Budesonide 3mg DR Capsules

Budesonide is a potent glucocorticoid with high topical anti-inflammatory activity. It acts by binding to glucocorticoid receptors, forming a complex that translocates to the nucleus, where it modulates gene expression. This leads to the inhibition of inflammatory mediators (e.g., prostaglandins, leukotrienes, cytokines) and inflammatory cell migration, reducing inflammation in the gastrointestinal tract. The delayed-release capsule formulation is designed to release budesonide in the ileum and ascending colon, providing targeted local action with reduced systemic exposure due to extensive first-pass metabolism.

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 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. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you notice any of the following:

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 an exhaustive 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 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 any symptoms that occurred.
If you have liver disease, as this may affect how 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 infection of the eye
+ Malaria infection in the brain
+ Threadworm infestation
+ Any other infection

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 drug.

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 if it is safe 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.

Important Information About Your Medication

It is crucial that you inform all of 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 with your doctor before stopping, as you may need to gradually taper off the medication.

Infection Risk and Prevention

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 associated with steroid use can range from mild to severe and potentially life-threatening. The risk of infection 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 exposure to these viruses, as they can be severe or even life-threatening in people taking steroid medications. If you have been exposed to chickenpox or measles, consult with your doctor. Additionally, discuss any vaccinations with your doctor before receiving them, 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 production of natural steroids in your body. If you experience a fever, infection, surgery, or injury, consult with 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 with your doctor about any questions or concerns.

Dietary Interactions and Vaccinations

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

Missed Doses and Stopping the 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, inform your doctor.

Rare but Serious Side Effects

A type of cancer called Kaposi's sarcoma has been reported in people taking medications like this one for an extended period. 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. This medication may affect growth in children and teenagers; regular growth checks may be necessary. Consult with your doctor about any concerns.

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, clarithromycin, grapefruit juice): Significantly increase systemic exposure to budesonide, leading to increased risk of corticosteroid-related side effects (e.g., Cushing's syndrome, adrenal suppression).

• Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem): May increase systemic exposure to budesonide, requiring caution and monitoring.
• Live attenuated vaccines: May reduce the immune response to vaccines and increase the risk of adverse reactions from live vaccines due to immunosuppression.

• Oral contraceptives: May increase budesonide exposure, but generally not clinically significant.

• Increased thirst or urination (hyperglycemia)
• Swelling in ankles or feet (fluid retention)
• Unusual weight gain, especially in face/trunk (Cushingoid features)
• Muscle weakness or fatigue
• Mood changes (irritability, depression, euphoria)
• Difficulty sleeping
• Increased susceptibility to infections (fever, chills, sore throat, malaise)
• Slow wound healing
• Easy bruising
• Abdominal pain, nausea, vomiting (adrenal insufficiency)
• Dizziness or lightheadedness (adrenal insufficiency)
• Worsening of Crohn's symptoms

Budesonide is classified as Pregnancy Category C. Studies in animals have shown adverse effects on the fetus. There are no adequate and well-controlled studies in pregnant women. Budesonide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. For women with active Crohn's disease, uncontrolled inflammation during pregnancy can pose significant risks to both mother and fetus, so the benefits of treatment often outweigh the risks.

Budesonide is excreted into breastmilk in small amounts. Systemic absorption by the infant is expected to be low due to budesonide's low oral bioavailability and high protein binding. It is generally considered acceptable for use during breastfeeding, but caution is advised, and the infant should be monitored for any adverse effects.

Children, especially those on long-term therapy, should be monitored for growth suppression. The lowest effective dose should be used. Safety and efficacy have been established for Crohn's disease in children 8 years and older weighing >25 kg.

No specific dosage adjustment is required based on age. However, elderly patients may be more susceptible to the systemic side effects of corticosteroids, such as osteoporosis, hypertension, and diabetes. Monitor closely for these effects.

• Budesonide DR capsules are designed for targeted delivery to the ileum and ascending colon, making them particularly useful for Crohn's disease affecting these areas.
• Due to extensive first-pass metabolism in the liver, budesonide has significantly lower systemic bioavailability compared to other oral corticosteroids like prednisone, leading to fewer systemic side effects.
• Despite its local action, prolonged use or high doses can still lead to systemic corticosteroid effects, including adrenal suppression. Tapering is essential when discontinuing therapy.
• Patients should be educated on the importance of taking the capsule whole and avoiding grapefruit products to maintain the drug's intended release profile and minimize systemic exposure.
• Budesonide is primarily used for induction of remission in mild to moderate Crohn's disease and for maintenance for a limited period (up to 3 months) after induction, not typically for long-term maintenance due to potential for adrenal suppression.

• Other oral corticosteroids (e.g., Prednisone, Methylprednisolone)
• Aminosalicylates (e.g., Mesalamine, Sulfasalazine)
• Immunomodulators (e.g., Azathioprine, 6-Mercaptopurine, Methotrexate)
• Biologic agents (e.g., Infliximab, Adalimumab, Vedolizumab, Ustekinumab)
• Janus Kinase (JAK) inhibitors (e.g., Tofacitinib, Upadacitinib)

If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication. It is also important to note that some medications may have additional patient information leaflets, so be sure to consult with your pharmacist if you have any questions. If you are unsure about any aspect of your medication, including its use, potential side effects, or interactions, do not hesitate to discuss your concerns 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 name of the medication taken, the amount, and the time it was taken, to ensure you receive appropriate and timely care.