Pulmicort 0.5mg/2ml Respules 30x2ml

Budesonide is a potent glucocorticoid that exhibits strong anti-inflammatory activity. It works by binding to glucocorticoid receptors in the cytoplasm, translocating to the nucleus, and modulating gene expression. This leads to the inhibition of inflammatory mediators (e.g., cytokines, chemokines, eicosanoids) and inflammatory cells (e.g., mast cells, eosinophils, lymphocytes, macrophages, neutrophils), thereby reducing airway hyperresponsiveness and inflammation 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 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 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 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 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 notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:

Common cold symptoms
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, 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 allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to avoid 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 vital to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or change 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 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 medical professionals 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, consult your doctor promptly.

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 to determine the best course of action.

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, voriconazole): May significantly increase systemic exposure to budesonide, leading to increased risk of systemic corticosteroid effects (e.g., Cushing's syndrome, adrenal suppression).

• 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.

• Wheezing
• Shortness of breath
• Cough
• Chest tightness
• Increased use of rescue inhaler
• Difficulty sleeping due to asthma symptoms
• Oral white patches (thrush)
• Hoarseness
• Sore throat

Budesonide is generally considered one of the preferred inhaled corticosteroids for asthma management during pregnancy due to extensive data supporting its safety. It is classified as Pregnancy Category B (older classification). The benefits of maintaining asthma control outweigh the potential risks.

Budesonide is excreted into breast milk in small amounts. However, the amount is considered clinically insignificant due to its low oral bioavailability and extensive first-pass metabolism in the infant. It is rated L2 (likely compatible) by LactMed. Use is generally considered safe during breastfeeding.

Pulmicort Respules are specifically approved for the maintenance treatment of asthma in children 12 months to 8 years of age. Monitor growth velocity closely. Risk of oral candidiasis and hoarseness. Adrenal suppression is rare but possible with high doses or prolonged use.

No specific dose adjustments are generally required. However, elderly patients may be more susceptible to systemic corticosteroid effects (e.g., osteoporosis, cataracts, glaucoma) and should be monitored accordingly.

• Pulmicort Respules are designed for use with a jet nebulizer equipped with a mouthpiece or face mask, not for use with ultrasonic nebulizers.
• This medication is a controller medication and should be used daily for prevention, not for acute asthma attacks.
• Proper technique for nebulizer use is crucial for effective drug delivery.
• Always rinse the mouth and gargle with water (and spit out) after each use to minimize the risk of oral candidiasis (thrush) and dysphonia.
• Growth monitoring is essential for pediatric patients on long-term ICS therapy, though the impact on final adult height is generally minimal with appropriate dosing.

• Other inhaled corticosteroids (e.g., fluticasone propionate, mometasone furoate, ciclesonide, beclomethasone dipropionate)
• Leukotriene receptor antagonists (e.g., montelukast)
• Long-acting beta-agonists (LABAs) - often in combination with ICS for older children/adults
• Cromolyn sodium (less commonly used)

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 taken, the amount, and the time it occurred.