Pulmicort 0.25mg/2ml Respule 30x2ml
It is used to treat asthma.It may be given to you for other reasons. Talk with the doctor.Do not use this drug to treat an asthma attack. Use a rescue inhaler. Talk with your doctor.
Drug Class
Corticosteroid, Inhaled
Pharmacologic Class
Glucocorticoid Receptor Agonist
Pregnancy Category
Category B (older classification, current labeling provides risk summary)
FDA Approved
Jul 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Budesonide is an inhaled corticosteroid medication used to prevent asthma attacks and improve breathing. It works by reducing inflammation in the airways of your lungs. It is not a rescue inhaler and will not help during a sudden asthma attack.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is for inhalation only, using a special machine called a nebulizer that delivers the liquid solution directly into your lungs.
Important Administration Instructions:
- Do not swallow this medication.
- Do not mix any other medications with this drug in the nebulizer.
- Gently shake the nebulizer before each use.
- If you are using a face mask, wash your face after each dose.
- Continue using this medication as directed by your doctor or healthcare provider, even if you start feeling well.
- After each use, rinse your mouth with water. Do not swallow the rinse water; spit it out instead.
- If you are taking more than one inhaled medication, consult your doctor about the best order for taking your medications.
Storage and Disposal
- Store the medication upright at room temperature.
- Do not freeze the medication.
- Protect it from light.
What to Do If You Miss a Dose
If you miss a dose, skip it and return to your regular dosing schedule. Do not take two doses at the same time or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is for inhalation only, using a special machine called a nebulizer that delivers the liquid solution directly into your lungs.
Important Administration Instructions:
- Do not swallow this medication.
- Do not mix any other medications with this drug in the nebulizer.
- Gently shake the nebulizer before each use.
- If you are using a face mask, wash your face after each dose.
- Continue using this medication as directed by your doctor or healthcare provider, even if you start feeling well.
- After each use, rinse your mouth with water. Do not swallow the rinse water; spit it out instead.
- If you are taking more than one inhaled medication, consult your doctor about the best order for taking your medications.
Storage and Disposal
- Store the medication upright at room temperature.
- Do not freeze the medication.
- Protect it from light.
What to Do If You Miss a Dose
If you miss a dose, skip it and return to your regular dosing schedule. Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Use regularly as prescribed, even when feeling well, to maintain asthma control.
- Rinse your mouth thoroughly with water and spit it out after each use to prevent oral thrush (a fungal infection in the mouth).
- Do not use for sudden asthma attacks; use your prescribed rescue inhaler for those.
- Keep track of your asthma symptoms and peak flow readings if advised by your doctor.
- Avoid triggers that worsen your asthma (e.g., allergens, smoke, cold air).
- Ensure proper inhalation technique with your nebulizer.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Not typically used as primary maintenance for adults; often for acute exacerbations or when other ICS forms are unsuitable. Doses vary, e.g., 0.5 mg to 1 mg once or twice daily.
Dose Range:
0.25 - 1 mg
Condition-Specific Dosing:
Asthma Maintenance (off-label for adults):
0.5 mg to 1 mg once or twice daily, adjusted based on response.
Pediatric Dosing
Neonatal:
Not established
Infant:
12 months to 8 years: Initial dose 0.25 mg to 0.5 mg once daily or divided twice daily. Max 1 mg/day.
Child:
12 months to 8 years: Initial dose 0.25 mg to 0.5 mg once daily or divided twice daily. Max 1 mg/day. For severe persistent asthma, initial dose up to 1 mg daily.
Adolescent:
Similar to child dosing, or may transition to adult-like dosing if appropriate. Typically 0.25 mg to 0.5 mg once or twice daily.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed.
Dialysis:
No specific adjustment needed; budesonide is highly protein-bound and not significantly removed by dialysis.
Hepatic Impairment:
Mild:
Caution advised; monitor for increased systemic corticosteroid effects.
Moderate:
Caution advised; monitor for increased systemic corticosteroid effects. Dose reduction may be necessary.
Severe:
Caution advised; monitor for increased systemic corticosteroid effects. Dose reduction likely necessary.
Pharmacology
Mechanism of Action
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 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, leukotrienes, prostaglandins). This action reduces airway hyperresponsiveness, inflammation, and mucus production in the lungs.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 6-16% (systemic bioavailability after inhalation due to high first-pass metabolism)
Tmax:
Approximately 10-30 minutes post-inhalation
FoodEffect:
Not applicable for inhaled formulation.
Distribution:
Vd:
Approximately 3 L/kg
ProteinBinding:
Approximately 85-90%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 2-3 hours (systemic)
Clearance:
Approximately 0.9-1.5 L/min
ExcretionRoute:
Approximately 60% via urine and 40% via feces, primarily as metabolites.
Unchanged:
<1% (in urine)
Pharmacodynamics
OnsetOfAction:
Clinical improvement may be seen within 24 hours, but full therapeutic effect may take 1-2 weeks.
PeakEffect:
Typically achieved within 1-2 weeks of regular use.
DurationOfAction:
Approximately 12-24 hours (allows for once or twice daily dosing).
Safety & Warnings
Side Effects
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 discolored sputum
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Signs of adrenal gland problems, such as:
+ Severe nausea 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, 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. 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:
Signs of a common cold
Nose or throat irritation
Upset stomach
Cough
Nosebleed
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, don't hesitate to reach out to your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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 discolored sputum
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Signs of adrenal gland problems, such as:
+ Severe nausea 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, 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. 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:
Signs of a common cold
Nose or throat irritation
Upset stomach
Cough
Nosebleed
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, don't hesitate to reach out to your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Worsening asthma symptoms (e.g., increased wheezing, shortness of breath, cough)
- Increased need for your rescue inhaler
- Signs of oral thrush (white patches in your mouth or on your tongue)
- Hoarseness or sore throat that persists
- Signs of infection (fever, chills, increased mucus production)
- Unusual tiredness or weakness (may indicate adrenal suppression, especially after long-term high dose use)
Before Using This Medicine
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.
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 they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to:
Discuss all your medications and health problems with your doctor and pharmacist to verify that it is safe to take this medication in conjunction with your other treatments.
* Avoid starting, stopping, or changing the dosage of any medication without first consulting your doctor. This precaution will help prevent potential interactions and adverse effects.
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.
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 they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to:
Discuss all your medications and health problems with your doctor and pharmacist to verify that it is safe to take this medication in conjunction with your other treatments.
* Avoid starting, stopping, or changing the dosage of any medication without first consulting your doctor. This precaution will help prevent potential interactions and adverse effects.
Precautions & Cautions
Important Warnings and Precautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure your safety and prevent potential interactions.
Infection Risk
You may be more susceptible to infections while taking this drug. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with people who have infections, colds, or flu.
Respiratory Problems
If your breathing problems worsen, your rescue inhaler is not effective, or you need to use it more frequently, contact your doctor immediately.
Steroid Replacement Therapy
When transitioning from an oral steroid to another form of steroid, you may experience 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 immediately 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.
Stopping the Medication
If you have been taking this drug for an extended period, consult your doctor before stopping or reducing the dosage, as you may need to taper off the medication gradually.
Viral Infections
If you have not had chickenpox or measles before, avoid exposure to these viruses, as they can be severe or even life-threatening in people taking steroid medications like this one. If you have been exposed, contact your doctor promptly.
Long-term Use Risks
Prolonged use of this medication may increase the risk of:
Osteoporosis: Talk to your doctor about your risk factors and consider having a bone density test as recommended.
Cataracts or Glaucoma: Regular eye exams and monitoring of eye pressure are crucial to detect potential problems early.
Growth Effects in Children and Teens: Regular growth checks may be necessary to monitor potential effects on growth and development.
Special Considerations
Elderly Patients (65+ years): Use this medication with caution, as you may be more susceptible to side effects.
* Pregnancy and Breastfeeding: Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to discuss the benefits and risks of this medication for both you and your baby.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure your safety and prevent potential interactions.
Infection Risk
You may be more susceptible to infections while taking this drug. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with people who have infections, colds, or flu.
Respiratory Problems
If your breathing problems worsen, your rescue inhaler is not effective, or you need to use it more frequently, contact your doctor immediately.
Steroid Replacement Therapy
When transitioning from an oral steroid to another form of steroid, you may experience 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 immediately 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.
Stopping the Medication
If you have been taking this drug for an extended period, consult your doctor before stopping or reducing the dosage, as you may need to taper off the medication gradually.
Viral Infections
If you have not had chickenpox or measles before, avoid exposure to these viruses, as they can be severe or even life-threatening in people taking steroid medications like this one. If you have been exposed, contact your doctor promptly.
Long-term Use Risks
Prolonged use of this medication may increase the risk of:
Osteoporosis: Talk to your doctor about your risk factors and consider having a bone density test as recommended.
Cataracts or Glaucoma: Regular eye exams and monitoring of eye pressure are crucial to detect potential problems early.
Growth Effects in Children and Teens: Regular growth checks may be necessary to monitor potential effects on growth and development.
Special Considerations
Elderly Patients (65+ years): Use this medication with caution, as you may be more susceptible to side effects.
* Pregnancy and Breastfeeding: Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to discuss the benefits and risks of this medication for both you and your baby.
Overdose Information
Overdose Symptoms:
- Acute overdose is unlikely to cause severe problems due to low systemic absorption.
- Chronic overdose or very high doses may lead to signs of hypercorticism (e.g., Cushingoid features, adrenal suppression, hyperglycemia, fluid retention).
What to Do:
In case of suspected overdose, seek medical attention. Management is generally supportive. For chronic overdose, gradual dose reduction may be considered under medical supervision. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Major Interactions
- 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).
Moderate Interactions
- Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, verapamil): May increase budesonide systemic exposure, requiring caution and monitoring.
Confidence Interactions
Monitoring
Baseline Monitoring
Asthma control assessment
Rationale: To establish baseline disease severity and guide initial dosing.
Timing: Prior to initiation of therapy.
Lung function (e.g., FEV1, Peak Expiratory Flow)
Rationale: To establish baseline pulmonary function.
Timing: Prior to initiation of therapy.
Growth velocity (in pediatric patients)
Rationale: To establish baseline growth rate, as inhaled corticosteroids can potentially affect growth.
Timing: Prior to initiation of therapy.
Ocular exam (for patients with history of glaucoma/cataracts or long-term high dose use)
Rationale: To establish baseline ocular health, as corticosteroids can increase intraocular pressure or cause cataracts.
Timing: Prior to initiation of therapy.
Routine Monitoring
Asthma symptoms and control
Frequency: Regularly (e.g., at each follow-up visit, or daily by patient)
Target: Well-controlled asthma (minimal symptoms, no nocturnal awakenings, minimal rescue inhaler use)
Action Threshold: Increased symptoms, increased rescue inhaler use, decreased peak flow readings.
Lung function (FEV1 or PEF)
Frequency: Periodically (e.g., every 3-12 months, or as clinically indicated)
Target: Improved or stable lung function compared to baseline.
Action Threshold: Significant decline in lung function.
Growth velocity (in pediatric patients)
Frequency: Every 3-6 months (or at each well-child visit)
Target: Normal growth curve progression for age.
Action Threshold: Significant deviation from expected growth curve.
Signs of systemic corticosteroid effects (e.g., adrenal suppression, Cushingoid features, bone mineral density, ocular effects)
Frequency: Periodically, especially with higher doses or long-term use.
Target: Absence of signs/symptoms.
Action Threshold: Development of new symptoms or signs.
Oral cavity inspection
Frequency: At each follow-up visit
Target: Absence of oral candidiasis.
Action Threshold: Presence of white patches in mouth/throat.
Symptom Monitoring
- Increased wheezing
- Shortness of breath
- Chest tightness
- Cough
- Increased need for rescue inhaler (e.g., albuterol)
- Nocturnal asthma symptoms
- Signs of oral thrush (white patches in mouth/throat)
- Hoarseness
- Sore throat
Special Patient Groups
Pregnancy
Budesonide is generally considered one of the preferred inhaled corticosteroids for asthma management during pregnancy due to extensive data showing no increased risk of congenital malformations. Asthma control is crucial during pregnancy to ensure adequate oxygenation for both mother and fetus.
Trimester-Specific Risks:
First Trimester:
Data from large epidemiological studies suggest no increased risk of major congenital malformations with budesonide use during early pregnancy.
Second Trimester:
No specific increased risks identified.
Third Trimester:
No specific increased risks identified.
Lactation
Budesonide is considered compatible with breastfeeding. It is excreted into breast milk in very small amounts, and systemic exposure in the infant is expected to be negligible due to high first-pass metabolism.
Infant Risk:
Low risk to infant. Monitor for signs of systemic corticosteroid effects, though unlikely.
Pediatric Use
Budesonide inhalation suspension is commonly used in infants and young children for asthma management. Close monitoring of growth velocity is essential, as inhaled corticosteroids can potentially affect growth, though the clinical significance is often small. Monitor for signs of systemic corticosteroid effects (e.g., adrenal suppression).
Geriatric Use
No specific dose adjustments are generally required based on age alone. However, geriatric patients may be more susceptible to systemic corticosteroid effects (e.g., bone mineral density loss, cataracts, glaucoma), especially with higher doses or pre-existing conditions. Monitor closely for adverse effects.
Clinical Information
Clinical Pearls
- Pulmicort Respules are for nebulization only; they are not for direct oral ingestion or injection.
- Always shake the respule gently before use.
- Ensure proper nebulizer technique is taught to patients/caregivers.
- Emphasize that this is a controller medication, not a rescue medication for acute asthma attacks.
- Rinsing the mouth after each use is critical to prevent oral candidiasis (thrush).
- Patients should be advised to contact their healthcare provider if their asthma symptoms worsen or if they need to use their rescue inhaler more frequently.
- Consider the potential for systemic effects (e.g., adrenal suppression, growth velocity changes in children) with long-term, high-dose use, and monitor appropriately.
Alternative Therapies
- Other inhaled corticosteroids (ICS) such as fluticasone propionate (Flovent), mometasone furoate (Asmanex), ciclesonide (Alvesco), beclomethasone dipropionate (Qvar).
- Long-acting beta-agonists (LABA) in combination with ICS (e.g., budesonide/formoterol - Symbicort, fluticasone/salmeterol - Advair).
- Leukotriene receptor antagonists (e.g., montelukast).
- Oral corticosteroids (for acute exacerbations or severe persistent asthma, not for long-term maintenance).
- Biologic therapies (e.g., omalizumab, mepolizumab, benralizumab, dupilumab) for severe asthma.
Cost & Coverage
Average Cost:
Varies widely, typically $100 - $300+ per 30 x 2ml respules (0.25mg/2ml)
Generic Available:
Yes
Insurance Coverage:
Often Tier 2 or Tier 3, depending on insurance plan and formulary. Generic versions are typically Tier 1 or 2.
General Drug Facts
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 medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.