Accuneb Inhalation Sol 0.63mg/3ml

Albuterol is a selective beta-2 adrenergic agonist. It acts by stimulating beta-2 adrenergic receptors in the 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, resulting in bronchodilation.

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when 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
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 notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:

Feeling nervous or excitable
Dizziness or headache
Upset stomach or vomiting
Shakiness
Throat irritation
Runny nose

Reporting Side Effects

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.

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 symptoms you experienced.
If you are currently taking another medication similar to this one. If you are unsure, consult your doctor or pharmacist for clarification.

Please note that this is not an exhaustive list of all potential interactions with this medication. To ensure your safety, it is crucial to:

Inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Share information about your health problems, as they may interact with this medication.
* Verify that it is safe to take this medication with all your other medications and health conditions before starting, stopping, or changing the dose of any medication. Always consult your doctor before making any changes to your medication regimen.

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 promptly.

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 immediately.

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, 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 outcome for you and your baby.

• Beta-adrenergic blocking agents (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.

• Diuretics (e.g., loop or thiazide diuretics): May potentiate the 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 (e.g., epinephrine, pseudoephedrine): May potentiate adverse cardiovascular effects. Use with caution.

• Worsening shortness of breath
• Increased wheezing or coughing
• Chest tightness
• Paradoxical bronchospasm (worsening of breathing immediately after use)
• Palpitations or rapid heart rate
• Tremor or nervousness
• Dizziness or lightheadedness

Albuterol is classified as 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. Clinical experience suggests that albuterol can be used safely during pregnancy when indicated for asthma control, as uncontrolled asthma poses greater risks to both mother and fetus.

Albuterol is excreted in human milk. However, due to its low systemic absorption following inhalation and relatively short half-life, the amount transferred to breast milk is likely small. The American Academy of Pediatrics considers albuterol compatible with breastfeeding. Use with caution and monitor the infant for potential adverse effects (e.g., irritability, tremor, tachycardia).

Accuneb 0.63mg/3ml is specifically indicated for children 2 to 12 years of age. Albuterol is widely used and generally well-tolerated in pediatric patients for the treatment of bronchospasm. Proper dosing based on age and weight, and correct nebulizer technique, are crucial. Monitor for systemic adverse effects, especially with frequent use.

Use with caution in elderly patients, particularly those with underlying cardiovascular disease, hypertension, or diabetes, due to the potential for systemic beta-adrenergic effects (e.g., tachycardia, palpitations, tremor, hyperglycemia). Start with the lowest effective dose and titrate carefully. Monitor for adverse effects.

• Accuneb 0.63mg/3ml is a lower strength albuterol solution, primarily intended for pediatric patients aged 2-12 years.
• It is a rescue medication for acute bronchospasm, not a maintenance therapy. Patients should have a long-term controller medication if needed.
• Educate patients and caregivers on the proper use of the nebulizer and the importance of not exceeding prescribed doses.
• Monitor for paradoxical bronchospasm, which is rare but serious, characterized by immediate worsening of breathing after administration.
• Overuse of albuterol can indicate worsening asthma control and may lead to increased adverse effects (e.g., tachycardia, tremor, hypokalemia). Advise patients to seek medical attention if they need to use their rescue inhaler more frequently.

• Levalbuterol (Xopenex): R-isomer of albuterol, a SABA with potentially fewer side effects (e.g., less tachycardia, tremor) in some patients.
• Long-acting beta-agonists (LABAs) (e.g., Salmeterol, Formoterol): Used for maintenance therapy, not acute relief, often in combination with inhaled corticosteroids.
• Inhaled Corticosteroids (ICS) (e.g., Fluticasone, Budesonide): First-line maintenance therapy for persistent asthma.
• Leukotriene Receptor Antagonists (LTRAs) (e.g., Montelukast): Oral medications for asthma maintenance and allergic rhinitis.
• Systemic Corticosteroids (e.g., Prednisone): Used for acute severe asthma exacerbations.

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 is a good idea to consult with your pharmacist. If you have any questions or concerns about this 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 reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the quantity, and the time it occurred.