Uceris 2mg/actuation 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
Pharmacologic Class
Glucocorticoid receptor agonist; Anti-inflammatory agent
Pregnancy Category
Not available
FDA Approved
Jan 2014
DEA Schedule
Not Controlled
Overview
What is this medicine?
Uceris Rectal Foam is a medicine containing a steroid called budesonide. It is used to treat mild to moderate ulcerative colitis, a condition that causes inflammation and sores in the large intestine. The foam is applied directly into the rectum to reduce inflammation and help heal the lining of the bowel, with less effect on the rest of the body compared to steroid pills.
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 gently 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 are 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 is 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 gently 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 are 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 is 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 for diet and other lifestyle changes recommended for ulcerative colitis.
- Maintain good hygiene, especially around the rectal area, to prevent irritation or infection.
- Report any new or worsening symptoms to your healthcare provider.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
2 mg (one actuation) rectally twice daily for 2 weeks, then 2 mg (one actuation) once daily for 4 weeks.
Dose Range:
2 - 4 mg
Condition-Specific Dosing:
active_mild_to_moderate_ulcerative_colitis_extending_up_to_splenic_flexure:
Induction of remission: 2 mg (one actuation) rectally twice daily for 2 weeks, then 2 mg (one actuation) once daily for 4 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment necessary.
Moderate:
No dose adjustment necessary.
Severe:
No dose adjustment necessary.
Dialysis:
No specific recommendations; systemic exposure is low.
Hepatic Impairment:
Mild:
No dose adjustment necessary.
Moderate:
Use with caution; systemic exposure may increase significantly.
Severe:
Use with caution; systemic exposure may increase significantly. Avoid if possible.
Confidence:
Medium
Pharmacology
Mechanism of Action
Budesonide is a potent glucocorticoid that exerts local anti-inflammatory effects. It has a high topical potency and a high first-pass metabolism in the liver, which limits systemic exposure and reduces the risk of systemic corticosteroid side effects. It acts by binding to glucocorticoid receptors, modulating gene expression to inhibit the release of inflammatory mediators and suppress immune cell function.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 10% (rectal foam, due to extensive first-pass metabolism)
Tmax:
Approximately 1.5 hours
FoodEffect:
Not applicable for rectal administration.
Distribution:
Vd:
Approximately 2-3 L/kg
ProteinBinding:
Approximately 85-90%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 2-3 hours
Clearance:
Approximately 1.2-1.5 L/min
ExcretionRoute:
Urine (approximately 60%), feces (approximately 40%)
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Days to weeks (clinical effect)
PeakEffect:
Weeks (clinical remission)
DurationOfAction:
Related to dosing frequency and local retention
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 immediately or seek emergency 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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Drowsiness
+ Increased thirst or hunger
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
Signs of a weak adrenal gland, 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 wound healing
Signs of infection, such as:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or discolored sputum
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Skin changes, including:
+ Acne
+ Stretch marks
+ Slow healing
+ Excessive hair growth
Swelling of the ankles
Unexplained bruising or bleeding
Changes in vision
Bone or joint pain
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 symptoms that bother you or persist, contact your doctor for guidance:
* Upset stomach
Reporting Side Effects
This list is not exhaustive, and you may experience other 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 immediately or seek emergency 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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Drowsiness
+ Increased thirst or hunger
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
Signs of a weak adrenal gland, 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 wound healing
Signs of infection, such as:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or discolored sputum
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Skin changes, including:
+ Acne
+ Stretch marks
+ Slow healing
+ Excessive hair growth
Swelling of the ankles
Unexplained bruising or bleeding
Changes in vision
Bone or joint pain
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 symptoms that bother you or persist, contact your doctor for guidance:
* Upset stomach
Reporting Side Effects
This list is not exhaustive, and you may experience other 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:
- Increased rectal bleeding or pain
- Severe abdominal pain
- Fever or chills (signs of infection)
- Unusual fatigue or weakness
- Nausea or vomiting
- Dizziness or lightheadedness
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
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 and circumstances before starting this medication:
If you have a known allergy to budesonide or any component of this medication. Describe your allergic reaction, including the symptoms you experienced.
If you have any other bowel problems or conditions that may affect your digestive system.
If you have an active infection, as this medication may exacerbate certain conditions.
If you have been diagnosed with tuberculosis (TB), discuss your condition with your doctor to determine the best course of treatment.
If you are taking any prescription or over-the-counter medications, including natural products and vitamins, that may interact with this medication. Certain medications, such as those used to treat HIV, infections, and depression, should not be taken concurrently with this drug. Your doctor or pharmacist can provide guidance on potential interactions.
Be aware that this is not an exhaustive list of all medications or health conditions that may interact with this drug.
To ensure safe treatment, it is crucial to:
Inform your doctor and pharmacist about all medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss your medical history and any existing health problems with your doctor.
Verify that it is safe to take this medication with your other medications and health conditions.
Do not initiate, discontinue, or modify the dosage of any medication without consulting your doctor.
It is essential to inform your doctor about the following conditions and circumstances before starting this medication:
If you have a known allergy to budesonide or any component of this medication. Describe your allergic reaction, including the symptoms you experienced.
If you have any other bowel problems or conditions that may affect your digestive system.
If you have an active infection, as this medication may exacerbate certain conditions.
If you have been diagnosed with tuberculosis (TB), discuss your condition with your doctor to determine the best course of treatment.
If you are taking any prescription or over-the-counter medications, including natural products and vitamins, that may interact with this medication. Certain medications, such as those used to treat HIV, infections, and depression, should not be taken concurrently with this drug. Your doctor or pharmacist can provide guidance on potential interactions.
Be aware that this is not an exhaustive list of all medications or health conditions that may interact with this drug.
To ensure safe treatment, it is crucial to:
Inform your doctor and pharmacist about all medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss your medical history and any existing health problems with your doctor.
Verify that it is safe to take this medication with your other medications and health conditions.
Do not initiate, discontinue, or modify the dosage of any medication without 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. 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 to ensure it remains within a healthy range.
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 to prevent potential complications.
If you have not had chickenpox, measles, or the corresponding vaccines, and you come into contact with someone who has these conditions, 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 a different 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 signs.
In situations where you suffer a severe injury, undergo surgery, or develop an 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 that you may need extra steroids in emergency situations.
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 to ensure it remains within a healthy range.
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 to prevent potential complications.
If you have not had chickenpox, measles, or the corresponding vaccines, and you come into contact with someone who has these conditions, 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 a different 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 signs.
In situations where you suffer a severe injury, undergo surgery, or develop an 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 that you may need extra steroids in emergency situations.
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:
- While overdose with rectal foam is unlikely due to low systemic absorption, symptoms of excessive corticosteroid exposure could include: fluid retention, swelling, high blood pressure, muscle weakness, mood changes, or signs of Cushing's syndrome (e.g., moon face, buffalo hump).
What to Do:
In case of suspected overdose, contact a poison control center immediately. Call 1-800-222-1222. Treatment is generally supportive and symptomatic.
Drug Interactions
Major Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, cobicistat, clarithromycin, grapefruit juice)
Monitoring
Baseline Monitoring
Clinical assessment of ulcerative colitis symptoms
Rationale: To establish baseline disease activity and monitor response to treatment.
Timing: Prior to initiation of therapy
Complete Blood Count (CBC)
Rationale: To assess for anemia or other blood dyscrasias associated with UC or potential systemic corticosteroid effects (rare with rectal foam).
Timing: Prior to initiation of therapy
Electrolytes (Potassium, Sodium)
Rationale: To establish baseline and monitor for potential electrolyte imbalances, though rare with low systemic absorption.
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical assessment of ulcerative colitis symptoms (e.g., stool frequency, rectal bleeding, urgency)
Frequency: Weekly during induction, then as clinically indicated
Target: Reduction or resolution of symptoms
Action Threshold: Lack of improvement or worsening symptoms may indicate need for alternative therapy.
Signs and symptoms of HPA axis suppression (e.g., fatigue, weakness, nausea, vomiting, hypotension)
Frequency: Periodically, especially if systemic effects are suspected or prolonged use
Target: Absence of symptoms
Action Threshold: If suspected, perform ACTH stimulation test. Consider dose reduction or discontinuation if HPA axis suppression occurs.
Signs and symptoms of infection (e.g., fever, malaise, localized pain)
Frequency: Routinely
Target: Absence of infection
Action Threshold: Promptly evaluate and treat any suspected infection.
Symptom Monitoring
- Rectal bleeding
- Stool frequency
- Urgency
- Abdominal pain
- Fatigue
- Weakness
- Nausea
- Vomiting
- Dizziness
- Signs of infection (fever, chills, increased pain)
Special Patient Groups
Pregnancy
Budesonide is generally considered a preferred corticosteroid during pregnancy due to its high first-pass metabolism and low systemic bioavailability. Data from observational studies and postmarketing experience with oral budesonide use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. However, animal studies have shown teratogenicity. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally considered lower risk than systemic corticosteroids due to low systemic absorption.
Second Trimester:
Generally considered lower risk than systemic corticosteroids due to low systemic absorption.
Third Trimester:
Generally considered lower risk than systemic corticosteroids due to low systemic absorption.
Lactation
Budesonide is present in human milk. However, due to the low systemic absorption of budesonide from rectal foam, the amount transferred into breast milk is expected to be very low. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Uceris Rectal Foam and any potential adverse effects on the breastfed infant.
Infant Risk:
Low risk of adverse effects on the breastfed infant due to low systemic exposure.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Use in children is off-label and should be done with caution, monitoring for systemic corticosteroid effects, including growth suppression.
Geriatric Use
No specific dose adjustment is required for geriatric patients. However, elderly patients may be more susceptible to the systemic effects of corticosteroids, even with low systemic absorption, due to age-related comorbidities or polypharmacy. Monitor for adverse effects.
Clinical Information
Clinical Pearls
- Uceris Rectal Foam is designed for local action in the rectum and distal colon, minimizing systemic corticosteroid side effects.
- Proper administration technique is crucial for efficacy. Patients should be instructed on how to use the applicator correctly.
- It is indicated for induction of remission, not for maintenance therapy.
- Patients should be advised that while systemic side effects are less common, they can still occur, especially with prolonged use or in sensitive individuals.
- Avoid concomitant use with strong CYP3A4 inhibitors (e.g., grapefruit juice, ketoconazole) as this can significantly increase systemic exposure to budesonide.
Alternative Therapies
- Hydrocortisone rectal foam/enema (e.g., Cortifoam, Colocort)
- Mesalamine rectal formulations (e.g., Canasa, Rowasa)
- Oral 5-aminosalicylates (5-ASAs) (e.g., mesalamine, sulfasalazine)
- Systemic corticosteroids (e.g., prednisone, methylprednisolone) for more severe disease or non-responders
- Immunomodulators (e.g., azathioprine, 6-mercaptopurine)
- Biologic therapies (e.g., infliximab, adalimumab, vedolizumab) for moderate to severe ulcerative colitis
Cost & Coverage
Average Cost:
$1000 - $1500 per 60g canister (14 doses)
Insurance Coverage:
Tier 3 (Non-preferred Brand) or Tier 2 (Preferred Brand) depending on formulary
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.