Pulmicort 90mcg Flexhaler(60 Puffs)
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
FDA Approved
Mar 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Pulmicort Flexhaler is an inhaled corticosteroid that helps prevent asthma symptoms like wheezing and shortness of breath. It works by reducing inflammation in your airways, making it easier to breathe. It is not a rescue inhaler for sudden asthma attacks.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication properly, follow your doctor's instructions and read all accompanying information carefully. This medication is for inhalation only.
Before using the inhaler for the first time, prime it by twisting the brown grip as far as it will go in both directions, then repeat the process. Do not use a spacer with this inhaler. After each use, replace the cap on the inhaler.
Continue using this medication as directed by your doctor or healthcare provider, even if you start feeling well. After each dose, rinse your mouth with water, but do not swallow the rinse water - spit it out instead.
If you are taking multiple inhaled medications, consult your doctor to determine the best order for taking them.
Storing and Disposing of Your Medication
Store the inhaler at room temperature and discard it after the expiration date shown on the device. Keep it in a dry place, avoiding storage in a bathroom.
Missing a Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To use this medication properly, follow your doctor's instructions and read all accompanying information carefully. This medication is for inhalation only.
Before using the inhaler for the first time, prime it by twisting the brown grip as far as it will go in both directions, then repeat the process. Do not use a spacer with this inhaler. After each use, replace the cap on the inhaler.
Continue using this medication as directed by your doctor or healthcare provider, even if you start feeling well. After each dose, rinse your mouth with water, but do not swallow the rinse water - spit it out instead.
If you are taking multiple inhaled medications, consult your doctor to determine the best order for taking them.
Storing and Disposing of Your Medication
Store the inhaler at room temperature and discard it after the expiration date shown on the device. Keep it in a dry place, avoiding storage in a bathroom.
Missing a Dose
If you miss a dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Use regularly as prescribed, even when feeling well, for best results.
- Rinse your mouth with water and spit it out after each dose to prevent oral thrush (a fungal infection in the mouth).
- Do not stop using this medication suddenly without consulting your doctor.
- Keep track of your asthma symptoms and peak flow readings if advised by your doctor.
- Ensure you have a separate rescue inhaler (e.g., albuterol) for sudden asthma attacks.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose varies based on prior therapy. For patients previously on bronchodilators alone: 360 mcg (4 inhalations of 90 mcg) twice daily. For patients previously on inhaled corticosteroids: 360 mcg (4 inhalations of 90 mcg) twice daily, or 720 mcg (8 inhalations of 90 mcg) twice daily.
Dose Range:
360 - 720 mg
Condition-Specific Dosing:
asthmaMaintenance:
360-720 mcg twice daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For children 6 years and older: Initial dose varies based on prior therapy. For patients previously on bronchodilators alone: 180 mcg (2 inhalations of 90 mcg) twice daily. For patients previously on inhaled corticosteroids: 180 mcg (2 inhalations of 90 mcg) twice daily, or 360 mcg (4 inhalations of 90 mcg) twice daily.
Adolescent:
Same as adult dosing for children 12 years and older.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific recommendations; systemic exposure is low.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
Consider dose reduction; monitor for increased systemic corticosteroid effects.
Severe:
Consider dose reduction; monitor for increased systemic corticosteroid effects. Budesonide is primarily metabolized by the liver.
Confidence:
Medium
Pharmacology
Mechanism of Action
Budesonide is a potent glucocorticoid that exerts anti-inflammatory effects in the lungs. It inhibits multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in allergic and non-allergic mediated inflammation. These anti-inflammatory actions contribute to the reduction of bronchial hyperreactivity and improvement in lung function in asthma.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 15% (oral bioavailability is low due to extensive first-pass metabolism, but pulmonary bioavailability is higher, around 39% of the metered dose)
Tmax:
Approximately 10 minutes (after inhalation)
FoodEffect:
Not applicable (inhaled)
Distribution:
Vd:
Approximately 3 L/kg
ProteinBinding:
Approximately 85-90%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 2-3 hours
Clearance:
Approximately 0.9-1.5 L/min
ExcretionRoute:
Primarily urine (60%) and feces (40%) as metabolites
Unchanged:
Less than 1% (in urine)
Pharmacodynamics
OnsetOfAction:
Within 24 hours (for initial effect), full therapeutic effect may take 1-2 weeks or longer.
PeakEffect:
1-2 weeks
DurationOfAction:
Approximately 12 hours (when dosed twice daily)
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 immediate medical attention:
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
+ Pain while urinating
+ Mouth sores
+ Wounds that won't heal
Signs of a weak adrenal gland, such as:
+ Severe stomach upset or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Feeling extremely tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, including:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Chest pain
Anxiety
Severe diarrhea
Severe stomach pain, upset stomach, or vomiting
Decreased appetite
Very bad headache
Feeling very 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:
Signs of a common cold
Nose or throat irritation
Upset stomach
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.
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, 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
+ Pain while urinating
+ Mouth sores
+ Wounds that won't heal
Signs of a weak adrenal gland, such as:
+ Severe stomach upset or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Feeling extremely tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, including:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Chest pain
Anxiety
Severe diarrhea
Severe stomach pain, upset stomach, or vomiting
Decreased appetite
Very bad headache
Feeling very 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:
Signs of a common cold
Nose or throat irritation
Upset stomach
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.
Seek Immediate Medical Attention If You Experience:
- Worsening asthma symptoms (e.g., increased wheezing, shortness of breath, cough) despite regular use.
- White patches in your mouth or throat (oral thrush).
- Hoarseness or voice changes.
- Signs of infection (e.g., fever, chills, increased mucus production).
- Unusual bruising, fatigue, or weakness (signs of systemic corticosteroid effects, rare with inhaled forms).
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 allergic reaction you experienced, including any symptoms that occurred.
If you have a milk allergy, as this may be relevant to your treatment.
Potential interactions with other medications or health conditions. To ensure safe treatment, disclose all of your:
+ Prescription medications
+ Over-the-counter (OTC) medications
+ Natural products
+ Vitamins
Any existing health problems, as these may affect the safety and efficacy of this medication.
Remember to consult with your doctor before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any medication. Your doctor and pharmacist will help you determine whether it is safe to take this medication in combination with your other medications and health conditions.
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.
If you have a milk allergy, as this may be relevant to your treatment.
Potential interactions with other medications or health conditions. To ensure safe treatment, disclose all of your:
+ Prescription medications
+ Over-the-counter (OTC) medications
+ Natural products
+ Vitamins
Any existing health problems, as these may affect the safety and efficacy of this medication.
Remember to consult with your doctor before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any medication. Your doctor and pharmacist will help you determine whether it is safe to take this medication in combination with your other medications and health conditions.
Precautions & Cautions
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 your breathing problems worsen, your rescue inhaler becomes less effective, or you need to use it more often, contact your doctor immediately.
When transitioning from an oral steroid to a different 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 promptly if you encounter any of these signs.
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 indicating that you may need extra steroids in such situations.
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 gradually taper off the drug.
Be cautious of chickenpox and measles, as these infections can be severe or even fatal in individuals taking steroid medications like this one. Avoid close contact with people who have chickenpox or measles if you have not previously had these illnesses. If you have been exposed to either of these infections, 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 tests.
Prolonged use may also raise the risk of cataracts or glaucoma. Regularly check your eye pressure as advised by your doctor and discuss any concerns with them.
If you are 65 or older, use this medication with caution, as you may be more prone to side effects.
In some cases, this drug may affect growth in children and teenagers, and they may require regular growth checks. Consult your doctor to discuss this potential risk.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the benefits and risks of this medication to you and your baby.
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 your breathing problems worsen, your rescue inhaler becomes less effective, or you need to use it more often, contact your doctor immediately.
When transitioning from an oral steroid to a different 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 promptly if you encounter any of these signs.
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 indicating that you may need extra steroids in such situations.
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 gradually taper off the drug.
Be cautious of chickenpox and measles, as these infections can be severe or even fatal in individuals taking steroid medications like this one. Avoid close contact with people who have chickenpox or measles if you have not previously had these illnesses. If you have been exposed to either of these infections, 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 tests.
Prolonged use may also raise the risk of cataracts or glaucoma. Regularly check your eye pressure as advised by your doctor and discuss any concerns with them.
If you are 65 or older, use this medication with caution, as you may be more prone to side effects.
In some cases, this drug may affect growth in children and teenagers, and they may require regular growth checks. Consult your doctor to discuss this potential risk.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the benefits and risks of this medication to you and your baby.
Overdose Information
Overdose Symptoms:
- Acute overdose is unlikely to cause severe problems due to the low systemic absorption of inhaled budesonide. However, chronic overdose may lead to signs of hypercorticism (e.g., Cushing's syndrome, adrenal suppression).
What to Do:
In case of suspected acute overdose, seek medical attention. For chronic overdose, gradual withdrawal of the medication under medical supervision may be necessary. Call a poison control center at 1-800-222-1222.
Drug Interactions
Major Interactions
- Strong CYP3A4 inhibitors (e.g., Ketoconazole, Itraconazole, Ritonavir, Atazanavir, Clarithromycin, Indinavir, Nelfinavir, Saquinavir, Telithromycin, Voriconazole)
Moderate Interactions
- Moderate CYP3A4 inhibitors (e.g., Erythromycin, Diltiazem, Verapamil, Grapefruit juice)
Monitoring
Baseline Monitoring
Pulmonary Function Tests (e.g., FEV1)
Rationale: To establish baseline lung function and assess asthma severity.
Timing: Prior to initiation of therapy
Asthma Control Assessment (e.g., ACT score)
Rationale: To establish baseline symptom control.
Timing: Prior to initiation of therapy
Growth (in pediatric patients)
Rationale: Inhaled corticosteroids can affect growth velocity in children.
Timing: Prior to initiation of therapy
Routine Monitoring
Asthma Symptoms and Control
Frequency: Regularly (e.g., daily symptom diary, monthly clinic visits)
Target: Minimal symptoms, infrequent rescue inhaler use, no nocturnal awakenings
Action Threshold: Worsening symptoms, increased rescue inhaler use, decreased peak flow readings
Pulmonary Function Tests (FEV1)
Frequency: Periodically (e.g., every 3-12 months, or as clinically indicated)
Target: Maintain optimal lung function for the individual
Action Threshold: Significant decline from baseline or expected values
Oral Cavity Inspection (for candidiasis)
Frequency: Regularly (e.g., at each clinic visit)
Target: Absence of white patches
Action Threshold: Presence of white patches (oral thrush)
Growth (in pediatric patients)
Frequency: Regularly (e.g., every 3-6 months)
Target: Normal growth velocity for age
Action Threshold: Significant reduction in growth velocity
Signs of Adrenal Suppression (rare)
Frequency: Periodically, especially with high doses or prolonged use
Target: Absence of symptoms (e.g., fatigue, weakness, nausea, hypotension)
Action Threshold: Development of symptoms suggestive of adrenal insufficiency
Ocular Examination (for cataracts/glaucoma, long-term high dose)
Frequency: Annually or as clinically indicated for patients on high doses for prolonged periods
Target: Normal intraocular pressure, absence of cataracts
Action Threshold: Increased intraocular pressure, development of cataracts
Symptom Monitoring
- Worsening asthma symptoms (e.g., increased wheezing, shortness of breath, cough)
- Increased need for rescue inhaler (short-acting beta-agonist)
- Oral candidiasis (white patches in mouth or throat)
- Hoarseness or dysphonia
- Signs of systemic corticosteroid effects (e.g., easy bruising, moon face, weight gain, fatigue, weakness)
Special Patient Groups
Pregnancy
Budesonide is generally considered the preferred inhaled corticosteroid for asthma management during pregnancy due to extensive human data showing no increased risk of congenital malformations. It is classified as Pregnancy Category B.
Trimester-Specific Risks:
First Trimester:
No increased risk of congenital malformations observed in human studies.
Second Trimester:
No specific risks identified.
Third Trimester:
No specific risks identified.
Lactation
Budesonide is excreted into breast milk in small amounts. However, due to its low oral bioavailability, systemic exposure to the infant is expected to be negligible. It is considered compatible with breastfeeding (Lactation Risk L2).
Infant Risk:
Low risk of adverse effects to the breastfed infant.
Pediatric Use
Monitor growth velocity in pediatric patients receiving inhaled corticosteroids, as they may cause a reduction in growth velocity. Use the lowest effective dose.
Geriatric Use
No specific dose adjustments are required. Monitor for potential systemic corticosteroid effects, though these are rare with inhaled forms.
Clinical Information
Clinical Pearls
- Pulmicort Flexhaler is a maintenance medication and should be used consistently, not for acute asthma attacks.
- Proper inhalation technique is crucial for effective delivery of the medication to the lungs. Patients should be instructed on how to use the Flexhaler device correctly.
- Rinsing the mouth after each dose helps prevent oral candidiasis (thrush) and hoarseness.
- Patients transitioning from oral corticosteroids to inhaled budesonide should be monitored for signs of adrenal insufficiency.
- Regular follow-up with a healthcare provider is important to assess asthma control and adjust therapy as needed.
Alternative Therapies
- Fluticasone propionate (Flovent HFA, Flovent Diskus)
- Mometasone furoate (Asmanex Twisthaler, Asmanex HFA)
- Beclomethasone dipropionate (Qvar RediHaler)
- Ciclesonide (Alvesco)
Cost & Coverage
Average Cost:
Varies, typically $200-$400 per 60-puff inhaler
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (preferred brand or non-preferred brand)
General Drug Facts
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 your 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 details about the medication taken, the amount, and the time it happened.