Budesonide 0.25mg/2ml Vials 2ml

Budesonide is a potent glucocorticoid that exhibits potent anti-inflammatory activity. It works by binding to glucocorticoid receptors, leading to the activation of anti-inflammatory genes and the repression of pro-inflammatory genes. This results in reduced inflammation in the airways, decreased airway hyperresponsiveness, and reduced mucus production, thereby improving asthma symptoms.

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: 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 a weak adrenal gland: 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 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 that bother you or persist, contact your doctor or seek medical attention:

Signs of a common cold
Nose or throat irritation
Upset stomach
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.
* 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 worsening 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 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 gradual tapering may be necessary.

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, notify 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 medication 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, atazanavir, clarithromycin, indinavir, nelfinavir, saquinavir, telithromycin)

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

• Wheezing
• Shortness of breath
• Cough
• Chest tightness
• Increased use of rescue inhaler
• Oral thrush (white patches in mouth/throat)
• Hoarseness/dysphonia
• Sore throat
• Signs of infection (fever, increased cough, discolored sputum)

Budesonide is generally considered one of the preferred inhaled corticosteroids for asthma management during pregnancy due to extensive human data showing no increased risk of congenital malformations. Use during pregnancy should be based on a careful risk-benefit assessment, as uncontrolled asthma poses greater risks to both mother and fetus.

Budesonide is excreted into breast milk, but the amount is very low and systemic exposure in the infant is expected to be negligible. It is considered compatible with breastfeeding. Monitor the infant for any signs of adverse effects, though unlikely.

Approved for maintenance treatment of asthma in children 12 months to 8 years of age. Growth velocity should be monitored regularly. Potential for systemic corticosteroid effects (e.g., adrenal suppression, growth retardation) should be considered, though generally low with recommended doses.

No specific dose adjustments are generally required. However, elderly patients may be more susceptible to systemic corticosteroid effects, and comorbidities should be considered.

• Budesonide inhalation suspension is for maintenance therapy and should not be used for acute asthma attacks.
• Proper nebulizer technique is crucial for effective drug delivery. Ensure the patient/caregiver is properly trained.
• Rinsing the mouth after each use is essential to minimize the risk of oral candidiasis (thrush).
• Monitor growth in pediatric patients, especially during long-term therapy, although systemic effects are generally minimal at recommended doses.
• Patients should be advised to carry a rescue inhaler (e.g., albuterol) for acute symptoms.
• Gradual tapering may be necessary if discontinuing after prolonged high-dose therapy to avoid adrenal insufficiency.

• Other inhaled corticosteroids (e.g., fluticasone propionate, mometasone furoate, ciclesonide, beclomethasone dipropionate)
• Leukotriene receptor antagonists (e.g., montelukast)
• Cromolyn sodium (mast cell stabilizer - less commonly used)
• Long-acting beta-agonists (LABAs - always in combination with ICS for asthma)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.