Budesonide 1mg/2ml Respules 2ml

Budesonide is a potent glucocorticoid with high topical anti-inflammatory activity. It exerts its effects by binding to glucocorticoid receptors in the cytoplasm, leading to a cascade of events that modulate gene expression. This results in the inhibition of inflammatory cells (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines), thereby reducing airway inflammation, bronchial hyperresponsiveness, and mucus production in the lungs.

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 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 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 adrenal gland problems, such as:
+ Severe stomach upset or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Extreme fatigue
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, including:
+ Weight gain in the upper back or abdomen
+ Moon face
+ Severe headache
+ Slow wound healing
Chest pain
Anxiety
Severe diarrhea
Severe stomach pain, upset stomach, or vomiting
Decreased appetite
Severe headache
Feeling extremely tired or weak
Bone or joint pain
Changes in vision
Redness or white patches in the mouth or throat
Abnormal burning, numbness, or tingling sensations

Respiratory Emergency

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 immediate medical attention.

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help if they bother you or persist:

Signs of a common cold
Nose or throat irritation
Upset stomach
Cough
Nosebleed

Reporting Side Effects

This list is not exhaustive, and you may experience other 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 as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or exacerbate certain health problems.

To ensure safe use, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
Any health problems you have

Before making any changes to your medication regimen, consult with your doctor to confirm that it is safe to:
Start taking this medication
Stop taking this medication
Change the dosage of this medication or any other medication you are taking

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

While using this drug, you may be more susceptible to infections. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with individuals who have infections, colds, or flu.

If you experience a worsening of your breathing problems, or if your rescue inhaler becomes less effective or is needed more often, contact your doctor immediately.

When transitioning from an oral steroid to a different form of steroid, there is a risk of severe and potentially life-threatening side effects. Be aware of symptoms such as weakness, fatigue, dizziness, nausea, vomiting, confusion, or low blood sugar, and seek medical attention promptly if you experience any of these.

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

If you have been taking this medication for an extended period, consult your doctor before stopping or reducing the dosage, as you may need to taper off the drug gradually.

Be cautious of exposure to chickenpox or measles, as these infections can be severe or even fatal in individuals taking steroid medications like this one. Avoid contact with anyone who has chickenpox or measles if you have not previously had these illnesses. If you have been exposed, consult your doctor.

Long-term use of this medication may increase the risk of osteoporosis (weak bones). Discuss your risk factors with your doctor and follow their recommendations for bone density testing.

Prolonged use may also raise the risk of cataracts or glaucoma. Regularly schedule eye exams and discuss any concerns with your doctor.

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 drug may affect growth in some cases. Regular growth checks may be necessary, so consult your doctor.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, cobicistat)

• Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem)

• Worsening asthma symptoms (e.g., increased wheezing, shortness of breath, cough)
• Increased frequency of rescue inhaler use
• Signs of oral candidiasis (white patches in mouth or throat)
• Signs of infection (fever, chills, increased sputum)
• Symptoms of adrenal insufficiency (fatigue, weakness, nausea, vomiting, dizziness)
• Blurred vision or eye pain (potential for cataracts/glaucoma)

Budesonide is generally considered one of the preferred inhaled corticosteroids for asthma management during pregnancy due to its low systemic absorption and extensive experience with its use. It is classified as Pregnancy Category B (older system), indicating no evidence of risk in animal studies and no adequate and well-controlled studies in pregnant women, but human data suggest low risk.

Budesonide is considered compatible with breastfeeding. It is excreted into breast milk in very small amounts, and systemic effects on the infant are unlikely due to the low oral bioavailability of budesonide.

Budesonide inhalation suspension is commonly used in pediatric patients, including infants as young as 12 months, for asthma maintenance. Close monitoring of growth velocity is recommended due to the potential for systemic corticosteroid effects, although typically minimal with inhaled forms. Adrenal function should be monitored, especially if transitioning from oral corticosteroids.

No specific dose adjustments are typically required for geriatric patients. However, older patients may be more susceptible to systemic corticosteroid effects (e.g., bone density loss, cataracts, glaucoma), so monitoring for these effects is prudent.

• Budesonide inhalation suspension is a maintenance medication for asthma and should be used regularly, not for acute asthma attacks. Patients should always have a rescue inhaler (e.g., albuterol) available.
• Proper nebulizer technique is crucial for effective drug delivery. Patients/caregivers should be thoroughly instructed.
• Rinsing the mouth and gargling with water (and spitting it out) after each use helps prevent oral candidiasis (thrush).
• Monitor pediatric patients' growth velocity annually, as inhaled corticosteroids can rarely cause a small, reversible reduction in growth rate.
• Patients transitioning from systemic corticosteroids to inhaled budesonide should be carefully monitored for signs of adrenal insufficiency, and systemic steroids should be tapered gradually.

• Other inhaled corticosteroids (e.g., fluticasone propionate, mometasone furoate, ciclesonide, beclomethasone dipropionate)
• Long-acting beta-agonists (LABAs) - often used in combination with ICS for better control
• Leukotriene receptor antagonists (e.g., montelukast)
• Mast cell stabilizers (e.g., cromolyn)
• Biologic therapies (e.g., omalizumab, mepolizumab, benralizumab, dupilumab) for severe asthma

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's a good idea to check with your pharmacist for more information. If you have any questions or concerns about your 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.