Budesonide 32mcg Nas Spray (120)otc
It is used to ease allergy signs.
Drug Class
Corticosteroid, Nasal
Pharmacologic Class
Glucocorticoid Receptor Agonist
Pregnancy Category
Category B
FDA Approved
Mar 2014
DEA Schedule
Not Controlled
Overview
What is this medicine?
Budesonide nasal spray is a medicine that helps relieve allergy symptoms like sneezing, runny nose, and stuffy nose. It works by reducing inflammation in your nose. It's a type of steroid, but it works locally in your nose with very little going into your body.
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. Continue using the medication as directed, even if your symptoms improve.
Administration Instructions
Do not take this medication by mouth. It is for nasal use only. Avoid getting it in your mouth or eyes, as it may cause burning.
Before using, shake the bottle well. Prime the pump before the first use or if you haven't used it for 2 days.
Blow your nose before using the medication.
Close one nostril and gently tilt your head forward.
Insert the nose spray tube into the other nostril. While breathing in through your nose, press the pump once to release the spray.
Breathe out through your mouth. Make sure to spray the medication up into your nose, avoiding the septum (the wall between the nostrils).
* Carefully follow the cleaning instructions provided.
Storage and Disposal
Store the medication at room temperature, protected from light and in a dry place. Do not store it in a bathroom, and avoid freezing. Discard the medication after the specified number of sprays have been used, even if it seems like there is still medication left.
Missed Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular 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. Continue using the medication as directed, even if your symptoms improve.
Administration Instructions
Do not take this medication by mouth. It is for nasal use only. Avoid getting it in your mouth or eyes, as it may cause burning.
Before using, shake the bottle well. Prime the pump before the first use or if you haven't used it for 2 days.
Blow your nose before using the medication.
Close one nostril and gently tilt your head forward.
Insert the nose spray tube into the other nostril. While breathing in through your nose, press the pump once to release the spray.
Breathe out through your mouth. Make sure to spray the medication up into your nose, avoiding the septum (the wall between the nostrils).
* Carefully follow the cleaning instructions provided.
Storage and Disposal
Store the medication at room temperature, protected from light and in a dry place. Do not store it in a bathroom, and avoid freezing. Discard the medication after the specified number of sprays have been used, even if it seems like there is still medication left.
Missed Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Avoid known allergens (e.g., pollen, dust mites, pet dander) to reduce symptom severity.
- Use regularly as directed, even when symptoms improve, for best results.
- Clean the nasal spray applicator regularly as instructed in the package insert.
Available Forms & Alternatives
Available Strengths:
- Budesonide 1mg/2ml Respules 2ml
- Budesonide 0.25mg/2ml Vials 2ml
- Budesonide 32mcg Nas Spray (120)otc
- Budesonide 0.5mg/2ml Vials 2ml
- Budesonide 0.25mg/2ml Vials 2ml
- Budesonide 0.5mg/2ml Vials 2ml
- Budesonide ER 9mg Tablets
- Budesonide ER 9mg Tablets
- Budesonide 1mg/2ml Respules 2ml
- Budesonide 3mg DR Capsules
- Budesonide 0.5mg/2ml Vials 2ml
- Budesonide 2mg/act Rectal Foam
- Budesonide 0.5mg/2ml Vials, 2ml
Dosing & Administration
Adult Dosing
Standard Dose:
2 sprays (64 mcg) per nostril once daily initially, then may reduce to 1 spray (32 mcg) per nostril once daily for maintenance.
Dose Range:
32 - 128 mg
Condition-Specific Dosing:
initial:
64 mcg per nostril once daily
maintenance:
32 mcg per nostril once daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For children 6-11 years: 1 spray (32 mcg) per nostril once daily. Max 64 mcg/day.
Adolescent:
For children 12 years and older: Same as adult dosing.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No adjustment needed
Hepatic Impairment:
Mild:
No adjustment needed for nasal spray due to low systemic absorption
Moderate:
Use with caution; consider lower doses if systemic effects are a concern, though unlikely with nasal spray.
Severe:
Use with caution; increased systemic exposure possible. Monitor for signs of corticosteroid effects.
Pharmacology
Mechanism of Action
Budesonide is a potent glucocorticoid with strong topical anti-inflammatory activity. It works by binding to glucocorticoid receptors, inhibiting the release of inflammatory mediators (e.g., histamine, leukotrienes, prostaglandins), and suppressing the migration of inflammatory cells (e.g., eosinophils, mast cells, lymphocytes, macrophages, neutrophils) to the site of inflammation. This reduces swelling, itching, and mucus production in the nasal passages.
Pharmacokinetics
Absorption:
Bioavailability:
6-10% (systemic, due to high first-pass metabolism)
Tmax:
0.3-1.5 hours
FoodEffect:
Not applicable for nasal spray
Distribution:
Vd:
2.2-3.9 L/kg
ProteinBinding:
85-90%
CnssPenetration:
Limited
Elimination:
HalfLife:
2-4 hours
Clearance:
0.9-1.8 L/min
ExcretionRoute:
Primarily renal (60%) and fecal (40%) as metabolites
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Several hours (initial effect), 1-2 days (significant relief)
PeakEffect:
1-2 weeks (maximum benefit)
DurationOfAction:
24 hours
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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
Nose sores
A whistling sound when breathing
Redness or white patches in the mouth or throat
Changes in vision
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 experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Nosebleeds
Nose or throat irritation
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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
Nose sores
A whistling sound when breathing
Redness or white patches in the mouth or throat
Changes in vision
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 experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Nosebleeds
Nose or throat irritation
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Persistent nosebleeds or nasal irritation
- Signs of infection (e.g., fever, severe facial pain, discolored nasal discharge)
- Worsening of allergy symptoms after 1-2 weeks of use
- Signs of adrenal suppression (rare with nasal spray, but possible with very high doses or long-term use): unusual tiredness, weakness, nausea, vomiting, dizziness
- Signs of eye problems (e.g., blurred vision, eye pain, glaucoma, cataracts - rare with nasal spray, but possible with long-term 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, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are considering giving this medication to a child, note that it is not recommended for children under 6 years of age. Do not administer this medication to a child younger than 6 years old.
To ensure safe use, tell your doctor and pharmacist about:
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Any health problems you have, as this medication may interact with other drugs or health conditions.
It is crucial to verify that it is safe to take this medication 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, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are considering giving this medication to a child, note that it is not recommended for children under 6 years of age. Do not administer this medication to a child younger than 6 years old.
To ensure safe use, tell your doctor and pharmacist about:
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Any health problems you have, as this medication may interact with other drugs or health conditions.
It is crucial to verify that it is safe to take this medication 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. You may not experience the full effects of this drug until after 2 weeks of treatment.
If you have recently undergone nose surgery, or have experienced a nose injury, ulcers, or sores, be sure to discuss this with your doctor. Long-term use of this medication may increase your risk of developing cataracts or glaucoma, so it is crucial to consult with your doctor about this potential risk.
If you are exposed to someone with chickenpox or measles and you have not had these illnesses or been vaccinated against them, consult your doctor as soon as possible. In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Your doctor will need to monitor your child's growth and development while they are taking this medication.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is vital to discuss the potential benefits and risks of this medication with your doctor, as they will need to weigh the advantages and disadvantages for both you and your baby.
If you have recently undergone nose surgery, or have experienced a nose injury, ulcers, or sores, be sure to discuss this with your doctor. Long-term use of this medication may increase your risk of developing cataracts or glaucoma, so it is crucial to consult with your doctor about this potential risk.
If you are exposed to someone with chickenpox or measles and you have not had these illnesses or been vaccinated against them, consult your doctor as soon as possible. In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Your doctor will need to monitor your child's growth and development while they are taking this medication.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is vital to discuss the potential benefits and risks of this medication with your doctor, as they will need to weigh the advantages and disadvantages for both you and your baby.
Overdose Information
Overdose Symptoms:
- Acute overdose is unlikely due to the low systemic absorption of budesonide nasal spray. Chronic overdose or very high doses could potentially lead to signs of hypercorticism (e.g., Cushing's syndrome symptoms), but this is extremely rare with nasal use.
What to Do:
If overdose is suspected, contact a poison control center (1-800-222-1222) or seek immediate medical attention. Treatment is generally supportive.
Drug Interactions
Major Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin)
Moderate Interactions
- Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, verapamil, grapefruit juice)
Monitoring
Routine Monitoring
Nasal symptoms (congestion, runny nose, sneezing, itching)
Frequency: Daily, or as needed
Target: Improved or resolved symptoms
Action Threshold: Lack of improvement after 1-2 weeks, or worsening symptoms
Nasal irritation, nosebleeds
Frequency: As needed
Target: Absence of side effects
Action Threshold: Persistent or severe irritation/bleeding
Growth (in pediatric patients on long-term therapy)
Frequency: Periodically (e.g., annually)
Target: Normal growth velocity
Action Threshold: Growth retardation
Symptom Monitoring
- Nasal congestion
- Runny nose
- Sneezing
- Nasal itching
- Post-nasal drip
- Nosebleeds
- Nasal irritation
- Sore throat
- Cough
Special Patient Groups
Pregnancy
Budesonide is generally considered one of the preferred inhaled/nasal corticosteroids during pregnancy due to its low systemic absorption and extensive human data suggesting no increased risk of major birth defects. Use only if clearly needed and potential benefits outweigh risks.
Trimester-Specific Risks:
First Trimester:
Low risk; extensive data from inhaled budesonide suggest no increased risk of major birth defects.
Second Trimester:
Low risk; continued use generally considered safe if indicated.
Third Trimester:
Low risk; continued use generally considered safe if indicated.
Lactation
Budesonide is considered compatible with breastfeeding. It is excreted into breast milk in very small amounts, and systemic exposure to the infant is expected to be negligible due to the drug's high first-pass metabolism.
Infant Risk:
L1 (Safest)
Pediatric Use
Approved for children 6 years and older. Long-term use in children should be monitored for potential effects on growth velocity, although systemic effects are minimal with recommended nasal doses.
Geriatric Use
No specific dose adjustment is required. Efficacy and safety are generally similar to younger adults. Use with caution in patients with pre-existing conditions that may be exacerbated by corticosteroids (e.g., glaucoma, cataracts), though systemic absorption is low.
Clinical Information
Clinical Pearls
- Budesonide nasal spray is an effective first-line treatment for allergic rhinitis, including seasonal and perennial allergies.
- Consistent, daily use is key for optimal efficacy; it may take several days to 1-2 weeks to achieve full therapeutic benefit.
- Shake the bottle gently before each use and prime the pump if it hasn't been used for a few days.
- Aim the spray away from the nasal septum (the wall between your nostrils) to reduce the risk of nosebleeds.
- Rinse mouth after use if any spray drips down the throat, though this is less common with nasal sprays than inhaled corticosteroids.
- Patients should be advised that this is not an immediate relief medication and should not be used for acute allergy attacks.
Alternative Therapies
- Other intranasal corticosteroids (e.g., fluticasone propionate, mometasone furoate, triamcinolone acetonide)
- Oral antihistamines (e.g., loratadine, cetirizine, fexofenadine)
- Nasal antihistamines (e.g., azelastine)
- Nasal cromolyn sodium
- Oral decongestants (short-term use)
- Nasal saline rinses
Cost & Coverage
Average Cost:
$15 - $30 per 120 spray bottle
Generic Available:
Yes
Insurance Coverage:
Often not covered by prescription insurance as it is OTC, but may be eligible for FSA/HSA reimbursement.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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.