Pulmicort 180mcg Flexhalr(120puffs)
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
Antiasthmatic, Anti-inflammatory
Pharmacologic Class
Corticosteroid, Inhalant
Pregnancy Category
Category B
FDA Approved
Jan 2006
DEA Schedule
Not Controlled
Overview
What is this medicine?
Pulmicort Flexhaler is an inhaled medicine that contains a corticosteroid called budesonide. It works by reducing inflammation in your lungs, which helps to prevent asthma symptoms like wheezing, shortness of breath, and coughing. It is a 'controller' medicine, meaning you need to use it regularly every day, even when you feel well, to keep your asthma under control. It is NOT for sudden asthma attacks.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication effectively, 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 inhalation, rinse your mouth with water to prevent irritation, but do not swallow the water. Instead, spit it out.
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, away from moisture, and avoid storing it in a bathroom. Dispose of the inhaler after the expiration date shown on the device.
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 make up for the missed one.
To use this medication effectively, 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 inhalation, rinse your mouth with water to prevent irritation, but do not swallow the water. Instead, spit it out.
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, away from moisture, and avoid storing it in a bathroom. Dispose of the inhaler after the expiration date shown on the device.
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 make up for the missed one.
Lifestyle & Tips
- Use exactly as prescribed, even if you feel better.
- Rinse your mouth with water and spit it out after each use to help prevent oral thrush (a fungal infection in the mouth).
- Do not use this medicine for sudden asthma attacks; use your rescue inhaler (e.g., albuterol) 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., smoke, allergens).
- Ensure proper inhaler technique; ask your pharmacist or doctor to demonstrate if unsure.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
180 mcg (1 inhalation) twice daily or 360 mcg (2 inhalations) twice daily
Dose Range:
180 - 720 mg
Condition-Specific Dosing:
mild_moderate_asthma:
180 mcg (1 inhalation) twice daily
severe_asthma:
360 mcg (2 inhalations) twice daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For children 6 to <12 years: 180 mcg (1 inhalation) twice daily. Maximum 360 mcg (2 inhalations) twice daily.
Adolescent:
For adolescents âĨ12 years: Same as adult dosing (180 mcg or 360 mcg twice daily).
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment necessary
Moderate:
No dosage adjustment necessary
Severe:
No dosage adjustment necessary
Dialysis:
No specific recommendations; systemic exposure is low.
Hepatic Impairment:
Mild:
No dosage adjustment necessary
Moderate:
Use with caution; monitor for increased systemic corticosteroid effects.
Severe:
Use with caution; monitor for increased systemic corticosteroid effects. Dosage reduction may be considered.
Confidence:
Medium
Pharmacology
Mechanism of Action
Budesonide is a potent glucocorticoid that exhibits strong anti-inflammatory activity. It works 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, upregulating anti-inflammatory proteins (e.g., lipocortin-1) and downregulating pro-inflammatory mediators (e.g., cytokines, chemokines, adhesion molecules). This action reduces airway hyperresponsiveness, edema, and mucus production in the lungs.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 39% (oral bioavailability of swallowed dose due to high first-pass metabolism); Systemic bioavailability after inhalation is approximately 34% of the nominal dose.
Tmax:
Approximately 10 minutes after 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
Clearance:
Approximately 0.9-1.2 L/min
ExcretionRoute:
Primarily urine (60%) and feces (40%) as metabolites
Unchanged:
Negligible amount excreted unchanged
Pharmacodynamics
OnsetOfAction:
Within 24 hours (initial effects), but full therapeutic benefit may not be achieved until 1-2 weeks or longer.
PeakEffect:
Typically within 1-2 weeks of regular use.
DurationOfAction:
Approximately 12 hours (allows for 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
Mild stomach upset
This list is not exhaustive, and you may experience other side effects not mentioned here. 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 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
Mild stomach upset
This list is not exhaustive, and you may experience other side effects not mentioned here. 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, need for rescue inhaler)
- Signs of oral thrush (white patches in mouth or on tongue)
- Hoarseness or voice changes
- Sore throat
- Signs of infection (fever, chills, body aches, increased mucus, change in mucus color)
- Vision changes (blurred vision, eye pain)
- Unexplained weight gain, swelling, or muscle weakness (signs of systemic corticosteroid effects, rare with inhaled doses)
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
+ Health problems
Your doctor and pharmacist need this information to assess whether it is safe for you to take this medication in combination with your other treatments. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm the safety of these changes.
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
+ Health problems
Your doctor and pharmacist need this information to assess whether it is safe for you to take this medication in combination with your other treatments. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm the safety of these changes.
Precautions & Cautions
Important Information About Your Medication
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure that you receive the best possible care.
Infection Risk
While taking this medication, you may be more susceptible to infections. To minimize this risk, wash your hands frequently and avoid close contact with people who have infections, colds, or flu.
Monitoring Your Condition
If your breathing problems worsen, your rescue inhaler is not effective, or you need to use it more frequently, contact your doctor immediately.
Transitioning from Oral Steroids
If you are switching from an oral steroid to a different form of steroid, be aware that you may experience severe and potentially life-threatening side effects. These can include weakness, fatigue, dizziness, nausea, vomiting, confusion, or low blood sugar. If you experience any of these symptoms, contact your doctor right away.
Managing Stressful Situations
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 that you may need extra steroids in these situations.
Stopping Your Medication
If you have been taking this medication for an extended period, consult with your doctor before stopping. You may need to gradually taper off the medication to avoid any potential complications.
Viral Infections
If you have not had chickenpox or measles before, avoid close contact with anyone who has these infections, as they can be severe or even life-threatening in people taking steroid medications like this one. If you have been exposed to chickenpox or measles, contact your doctor immediately.
Long-term Effects
Prolonged use of this medication may increase your risk of developing weak bones (osteoporosis). Discuss your individual risk factors with your doctor and follow their recommendations for bone density testing.
Eye Health
Long-term use of this medication may also increase your risk of developing cataracts or glaucoma. Have your eye pressure checked regularly, as advised by your doctor.
Special Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Pediatric Use
In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary. Consult with your doctor to discuss any concerns.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. They will help you weigh the benefits and risks of this medication for you and your baby.
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure that you receive the best possible care.
Infection Risk
While taking this medication, you may be more susceptible to infections. To minimize this risk, wash your hands frequently and avoid close contact with people who have infections, colds, or flu.
Monitoring Your Condition
If your breathing problems worsen, your rescue inhaler is not effective, or you need to use it more frequently, contact your doctor immediately.
Transitioning from Oral Steroids
If you are switching from an oral steroid to a different form of steroid, be aware that you may experience severe and potentially life-threatening side effects. These can include weakness, fatigue, dizziness, nausea, vomiting, confusion, or low blood sugar. If you experience any of these symptoms, contact your doctor right away.
Managing Stressful Situations
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 that you may need extra steroids in these situations.
Stopping Your Medication
If you have been taking this medication for an extended period, consult with your doctor before stopping. You may need to gradually taper off the medication to avoid any potential complications.
Viral Infections
If you have not had chickenpox or measles before, avoid close contact with anyone who has these infections, as they can be severe or even life-threatening in people taking steroid medications like this one. If you have been exposed to chickenpox or measles, contact your doctor immediately.
Long-term Effects
Prolonged use of this medication may increase your risk of developing weak bones (osteoporosis). Discuss your individual risk factors with your doctor and follow their recommendations for bone density testing.
Eye Health
Long-term use of this medication may also increase your risk of developing cataracts or glaucoma. Have your eye pressure checked regularly, as advised by your doctor.
Special Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Pediatric Use
In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary. Consult with your doctor to discuss any concerns.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. They will help you weigh the benefits and risks of this medication for you and your baby.
Overdose Information
Overdose Symptoms:
- Acute overdose is unlikely due to the low systemic absorption of inhaled budesonide.
- Chronic overdose may lead to signs of hypercorticism (e.g., Cushing's syndrome symptoms like moon face, buffalo hump, central obesity, striae, easy bruising, muscle weakness, acne, hirsutism, menstrual irregularities, hypertension, hyperglycemia, hypokalemia, osteoporosis, growth retardation in children, adrenal suppression).
What to Do:
In case of suspected overdose, contact a poison control center immediately or seek emergency medical attention. For chronic overdose, gradual withdrawal of the corticosteroid may be necessary under medical supervision. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Major Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, atazanavir, clarithromycin, indinavir, nelfinavir, saquinavir, telithromycin, voriconazole, cobicistat-containing products)
Moderate Interactions
- Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, verapamil, grapefruit juice)
Monitoring
Baseline Monitoring
Asthma symptom control (e.g., FEV1, PEF, symptom frequency)
Rationale: To establish baseline disease severity and guide initial dosing.
Timing: Prior to initiation of therapy
Growth (in pediatric patients)
Rationale: Inhaled corticosteroids can potentially affect growth velocity in children.
Timing: Prior to initiation of therapy
Ophthalmic exam (for patients with history of glaucoma/cataracts or at high risk)
Rationale: Long-term use of corticosteroids can increase risk of glaucoma or cataracts.
Timing: Prior to initiation of therapy
Routine Monitoring
Asthma symptom control (e.g., FEV1, PEF, symptom frequency, rescue inhaler use)
Frequency: Regularly (e.g., every 1-3 months initially, then every 3-12 months once stable)
Target: Optimal asthma control with minimal symptoms and rescue inhaler use.
Action Threshold: Increased symptoms, increased rescue inhaler use, decreased lung function, or frequent exacerbations indicate need for dose adjustment or re-evaluation.
Growth (in pediatric patients)
Frequency: Periodically (e.g., every 3-6 months)
Target: Normal growth velocity for age.
Action Threshold: Significant reduction in growth velocity may warrant dose reduction or alternative therapy.
Signs/symptoms of oral candidiasis
Frequency: At each visit
Target: Absence of oral thrush.
Action Threshold: Presence of white patches in mouth/throat requires antifungal treatment and proper rinsing technique review.
Signs/symptoms of systemic corticosteroid effects (e.g., adrenal suppression, bone mineral density, skin thinning)
Frequency: Periodically, especially with high doses or long-term use
Target: Absence of clinical signs.
Action Threshold: Clinical signs warrant investigation and potential dose adjustment.
Ophthalmic exam (for long-term high-dose users)
Frequency: Annually or as clinically indicated
Target: Normal intraocular pressure, absence of cataracts.
Action Threshold: Elevated IOP or cataract formation requires ophthalmology referral.
Symptom Monitoring
- Increased wheezing
- Shortness of breath
- Chest tightness
- Cough
- Increased use of rescue inhaler
- Oral thrush (white patches in mouth/throat)
- Hoarseness
- Sore throat
- Signs of infection (fever, chills, increased sputum)
Special Patient Groups
Pregnancy
Budesonide is considered one of the preferred inhaled corticosteroids for asthma management during pregnancy due to extensive human data showing no increased risk of major congenital malformations. Asthma control is crucial during pregnancy to ensure adequate oxygenation for both mother and fetus.
Trimester-Specific Risks:
First Trimester:
Data from epidemiological studies and post-marketing surveillance suggest no increased risk of major congenital malformations.
Second Trimester:
No specific risks identified.
Third Trimester:
No specific risks identified.
Lactation
Budesonide is excreted in human milk. However, at therapeutic inhaled doses, the systemic exposure to the nursing infant is expected to be negligible. It is considered compatible with breastfeeding.
Infant Risk:
Low risk; generally considered safe for use during lactation.
Pediatric Use
Pulmicort Flexhaler is approved for children 6 years and older. Monitor growth velocity regularly, as inhaled corticosteroids can potentially affect growth, although the clinical significance is often small. Use the lowest effective dose.
Geriatric Use
No specific dosage adjustments are required for elderly patients. However, monitor for potential systemic corticosteroid effects (e.g., bone mineral density, cataracts, glaucoma) in patients with pre-existing conditions or those on long-term high doses, as elderly patients may be more susceptible.
Clinical Information
Clinical Pearls
- Pulmicort Flexhaler is a maintenance medication for asthma and should be used consistently, not for acute attacks.
- Always instruct patients to rinse their mouth thoroughly with water and spit after each dose to minimize the risk of oral candidiasis (thrush) and dysphonia.
- Ensure patients understand proper inhaler technique, as incorrect use can lead to reduced drug delivery and efficacy.
- Patients transitioning from oral corticosteroids to inhaled budesonide should be monitored for signs of adrenal insufficiency.
- Counsel patients that full therapeutic benefit may take 1-2 weeks or longer to be achieved.
- Regular follow-up is important to assess asthma control and adjust therapy as needed.
Alternative Therapies
- Other inhaled corticosteroids (ICS) such as fluticasone propionate (Flovent HFA/Diskus), mometasone furoate (Asmanex Twisthaler), beclomethasone dipropionate (Qvar RediHaler), ciclesonide (Alvesco).
- Leukotriene receptor antagonists (e.g., montelukast, zafirlukast)
- Long-acting beta-agonists (LABA) (always in combination with ICS for asthma)
- Long-acting muscarinic antagonists (LAMA) (e.g., tiotropium, as add-on therapy for severe asthma)
- Biologic therapies (e.g., omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab) for severe asthma.
Cost & Coverage
Average Cost:
Varies widely, typically $200-$400 per 120-puff inhaler
Insurance Coverage:
Tier 2 or Tier 3 (Brand-name drug, may require prior authorization or step therapy)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may have additional patient information leaflets, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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.