Budesonide/form 80/4.5mcg (120 Inh)

Budesonide is a potent glucocorticoid with anti-inflammatory properties. It reduces inflammation in the airways, decreasing hyperresponsiveness. Formoterol is a long-acting selective beta2-adrenergic agonist (LABA) that stimulates beta2-receptors in the bronchial smooth muscle, leading to bronchodilation and relaxation of the airways.

Serious 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 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 infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Signs of high blood sugar, such as:
+ Confusion
+ Drowsiness
+ Excessive thirst or hunger
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
Signs of low potassium levels, including:
+ Muscle pain or weakness
+ Muscle cramps
+ Abnormal heartbeat
Signs of a weak adrenal gland, such as:
+ Severe nausea or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Fatigue
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of high or low blood pressure, including:
+ Severe headache or dizziness
+ Fainting
+ Changes in vision
Chest pain or pressure
Rapid or abnormal heartbeat
Shakiness
Nervousness or excitability
Bone pain
Dizziness or fainting
Seizures
Severe nausea or vomiting
Fatigue or weakness
Sleep disturbances
Abnormal sensations, such as burning, numbness, or tingling
Flu-like symptoms
Sinus pain
Changes in vision, eye pain, or severe eye irritation
Redness or white patches in the mouth or throat
Mouth irritation or mouth sores

Respiratory Problems: A Life-Threatening Condition

This medication can cause severe breathing problems, which may be life-threatening. If you experience trouble breathing, worsening breathing, wheezing, or coughing after taking this medication, use a rescue inhaler and seek medical help immediately.

Other 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 contact your doctor or seek medical attention if you notice any of the following:

Headache
Stomach pain
Nose or throat irritation
Common cold symptoms
Back pain
Nausea or vomiting

These are not all the possible side effects that may occur. 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, any of its components, or other substances, such as foods or drugs. 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 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 discuss the following with your doctor and pharmacist:

All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Any existing health problems you have

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. This will help prevent any potential interactions or adverse effects.

Important Warnings and Cautions

Before taking this medication, inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using it. If you have diabetes (high blood sugar), discuss this with your doctor, as this medication may increase your blood sugar levels.

It may take up to 2 weeks to experience the full effects of this medication. If your breathing problems worsen, your rescue inhaler becomes less effective, or you need to use it more frequently, contact your doctor immediately.

Dosage and Administration

Do not exceed the prescribed dose or use this medication more often than directed. Overdose can be fatal. Consult your doctor if you have any concerns.

Special Considerations

When switching from an oral steroid to another form of steroid, you may be at risk for severe and potentially life-threatening side effects. Monitor for signs such as weakness, fatigue, dizziness, nausea, vomiting, confusion, or low blood sugar, and contact your doctor immediately if you experience any of these symptoms.

If you have a severe injury, undergo surgery, or develop an infection, you may require additional doses of oral steroids to help your body cope with these stresses. Carry a warning card indicating that you may need extra steroids in certain situations.

Long-term Use

Prolonged use of this medication may increase your risk of developing cataracts or glaucoma. Consult your doctor and schedule regular eye exams as recommended.

Long-term use may also lead to osteoporosis (weak bones). Discuss your risk factors with your doctor and ask about any concerns you may have. Additionally, you may be more susceptible to infections; therefore, practice good hygiene by washing your hands frequently and avoiding people with infections, colds, or flu.

Infections and Vaccinations

If you have not had chickenpox or measles before, avoid exposure to anyone with these conditions, as they can be severe or even fatal in people taking steroid medications like this one. If you have been exposed, contact your doctor immediately.

Special Populations

If you are 65 or older, use this medication with caution, as you may be more prone to side effects.

In children and adolescents, this medication may affect growth in some cases. Regular growth checks may be necessary; consult your doctor for more information.

Pregnancy and Breastfeeding

If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor.

COPD

If you have chronic obstructive pulmonary disease (COPD), you are at a higher risk of developing pneumonia. This medication may further increase this risk; consult your doctor to discuss the potential risks and benefits.

• Acute bronchospasm (not for rescue therapy)
• Status asthmaticus

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, atazanavir, clarithromycin, indinavir, nelfinavir, saquinavir, telithromycin): May significantly increase budesonide systemic exposure, leading to increased risk of Cushing's syndrome and adrenal suppression.
• Other long-acting beta2-agonists (LABAs): Increased risk of cardiovascular adverse effects.
• Beta-blockers (non-cardioselective): May block the bronchodilatory effect of formoterol and cause severe bronchospasm, especially in patients with asthma.
• QT-prolonging drugs (e.g., quinidine, disopyramide, procainamide, phenothiazines, tricyclic antidepressants): Increased risk of ventricular arrhythmias due to additive QT prolongation.

• Diuretics (loop or thiazide): May potentiate hypokalemia and/or ECG changes associated with beta-agonists.
• Tricyclic antidepressants (TCAs) and Monoamine Oxidase Inhibitors (MAOIs): May potentiate the cardiovascular effects of formoterol (e.g., hypertension, tachycardia).
• Sympathomimetics: Additive effects on cardiovascular system.
• Xanthine derivatives (e.g., theophylline): May potentiate hypokalemia.

• Not specifically identified as minor interactions with significant clinical impact for this combination.

• Worsening asthma/COPD symptoms (e.g., increased shortness of breath, wheezing, cough)
• Increased need for rescue inhaler
• Chest pain or palpitations
• Tremor or nervousness
• Oral candidiasis (thrush) - inspect mouth and throat
• Hoarseness or dysphonia
• Blurred vision or eye pain (potential for glaucoma/cataracts)
• Signs of infection (e.g., fever, increased sputum production)

Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Uncontrolled asthma poses a greater risk to both mother and fetus than the medication itself. Budesonide is generally considered safer than other inhaled corticosteroids in pregnancy.

Budesonide is excreted in breast milk but at low levels, and systemic exposure in the infant is expected to be minimal. Formoterol is also excreted in breast milk. The benefits of breastfeeding should be weighed against the potential risks. Generally considered compatible with breastfeeding due to low systemic absorption.

Closely monitor growth velocity in pediatric patients receiving inhaled corticosteroids, as they may cause a reduction in growth. Use the lowest effective dose. Adrenal suppression is a potential risk, especially with higher doses or prolonged use. Not recommended for children under 6 years of age.

No specific dose adjustment is required. However, elderly patients may be more susceptible to the cardiovascular effects of LABAs (e.g., tremor, palpitations) and systemic corticosteroid effects (e.g., osteoporosis, cataracts, glaucoma). Monitor for comorbidities and potential drug interactions.

• Budesonide/Formoterol is a maintenance medication and should not be used for acute relief of bronchospasm. Patients should always have a short-acting beta-agonist (SABA) rescue inhaler available.
• Proper inhaler technique is crucial for efficacy. Educate patients on how to use the inhaler correctly and confirm their technique.
• Rinsing the mouth and gargling with water after each dose helps prevent oral candidiasis (thrush) and dysphonia.
• Patients should be advised not to stop therapy abruptly, especially if on high doses, due to the risk of adrenal insufficiency.
• Regular follow-up is important to assess asthma/COPD control, monitor for adverse effects, and ensure adherence.

• Inhaled Corticosteroids (ICS) monotherapy (e.g., budesonide, fluticasone, mometasone)
• Long-Acting Beta2-Agonists (LABA) monotherapy (e.g., formoterol, salmeterol, arformoterol) - generally not recommended for asthma without an ICS.
• Long-Acting Muscarinic Antagonists (LAMA) (e.g., tiotropium, umeclidinium) - primarily for COPD, sometimes add-on for severe asthma.
• Oral corticosteroids (for severe exacerbations or refractory disease)
• Leukotriene Receptor Antagonists (LTRAs) (e.g., montelukast)
• Immunomodulators (e.g., omalizumab, mepolizumab, dupilumab) for severe asthma.

If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about this 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, including the amount taken and the time it happened, to facilitate prompt and effective treatment.