Budesonide 2mg/act Rectal Foam
It is used to treat ulcerative colitis. It may be given to you for other reasons. Talk with the doctor.
Drug Class
Corticosteroid, Anti-inflammatory
Pharmacologic Class
Glucocorticoid
Pregnancy Category
Category C
FDA Approved
Jan 2014
DEA Schedule
Not Controlled
Overview
What is this medicine?
Budesonide rectal foam is a medicine used to treat mild to moderate ulcerative colitis, a type of inflammatory bowel disease that affects the large intestine. It's a steroid that works directly in your colon to reduce inflammation, with less effect on the rest of your body compared to other steroids.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. This medication is designed for rectal use only and should not be taken orally.
Before using the medication, empty your bowels by using the bathroom. To prepare the can, hold it in your hands and shake it for 10 to 15 seconds to warm it up. If you need additional lubricant for the applicator, you can use petrolatum or petroleum jelly.
You can use this medication while standing, lying down, or sitting. If you're using it in the evening, apply it right before bedtime. After application, try to avoid emptying your bowels until the next morning.
Important Safety Precautions
Be aware that this medication is flammable, so do not use it near an open flame or while smoking. Continue using the medication as directed, even if your symptoms improve.
Storing and Disposing of Your Medication
Store the medication at room temperature, avoiding refrigeration or freezing. Protect it from heat and open flames. Do not puncture or burn the can, even if it seems empty. Keep all medications in a safe place, out of the reach of children and pets.
What to Do If You Miss a Dose
If you miss a dose, use 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 extra doses.
To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. This medication is designed for rectal use only and should not be taken orally.
Before using the medication, empty your bowels by using the bathroom. To prepare the can, hold it in your hands and shake it for 10 to 15 seconds to warm it up. If you need additional lubricant for the applicator, you can use petrolatum or petroleum jelly.
You can use this medication while standing, lying down, or sitting. If you're using it in the evening, apply it right before bedtime. After application, try to avoid emptying your bowels until the next morning.
Important Safety Precautions
Be aware that this medication is flammable, so do not use it near an open flame or while smoking. Continue using the medication as directed, even if your symptoms improve.
Storing and Disposing of Your Medication
Store the medication at room temperature, avoiding refrigeration or freezing. Protect it from heat and open flames. Do not puncture or burn the can, even if it seems empty. Keep all medications in a safe place, out of the reach of children and pets.
What to Do If You Miss a Dose
If you miss a dose, use 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 extra doses.
Lifestyle & Tips
- Follow your doctor's instructions carefully regarding diet and other treatments for ulcerative colitis.
- Avoid grapefruit and grapefruit juice while using this medication, as it can increase the amount of budesonide in your body.
- Maintain good hygiene when administering the foam.
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 mg (one metered dose) rectally once daily for 2 weeks, followed by 2 mg every other day for an additional 4 weeks.
Dose Range:
2 - 2 mg
Condition-Specific Dosing:
Ulcerative Colitis (mild to moderate, distal):
2 mg (one metered dose) rectally once daily for 2 weeks, followed by 2 mg every other day for an additional 4 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
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; consider reducing dose or increasing dosing interval due to increased systemic exposure.
Severe:
Contraindicated due to significantly increased systemic exposure and risk of hypercorticism.
Confidence:
High
Pharmacology
Mechanism of Action
Budesonide is a potent glucocorticoid with high topical anti-inflammatory activity. It works by binding to glucocorticoid receptors, inhibiting the release of inflammatory mediators (e.g., prostaglandins, leukotrienes, cytokines) and suppressing the migration of inflammatory cells to the affected area. Its high first-pass metabolism in the liver limits systemic exposure, concentrating its action locally in the colon.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 34% (systemic bioavailability after rectal administration, due to high first-pass metabolism)
Tmax:
Approximately 1.5 hours (for rectal foam)
FoodEffect:
Not applicable for rectal foam.
Distribution:
Vd:
Approximately 2.2-3.9 L/kg
ProteinBinding:
Approximately 85-90%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 2-3 hours (systemic)
Clearance:
Approximately 10-15 L/hr
ExcretionRoute:
Primarily urine (60%) and feces (40%) as metabolites
Unchanged:
Less than 1% (in urine)
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 2-4 weeks.
PeakEffect:
Not precisely defined for clinical effect; related to sustained local anti-inflammatory action.
DurationOfAction:
Local effect persists due to retention in the colon; systemic half-life is short.
Confidence:
Medium
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 high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of a weak adrenal gland, such as:
+ Severe upset stomach or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Feeling very 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
Signs of infection, such as:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Pain while urinating
+ Mouth sores
+ Wounds that will not heal
Skin changes, including:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Swelling of the ankles
Unexplained bruising or bleeding
Changes in eyesight
Bone or joint pain
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
* Upset stomach
This is not a comprehensive list of all 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 high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of a weak adrenal gland, such as:
+ Severe upset stomach or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Feeling very 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
Signs of infection, such as:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Pain while urinating
+ Mouth sores
+ Wounds that will not heal
Skin changes, including:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Swelling of the ankles
Unexplained bruising or bleeding
Changes in eyesight
Bone or joint pain
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
* Upset stomach
This is not a comprehensive list of all 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:
- Signs of infection (fever, chills, sore throat)
- Unusual bruising or bleeding
- Increased thirst or urination (signs of high blood sugar)
- Swelling in ankles or feet
- Muscle weakness
- Vision changes
- Worsening of ulcerative colitis symptoms
- Signs of adrenal suppression (fatigue, weakness, nausea, vomiting, dizziness)
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 conditions to ensure safe treatment:
Any allergy to budesonide or any component of this medication. If you have an allergy, provide details about the allergic reaction and its symptoms.
Presence of other bowel problems, as this may affect the treatment.
Any existing infections, as this medication may interact with certain conditions.
If you have tuberculosis (TB), discuss this with your doctor, as it may impact your treatment plan.
Additionally, inform your doctor about all medications you are currently taking, including:
Prescription and over-the-counter (OTC) medications
Natural products
* Vitamins
Certain medications, such as those used to treat HIV, infections, depression, and other conditions, may interact with this drug. Your doctor or pharmacist can advise you on potential interactions. This is not an exhaustive list, and it is crucial to disclose all your medications and health problems to ensure safe treatment.
To avoid potential interactions, do not start, stop, or change the dose of any medication without consulting your doctor. It is your responsibility to verify that it is safe to take this medication with all your existing medications and health conditions.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergy to budesonide or any component of this medication. If you have an allergy, provide details about the allergic reaction and its symptoms.
Presence of other bowel problems, as this may affect the treatment.
Any existing infections, as this medication may interact with certain conditions.
If you have tuberculosis (TB), discuss this with your doctor, as it may impact your treatment plan.
Additionally, inform your doctor about all medications you are currently taking, including:
Prescription and over-the-counter (OTC) medications
Natural products
* Vitamins
Certain medications, such as those used to treat HIV, infections, depression, and other conditions, may interact with this drug. Your doctor or pharmacist can advise you on potential interactions. This is not an exhaustive list, and it is crucial to disclose all your medications and health problems to ensure safe treatment.
To avoid potential interactions, do not start, stop, or change the dose of any medication without consulting your doctor. It is your responsibility to verify that it is safe to take this medication with all your existing 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. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss any concerns or questions with your doctor.
As this medication may increase your risk of infection, it is crucial to practice good hygiene by washing your hands frequently and avoiding close contact with individuals who have infections, colds, or flu.
If you have diabetes (high blood sugar), consult your doctor, as this medication may affect your blood sugar levels. Monitor your blood sugar as instructed by your doctor.
Your doctor may recommend a bone density test to assess the health of your bones. Additionally, if you are taking this medication long-term, you will need to have your eye pressure checked regularly.
If you have not had chickenpox, measles, or the vaccines for these conditions, and you come into contact with someone who has either of these illnesses, inform your doctor immediately.
To avoid potential interactions, do not consume grapefruit or grapefruit juice while taking this medication.
When transitioning from an oral steroid to another form of steroid, you may be at risk for 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 medical professionals of this potential need.
This medication is not approved for use in children, so it is essential to discuss any concerns with your doctor.
If you are pregnant or become pregnant while taking this medication, inform your doctor right away, as it may harm the unborn baby. Additionally, if you are breastfeeding, consult your doctor to discuss any potential risks to your baby.
As this medication may increase your risk of infection, it is crucial to practice good hygiene by washing your hands frequently and avoiding close contact with individuals who have infections, colds, or flu.
If you have diabetes (high blood sugar), consult your doctor, as this medication may affect your blood sugar levels. Monitor your blood sugar as instructed by your doctor.
Your doctor may recommend a bone density test to assess the health of your bones. Additionally, if you are taking this medication long-term, you will need to have your eye pressure checked regularly.
If you have not had chickenpox, measles, or the vaccines for these conditions, and you come into contact with someone who has either of these illnesses, inform your doctor immediately.
To avoid potential interactions, do not consume grapefruit or grapefruit juice while taking this medication.
When transitioning from an oral steroid to another form of steroid, you may be at risk for 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 medical professionals of this potential need.
This medication is not approved for use in children, so it is essential to discuss any concerns with your doctor.
If you are pregnant or become pregnant while taking this medication, inform your doctor right away, as it may harm the unborn baby. Additionally, if you are breastfeeding, consult your doctor to discuss any potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Symptoms of hypercorticism (e.g., Cushingoid features, hyperglycemia, hypertension, fluid retention)
- Adrenal suppression
What to Do:
There is no specific antidote for budesonide overdose. Treatment is symptomatic and supportive. In cases of acute overdose, no specific medical attention is usually required. For chronic overdose, gradual withdrawal of the drug may be necessary. Call 1-800-222-1222 (Poison Control Center) for advice.
Drug Interactions
Major Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, nelfinavir, grapefruit juice) - significantly increase systemic exposure to budesonide, leading to potential hypercorticism.
Moderate Interactions
- Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, verapamil)
- Oral contraceptives (may increase systemic exposure to budesonide, though typically not clinically significant with rectal foam)
- Live attenuated vaccines (risk of disseminated infection)
Minor Interactions
- Not well-documented for minor interactions with rectal foam due to low systemic absorption.
Monitoring
Baseline Monitoring
Liver function tests (LFTs)
Rationale: To assess hepatic impairment, especially given extensive first-pass metabolism and contraindication in severe impairment.
Timing: Prior to initiation of therapy.
Adrenal function assessment (e.g., morning cortisol)
Rationale: To assess for pre-existing adrenal suppression, especially if transitioning from systemic corticosteroids.
Timing: Prior to initiation, if clinically indicated.
Routine Monitoring
Clinical symptoms of ulcerative colitis (e.g., rectal bleeding, stool frequency, urgency)
Frequency: Regularly throughout treatment and follow-up.
Target: Improvement or resolution of symptoms.
Action Threshold: Lack of improvement or worsening symptoms may indicate need for alternative therapy.
Signs/symptoms of hypercorticism (e.g., Cushingoid features, hyperglycemia, hypertension)
Frequency: Periodically, especially if used long-term or with concomitant CYP3A4 inhibitors.
Target: Absence of signs/symptoms.
Action Threshold: Presence of symptoms warrants evaluation and potential dose adjustment or discontinuation.
Growth monitoring (in pediatric patients, if used off-label)
Frequency: Regularly.
Target: Normal growth velocity.
Action Threshold: Growth retardation may indicate systemic corticosteroid effects.
Symptom Monitoring
- Rectal bleeding
- Stool frequency
- Abdominal pain
- Urgency
- Weight changes
- Mood changes
- Increased thirst/urination (signs of hyperglycemia)
- Swelling (fluid retention)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies show adverse effects, but human data are limited. Budesonide is generally preferred over other systemic corticosteroids due to lower systemic exposure.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of cleft palate in animal studies; human data are inconclusive.
Second Trimester:
Generally considered safer than first trimester, but systemic effects should be monitored.
Third Trimester:
Potential for fetal growth restriction, adrenal suppression in the neonate, and premature delivery with prolonged use of systemic corticosteroids. Localized rectal foam use minimizes this risk.
Lactation
Budesonide is excreted in human milk. Due to the low systemic absorption of budesonide rectal foam, the amount transferred to breast milk is expected to be low. Weigh the developmental and health benefits of breastfeeding against the mother’s clinical need for budesonide and any potential adverse effects on the breastfed infant.
Infant Risk:
L3 (Moderate risk) - Monitor infant for signs of systemic corticosteroid effects (e.g., growth suppression, adrenal suppression) though unlikely with rectal foam.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Use in children is off-label and should be done with caution, considering potential for systemic effects on growth and development.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger patients. Dosage adjustment is generally not required based on age alone, but monitor for age-related comorbidities and polypharmacy.
Clinical Information
Clinical Pearls
- Budesonide rectal foam is designed for local action in the distal colon, minimizing systemic corticosteroid side effects due to extensive first-pass metabolism.
- It is crucial to instruct patients on proper administration technique for the rectal foam to ensure optimal drug delivery and retention.
- Patients transitioning from systemic corticosteroids to budesonide rectal foam should be monitored for signs of adrenal insufficiency, as the lower systemic exposure of budesonide may not be sufficient to replace systemic steroid effects.
- Avoid concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole, grapefruit juice) due to the risk of increased systemic budesonide exposure and potential for hypercorticism.
- The typical course is 6 weeks (2 weeks daily, 4 weeks every other day); prolonged use should be carefully considered.
Alternative Therapies
- 5-aminosalicylates (5-ASAs) such as mesalamine (rectal or oral)
- Other corticosteroids (e.g., hydrocortisone rectal foam/enema, prednisone oral)
- Immunomodulators (e.g., azathioprine, mercaptopurine)
- Biologic agents (e.g., infliximab, adalimumab, vedolizumab)
- Janus kinase (JAK) inhibitors (e.g., tofacitinib)
Cost & Coverage
Average Cost:
Not available Not available
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Specialty/Non-preferred Brand)
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 information about the medication taken, the amount, and the time it happened.