Ortikos 9mg ER Capsules

Budesonide is a glucocorticosteroid that exerts potent anti-inflammatory effects. It acts by binding to glucocorticoid receptors, leading to the transcription of anti-inflammatory proteins and the inhibition of pro-inflammatory mediators. In the context of ulcerative colitis, the extended-release formulation delivers budesonide to the colon, where it acts locally to reduce inflammation with reduced systemic exposure due to extensive first-pass metabolism.

Serious Side Effects: Seek Medical Attention Immediately

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 help right away:

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 or seek medical help:

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 the symptoms that occurred.
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, such as bacterial, viral, or fungal infections, including:
+ 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, such as 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.

This is not an exhaustive list of all possible interactions. Therefore, it is crucial to discuss all your medications and health conditions with your doctor and pharmacist to ensure safe treatment. Do not 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 worsen existing infections and make it more challenging to detect signs of infection. Infections can range from mild to severe and potentially life-threatening. The risk of infection is higher with higher doses of steroids. To minimize this risk, 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 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

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.

Adrenal Insufficiency

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 these stresses. Carry a warning card indicating that you may need extra steroids in certain situations.

Long-term Use and Potential Side Effects

Long-term use of this medication may increase the risk of osteoporosis (weak bones). Discuss your risk factors with your doctor. Additionally, long-term use may raise the risk of cataracts or glaucoma. Consult your doctor if you have any concerns.

Interactions and Precautions

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

Missed Doses and Stopping the Medication

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

Rare but Serious Side Effects

There is a potential risk of developing Kaposi's sarcoma, a type of cancer, with long-term use of medications like this one. 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, and regular growth checks may be necessary. Consult your doctor if you have any concerns.

Pregnancy and Breastfeeding

This medication may harm an unborn baby if taken during pregnancy. If you become pregnant or are planning to become pregnant, inform your doctor immediately. If you are breastfeeding, discuss the potential risks to your baby with your doctor.

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, nelfinavir, grapefruit juice): Concomitant use can significantly increase systemic exposure to budesonide, leading to increased risk of Cushing's syndrome and adrenal suppression. Avoid concomitant use.

• Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, verapamil): May increase budesonide exposure; monitor for corticosteroid side effects.
• Oral contraceptives: May increase budesonide exposure; monitor for corticosteroid side effects.
• Live attenuated vaccines: May reduce immune response to vaccines and increase risk of adverse reactions from live vaccines. Avoid administration of live vaccines to patients receiving immunosuppressive doses of corticosteroids.

• Cimetidine: May slightly increase budesonide exposure, but generally not clinically significant.
• Omeprazole: No significant interaction.

• Signs of infection (fever, chills, increased pain, malaise)
• Symptoms of adrenal insufficiency (fatigue, weakness, nausea, vomiting, dizziness, hypotension)
• Symptoms of hypercorticism (moon face, central obesity, striae, acne, hirsutism, easy bruising)
• Changes in mood or behavior (irritability, depression, euphoria)
• Gastrointestinal symptoms (abdominal pain, diarrhea, rectal bleeding) to assess disease activity

Risk Summary: Limited data on budesonide use in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. However, budesonide is a corticosteroid, and corticosteroids can cross the placenta. Animal reproduction studies with budesonide have shown adverse developmental effects (e.g., increased fetal loss, decreased pup weights, skeletal abnormalities) at doses that were maternally toxic. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Risk Summary: Budesonide is present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Ortikos and any potential adverse effects on the breastfed infant from Ortikos or from the underlying maternal condition. Limited data suggest that the total daily oral dose of budesonide available to the infant via breast milk is low.

Safety and effectiveness of Ortikos have not been established in pediatric patients. Ortikos is not approved for use in pediatric patients with ulcerative colitis.

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. Monitor for age-related comorbidities and potential for increased susceptibility to corticosteroid side effects (e.g., osteoporosis, diabetes, glaucoma).

• Ortikos is a locally acting corticosteroid designed to minimize systemic side effects, making it a preferred option for mild to moderate ulcerative colitis compared to systemic corticosteroids.
• It is crucial to take Ortikos in the morning to align with the body's natural diurnal cortisol rhythm.
• Patients should be educated about the importance of avoiding grapefruit and grapefruit juice due to significant drug interaction.
• While systemic side effects are reduced, patients should still be monitored for signs of adrenal suppression, especially if transitioning from other corticosteroids or during periods of stress.
• Ortikos is for induction of remission, not for maintenance therapy. Patients should be transitioned to appropriate maintenance therapy once remission is achieved.

• Other oral corticosteroids (e.g., prednisone, methylprednisolone) for more severe disease or if budesonide is ineffective (with higher systemic side effects).
• 5-aminosalicylates (5-ASAs) (e.g., mesalamine, sulfasalazine) for mild to moderate ulcerative colitis, often used for maintenance.
• Immunomodulators (e.g., azathioprine, 6-mercaptopurine) for moderate to severe disease or steroid-dependent patients.
• Biologic therapies (e.g., infliximab, adalimumab, vedolizumab, ustekinumab) for moderate to severe ulcerative colitis.
• Janus kinase (JAK) inhibitors (e.g., tofacitinib) for moderate to severe ulcerative colitis.

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.