanged in urine, with the remainder as the sulfate conjugate.
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Pharmacodynamics

OnsetOfAction: Approximately 30 minutes
PeakEffect: Approximately 2 to 3 hours
DurationOfAction: 4 to 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
+ Difficulty 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 vision
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 lesions that resemble 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 unusual symptoms, contact your doctor for advice:

Feeling nervous or 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, don't hesitate to reach out to 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 of breathing difficulties or asthma symptoms despite taking medication.
  • Chest pain or discomfort.
  • Severe dizziness or fainting.
  • Irregular or very fast heartbeat (palpitations).
  • Severe headache.
  • Muscle weakness or cramps (signs of low potassium).
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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. 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 health problems, including any medical conditions or concerns

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:

  • Tachycardia (very fast heart rate)
  • Palpitations
  • Tremor (shakiness)
  • Nervousness
  • Headache
  • Dizziness
  • Nausea
  • Vomiting
  • Hypokalemia (low potassium, leading to muscle weakness, cramps, or abnormal heart rhythms)
  • Hyperglycemia (high blood sugar)
  • Metabolic acidosis

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Treatment is supportive and symptomatic, including monitoring of vital signs, ECG, and serum potassium levels.

Drug Interactions

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Contraindicated Interactions

  • Non-selective beta-blockers (e.g., propranolol, carvedilol): May block the bronchodilator effect of albuterol and produce severe bronchospasm in asthmatic patients. Use is generally contraindicated.
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Major Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) and Tricyclic Antidepressants (TCAs): May potentiate the cardiovascular effects of albuterol (e.g., increased heart rate, blood pressure). Use with extreme caution or avoid within 2 weeks of discontinuing MAOIs/TCAs.
  • Diuretics (loop or thiazide): May potentiate the hypokalemic effect of beta-agonists, especially at high doses. Monitor potassium levels.
  • Other sympathomimetic agents (e.g., epinephrine, pseudoephedrine): Concomitant use may potentiate adverse cardiovascular effects. Avoid concurrent use.
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Moderate Interactions

  • Digoxin: Albuterol may decrease serum digoxin levels. Monitor digoxin levels.
  • Other short-acting beta-agonists: Concurrent use is generally not recommended due to increased risk of adverse effects.
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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.

Vital Signs (Heart Rate, Blood Pressure)

Rationale: Albuterol can cause tachycardia and blood pressure changes.

Timing: Prior to initiation of therapy.

Serum Potassium

Rationale: Albuterol can cause transient hypokalemia, especially at high doses or with concomitant diuretics.

Timing: Prior to initiation, especially in patients at risk for hypokalemia.

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Routine Monitoring

Respiratory Status (e.g., dyspnea, wheezing, cough)

Frequency: Daily, or as needed based on symptoms

Target: Improved breathing, reduced symptoms

Action Threshold: Worsening symptoms, increased rescue inhaler use, or lack of response may indicate need for re-evaluation of therapy.

Heart Rate and Blood Pressure

Frequency: Periodically, or if patient reports palpitations/tremor

Target: Within patient's normal range

Action Threshold: Persistent tachycardia (>100 bpm at rest) or significant hypertension/hypotension.

Serum Potassium

Frequency: Periodically, especially with high doses or concomitant diuretics

Target: 3.5-5.0 mEq/L

Action Threshold: Potassium < 3.5 mEq/L, especially if symptomatic.

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Symptom Monitoring

  • Tremor
  • Nervousness
  • Palpitations
  • Headache
  • Dizziness
  • Muscle cramps
  • Paradoxical bronchospasm (rare, but severe worsening of breathing)

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 is generally not preferred over inhaled forms during pregnancy due to higher systemic exposure.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity observed in animal studies at high doses; human data are limited.
Second Trimester: Generally considered safer than first trimester, but systemic exposure from oral form is a consideration.
Third Trimester: May inhibit uterine contractions (tocolytic effect) and cause maternal/fetal tachycardia or hypokalemia. Monitor for these effects if used near term.
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Lactation

Albuterol is excreted in human milk. While levels are generally low, 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). Inhaled albuterol is generally preferred due to lower systemic exposure.

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

Dosing is weight-based for younger children. Oral albuterol is generally reserved for children who cannot use inhaled forms or require systemic bronchodilation, due to higher incidence of systemic side effects (e.g., tremor, nervousness, tachycardia) compared to inhaled albuterol. Close monitoring for adverse effects is crucial.

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Geriatric Use

Elderly patients may be more sensitive to the effects of sympathomimetic amines, particularly cardiovascular effects (e.g., tachycardia, palpitations, hypertension) and CNS effects (e.g., tremor, nervousness). Start with the lowest effective dose (e.g., 2 mg three or four times a day) and titrate cautiously based on response and tolerability. Monitor for adverse effects.

Clinical Information

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Clinical Pearls

  • Oral albuterol tablets are less commonly used than inhaled albuterol due to a slower onset of action and a higher incidence of systemic side effects (e.g., tremor, nervousness, tachycardia) because of greater systemic absorption.
  • Inhaled albuterol is the preferred route for acute bronchospasm and maintenance therapy in most patients due to its rapid onset and targeted delivery to the lungs, minimizing systemic adverse effects.
  • Oral albuterol may be considered for patients who cannot effectively use inhaled formulations or for those who require a more sustained systemic bronchodilator effect, though long-acting beta-agonists (LABAs) are generally preferred for maintenance.
  • Patients should be advised to report any worsening of asthma or COPD symptoms, as this may indicate a need for adjustment of therapy, including the addition of anti-inflammatory agents.
  • Monitor for hypokalemia, especially in patients receiving concomitant diuretics or corticosteroids, or those with underlying cardiac conditions.
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Alternative Therapies

  • Inhaled short-acting beta-agonists (SABAs) (e.g., albuterol HFA, levalbuterol HFA)
  • Inhaled long-acting beta-agonists (LABAs) (e.g., salmeterol, formoterol)
  • Inhaled corticosteroids (ICS) (e.g., fluticasone, budesonide)
  • Combination ICS/LABA inhalers
  • Leukotriene receptor antagonists (e.g., montelukast)
  • Theophylline (less common due to narrow therapeutic index)
  • Systemic corticosteroids (for acute exacerbations)
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Cost & Coverage

Average Cost: $15 - $50 per 100 tablets (4mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred generic)
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General Drug Facts

If your symptoms or health condition do not improve or worsen over time, 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. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for clarification and 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 detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred.