Proventil 4mg Tablets
It is used to open the airways in lung diseases where spasm may cause breathing problems.
Drug Class
Bronchodilator
Pharmacologic Class
Selective Beta2-Adrenergic Agonist
Pregnancy Category
Category C
FDA Approved
Sep 1981
DEA Schedule
Not Controlled
Overview
What is this medicine?
Albuterol tablets are a medication used to help open up the airways in your lungs, making it easier to breathe. They are commonly prescribed for conditions like asthma and chronic obstructive pulmonary disease (COPD) to relieve symptoms such as wheezing, shortness of breath, and chest tightness.
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 your medication at room temperature, away from light and moisture. Keep it in a dry place, avoiding storage in a bathroom. Always keep your medications in a secure 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 by your pharmacist. Instead, check with your pharmacist for guidance on proper disposal 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 scheduled dose, skip the missed dose and resume your regular dosing schedule. Avoid taking two doses at the same time or taking extra doses. If you use this medication as needed, do not take it more frequently than directed by your doctor.
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 your medication at room temperature, away from light and moisture. Keep it in a dry place, avoiding storage in a bathroom. Always keep your medications in a secure 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 by your pharmacist. Instead, check with your pharmacist for guidance on proper disposal 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 scheduled dose, skip the missed dose and resume your regular dosing schedule. Avoid taking two doses at the same time or taking extra doses. If you use this medication as needed, do not take it more frequently than directed by your doctor.
Lifestyle & Tips
- Avoid known triggers for your breathing problems (e.g., allergens, smoke, pollution).
- If you smoke, quitting is highly recommended to improve lung health.
- Follow your healthcare provider's instructions for managing your condition, including other prescribed medications.
- Maintain a healthy lifestyle with regular exercise (as tolerated) and a balanced diet.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
2 mg or 4 mg, 3 or 4 times daily
Dose Range:
2 - 8 mg
Condition-Specific Dosing:
initial_dose:
2 mg 3 or 4 times daily
maintenance_dose:
4 mg 3 or 4 times daily
maximum_daily_dose:
32 mg in divided doses
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
6-12 years: 2 mg 3 or 4 times daily. May increase to 4 mg 3 or 4 times daily if needed. Max 24 mg/day.
Adolescent:
>12 years: Same as adult dosing (2 mg or 4 mg, 3 or 4 times daily)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended
Moderate:
Consider lower initial dose and careful monitoring
Severe:
Consider lower initial dose (e.g., 2 mg twice daily) and careful monitoring due to renal excretion
Dialysis:
Not specifically studied, but likely requires dose reduction and careful monitoring
Hepatic Impairment:
Mild:
No specific adjustment recommended
Moderate:
No specific adjustment recommended
Severe:
No specific adjustment recommended
Pharmacology
Mechanism of Action
Albuterol is a selective beta2-adrenergic agonist. It acts on beta2-adrenergic receptors in bronchial smooth muscle, 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, inhibition of mediator release from mast cells, and increased ciliary activity.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 50%
Tmax:
2-3 hours
FoodEffect:
Food may delay absorption but does not significantly affect the extent of absorption.
Distribution:
Vd:
Approximately 3 L/kg
ProteinBinding:
10-20%
CnssPenetration:
Limited
Elimination:
HalfLife:
4-6 hours (oral)
Clearance:
Not readily available as a single value; primarily renal excretion.
ExcretionRoute:
Urine (80-100% within 24 hours)
Unchanged:
Approximately 60% excreted unchanged in urine
Pharmacodynamics
OnsetOfAction:
30 minutes
PeakEffect:
2-3 hours
DurationOfAction:
4-6 hours
Safety & Warnings
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
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. Many people may not experience any side effects or may only have mild 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.
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
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. Many people may not experience any side effects or may only have mild 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.
Seek Immediate Medical Attention If You Experience:
- Worsening shortness of breath or wheezing despite taking the medication.
- Chest pain or discomfort.
- Severe or persistent palpitations (feeling your heart race or pound).
- Dizziness or lightheadedness.
- Severe tremor or nervousness.
- Any signs of an allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing).
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 medications, foods, or substances. 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 disclose all your medications (including prescription, over-the-counter, natural products, and vitamins) and health issues to your doctor and pharmacist. This will help ensure that it is safe for you to take this medication in conjunction with your other medications and health conditions.
Remember, do not start, stop, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
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 medications, foods, or substances. 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 disclose all your medications (including prescription, over-the-counter, natural products, and vitamins) and health issues to your doctor and pharmacist. This will help ensure that it is safe for you to take this medication in conjunction with your other medications and health conditions.
Remember, do not start, stop, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
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 monitor your blood sugar levels closely while taking this medication.
Before taking this medication, discuss your pregnancy status or plans to become pregnant or breastfeed with your doctor. This will enable you to weigh the benefits and risks of the medication for both you and your baby.
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 monitor your blood sugar levels closely while taking this medication.
Before taking this medication, discuss your pregnancy status or plans to become pregnant or breastfeed with your doctor. This will enable you to weigh the benefits and risks of the medication for both you and your baby.
Overdose Information
Overdose Symptoms:
- Tachycardia (rapid heart rate)
- Palpitations
- Tremor
- Headache
- Nervousness
- Nausea
- Vomiting
- Hypokalemia (low potassium levels)
- Hyperglycemia (high blood sugar)
- Metabolic acidosis
What to Do:
Seek immediate medical attention. Call emergency services (e.g., 911 in the US) or a poison control center (e.g., 1-800-222-1222 in the US). Treatment is supportive and symptomatic, which may include monitoring vital signs, ECG, and electrolyte levels. In severe cases, a cardioselective beta-blocker may be considered, but only with extreme caution due to the risk of inducing bronchospasm.
Drug Interactions
Contraindicated Interactions
- Non-selective beta-blockers (e.g., propranolol, carvedilol) due to antagonism of albuterol's effects and potential for severe bronchospasm.
Major Interactions
- Diuretics (loop or thiazide): May potentiate ECG changes and/or hypokalemia associated with beta-agonists, especially at higher doses.
- Digoxin: Albuterol may decrease serum digoxin levels.
- Monoamine Oxidase Inhibitors (MAOIs) and Tricyclic Antidepressants (TCAs): May potentiate the cardiovascular effects of albuterol (e.g., increased heart rate, blood pressure).
Moderate Interactions
- Other sympathomimetic agents: Additive cardiovascular effects; use with caution.
- QTc-prolonging drugs: Theoretical risk of additive QTc prolongation, though albuterol's effect on QTc is generally minor.
Monitoring
Baseline Monitoring
Pulmonary Function Tests (e.g., FEV1)
Rationale: To assess baseline lung function and severity of reversible airway obstruction.
Timing: Prior to initiation of therapy
Heart Rate and Blood Pressure
Rationale: To establish baseline cardiovascular status, as albuterol can cause tachycardia and blood pressure changes.
Timing: Prior to initiation of therapy
Serum Potassium
Rationale: To establish baseline, especially if patient is on diuretics or has risk factors for hypokalemia.
Timing: Prior to initiation of therapy (if indicated)
Routine Monitoring
Symptom Control (e.g., shortness of breath, wheezing, cough)
Frequency: Regularly, at each visit or as needed by patient
Target: Improved or stable symptoms
Action Threshold: Worsening symptoms, increased frequency of use, or lack of efficacy
Heart Rate and Blood Pressure
Frequency: Periodically, at routine follow-up visits
Target: Within patient's normal range or acceptable limits
Action Threshold: Persistent tachycardia, palpitations, or significant hypertension
Serum Potassium
Frequency: Periodically, if patient is on high doses, has renal impairment, or is on concomitant diuretics
Target: 3.5-5.0 mEq/L
Action Threshold: Hypokalemia (<3.5 mEq/L)
Tremor/Nervousness
Frequency: Regularly, inquire about side effects
Target: Minimal or tolerable
Action Threshold: Severe or intolerable tremor/nervousness
Symptom Monitoring
- Worsening shortness of breath
- Increased wheezing or coughing
- Chest tightness
- Palpitations or rapid heart rate
- Tremor or nervousness
- Dizziness or lightheadedness
Special Patient Groups
Pregnancy
Albuterol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown some evidence of teratogenicity at high doses, but human data are limited. It is a Category C drug.
Trimester-Specific Risks:
First Trimester:
Limited human data; generally, avoid non-essential medications during the first trimester if possible. Risk of congenital anomalies is not clearly established in humans.
Second Trimester:
Generally considered safer than the first trimester, but use only if clearly needed.
Third Trimester:
May inhibit uterine contractions and cause maternal tachycardia or hyperglycemia. Neonatal hypoglycemia has been reported rarely.
Lactation
Albuterol is excreted into breast milk. Use with caution in nursing mothers. The amount transferred to the infant is generally small, but potential for adverse effects exists.
Infant Risk:
Low risk. Monitor breastfed infants for signs of irritability, tremor, or tachycardia. The benefits of breastfeeding should be weighed against the potential risks.
Pediatric Use
Dosing is weight- or age-adjusted. Oral albuterol is generally not recommended for children under 6 years of age due to limited data and higher risk of systemic side effects compared to inhaled forms. Close monitoring for side effects is crucial.
Geriatric Use
Elderly patients may be more sensitive to the effects of sympathomimetic amines, particularly cardiovascular effects (e.g., tachycardia, palpitations, hypertension). Start with lower doses and titrate carefully, monitoring for adverse reactions.
Clinical Information
Clinical Pearls
- Oral albuterol has a slower onset of action and a longer duration compared to inhaled albuterol, making it less suitable for acute bronchospasm relief.
- Systemic side effects (e.g., tremor, nervousness, tachycardia) are more common and pronounced with oral albuterol compared to inhaled forms due to higher systemic absorption.
- Oral albuterol is typically reserved for patients who cannot use inhaled therapy effectively or who require additional bronchodilation beyond what inhaled therapy provides.
- Patients should be educated on the difference between oral and inhaled albuterol and when to use each formulation.
Alternative Therapies
- Inhaled short-acting beta-agonists (SABAs) like albuterol HFA (e.g., Ventolin HFA, ProAir HFA, Proventil HFA), levalbuterol (e.g., Xopenex HFA)
- Long-acting beta-agonists (LABAs) (e.g., salmeterol, formoterol) (often in combination with inhaled corticosteroids)
- Inhaled corticosteroids (ICS) (e.g., fluticasone, budesonide)
- Long-acting muscarinic antagonists (LAMAs) (e.g., tiotropium, umeclidinium)
- Combination ICS/LABA inhalers (e.g., Advair, Symbicort, Dulera, Breo)
- Oral corticosteroids (for acute exacerbations)
- Leukotriene receptor antagonists (e.g., montelukast)
Cost & Coverage
Average Cost:
$10 - $50 per 30 tablets (4mg generic)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic formulations)
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 medication prescribed to someone else.
You may find additional patient information leaflets for certain medications. If you have questions or concerns, consult your pharmacist for more information.
If you have any questions or concerns about your medication, do not 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 emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount, and the time it occurred.
To ensure your safety and the effectiveness of your treatment, never share your medication with others or take medication prescribed to someone else.
You may find additional patient information leaflets for certain medications. If you have questions or concerns, consult your pharmacist for more information.
If you have any questions or concerns about your medication, do not 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 emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount, and the time it occurred.