Albuterol Sulfate Syrup (2mg/5ml)

Manufacturer QUAGEN PHARMACEUTICALS Active Ingredient Albuterol Syrup(al BYOO ter ole) Pronunciation al BYOO ter ole SUL fate
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 sulfate syrup is a liquid medicine used to help you breathe easier when you have asthma or other lung conditions. It works by relaxing the muscles in your airways, making them wider so air can flow in and out more freely. This helps relieve symptoms like wheezing, coughing, and shortness of breath.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food. If you are using the liquid form, measure your dose accurately using the measuring device that comes with the medication. If no device is provided, ask your pharmacist for a suitable measuring tool.

Storing and Disposing of Your Medication

Store your medication at room temperature, away from light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. Keep all medications out of the reach of children and pets. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication, and consider participating in a drug take-back program in your area.

What to Do If You Miss a Dose

If you take this medication regularly, take the missed dose as soon as you remember. However, if it's almost 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

  • Take your medicine exactly as prescribed by your doctor. Do not take more or less than directed.
  • Do not stop taking other asthma medications unless advised by your doctor.
  • Avoid known asthma triggers (e.g., allergens, smoke, cold air, exercise if not pre-treated).
  • Carry a rescue inhaler (if prescribed) for sudden worsening of symptoms.
  • Report any worsening of symptoms or increased need for this medication to your doctor immediately.

Dosing & Administration

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Adult Dosing

Standard Dose: 2 mg (5 mL) or 4 mg (10 mL) three or four times daily
Dose Range: 2 - 8 mg

Condition-Specific Dosing:

initialDose: Start with 2 mg (5 mL) three or four times daily. If adequate response is not obtained, dose may be cautiously increased to 4 mg (10 mL) three or four times daily.
maximumDose: Maximum daily dose is 32 mg (80 mL) in divided doses.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established for routine use; use with caution and under strict medical supervision if considered.
Child: 2-6 years: 0.1 mg/kg/dose three times daily, not to exceed 2 mg (5 mL) per dose. 6-12 years: 2 mg (5 mL) three or four times daily. If adequate response is not obtained, dose may be cautiously increased to 4 mg (10 mL) three or four times daily. Maximum daily dose is 24 mg (60 mL) in divided doses.
Adolescent: 12 years and older: Same as adult dosing, 2 mg (5 mL) or 4 mg (10 mL) three or four times daily. Maximum daily dose is 32 mg (80 mL) in divided doses.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended, but monitor for increased adverse effects.
Severe: Use with caution; consider lower initial doses and monitor for increased adverse effects due to potential for reduced excretion.
Dialysis: Albuterol is not significantly removed by hemodialysis. No specific dose adjustment recommended, but monitor for adverse effects.

Hepatic Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended, but monitor for increased adverse effects.
Severe: Use with caution; consider lower initial doses and monitor for increased adverse effects due to potential for altered metabolism.

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 bronchial tree, 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 some inhibition of microvascular leakage, resulting in bronchodilation.
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Pharmacokinetics

Absorption:

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

Distribution:

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

Elimination:

HalfLife: Approximately 4-6 hours (oral)
Clearance: Approximately 0.48 L/hr/kg
ExcretionRoute: Primarily renal (urine), with a small amount in feces.
Unchanged: Approximately 60% of an oral dose is excreted in urine as unchanged drug and its sulfate conjugate.
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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 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 attention 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
+ 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
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 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, 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 asthma symptoms (e.g., increased wheezing, shortness of breath, cough) despite taking the medication.
  • Chest pain or discomfort.
  • Fast or irregular heartbeat (palpitations).
  • Severe headache.
  • Dizziness or lightheadedness.
  • Muscle cramps or weakness (signs of low potassium).
  • Paradoxical bronchospasm (sudden worsening of breathing immediately after taking the medication).
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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 drugs, foods, or substances. Be sure to describe the allergic reaction and its symptoms.
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.

Please note that this is not an exhaustive list of all possible drug interactions or health concerns that may affect your use of this medication.

To ensure your safety, it is crucial to discuss the following with your doctor and pharmacist:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your overall health and any existing medical conditions

Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm that it is safe to do so in conjunction with 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 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 breast-feeding. Your doctor will discuss the potential benefits and risks of using this medication during these situations to ensure the best 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 (pounding heart)
  • Tremor (shaking)
  • Nervousness
  • Headache
  • Dizziness
  • Nausea
  • Vomiting
  • Hypokalemia (low potassium levels, which can lead to muscle weakness or abnormal heart rhythms)
  • Hyperglycemia (high blood sugar)
  • Metabolic acidosis

What to Do:

Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive and symptomatic. Beta-blockers (e.g., cardioselective beta-blockers) may be considered in severe cases, but only with extreme caution due to the risk of inducing bronchospasm.

Drug Interactions

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Major Interactions

  • 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 (loop or thiazide): 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.
  • Other sympathomimetic agents: Concomitant use may potentiate adverse cardiovascular effects. Use with caution.

Monitoring

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Baseline Monitoring

Pulmonary function tests (e.g., FEV1)

Rationale: To establish baseline lung function and assess disease severity.

Timing: Prior to initiation of therapy.

Vital signs (heart rate, blood pressure)

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

Timing: Prior to initiation of therapy.

Serum potassium

Rationale: To establish baseline, especially in patients at risk for hypokalemia (e.g., on diuretics).

Timing: Prior to initiation of therapy, if indicated.

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Routine Monitoring

Symptom control (wheezing, shortness of breath, cough)

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

Target: Improved or controlled symptoms

Action Threshold: Worsening symptoms, increased frequency of use, or lack of response may indicate need for re-evaluation of asthma control and therapy.

Adverse effects (e.g., tremor, nervousness, tachycardia, palpitations)

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

Target: Absence or minimal, tolerable side effects

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

Heart rate and blood pressure

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

Target: Within patient's normal range

Action Threshold: Significant or sustained increases may require re-evaluation.

Serum potassium

Frequency: Periodically, especially with high doses or concomitant diuretic use.

Target: 3.5-5.0 mEq/L

Action Threshold: Hypokalemia (K < 3.5 mEq/L) may require supplementation or dose adjustment.

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Symptom Monitoring

  • Worsening shortness of breath
  • Increased wheezing
  • Increased cough
  • Chest tightness
  • Increased need for rescue medication
  • Paradoxical bronchospasm (rare, but severe worsening of breathing immediately after dosing)

Special Patient Groups

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Pregnancy

Albuterol is Pregnancy Category C. It should be used 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 may inhibit uterine contractions.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity observed in animal studies at high doses; human data are limited but generally reassuring for inhaled forms. Oral form has higher systemic exposure.
Second Trimester: Generally considered safer than first trimester, but still Category C. Monitor for maternal cardiovascular effects.
Third Trimester: May inhibit uterine contractions (tocolytic effect) and cause transient maternal and fetal tachycardia and hyperglycemia. Use with caution near term.
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Lactation

Albuterol is excreted in human milk. While the amount is likely small and adverse effects on the infant are not expected, caution should be exercised when albuterol is administered to a nursing mother. The benefits of breastfeeding should be weighed against the potential risks.

Infant Risk: Low risk of adverse effects on the infant, but monitor for irritability, tremor, or changes in feeding/sleep patterns.
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Pediatric Use

Albuterol syrup is commonly used in pediatric patients for asthma and bronchospasm. Dosing is weight-based for younger children and age-based for older children and adolescents. Close monitoring for adverse effects (e.g., tremor, nervousness, tachycardia) is important, especially in younger children who may be more sensitive to these effects.

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Geriatric Use

Elderly patients may be more sensitive to the effects of sympathomimetic amines, including cardiovascular effects (e.g., tachycardia, palpitations, hypertension) and central nervous system effects (e.g., nervousness, tremor). Lower initial doses and careful titration may be appropriate. Monitor for comorbidities and polypharmacy that may increase risk of adverse effects or drug interactions.

Clinical Information

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Clinical Pearls

  • Albuterol syrup provides systemic bronchodilation and is an alternative for patients who cannot use inhaled formulations.
  • Due to systemic absorption, oral albuterol may have a higher incidence of systemic side effects (e.g., tremor, tachycardia, nervousness) compared to inhaled albuterol.
  • It is a rescue medication, not a controller medication. Patients should not rely solely on albuterol for daily asthma control.
  • Educate patients on proper measurement of the liquid dose using an oral syringe or measuring spoon, not a household spoon.
  • Worsening symptoms or increased frequency of use (e.g., needing it more than twice a week for symptom control, not exercise-induced) indicates poor asthma control and warrants medical re-evaluation.
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Alternative Therapies

  • Inhaled short-acting beta-agonists (SABAs) like albuterol HFA or nebulized albuterol solution (preferred for acute relief due to faster onset and fewer systemic side effects).
  • Levalbuterol (Xopenex) - R-isomer of albuterol, may have fewer side effects for some patients.
  • Inhaled corticosteroids (ICS) - for long-term asthma control.
  • Long-acting beta-agonists (LABAs) - used in combination with ICS for long-term control.
  • Anticholinergics (e.g., ipratropium) - for COPD or as an alternative/add-on for asthma.
  • Systemic corticosteroids - for acute severe exacerbations.
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Cost & Coverage

Average Cost: $15 - $50 per 480 mL 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 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.