Budesonide/form 160/4.5mcg(120 Inh)

Budesonide is a potent glucocorticoid with anti-inflammatory properties. It inhibits multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in allergic and non-allergic mediated inflammation. Formoterol is a long-acting selective beta2-adrenergic agonist (LABA). It acts locally in the lung as a bronchodilator by stimulating beta2-adrenergic receptors in the smooth muscle of the airways, leading to relaxation of bronchial smooth muscle.

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 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 irregular heartbeat
Shakiness
Feeling nervous or excitable
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 Warning

This medication can cause severe breathing problems, which may be life-threatening. If you experience difficulty breathing, worsening breathing, wheezing, or coughing after taking this medication, use a rescue inhaler and 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 don't go away, contact your doctor:

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

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.

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.

This list is not exhaustive, and it is crucial to discuss all your medications and health conditions with your doctor. Please provide your doctor and pharmacist with a comprehensive list of:

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

It is vital to verify that it is safe to take this medication in conjunction with your other medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.

Important Warnings and Cautions

If you are taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists.

Diabetes Warning
If you have high blood sugar (diabetes), consult your doctor, as this medication may increase your blood sugar levels.

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

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

Steroid Replacement Therapy
When transitioning from oral steroids to another form of steroid, you may be at risk for severe and potentially life-threatening side effects, such as weakness, fatigue, dizziness, nausea, vomiting, confusion, or low blood sugar. Seek medical attention immediately if you experience any of these symptoms.

In cases of injury, surgery, or infection, you may require additional oral steroid doses to help your body cope with stress. Carry a warning card indicating that you may need extra steroids in such situations.

Long-term Use and Eye Health
Prolonged use of this medication may increase the risk of cataracts or glaucoma. Consult your doctor and undergo regular eye exams as recommended.

Bone Health and Infection Risk
Long-term use may also lead to weak bones (osteoporosis). Discuss your risk factors with your doctor. Additionally, you may be more susceptible to infections. To minimize this risk, practice good hygiene by washing your hands frequently and avoiding people with infections, colds, or flu.

Viral Infections
If you have not had chickenpox or measles before, avoid exposure to these viruses, as they can be severe or even fatal in people taking steroid medications like this one. If you have been exposed, consult your doctor.

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

Pediatric Considerations
This medication may affect growth in children and teenagers. 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 Considerations
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 this potential complication.

• 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-adrenergic agonists (LABAs): Increased risk of cardiovascular adverse effects.
• Monoamine Oxidase Inhibitors (MAOIs) and Tricyclic Antidepressants (TCAs): May potentiate the effect of formoterol on the cardiovascular system, leading to prolonged QTc interval and increased risk of ventricular arrhythmias.

• Beta-blockers (non-cardioselective): May block the bronchodilatory effect of formoterol and cause severe bronchospasm, especially in patients with asthma. Cardioselective beta-blockers should be used with caution.
• Diuretics (loop or thiazide): May potentiate hypokalemia and/or ECG changes (e.g., QTc prolongation) associated with beta-agonists.
• Drugs that prolong QTc interval (e.g., antiarrhythmics, antipsychotics): Increased risk of ventricular arrhythmias with formoterol.

• Xanthine derivatives (e.g., theophylline): May potentiate hypokalemia.

• Worsening asthma/COPD symptoms (e.g., increased shortness of breath, wheezing, cough)
• Increased use of rescue inhaler
• Signs of oral candidiasis (white patches in mouth/throat)
• Signs of systemic corticosteroid effects (e.g., easy bruising, moon face, weight gain, fatigue)
• Signs of paradoxical bronchospasm (immediate worsening of breathing after inhalation)
• Cardiovascular symptoms (e.g., palpitations, chest pain, increased heart rate)
• Muscle cramps or tremors
• Blurred vision or eye pain

Budesonide is generally considered one of the preferred inhaled corticosteroids for asthma management during pregnancy due to extensive data showing no increased risk of major birth defects. Formoterol is a Category C drug. Use during pregnancy only 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.

Budesonide is excreted in breast milk in very small amounts, and adverse effects on the breastfed infant are not expected. Formoterol is also expected to be excreted in breast milk in small amounts. The benefits of breastfeeding should be weighed against the potential risks. Generally considered compatible with breastfeeding due to low systemic absorption and low levels in milk.

Approved for asthma in patients 6 years and older (80/4.5 mcg for 6 to <12 years, 160/4.5 mcg for ≥12 years). Not approved for COPD in pediatric patients. Monitor growth velocity regularly, as inhaled corticosteroids can cause a small reduction in growth rate. Use the lowest effective dose.

No overall differences in safety or effectiveness have been observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Use with caution in elderly patients with concomitant cardiovascular disease or other conditions that may be exacerbated by beta-agonists.

• This medication is a controller medication and should be used regularly, not for acute asthma attacks. Patients should always have a rescue inhaler (e.g., albuterol) available.
• Proper inhaler technique is crucial for efficacy. Patients should be instructed on how to use the metered-dose inhaler (MDI) with or without a spacer, and how to rinse their mouth after use.
• The black box warning for LABAs applies to monotherapy. When used in combination with an ICS, the benefits generally outweigh the risks for appropriate patients.
• Patients should be advised not to stop therapy abruptly, especially if on high doses, due to the risk of adrenal insufficiency.
• Monitor for systemic corticosteroid effects, especially with prolonged use or higher doses, such as adrenal suppression, bone mineral density changes, cataracts, and glaucoma.

• Inhaled Corticosteroids (ICS) monotherapy (e.g., budesonide, fluticasone, mometasone)
• Long-Acting Beta2-Adrenergic Agonists (LABA) monotherapy (not recommended for asthma without ICS)
• Long-Acting Muscarinic Antagonists (LAMA) (e.g., tiotropium, umeclidinium) - primarily for COPD, sometimes add-on for asthma
• ICS/LAMA/LABA triple therapy (e.g., Trelegy Ellipta) - for severe COPD or uncontrolled asthma
• Leukotriene Receptor Antagonists (LTRAs) (e.g., montelukast)
• Oral corticosteroids (for exacerbations or severe persistent disease)
• Biologic therapies (e.g., omalizumab, mepolizumab, dupilumab) - for severe asthma

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 emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it was taken.