Pulmicort 1mg/2ml Respules 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
Anti-inflammatory, Corticosteroid
Pharmacologic Class
Glucocorticoid
Pregnancy Category
Category B
FDA Approved
Jul 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Budesonide is an inhaled corticosteroid medication used to prevent and control asthma symptoms. It works by reducing inflammation in the airways of your lungs, making it easier to breathe. 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, which delivers the liquid solution directly into your lungs.
Important Administration Instructions:
Do not swallow this medication.
Do not mix any other medications 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, but do not swallow the rinse water; instead, spit it out.
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 the medication from light.
Missing 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, which delivers the liquid solution directly into your lungs.
Important Administration Instructions:
Do not swallow this medication.
Do not mix any other medications 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, but do not swallow the rinse water; instead, spit it out.
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 the medication from light.
Missing 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.
- Clean your nebulizer equipment regularly as instructed by the manufacturer.
- Avoid exposure to asthma triggers (e.g., smoke, allergens, pollutants).
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
0.5 mg to 1 mg twice daily
Dose Range:
0.5 - 2 mg
Condition-Specific Dosing:
asthma_maintenance:
0.5 mg to 1 mg twice daily, or 0.25 mg to 0.5 mg twice daily for mild-to-moderate asthma. Max 2 mg twice daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
0.25 mg or 0.5 mg once daily or divided twice daily for children 12 months to 8 years. Initial dose often 0.5 mg once daily or 0.25 mg twice daily.
Child:
0.25 mg or 0.5 mg once daily or divided twice daily for children 12 months to 8 years. Max 1 mg twice daily.
Adolescent:
0.5 mg to 1 mg twice daily, or 0.25 mg to 0.5 mg twice daily for mild-to-moderate asthma. Max 2 mg 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:
Monitor for increased systemic effects; no specific dose adjustment usually needed.
Moderate:
Consider dose reduction and monitor for increased systemic effects due to decreased metabolism.
Severe:
Consider dose reduction and monitor closely for increased systemic effects due to significantly decreased metabolism.
Pharmacology
Mechanism of Action
Budesonide is a potent glucocorticoid that exhibits strong topical anti-inflammatory activity. It works by binding to glucocorticoid receptors in the cytoplasm of target cells, forming a complex that translocates to the nucleus. This complex then modulates gene expression, leading to the synthesis of anti-inflammatory proteins (e.g., lipocortin) and inhibition of pro-inflammatory mediators (e.g., cytokines, chemokines, prostaglandins, leukotrienes). This action reduces airway hyperresponsiveness, inflammation, and mucus production in the lungs.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 15% (systemic bioavailability after inhalation due to first-pass metabolism); oral bioavailability is ~6-13%.
Tmax:
10-30 minutes after inhalation.
FoodEffect:
Not applicable for inhaled suspension; oral budesonide absorption is not significantly affected by food.
Distribution:
Vd:
Approximately 3 L/kg (in adults).
ProteinBinding:
85-90% (to plasma proteins).
CnssPenetration:
Limited
Elimination:
HalfLife:
2-3 hours (in adults).
Clearance:
Approximately 0.5 L/min (in adults).
ExcretionRoute:
Mainly via urine (60%) and feces (40%) as metabolites.
Unchanged:
<1% (in urine).
Pharmacodynamics
OnsetOfAction:
Within hours (initial effects); full therapeutic benefit may take 1-2 weeks.
PeakEffect:
1-2 weeks of regular use.
DurationOfAction:
12-24 hours (allowing for once or twice daily dosing).
Safety & Warnings
Side Effects
Serious 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
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. Many people may not experience any side effects or only minor ones. If you notice any of the following side effects or any other symptoms that bother you or don't go away, 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, 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.
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
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. Many people may not experience any side effects or only minor ones. If you notice any of the following side effects or any other symptoms that bother you or don't go away, 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, 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.
Seek Immediate Medical Attention If You Experience:
- Worsening asthma symptoms (increased wheezing, shortness of breath, cough)
- Increased need for your rescue inhaler
- Signs of infection (fever, chills, increased mucus, change in mucus color)
- White patches in your mouth or throat (oral thrush)
- Signs of allergic reaction (rash, hives, swelling of face/lips/tongue)
- Unusual tiredness, weakness, nausea, vomiting, or dizziness (signs of adrenal suppression, especially if switching from oral steroids)
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 as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or worsen certain health problems.
All medications you are currently taking, including:
+ Prescription medications
+ Over-the-counter (OTC) medications
+ Natural products
+ Vitamins
Any existing health problems or conditions you have.
To ensure your safety, it is crucial to verify that this medication can be taken with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting 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 worsen certain health problems.
All medications you are currently taking, including:
+ Prescription medications
+ Over-the-counter (OTC) medications
+ Natural products
+ Vitamins
Any existing health problems or conditions you have.
To ensure your safety, it is crucial to verify that this medication can be taken with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
While on this medication, 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, be aware that severe and potentially life-threatening side effects may occur. These can include symptoms such as weakness, fatigue, dizziness, nausea, vomiting, confusion, or low blood sugar. If you experience any of these symptoms, seek medical attention promptly.
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 with 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, 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 check your eye pressure as advised by 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; consult with 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.
While on this medication, 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, be aware that severe and potentially life-threatening side effects may occur. These can include symptoms such as weakness, fatigue, dizziness, nausea, vomiting, confusion, or low blood sugar. If you experience any of these symptoms, seek medical attention promptly.
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 with 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, 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 check your eye pressure as advised by 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; consult with 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.
Overdose Information
Overdose Symptoms:
- Acute overdose is unlikely to cause severe problems due to low systemic absorption.
- Chronic overdose may lead to signs of hypercorticism (e.g., Cushingoid features, adrenal suppression, hyperglycemia, hypertension).
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) for advice.
Drug Interactions
Major Interactions
- 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 Interactions
- 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.
- Other corticosteroids (systemic or inhaled): Increased risk of systemic corticosteroid effects.
Monitoring
Baseline Monitoring
Pulmonary Function Tests (PFTs)
Rationale: To establish baseline lung function and assess disease severity.
Timing: Prior to initiation of therapy.
Growth velocity (in pediatric patients)
Rationale: Inhaled corticosteroids can potentially affect growth in children.
Timing: Prior to initiation of therapy.
Ophthalmic exam (for patients at risk)
Rationale: Long-term use of corticosteroids can increase risk of cataracts or glaucoma.
Timing: Prior to initiation for patients with risk factors.
Routine Monitoring
Pulmonary Function Tests (PFTs)
Frequency: Periodically (e.g., every 6-12 months or as clinically indicated)
Target: Improvement in FEV1, FVC, PEF; reduction in symptoms.
Action Threshold: Lack of improvement or worsening symptoms may indicate need for dose adjustment or alternative therapy.
Growth velocity (in pediatric patients)
Frequency: Regularly (e.g., every 3-6 months)
Target: Normal growth curve for age.
Action Threshold: Significant deviation from expected growth curve may warrant dose reduction or alternative therapy.
Signs/symptoms of oral candidiasis (thrush)
Frequency: At each visit
Target: Absence of white patches in mouth/throat.
Action Threshold: Presence of thrush requires antifungal treatment and reinforcement of proper rinsing technique.
Signs/symptoms of systemic corticosteroid effects (e.g., adrenal suppression, Cushingoid features, bone mineral density changes)
Frequency: Periodically, especially with higher doses or prolonged use
Target: Absence of signs/symptoms.
Action Threshold: Presence of systemic effects may require dose reduction or evaluation for adrenal function.
Symptom Monitoring
- Frequency and severity of asthma symptoms (e.g., wheezing, shortness of breath, cough, chest tightness)
- Nocturnal awakenings due to asthma
- Need for rescue inhaler (short-acting beta-agonist) use
- Exacerbations requiring oral corticosteroids or emergency visits
Special Patient Groups
Pregnancy
Budesonide is considered one of the preferred inhaled corticosteroids for asthma management during pregnancy due to its Category B classification and extensive clinical experience. Uncontrolled asthma poses a greater risk to both mother and fetus than the potential risks of budesonide.
Trimester-Specific Risks:
First Trimester:
No increased risk of congenital malformations observed in human studies.
Second Trimester:
Generally considered safe and effective for maintaining asthma control.
Third Trimester:
Generally considered safe and effective for maintaining asthma control.
Lactation
Budesonide is excreted into breast milk in very small amounts. The amount transferred to the infant is considered clinically insignificant, and adverse effects on the breastfed infant are not expected. It is considered compatible with breastfeeding (Lactation Risk L2).
Infant Risk:
Low risk; monitor for signs of systemic corticosteroid effects (e.g., growth suppression) in the infant, though highly unlikely with inhaled doses.
Pediatric Use
Monitor growth velocity regularly in pediatric patients receiving inhaled corticosteroids, as a small reduction in growth rate has been observed in some studies. Use the lowest effective dose. Pulmicort Respules is approved for use in children as young as 12 months.
Geriatric Use
No specific dose adjustments are typically required for elderly patients. However, monitor for potential increased susceptibility to systemic corticosteroid effects (e.g., bone mineral density loss, cataracts, glaucoma) due to age-related physiological changes or comorbidities.
Clinical Information
Clinical Pearls
- Pulmicort Respules is for nebulization only; it is not for direct oral ingestion or injection.
- It is a controller medication, not a rescue medication. Patients should always have a short-acting beta-agonist (SABA) for acute asthma symptoms.
- Proper nebulizer technique is crucial for effective drug delivery. Patients/caregivers should be thoroughly instructed.
- Rinsing the mouth after each use helps prevent oral candidiasis (thrush), a common side effect.
- Patients transitioning from systemic corticosteroids to inhaled budesonide should be monitored for signs of adrenal insufficiency, especially during periods of stress or severe asthma exacerbations.
- The full therapeutic effect may not be seen for 1-2 weeks after starting therapy.
Alternative Therapies
- Fluticasone propionate inhalation (Flovent HFA, Flovent Diskus, Arnuity Ellipta)
- Mometasone furoate inhalation (Asmanex Twisthaler, Asmanex HFA)
- Ciclesonide inhalation (Alvesco)
- Beclomethasone dipropionate inhalation (Qvar RediHaler)
- Fluticasone furoate inhalation (Arnuity Ellipta)
Cost & Coverage
Average Cost:
$100 - $400 per 30 x 2ml ampules (generic)
Generic Available:
Yes
Insurance Coverage:
Typically Tier 2 or Tier 3 on most commercial and Medicare Part D plans. Generic versions are usually 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 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.