Ortikos 6mg ER Capsules
Overview
What is this medicine?
How to Use This Medicine
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. Take your medication in the morning, with or without food, as directed by your doctor. Swallow the tablet whole - do not chew, open, or crush it. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel well.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep the lid tightly closed and store all medications in a safe location, out of the reach of children and pets.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Take the capsule whole; do not chew, crush, or break it.
- Take the capsule once daily in the morning.
- Avoid eating grapefruit or drinking grapefruit juice while taking this medicine, as it can increase the amount of budesonide in your body.
- Inform your doctor if you are exposed to chickenpox or measles, as you may be at higher risk for severe infection.
- Carry a steroid warning card if you are at risk for adrenal suppression, especially during times of stress or illness.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
Side Effects
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 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 may cause side effects in some people. While many individuals 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 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 an exhaustive list of possible 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:
- Signs of infection: fever, chills, sore throat, body aches, unusual tiredness.
- Signs of adrenal insufficiency: severe fatigue, weakness, nausea, vomiting, dizziness, low blood pressure.
- Signs of high blood sugar: increased thirst, increased urination, blurred vision.
- Signs of Cushing's syndrome: moon face, weight gain, easy bruising, thinning skin.
- Mood changes: depression, anxiety, irritability, insomnia.
Before Using This Medicine
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 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 type of infection
Additionally, disclose all medications you are taking, including:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Some medications, particularly those used to treat HIV, infections, depression, and other conditions, may interact with this medication and should not be taken concurrently. Your doctor or pharmacist can advise you on potential interactions.
To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of all your medications and health conditions. This will enable them to verify that it is safe for you to take this medication in conjunction with your other treatments. Never start, stop, or modify the dosage of any medication without first consulting your doctor.
Precautions & Cautions
Adhere to your doctor's prescribed dosage and duration of treatment. Do not take this medication for longer than recommended by your doctor. 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. You may need to gradually taper off the medication to avoid any potential withdrawal effects.
Be aware that steroid medications, including this one, can increase the risk of infection. They can exacerbate existing infections 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 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 if you experience any symptoms of infection.
Some 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.
If you are taking this medication and have not had chickenpox or measles before, avoid exposure to anyone with these illnesses, as they can be severe or even fatal in people taking steroid medications. If you have been exposed to chickenpox or measles, consult your doctor promptly.
This medication can decrease the natural production of steroids in your body. If you experience a fever, infection, undergo surgery, or are injured, inform your doctor, as you may require additional oral steroid doses 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 of this medication can increase the risk of osteoporosis (weak bones). Discuss your risk factors with your doctor and ask about any concerns you may have. Additionally, prolonged use may raise the risk of cataracts or glaucoma, so consult your doctor about any concerns.
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 the 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, inform your doctor promptly.
There is a potential risk of developing Kaposi's sarcoma, a type of cancer, associated with long-term use of medications like this one. 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. This medication may also affect growth in children and teenagers, so regular growth checks may be necessary. Consult your doctor about any concerns.
If you are pregnant or become pregnant while taking this medication, inform your doctor immediately, as it may harm the unborn baby. If you are breastfeeding, discuss the potential risks to your baby with your doctor.
Overdose Information
Overdose Symptoms:
- Symptoms of hypercorticism (e.g., moon face, central obesity, easy bruising, fluid retention, high blood pressure, muscle weakness, mood changes).
- Acute overdose is rare due to the drug's low systemic bioavailability and high first-pass metabolism.
What to Do:
No specific antidote. Treatment is supportive and symptomatic. In case of suspected overdose, contact a poison control center immediately (e.g., 1-800-222-1222) or seek emergency medical attention.
Drug Interactions
Contraindicated Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, nelfinavir, cobicistat, grapefruit juice)
Major Interactions
- Moderate CYP3A4 inhibitors (e.g., diltiazem, verapamil, erythromycin, cimetidine)
Moderate Interactions
- Oral contraceptives (may increase budesonide exposure)
- Cholestyramine (may reduce budesonide absorption)
- Antacids (separate administration by at least 2 hours)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Rationale: To assess for pre-existing adrenal suppression, especially if transitioning from systemic corticosteroids.
Timing: Before initiation, if clinically indicated.
Rationale: Corticosteroids can cause potassium loss.
Timing: Before initiation, if clinically indicated.
Routine Monitoring
Frequency: Periodically, especially during stress, intercurrent illness, or dose changes.
Target: Not applicable
Action Threshold: If symptoms (e.g., fatigue, weakness, nausea, hypotension) occur, consider adrenal function testing and appropriate management.
Frequency: Routinely
Target: Not applicable
Action Threshold: Promptly evaluate and treat any new infections.
Frequency: Periodically for long-term use (e.g., every 1-2 years)
Target: Maintain healthy BMD
Action Threshold: If BMD decreases, consider bone protective measures or alternative therapy.
Frequency: Periodically for long-term use (e.g., annually)
Target: Not applicable
Action Threshold: If changes occur, refer to ophthalmologist.
Symptom Monitoring
- Signs of adrenal insufficiency (e.g., fatigue, weakness, nausea, vomiting, hypotension, dizziness)
- Signs of infection (e.g., fever, chills, sore throat, body aches)
- Changes in mood or behavior (e.g., depression, euphoria, insomnia)
- Fluid retention (e.g., swelling in ankles/feet)
- Gastrointestinal symptoms (e.g., abdominal pain, diarrhea, rectal bleeding) to assess disease activity
Special Patient Groups
Pregnancy
Budesonide is Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown teratogenic effects. Limited human data suggest low risk, but systemic exposure is low.
Trimester-Specific Risks:
Lactation
Budesonide is excreted in human milk. However, due to its low systemic bioavailability and high first-pass metabolism, infant exposure is expected to be low. Consider the developmental and health benefits of breastfeeding along with the motherβs clinical need for Ortikos and any potential adverse effects on the breastfed infant.
Pediatric Use
Safety and efficacy of Ortikos (budesonide extended-release capsules) for the maintenance of remission of mild to moderate active ulcerative colitis have not been established in pediatric patients. Budesonide extended-release capsules (e.g., Entocort EC) are approved for the treatment of mild to moderate active Crohn's disease in patients 8 years of age and older.
Geriatric Use
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 adverse effects (e.g., osteoporosis, cataracts, diabetes).
Clinical Information
Clinical Pearls
- Ortikos is designed for local action in the colon, minimizing systemic steroid side effects compared to traditional systemic corticosteroids.
- It is crucial to take the capsule whole, as crushing or chewing will destroy the extended-release properties and alter drug delivery.
- Always advise patients to avoid grapefruit and grapefruit juice due to significant CYP3A4 interaction.
- Patients transitioning from systemic corticosteroids should be carefully monitored for signs of adrenal insufficiency.
- While systemic side effects are reduced, long-term use can still carry risks like bone density loss and cataracts, necessitating periodic monitoring.
Alternative Therapies
- Other oral 5-aminosalicylates (5-ASAs) like mesalamine (e.g., Lialda, Apriso, Asacol HD)
- Other corticosteroids (e.g., prednisone, methylprednisolone - typically for induction, not maintenance)
- Immunomodulators (e.g., azathioprine, mercaptopurine)
- Biologic therapies (e.g., infliximab, adalimumab, vedolizumab, ustekinumab)
- Janus kinase (JAK) inhibitors (e.g., tofacitinib, upadacitinib)