Albuterol Sulfate 4mg 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
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 that helps open up the airways in your lungs, making it easier to breathe. It's used to prevent and treat wheezing, shortness of breath, and chest tightness caused by lung conditions like asthma and COPD.
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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 participate in a drug take-back program in your area, if available.

Missing a Dose

If you take this medication regularly and miss a dose, take it 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 exactly as prescribed; do not take more often or in larger doses than recommended.
  • Do not stop taking other asthma medications unless directed by your doctor.
  • Report any worsening of symptoms or increased need for this medication to your doctor.
  • Avoid triggers that worsen your breathing condition (e.g., smoke, allergens).
  • Maintain good hydration.

Dosing & Administration

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Adult Dosing

Standard Dose: 2 mg or 4 mg three or four times daily
Dose Range: 2 - 32 mg

Condition-Specific Dosing:

extendedRelease: 4 mg or 8 mg every 12 hours, not to exceed 32 mg/day in divided doses.
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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. >12 years: 2 mg or 4 mg three or four times daily.
Adolescent: 2 mg or 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: No specific adjustment recommended, monitor for increased side effects.
Severe: Consider dose reduction or extended dosing interval due to potential for accumulation and increased side effects. Start with lower doses (e.g., 2 mg twice daily).
Dialysis: Albuterol is dialyzable to some extent. Monitor for efficacy and side effects; dose adjustment may be needed.

Hepatic Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended.
Severe: No specific adjustment recommended, but caution is advised due to potential for altered metabolism and increased systemic exposure. Monitor for side 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 bronchi, leading to activation of adenyl cyclase, which increases intracellular cyclic-3',5'-adenosine monophosphate (cAMP). Increased cAMP levels cause relaxation of bronchial smooth muscle, inhibition of mediator release from mast cells, and to a lesser extent, inhibition of microvascular leakage and enhancement of mucociliary clearance.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 50% (oral)
Tmax: 2-3 hours (oral tablet)
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 tablet)
Clearance: Not available
ExcretionRoute: Renal (primarily as metabolites, some unchanged drug)
Unchanged: Approximately 60% (oral dose excreted in urine as metabolites, 20% as unchanged drug)
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Pharmacodynamics

OnsetOfAction: 30 minutes (oral tablet)
PeakEffect: 2-3 hours (oral tablet)
DurationOfAction: 4-6 hours (oral tablet)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately

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 medical help right away:

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
+ Passing out
+ 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
Fast or abnormal 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. 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 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 asthma or COPD symptoms despite taking medication
  • Chest pain or discomfort
  • Fast or irregular heartbeat (palpitations)
  • Severe dizziness or lightheadedness
  • Muscle cramps or weakness (signs of low potassium)
  • Severe headache
  • Allergic reaction (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 symptoms you experienced.
If you are currently taking 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 discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help you determine if it is safe to take this medication in conjunction with your other medications and health conditions.

Remember, do not start, stop, or adjust 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 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 outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Exaggerated beta-adrenergic stimulation
  • Tachycardia
  • Palpitations
  • Tremor
  • Headache
  • Nervousness
  • Nausea
  • Vomiting
  • Hyperglycemia
  • Hypokalemia
  • Metabolic acidosis

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic, often involving a cardioselective beta-blocker (with extreme caution in patients with bronchospasm).

Drug Interactions

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Major Interactions

  • Beta-blockers (e.g., Propranolol): May block the bronchodilatory effect of albuterol and produce severe bronchospasm in asthmatic patients.
  • MAOIs (e.g., Phenelzine) and TCAs (e.g., Amitriptyline): May potentiate the vascular effects of albuterol, leading to severe cardiovascular effects.
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Moderate Interactions

  • Diuretics (e.g., Furosemide, Hydrochlorothiazide): May exacerbate ECG changes and/or hypokalemia associated with beta-agonists, especially at higher doses.
  • Digoxin: Albuterol may decrease serum digoxin levels.
  • Other sympathomimetics: Concomitant use may potentiate cardiovascular effects.

Monitoring

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Baseline Monitoring

Pulmonary function tests (FEV1, FVC)

Rationale: To assess baseline lung function and severity of airway obstruction.

Timing: Prior to initiation of therapy.

Heart rate and rhythm

Rationale: Albuterol can cause tachycardia and arrhythmias.

Timing: Prior to initiation of therapy.

Serum potassium

Rationale: Albuterol can cause transient hypokalemia.

Timing: Prior to initiation, especially in patients at risk or on diuretics.

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Routine Monitoring

Symptom control (e.g., shortness of breath, wheezing)

Frequency: Regularly, at each visit or as needed by patient

Target: Improved or stable symptoms

Action Threshold: Worsening symptoms, increased need for rescue medication, or lack of response.

Peak expiratory flow (PEF)

Frequency: Daily (patient self-monitoring)

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

Action Threshold: Decrease in PEF by >20% from personal best.

Heart rate and blood pressure

Frequency: Periodically, at follow-up visits

Target: Within normal limits for patient

Action Threshold: Persistent tachycardia, palpitations, or significant hypertension.

Serum potassium

Frequency: Periodically, if patient is at risk for hypokalemia or on concomitant diuretics.

Target: 3.5-5.0 mEq/L

Action Threshold: <3.5 mEq/L

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Symptom Monitoring

  • Increased shortness of breath
  • Worsening wheezing or cough
  • Chest tightness
  • Increased use of rescue inhaler (if applicable)
  • Palpitations
  • Tremor
  • Nervousness
  • Muscle cramps

Special Patient Groups

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Pregnancy

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Oral albuterol is Category C. There are no adequate and well-controlled studies in pregnant women.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity based on animal studies at high doses, but human data are limited and conflicting.
Second Trimester: No specific increased risks identified, but caution advised.
Third Trimester: May inhibit uterine contractions and increase risk of maternal and neonatal tachycardia, hyperglycemia, and hypokalemia. Use with caution during labor and delivery.
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Lactation

It is not known whether albuterol is excreted in human milk. Caution should be exercised when albuterol is administered to a nursing mother. Consider the benefits of breastfeeding, the risk of infant exposure, and the risk of untreated maternal condition.

Infant Risk: Low risk, but monitor for irritability, tremor, or feeding difficulties. Oral albuterol has higher systemic exposure than inhaled.
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Pediatric Use

Oral albuterol is approved for use in children 2 years of age and older. Dosing is weight-based for younger children. Monitor for systemic side effects (tremor, tachycardia, nervousness) which may be more pronounced.

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Geriatric Use

Use with caution in elderly patients, as they may be more susceptible to the cardiovascular and CNS effects of beta-agonists. Start with lower doses and titrate slowly. Monitor for comorbidities like cardiovascular disease.

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, tachycardia) due to higher systemic absorption.
  • It is generally less preferred for acute bronchospasm compared to inhaled formulations due to its slower onset.
  • Patients should be advised not to exceed the recommended dose due to the risk of adverse cardiovascular effects.
  • Monitor for hypokalemia, especially in patients on diuretics or corticosteroids.
  • Oral albuterol is often used for maintenance therapy in patients who cannot use inhaled forms or require additional bronchodilation, but its use has declined with the advent of more effective and safer inhaled therapies.
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Alternative Therapies

  • Inhaled short-acting beta-agonists (SABAs) like albuterol (e.g., ProAir, Ventolin HFA, Proventil HFA)
  • Inhaled long-acting beta-agonists (LABAs) (e.g., Salmeterol, Formoterol)
  • Inhaled corticosteroids (ICS) (e.g., Fluticasone, Budesonide)
  • Combination ICS/LABA inhalers (e.g., Advair, Symbicort)
  • Leukotriene receptor antagonists (e.g., Montelukast)
  • Anticholinergics (e.g., Ipratropium, Tiotropium)
  • Theophylline (less common due to narrow therapeutic index)
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Cost & Coverage

Average Cost: Varies widely, typically $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'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 taken, the amount, and the time it happened.