Ventolin 2mg Tablets

Manufacturer ALLEN & HANBURYS 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 used to open up the airways in your lungs, making it easier to breathe. It's often used for conditions like asthma and chronic obstructive pulmonary disease (COPD). It works by relaxing 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 participate in a drug take-back program in your area, if available.

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

  • Avoid triggers that worsen your breathing (e.g., smoke, allergens, cold air).
  • Maintain good hydration.
  • Follow your doctor's instructions for other asthma/COPD medications (e.g., inhaled corticosteroids).
  • Do not exceed the prescribed dose, as this can lead to serious side effects.

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:

extendedRelease: 4 mg to 8 mg every 12 hours (for extended-release formulations, not applicable to 2mg immediate release tablets)
maximumDailyDose: 32 mg per day in divided doses
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (generally not recommended for routine use below 2 years)
Child: 2-5 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.
Adolescent: 12 years and older: 2 mg to 4 mg three or four times daily.
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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 metabolites. Albuterol and its metabolites are primarily renally excreted.
Dialysis: Not well studied; monitor closely. Albuterol is dialyzable to some extent.

Hepatic Impairment:

Mild: No specific adjustment recommended
Moderate: No specific adjustment recommended
Severe: No specific adjustment recommended; albuterol is not extensively metabolized by the liver, but caution is advised in severe hepatic dysfunction.

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). Increased cAMP levels cause relaxation of bronchial smooth muscle, resulting in bronchodilation. It also inhibits the release of mediators from mast cells in the airways.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 50% (oral, due to first-pass metabolism)
Tmax: 2-3 hours (for immediate-release tablets)
FoodEffect: Food may delay Tmax but does not significantly affect the extent of absorption (AUC).

Distribution:

Vd: Approximately 3 L/kg
ProteinBinding: Approximately 10%
CnssPenetration: Limited

Elimination:

HalfLife: 4-6 hours (for immediate-release tablets)
Clearance: Approximately 27 L/hr (renal and metabolic)
ExcretionRoute: Primarily renal (approximately 75-80% of a dose is excreted in urine within 24 hours as unchanged drug and metabolite)
Unchanged: Approximately 60% (of the absorbed 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
+ 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 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 or seek medical help:

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 using the medication.
  • Chest pain or discomfort.
  • Severe dizziness or lightheadedness.
  • Irregular or very fast heartbeat.
  • Muscle cramps or weakness (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, 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 disclose all of your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, as well as any existing health problems. Your doctor and pharmacist need this information to ensure safe use and potential interactions with this medication.

To guarantee your safety, always verify with your doctor before starting, stopping, or modifying the dose of any medication, including this one.
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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 this medication to both you and your baby, allowing you to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Exaggerated beta-adrenergic stimulation effects:
  • Tachycardia (very fast heart rate)
  • Palpitations
  • Tremor
  • Nervousness
  • Headache
  • Nausea and 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. Beta-blockers may be used cautiously in severe cases of cardiac effects, but only under strict medical supervision due to risk of bronchospasm.

Drug Interactions

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Major Interactions

  • Non-selective beta-blockers (e.g., propranolol, carvedilol): 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 (e.g., loop or thiazide diuretics): May potentiate the ECG changes and/or hypokalemia associated with beta-agonists, especially at higher doses. Monitor serum potassium.
  • Digoxin: Albuterol may decrease serum digoxin levels. Monitor digoxin levels.

Monitoring

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Baseline Monitoring

Pulmonary Function Tests (e.g., FEV1)

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

Timing: Prior to initiation of therapy.

Heart Rate and Blood Pressure

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

Timing: Prior to initiation of therapy.

Serum Potassium

Rationale: Beta-agonists 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

Symptom Control (e.g., frequency of shortness of breath, wheezing)

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

Target: Improved or stable symptoms, reduced need for rescue medication

Action Threshold: Worsening symptoms, increased frequency of use, or inadequate control indicates need for reassessment of therapy.

Adverse Effects (e.g., tremor, nervousness, palpitations)

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

Target: Absence or mild, tolerable side effects

Action Threshold: Persistent or severe adverse effects warrant dose reduction or discontinuation.

Heart Rate and Blood Pressure

Frequency: Periodically, especially during dose titration or in patients with cardiovascular comorbidities.

Target: Within normal limits or patient's baseline

Action Threshold: Significant or sustained increases may require dose adjustment or alternative therapy.

Serum Potassium

Frequency: Periodically, especially in patients on concomitant diuretics or with risk factors for hypokalemia.

Target: 3.5-5.0 mEq/L

Action Threshold: Levels below normal range may require potassium supplementation or dose adjustment.

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Symptom Monitoring

  • Increased shortness of breath or wheezing
  • Chest tightness
  • Cough
  • Palpitations or rapid heart rate
  • Tremor or shakiness
  • Nervousness or anxiety
  • Dizziness
  • Headache

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 and not recommended due to maternal and fetal risks.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity based on animal studies, but human data are limited and conflicting.
Second Trimester: Generally considered safer than first trimester, but still use with caution.
Third Trimester: May inhibit uterine contractions and cause maternal tachycardia, hyperglycemia, and hypokalemia. Fetal tachycardia and hypoglycemia have also been reported.
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Lactation

Albuterol is excreted into human milk in small amounts. It is generally considered compatible with breastfeeding by most experts, as the amount transferred to the infant is low and adverse effects are unlikely. Monitor the infant for signs of agitation, tremor, or poor feeding.

Infant Risk: Low risk (L2)
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Pediatric Use

Dosing is weight-based for younger children (2-5 years) and age-based for older children and adolescents. Safety and efficacy in children younger than 2 years have not been established for oral tablets. Close monitoring for adverse effects (e.g., hyperactivity, tremor) is important.

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Geriatric Use

Elderly patients may be more sensitive to the effects of sympathomimetic amines, particularly cardiovascular effects (e.g., tachycardia, arrhythmias, hypertension) and central nervous system effects (e.g., nervousness, tremor). Start with the lowest effective dose and titrate slowly, monitoring closely for adverse reactions. Patients with co-morbidities like cardiovascular disease or diabetes should be monitored carefully.

Clinical Information

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Clinical Pearls

  • Oral albuterol tablets have a slower onset and longer duration of action compared to inhaled albuterol, making them less suitable for acute bronchospasm relief.
  • They are typically used for maintenance therapy in patients who cannot use inhaled formulations or require systemic bronchodilation.
  • Patients should be educated on the difference between immediate-release and extended-release formulations if applicable, and to not crush or chew extended-release tablets.
  • Advise patients to report any worsening of symptoms or increased need for rescue inhalers, as this may indicate deteriorating asthma control.
  • Monitor for hypokalemia, especially in patients on concomitant diuretics or corticosteroids.
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Alternative Therapies

  • Inhaled short-acting beta-agonists (SABAs) (e.g., albuterol inhaler, levalbuterol inhaler)
  • Inhaled long-acting beta-agonists (LABAs) (e.g., salmeterol, formoterol)
  • Inhaled corticosteroids (ICS)
  • Long-acting muscarinic antagonists (LAMAs) (e.g., tiotropium)
  • Oral corticosteroids (e.g., prednisone)
  • Leukotriene receptor antagonists (e.g., montelukast)
  • Methylxanthines (e.g., theophylline)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 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 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's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't 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 medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.