Budesonide 0.5mg/2ml Vials, 2ml

Budesonide is a potent glucocorticoid that exhibits strong anti-inflammatory activity. It works by binding to glucocorticoid receptors in the cytoplasm of target cells, leading to the translocation of the receptor-ligand complex into the nucleus. This complex then modulates gene expression, leading to the synthesis of anti-inflammatory proteins (e.g., lipocortin-1) and the inhibition of pro-inflammatory mediators (e.g., cytokines, chemokines, prostaglandins, leukotrienes). In the airways, this reduces inflammation, bronchial hyperreactivity, and mucus production, thereby improving lung function in asthma.

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: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal
Signs of adrenal gland problems: severe nausea or vomiting, severe dizziness or fainting, muscle weakness, extreme fatigue, mood changes, decreased appetite, or weight loss
Signs of Cushing's syndrome: weight gain in the upper back or abdomen, moon face, severe headache, or slow healing
Chest pain
Anxiety
Severe diarrhea
Severe stomach pain, nausea, 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

This medication can cause severe breathing problems, which may be life-threatening, shortly after taking a dose. If you experience difficulty breathing, worsening breathing, wheezing, or coughing after using 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 for advice:

Common cold symptoms
Nose or throat irritation
Mild stomach upset
Cough
Nosebleed

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.

To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.

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, a decrease in the effectiveness of your rescue inhaler, or an increase in the frequency of using your rescue inhaler, contact your doctor immediately.

When transitioning from an oral steroid to another 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 the event of a 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 with you to alert healthcare providers of this potential need.

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.

If you have not previously had chickenpox or measles, avoid exposure to these illnesses, as they can be severe or even fatal in individuals taking steroid medications like this one. If you have been exposed to chickenpox or measles, consult your doctor immediately.

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

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

In some cases, this medication may affect growth in children and adolescents, and regular growth checks may be necessary. Consult your doctor to discuss this potential risk.

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): Can significantly increase systemic exposure to budesonide, leading to increased risk of systemic corticosteroid effects (e.g., Cushing's syndrome, adrenal suppression). Co-administration should be avoided unless the benefit outweighs the increased risk, and patients should be monitored for systemic corticosteroid side effects.

• Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, verapamil): May increase budesonide levels, but to a lesser extent than strong inhibitors. Monitor for systemic corticosteroid effects.
• Oral contraceptives: May increase plasma concentrations of budesonide, though generally not clinically significant.

• Worsening asthma symptoms (e.g., increased wheezing, shortness of breath, cough, chest tightness)
• Increased need for rescue bronchodilator (e.g., albuterol)
• Signs of oral candidiasis (thrush) - white patches in mouth/throat
• Signs of systemic corticosteroid effects (e.g., easy bruising, moon face, weight gain, mood changes, fatigue, weakness)
• Signs of infection (e.g., fever, increased cough, discolored sputum)

Budesonide is generally considered one of the preferred inhaled corticosteroids for asthma management during pregnancy due to extensive clinical experience and data suggesting low risk. Asthma control is crucial during pregnancy to ensure adequate oxygenation for both mother and fetus. Use the lowest effective dose.

Budesonide is excreted into breast milk in very small amounts. Systemic exposure to the breastfed infant is expected to be negligible. It is generally considered compatible with breastfeeding. Monitor the infant for any signs of adverse effects, though unlikely.

Budesonide inhalation suspension is specifically indicated for the maintenance treatment of asthma in children 12 months to 8 years of age. Close monitoring of growth velocity is recommended due to the potential for inhaled corticosteroids to affect growth. The lowest effective dose should be used.

No specific dose adjustment is required based on age. However, elderly patients may be more susceptible to systemic corticosteroid effects (e.g., bone mineral density loss, cataracts, glaucoma, adrenal suppression), so monitor closely.

• Budesonide inhalation suspension is a maintenance medication for asthma and should be used daily, not for acute asthma attacks.
• Ensure proper nebulizer technique is taught to caregivers and patients to maximize drug delivery to the lungs.
• Always rinse the mouth and spit after each use to minimize the risk of oral candidiasis (thrush).
• Monitor growth in pediatric patients receiving long-term budesonide therapy.
• Patients transitioning from oral corticosteroids to inhaled budesonide should be carefully monitored for signs of adrenal insufficiency.
• Advise patients to carry a rescue inhaler for acute symptoms, as budesonide does not provide immediate relief.

• Other inhaled corticosteroids (e.g., fluticasone propionate, mometasone furoate, ciclesonide, beclomethasone dipropionate)
• Leukotriene receptor antagonists (e.g., montelukast)
• Long-acting beta-agonists (LABAs) - always in combination with an ICS for asthma
• Cromolyn sodium (mast cell stabilizer)
• Oral corticosteroids (for severe exacerbations or refractory asthma, but with more systemic side effects)

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 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 information about what was taken, the amount, and the time it happened.