Budesonide ER 9mg Tablets

Budesonide is a glucocorticosteroid with high topical anti-inflammatory activity and low systemic activity. It works by binding to glucocorticoid receptors in the cytoplasm, leading to modulation of gene expression. This results in the inhibition of inflammatory mediators (e.g., cytokines, chemokines, prostaglandins, leukotrienes) and the upregulation of anti-inflammatory proteins. Its local action in the gastrointestinal tract and extensive first-pass metabolism contribute to its reduced systemic side effects compared to conventional oral corticosteroids.

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 medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of 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 infection, such as:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased sputum or change in color of sputum
+ Pain while passing urine
+ Mouth sores
+ Wound that will not heal
Skin changes, including:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Purple, red, blue, brown, or black bumps or patches on the skin or in the mouth
Signs of high blood pressure, such as:
+ Severe headache
+ Dizziness
+ Passing out
+ Change in eyesight
Signs of a weak adrenal gland, including:
+ Severe upset stomach or vomiting
+ Severe dizziness or passing out
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, such as:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Unexplained bruising or bleeding
Black, tarry, or bloody stools
Vomiting blood or coffee ground-like material
Swelling in the arms or legs
Shortness of breath
Bone pain
Change in eyesight

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Headache
Signs of a common cold
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Heartburn
Gas
Feeling dizzy, tired, or weak
Back pain
* Joint pain

This is not a complete list of 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.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions and situations to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
If you have liver disease, as this may affect the medication's efficacy or increase the risk of side effects.
If you have any type of infection, including bacterial, viral, or fungal infections, such as:
+ Amoeba infection (e.g., traveler's diarrhea)
+ Herpes infection of the eye
+ Malaria infection in the brain
+ Threadworm infestation
+ Other infections

Additionally, tell your doctor about all the medications you are taking, including:

Prescription and over-the-counter (OTC) medications
Natural products
Vitamins

Some medications, including those used to treat HIV, infections, depression, and other conditions, may interact with this medication and should not be taken together. Your doctor or pharmacist can advise you on potential interactions and help you avoid any adverse effects.

To ensure your safety, it is crucial to disclose all your medications and health problems to your doctor and pharmacist. They will help you determine whether it is safe to take this medication with your existing treatments and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor first.

Important Information About Your Medication

It is crucial that you inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests, as directed by your doctor, are necessary to monitor your health. If you are taking this medication long-term, you may also need to have your eye pressure and bone density checked.

Taking Your Medication as Directed

Do not take this medication for a longer period than prescribed by your doctor. If you have diabetes, it is essential to closely monitor your blood sugar levels. If you have been taking this medication for an extended period, consult your doctor before stopping, as you may need to gradually taper off the medication.

Infection Risks and Precautions

Steroid medications, including this one, can increase the risk of infection. They can cause existing infections to worsen and make it more challenging to detect signs of infection. Infections related to steroid use can range from mild to severe and potentially life-threatening. The risk of complications from these infections is typically higher with higher doses of steroids. To minimize the risk of infection, wash your hands frequently, avoid close contact with people who have infections, colds, or flu, and notify your doctor if you experience any signs of infection.

Reactivation of Latent Infections

Certain infections, such as tuberculosis and hepatitis B, can reactivate in patients taking medications like this one. Inform your doctor if you have a history of these infections.

Viral Infections and Vaccinations

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. If you have been exposed to chickenpox or measles, consult your doctor. Additionally, discuss your vaccination schedule with your doctor, as some vaccines may not be effective or may increase the risk of infection when taken with this medication.

Adrenal Insufficiency and Stress

This medication may decrease the natural production of steroids in your body. If you experience a fever, infection, surgery, or injury, consult your doctor, as you may require additional oral steroids to help your body cope with stress. Carry a warning card indicating that you may need extra steroids in certain situations.

Long-term Use and Potential Side Effects

Prolonged use of this medication may increase the risk of osteoporosis (weak bones). Discuss your risk factors with your doctor and ask about any concerns you may have. Long-term use may also raise the risk of cataracts or glaucoma; consult your doctor for more information.

Dietary Interactions and Vaccinations

Avoid consuming grapefruit and grapefruit juice while taking this medication. Before receiving any vaccinations, consult your doctor, as some vaccines may interact with this medication or increase the risk of infection.

Missed Doses and Withdrawal Symptoms

If you miss a dose or recently stopped taking this medication and experience symptoms such as fatigue, weakness, shakiness, rapid heartbeat, confusion, sweating, or dizziness, inform your doctor.

Rare but Serious Side Effects

In rare cases, long-term use of medications like this one has been associated with an increased risk of Kaposi's sarcoma, a type of cancer. Discuss this risk with your doctor.

Special Considerations

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. In children and adolescents, this medication may affect growth; regular growth checks may be necessary. Consult your doctor for more information.

Pregnancy and Breastfeeding

If you are pregnant or become pregnant while taking this medication, contact your doctor immediately, as it may harm the unborn baby. If you are breastfeeding, discuss the potential risks to your baby with your doctor.

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, nelfinavir) due to significant increase in systemic exposure and risk of hypercorticism.
• Grapefruit juice

• Moderate CYP3A4 inhibitors (e.g., erythromycin, clarithromycin, diltiazem, verapamil) - may require dose adjustment or increased monitoring for corticosteroid side effects.

• CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital) - may decrease budesonide exposure and efficacy.

• Not available

• Worsening or persistent gastrointestinal symptoms (e.g., abdominal pain, diarrhea, rectal bleeding)
• Signs of infection (fever, chills, sore throat, increased fatigue)
• Cushingoid features (e.g., moon face, weight gain, skin thinning, easy bruising, acne, hirsutism)
• Adrenal insufficiency symptoms (e.g., severe fatigue, weakness, nausea, vomiting, dizziness, hypotension)
• Mood changes (e.g., depression, irritability, anxiety)
• Vision changes (e.g., blurred vision, eye pain, cataracts, glaucoma)
• Muscle weakness or pain
• Swelling in ankles or feet

Category B. Studies in animals have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester. Generally considered a preferred corticosteroid for IBD during pregnancy due to its limited systemic absorption compared to other systemic corticosteroids.

L3 (Moderately Safe). Budesonide is excreted into breast milk in low amounts. The systemic exposure to the breastfed infant is expected to be low due to the drug's low oral bioavailability. Monitor the infant for signs of adverse effects, such as growth suppression.

Budesonide ER 9mg tablets (Uceris) are not approved for pediatric patients for the treatment of Ulcerative Colitis. Other formulations of budesonide (e.g., Entocort EC) are approved for Crohn's disease in children ≥8 years and weighing >25 kg.

No specific dose adjustment is required based on age. However, geriatric patients may be more susceptible to the adverse effects of corticosteroids, such as osteoporosis, cataracts, glaucoma, and diabetes. Monitor closely for these effects.

• Budesonide ER is a locally acting corticosteroid designed to minimize systemic side effects, making it a favorable option for inflammatory bowel disease compared to systemic steroids like prednisone.
• Strictly advise patients to avoid grapefruit and grapefruit juice due to significant CYP3A4 interaction, which can lead to increased systemic exposure and corticosteroid side effects.
• Emphasize that the extended-release tablets must be swallowed whole and not crushed, chewed, or broken, as this will alter the release profile and increase systemic absorption.
• Budesonide ER is for induction of remission in mild to moderate active ulcerative colitis; it is not indicated for maintenance therapy for UC or for severe disease.
• While systemic side effects are reduced, adrenal suppression can still occur, especially with prolonged use or in patients transitioning from systemic corticosteroids. Tapering may be necessary upon discontinuation.
• Patients should be educated on signs of infection and hypercorticism, and to report them promptly.

• Other corticosteroids (e.g., prednisone, methylprednisolone)
• Aminosalicylates (e.g., mesalamine, sulfasalazine)
• Immunomodulators (e.g., azathioprine, mercaptopurine, methotrexate)
• Biologic therapies (e.g., infliximab, adalimumab, vedolizumab, ustekinumab)
• Janus Kinase (JAK) inhibitors (e.g., tofacitinib)

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.