Proventil Syrup 2mg/5ml

Manufacturer SCHERING Active Ingredient Albuterol Syrup(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
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Albuterol syrup is a medicine that helps open up the airways in your lungs, making it easier to breathe. It's used to treat and prevent breathing problems like asthma and chronic obstructive pulmonary disease (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. If you're using the liquid form, measure your dose carefully using the measuring device that comes with the medication. If one isn't provided, ask your pharmacist for a suitable measuring device.

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. Instead, consult your pharmacist for guidance on the best disposal method or inquire about potential drug take-back programs in your area.

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 scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses. If you use this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
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Lifestyle & Tips

  • Avoid known asthma triggers (e.g., allergens, smoke, cold air).
  • Maintain good hydration.
  • Follow your asthma action plan if you have one.
  • Do not exceed the prescribed dose, as this can lead to serious side effects.

Dosing & Administration

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Adult Dosing

Standard Dose: 2-4 mg (1-2 teaspoonfuls) orally 3-4 times daily
Dose Range: 2 - 4 mg

Condition-Specific Dosing:

maximumDailyDose: 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/dose orally 3 times daily (maximum 2 mg/dose); 6-12 years: 2 mg (1 teaspoonful) orally 3-4 times daily
Adolescent: Over 12 years: 2-4 mg (1-2 teaspoonfuls) orally 3-4 times daily
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended
Moderate: Consider dose reduction for severe renal impairment due to renal excretion
Severe: Consider dose reduction (e.g., 50% of usual dose) and monitor for adverse effects
Dialysis: Albuterol is dialyzable; supplemental dose may be needed post-dialysis, but clinical data is limited. Monitor patient response.

Hepatic Impairment:

Mild: No specific adjustment recommended
Moderate: No specific adjustment recommended
Severe: No specific adjustment recommended

Pharmacology

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Mechanism of Action

Albuterol is a selective beta-2 adrenergic agonist. It acts on beta-2 adrenergic receptors in the smooth muscle of the bronchi, leading to activation of adenyl cyclase and increased 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 motility.
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Pharmacokinetics

Absorption:

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

Distribution:

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

Elimination:

HalfLife: 4-6 hours (oral)
Clearance: Not precisely quantified for oral route, but rapid elimination.
ExcretionRoute: Renal (primarily)
Unchanged: Approximately 60% of oral dose excreted unchanged in urine within 24 hours
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Pharmacodynamics

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

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: 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, or swelling of the mouth, face, lips, tongue, or throat.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Signs of low potassium levels: muscle pain or weakness, muscle cramps, or an irregular heartbeat.
Signs of a severe skin reaction (Stevens-Johnson syndrome, erythema multiforme): red, swollen, blistered, or peeling skin (with or without fever), ring-shaped skin lesions, red or irritated eyes, or sores in the mouth, throat, nose, or eyes.
Chest pain or pressure, rapid heartbeat, or abnormal heartbeat.
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 of breathing problems despite using the medication.
  • Chest pain or discomfort.
  • Severe dizziness or fainting.
  • Irregular or very fast heartbeat.
  • Muscle cramps or weakness (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 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 disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. Your doctor and pharmacist need this information to ensure safe treatment.

To avoid potential interactions, do not start, stop, or change the dosage of any medication without first consulting your doctor. It is your responsibility 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 overdose can be fatal. If you experience any concerns or questions, 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 possible outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Exaggerated beta-adrenergic stimulation effects:
  • Tachycardia (very fast heart rate)
  • Palpitations
  • Tremor (shakiness)
  • Nervousness
  • Headache
  • Dizziness
  • Nausea
  • Vomiting
  • Hyperglycemia (high blood sugar)
  • Hypokalemia (low potassium)
  • Metabolic acidosis

What to Do:

Seek immediate medical attention or call 911. Contact a poison control center (1-800-222-1222). Treatment is supportive and symptomatic. Consider a cardioselective beta-blocker if severe cardiac effects are present, but use with extreme caution in patients with a history of bronchospasm.

Drug Interactions

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Major Interactions

  • Beta-blockers (non-selective, e.g., propranolol): May block the bronchodilatory effect of albuterol and produce severe bronchospasm in asthmatic patients.
  • MAO inhibitors (MAOIs) and tricyclic antidepressants (TCAs): May potentiate the cardiovascular effects of albuterol.
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Moderate Interactions

  • Diuretics (e.g., thiazide diuretics, loop diuretics): May exacerbate ECG changes and/or hypokalemia associated with beta-agonists, especially at higher doses.
  • Digoxin: Albuterol may decrease serum digoxin levels (monitor digoxin levels).
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Minor Interactions

  • Other sympathomimetic agents: Additive cardiovascular effects (use with caution).

Monitoring

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Baseline Monitoring

Pulmonary function tests (e.g., FEV1)

Rationale: To assess baseline lung function and severity of asthma/COPD.

Timing: Prior to initiation of therapy

Heart rate and blood pressure

Rationale: To establish baseline cardiovascular status, as albuterol can cause tachycardia and hypertension.

Timing: Prior to initiation of therapy

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Routine Monitoring

Asthma/COPD symptoms (e.g., dyspnea, wheezing, cough)

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

Target: Improved symptom control, reduced frequency of rescue inhaler use

Action Threshold: Worsening symptoms, increased need for rescue medication, or lack of response to usual dose

Heart rate and rhythm

Frequency: Periodically, especially during dose titration or if patient reports palpitations

Target: Within normal limits or patient's baseline

Action Threshold: Persistent tachycardia, palpitations, or arrhythmias

Serum potassium

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

Target: 3.5-5.0 mEq/L

Action Threshold: Potassium < 3.5 mEq/L

Tremor, nervousness, headache

Frequency: Regularly, by patient report

Target: Minimal or tolerable

Action Threshold: Intolerable side effects requiring dose adjustment or discontinuation

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Symptom Monitoring

  • Worsening shortness of breath
  • Increased wheezing
  • Chest tightness
  • Increased cough
  • Increased use of rescue inhaler
  • Palpitations
  • Tremor
  • Nervousness
  • Headache
  • Dizziness

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. Albuterol can inhibit uterine contractions and may delay labor.

Trimester-Specific Risks:

First Trimester: Limited data, but generally considered low risk for major malformations based on human data.
Second Trimester: Generally considered safe for use if clinically indicated.
Third Trimester: May inhibit premature labor. Monitor for maternal tachycardia and hyperglycemia. Neonatal hypoglycemia has been reported with maternal use of beta-agonists.
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Lactation

Albuterol is excreted in human milk. Use with caution in nursing mothers. The amount excreted is generally small, but potential for adverse effects on the infant exists.

Infant Risk: Low to moderate. Monitor breastfed infant for signs of beta-adrenergic effects such as irritability, tremor, or tachycardia. Consider alternative if infant is premature or has underlying cardiac conditions.
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Pediatric Use

Widely used in pediatric patients. Dosing is weight-based for younger children and age-based for older children. Close monitoring for adverse effects (e.g., tremor, nervousness, tachycardia) is important, especially during dose titration.

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Geriatric Use

Use with caution in elderly patients, as they may be more susceptible to the cardiovascular and central nervous system adverse effects of beta-agonists (e.g., tremor, tachycardia, nervousness). Start with the lowest effective dose and titrate slowly, monitoring for adverse reactions.

Clinical Information

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Clinical Pearls

  • Albuterol syrup is a rescue medication for acute bronchospasm, but regular, long-term use of oral albuterol for chronic asthma is generally discouraged in favor of inhaled corticosteroids and long-acting beta-agonists due to systemic side effects.
  • Educate patients on the difference between rescue (albuterol) and controller medications.
  • Warn patients about potential for hypokalemia, especially with high doses or concomitant diuretic use.
  • Advise patients to report any worsening of symptoms or increased need for medication, as this may indicate worsening asthma control.
  • Oral albuterol has a slower onset and longer duration compared to inhaled albuterol, and is associated with more systemic side effects.
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Alternative Therapies

  • Inhaled short-acting beta-agonists (SABAs) like albuterol HFA or nebulizer solution (preferred for acute relief)
  • Inhaled corticosteroids (ICS) for long-term asthma control
  • Long-acting beta-agonists (LABAs) in combination with ICS for maintenance therapy
  • Leukotriene receptor antagonists (e.g., montelukast)
  • Theophylline (oral bronchodilator, less commonly used due to narrow therapeutic index)
  • Systemic corticosteroids (for acute severe exacerbations)
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Cost & Coverage

Average Cost: $15 - $50 per 480ml bottle (2mg/5ml)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective 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's a good idea to check with your pharmacist for more information. 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. 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 details about the medication taken, the amount, and the time it occurred.