Accuneb Inhalation Soln 1.25mg/3ml
It is used to open the airways in lung diseases where spasm may cause breathing problems.
Drug Class
Bronchodilator
Pharmacologic Class
Selective Beta-2 Adrenergic Agonist
Pregnancy Category
Category C
FDA Approved
Sep 1981
DEA Schedule
Not Controlled
Overview
What is this medicine?
Accuneb is a medicine that helps open up the airways in your lungs, making it easier to breathe. It's often called a 'rescue inhaler' because it works quickly to relieve symptoms like wheezing, shortness of breath, and chest tightness during an asthma attack or flare-up. It's used with a nebulizer, which turns the liquid medicine into a fine mist that you breathe in.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. This medication is for inhalation only, using a special machine called a nebulizer, which delivers the liquid solution directly into your lungs.
Before using the medication, check the solution for any signs of damage or contamination. Do not use the solution if it appears cloudy, is leaking, or contains particles. Additionally, do not use the solution if it has changed color. It is also important not to mix any other medications in the nebulizer.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep unused containers in their original foil pouch until you are ready to use them. After opening the pouch, check the packaging for information on how long the vials can be stored. Keep all medications in a safe and secure location, out of the reach of children and pets.
What to Do If You Miss a Dose
If you take this medication on a regular schedule, use the missed dose as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your normal dosing 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.
To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. This medication is for inhalation only, using a special machine called a nebulizer, which delivers the liquid solution directly into your lungs.
Before using the medication, check the solution for any signs of damage or contamination. Do not use the solution if it appears cloudy, is leaking, or contains particles. Additionally, do not use the solution if it has changed color. It is also important not to mix any other medications in the nebulizer.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep unused containers in their original foil pouch until you are ready to use them. After opening the pouch, check the packaging for information on how long the vials can be stored. Keep all medications in a safe and secure location, out of the reach of children and pets.
What to Do If You Miss a Dose
If you take this medication on a regular schedule, use the missed dose as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your normal dosing 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.
Lifestyle & Tips
- Always carry your rescue inhaler with you.
- Use proper nebulizer technique as instructed by your healthcare provider or pharmacist.
- Rinse your mouth with water after each use to prevent dry mouth and reduce the risk of oral thrush (though less common with nebulized albuterol than inhaled corticosteroids).
- Avoid triggers that worsen your breathing problems (e.g., allergens, smoke, cold air).
- Do not exceed the prescribed dose or frequency. Overuse can lead to serious side effects.
- Keep track of how often you use your rescue inhaler; increased use may indicate worsening asthma control and require a doctor's visit.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Not the standard single adult dose for albuterol. Standard adult dose for albuterol inhalation solution is 2.5 mg (one 3 mL vial of 0.083% solution) administered 3 to 4 times daily, as needed. If Accuneb 1.25mg/3ml is used, two vials would be required per dose.
Condition-Specific Dosing:
acute_bronchospasm:
2.5 mg (two 1.25 mg vials) via nebulization every 4-6 hours as needed.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For children 2 to 12 years of age: 1.25 mg (one 3 mL vial) administered three or four times daily, as needed, by nebulization.
Adolescent:
Typically treated with adult dosing (2.5 mg), but 1.25 mg may be used if clinically appropriate, requiring two vials per dose.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended. Use with caution and monitor for adverse effects due to potential for increased systemic exposure.
Dialysis:
No specific adjustment recommended. Albuterol is not significantly removed by hemodialysis.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended. Use with caution and monitor for adverse effects.
Pharmacology
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, inhibition of mediator release from mast cells, and to a lesser extent, inhibition of acetylcholine release from cholinergic nerve endings.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 10-20% (systemic after inhalation), 50% (oral)
Tmax:
0.5 to 2 hours (inhalation solution)
FoodEffect:
Not applicable for inhaled administration.
Distribution:
Vd:
Approximately 300 L
ProteinBinding:
10%
CnssPenetration:
Limited
Elimination:
HalfLife:
3.8 to 5 hours (systemic)
Clearance:
Approximately 270 mL/min
ExcretionRoute:
Renal (primarily)
Unchanged:
Approximately 69% of an intravenous dose is excreted unchanged in urine within 24 hours.
Pharmacodynamics
OnsetOfAction:
Within 5 minutes
PeakEffect:
60 to 90 minutes
DurationOfAction:
4 to 6 hours
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
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
Chest pain or pressure
Fast or abnormal heartbeat
Severe breathing problems, which can be life-threatening, especially when using an inhaler or liquid for breathing in. This may occur right after a dose or when using a new canister or vial of this medication. If you experience trouble breathing, worsening breathing, wheezing, or coughing, seek medical help immediately.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical attention:
Feeling nervous and excitable
Dizziness or headache
Upset stomach or vomiting
Shakiness
Throat irritation
Runny nose
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
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
Chest pain or pressure
Fast or abnormal heartbeat
Severe breathing problems, which can be life-threatening, especially when using an inhaler or liquid for breathing in. This may occur right after a dose or when using a new canister or vial of this medication. If you experience trouble breathing, worsening breathing, wheezing, or coughing, seek medical help immediately.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical attention:
Feeling nervous and excitable
Dizziness or headache
Upset stomach or vomiting
Shakiness
Throat irritation
Runny nose
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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 after using the medication.
- Need to use the medication more often than prescribed (e.g., more than every 4-6 hours, or more than 2 days a week for symptom control).
- Symptoms not improving or getting worse despite using the medication.
- Chest pain or rapid/pounding heartbeat (palpitations).
- Severe dizziness or lightheadedness.
- Muscle cramps or weakness (signs of low potassium).
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. This will help ensure that it is safe 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.
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. This will help ensure that it is safe 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.
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, immediately contact your doctor.
If you have diabetes (high blood sugar), it is crucial to closely monitor your blood sugar levels while taking this drug.
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 this medication to both you and your baby, allowing you to make an informed decision.
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, immediately contact your doctor.
If you have diabetes (high blood sugar), it is crucial to closely monitor your blood sugar levels while taking this drug.
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 this medication to both you and your baby, allowing you to make an informed decision.
Overdose Information
Overdose Symptoms:
- Exaggerated beta-adrenergic stimulation effects:
- Tachycardia (rapid heart rate)
- Palpitations (pounding heart)
- Tremor (shaking)
- Nervousness
- Headache
- Dizziness
- Nausea
- Vomiting
- Hypokalemia (low potassium)
- Hyperglycemia (high blood sugar)
- Metabolic acidosis
- Cardiac arrest (in severe cases)
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 considered in severe cases but must be used with extreme caution due to the risk of inducing bronchospasm.
Drug Interactions
Contraindicated Interactions
- Non-selective beta-blockers (e.g., propranolol, carvedilol, labetalol) due to antagonism of albuterol's effects and potential for severe bronchospasm.
Major Interactions
- Diuretics (thiazide or loop) - may potentiate ECG changes and/or hypokalemia.
- Digoxin - may decrease serum digoxin levels.
- Monoamine Oxidase Inhibitors (MAOIs) and Tricyclic Antidepressants (TCAs) - may potentiate the vascular effects of albuterol, increasing risk of cardiovascular adverse effects. Use with extreme caution or avoid within 14 days of discontinuing MAOIs/TCAs.
Moderate Interactions
- Other sympathomimetics - additive cardiovascular effects.
- Theophylline - increased risk of adverse effects (e.g., arrhythmias, seizures) with high doses of both.
Monitoring
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, especially for new diagnoses or significant changes in condition.
Vital Signs (Heart Rate, Blood Pressure)
Rationale: To establish baseline and identify potential cardiovascular risks.
Timing: Prior to initiation.
Serum Potassium
Rationale: To assess baseline, especially in patients at risk for hypokalemia (e.g., on diuretics, severe asthma exacerbation).
Timing: Prior to initiation, if indicated.
Routine Monitoring
Symptom Control (e.g., frequency of rescue inhaler use, nocturnal symptoms)
Frequency: Daily (patient self-monitoring), at each clinic visit (provider assessment)
Target: Minimal symptoms, infrequent rescue inhaler use (e.g., <2 days/week)
Action Threshold: Increased frequency of symptoms, increased rescue inhaler use, nocturnal awakenings, decreased peak flow readings.
Peak Expiratory Flow (PEF)
Frequency: Daily (patient self-monitoring, if applicable)
Target: Individualized based on personal best or predicted values.
Action Threshold: Significant drop from personal best (e.g., >20%).
Heart Rate and Blood Pressure
Frequency: Periodically, or if patient reports palpitations/tremor.
Target: Within normal limits for the patient.
Action Threshold: Persistent tachycardia, palpitations, or significant hypertension.
Serum Potassium
Frequency: Periodically, especially with high doses or concomitant diuretics.
Target: 3.5-5.0 mEq/L
Action Threshold: <3.5 mEq/L
Symptom Monitoring
- Wheezing
- Shortness of breath (dyspnea)
- Cough
- Chest tightness
- Increased work of breathing
- Palpitations
- Tremor
- Nervousness
Special Patient Groups
Pregnancy
Albuterol is a Pregnancy Category C drug. 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 on the fetus, but there are no adequate and well-controlled studies in pregnant women. It is commonly used for asthma management during pregnancy, as uncontrolled asthma poses a greater risk to both mother and fetus.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity observed in animal studies at high doses; human data are reassuring but limited.
Second Trimester:
Generally considered safe for use if clinically indicated.
Third Trimester:
May inhibit uterine contractions (tocolytic effect) at high doses, but this is generally not clinically significant with usual inhaled doses. Monitor for maternal tachycardia and hyperglycemia.
Lactation
Albuterol is excreted into human milk. However, due to low systemic absorption from inhaled administration, the amount transferred to breast milk is expected to be low, and adverse effects on the breastfed infant are unlikely. Use with caution and monitor the infant for signs of adverse effects (e.g., irritability, tremor, poor feeding).
Infant Risk:
Low risk (L3 - Moderately Safe)
Pediatric Use
Accuneb 1.25mg/3ml is specifically indicated for children 2 to 12 years of age. Safety and efficacy in children younger than 2 years have not been established for this specific concentration. For older children and adolescents, dosing may vary, often aligning with adult doses (2.5 mg). Proper nebulizer technique is crucial.
Geriatric Use
No specific dose adjustment is generally required. However, elderly patients may be more susceptible to the cardiovascular adverse effects of beta-agonists (e.g., tachycardia, tremor, hypertension). Use with caution and monitor for adverse effects, especially in those with pre-existing cardiovascular conditions.
Clinical Information
Clinical Pearls
- Accuneb 1.25mg/3ml is a lower-dose albuterol formulation, primarily intended for pediatric patients (2-12 years old).
- It is a 'rescue' medication, meaning it should be used for quick relief of acute bronchospasm, not for daily maintenance unless specifically prescribed for exercise-induced bronchospasm or as part of a specific regimen.
- Patients should be educated on the difference between rescue inhalers (like albuterol) and controller medications (like inhaled corticosteroids) and the importance of using both as prescribed.
- Overuse of albuterol (e.g., needing to use it more than twice a week for symptom control, or more than one canister per month) is a sign of poorly controlled asthma and warrants immediate medical re-evaluation.
- Proper nebulizer technique is essential for effective drug delivery. Patients should be instructed on how to use and clean their nebulizer equipment.
- Paradoxical bronchospasm can occur, though rarely. If this happens, discontinue the drug immediately and use an alternative bronchodilator.
Alternative Therapies
- Other Short-Acting Beta-Agonists (SABAs): Levalbuterol (Xopenex) - a single isomer of albuterol, may have fewer side effects.
- Long-Acting Beta-Agonists (LABAs): Salmeterol, Formoterol (used for maintenance, often in combination with inhaled corticosteroids).
- Inhaled Corticosteroids (ICS): Budesonide, Fluticasone (for long-term asthma control).
- Combination ICS/LABA: Fluticasone/Salmeterol (Advair), Budesonide/Formoterol (Symbicort).
- Anticholinergics: Ipratropium (Atrovent) - sometimes used in acute exacerbations, especially in COPD.
- Systemic Corticosteroids: Prednisone (for acute severe exacerbations).
Cost & Coverage
Average Cost:
Varies widely, typically $20-$100+ per 30 vials (1.25mg/3ml)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (often preferred generic)
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; consult your pharmacist for more information. If you have any questions or concerns about this medication, 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 reporting the overdose, be prepared to provide details about the medication taken, the amount, and the time it occurred.