Uceris ER 9mg Tablets

Budesonide is a glucocorticosteroid that exerts potent anti-inflammatory effects. It has a high topical anti-inflammatory activity and a high first-pass metabolism in the liver, leading to reduced systemic exposure compared to other oral corticosteroids. In ulcerative colitis, it acts locally in the colon to reduce inflammation.

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 immediate 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 production or change in sputum color
+ Pain while passing urine
+ Mouth sores
+ Wounds 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
+ Changes 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
Changes in eyesight

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 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 you experienced, including the symptoms that occurred.
If you have liver disease, as this may affect the way your body processes the medication.
If you have any type of infection, such as bacterial, viral, or fungal infections, including:
+ Amoeba infections (e.g., traveler's diarrhea)
+ Herpes infections of the eye
+ Malaria infections in the brain
+ Threadworm infestations
+ Other types of 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 which medications are safe to take with this medication.

To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of all your medications and health problems. This will help them determine whether it is safe for you to take this medication with 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 all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor will also require you to undergo regular blood tests and may recommend additional checks, such as eye pressure and bone density tests, especially if you are taking this medication long-term.

Adhere to your doctor's prescribed dosage and duration of treatment. Do not take this medication for an extended period beyond what your doctor has recommended. If you have diabetes, closely monitor your blood sugar levels, as this medication can affect them.

If you have been taking this medication for an extended period, consult your doctor before stopping treatment. Your doctor may recommend a gradual tapering off the medication to minimize potential side effects.

Be aware that steroid medications, including this one, can increase your risk of developing infections. These infections can be mild, severe, or even life-threatening. The risk of infection is higher with higher doses of steroids. To minimize this risk, practice good hygiene by washing your hands frequently, avoid close contact with people who have infections, colds, or flu, and notify your doctor immediately if you experience any signs of infection.

Additionally, if you have a history of tuberculosis or hepatitis B, inform your doctor, as these infections can reactivate while taking this medication. If you are exposed to chickenpox or measles, consult your doctor promptly, especially if you have not had these illnesses before or have not been vaccinated against them.

This medication can also lower your body's natural steroid production. If you experience a fever, infection, undergo surgery, or are injured, consult your doctor, as you may require additional oral steroids to help your body cope with these stresses. Carry a warning card with you to alert medical professionals that you may need extra steroids in emergency situations.

Long-term use of this medication can lead to osteoporosis (weak bones) and increase the risk of cataracts or glaucoma. Discuss your risk factors with your doctor and ask about any concerns you may have.

Avoid consuming grapefruit and grapefruit juice while taking this medication. Before receiving any vaccinations, consult your doctor, as some vaccines may not be effective or may increase your risk of infection when taken with this medication.

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, notify your doctor promptly.

Prolonged use of this medication has been associated with an increased risk of Kaposi's sarcoma, a type of cancer. Discuss this risk with your doctor.

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, and regular growth checks may be necessary. Consult your doctor to discuss any concerns.

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, consult your doctor to discuss any potential risks to your baby.

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, nelfinavir, cobicistat): Significantly increase systemic exposure to budesonide, leading to potential for increased corticosteroid-related side effects. Concomitant use should be avoided.

• Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, verapamil, cimetidine): May increase budesonide exposure; monitor for corticosteroid side effects.
• Grapefruit juice: Inhibits CYP3A4 and can significantly increase systemic exposure to budesonide. Avoid consumption.

• Oral contraceptives: May increase budesonide exposure, though clinical significance is generally low.

• Signs of infection (fever, chills, sore throat, increased pain or redness at site of injury)
• Symptoms of adrenal insufficiency (fatigue, weakness, nausea, vomiting, dizziness, hypotension)
• Changes in mood or behavior (irritability, anxiety, depression, insomnia)
• Gastrointestinal symptoms (abdominal pain, nausea, vomiting, diarrhea, blood in stool)
• Vision changes (blurred vision, eye pain)
• Muscle weakness or pain
• Skin changes (thinning, bruising, acne)

Uceris ER is Pregnancy Category B. Studies in animals have shown no evidence of harm to the fetus. However, there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed and the potential benefit outweighs the potential risk to the fetus.

Budesonide is excreted in human milk. However, due to the low systemic exposure of budesonide in the mother and the high first-pass metabolism in the infant, the amount of budesonide reaching the infant is expected to be low. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Uceris and any potential adverse effects on the breastfed infant from Uceris or from the underlying maternal condition. Monitor breastfed infants for signs of adrenal suppression.

Safety and effectiveness of Uceris ER in pediatric patients have not been established for ulcerative colitis. Not recommended for use in children.

No overall differences in safety or effectiveness were observed between elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out. Use with caution, monitoring for age-related side effects such as osteoporosis, diabetes, and hypertension.

• Uceris ER is designed for local action in the colon, minimizing systemic corticosteroid side effects due to its high first-pass metabolism.
• It is specifically indicated for induction of remission in mild to moderate active ulcerative colitis, not for maintenance therapy.
• Patients should be advised to swallow the tablet whole and avoid crushing or chewing to preserve the extended-release properties.
• Strong CYP3A4 inhibitors (e.g., ketoconazole, grapefruit juice) can significantly increase systemic exposure to budesonide, leading to increased risk of corticosteroid side effects. Avoid concomitant use.
• While systemic side effects are reduced, patients should still be monitored for signs of hypercorticism and adrenal suppression, especially with prolonged use or in susceptible individuals.

• Other oral corticosteroids (e.g., prednisone, methylprednisolone - generally for more severe disease or systemic effects)
• Aminosalicylates (e.g., mesalamine, sulfasalazine - often first-line for mild-moderate UC)
• Immunomodulators (e.g., azathioprine, mercaptopurine, methotrexate - for maintenance or more severe disease)
• Biologic agents (e.g., infliximab, adalimumab, vedolizumab, ustekinumab - for moderate to severe UC)
• Janus kinase (JAK) inhibitors (e.g., tofacitinib - for moderate to severe UC)

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 for more information. 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 details about the medication taken, the amount, and the time it happened.