Ortikos 6mg ER Capsules

Manufacturer FERRING Active Ingredient Budesonide Extended-Release Capsules (Ortikos)(byoo DES oh nide) Pronunciation byoo-DES-oh-nide
It is used to treat Crohn's disease.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Corticosteroid, Anti-inflammatory
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Pharmacologic Class
Glucocorticoid Receptor Agonist
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Pregnancy Category
C
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FDA Approved
Dec 2017
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Ortikos is a type of steroid medicine that works mainly in your gut to reduce inflammation caused by ulcerative colitis. Unlike other steroids, it's designed to have less effect on the rest of your body, which helps reduce common steroid side effects.
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How to Use This Medicine

Taking Your Medication

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.
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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.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 6 mg orally once daily in the morning
Dose Range: 6 - 6 mg

Condition-Specific Dosing:

maintenance_of_remission_of_mild_to_moderate_active_ulcerative_colitis: 6 mg orally once daily in the morning
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for Ortikos in UC. Budesonide ER is approved for Crohn's disease in pediatric patients (8 years and older) at different dosages.
Adolescent: Not established for Ortikos in UC. Budesonide ER is approved for Crohn's disease in pediatric patients (8 years and older) at different dosages.
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment needed.
Moderate: No dosage adjustment needed.
Severe: No dosage adjustment needed.
Dialysis: No specific recommendations; budesonide is not significantly removed by dialysis due to high protein binding.

Hepatic Impairment:

Mild: No dosage adjustment needed.
Moderate: Monitor for signs and symptoms of hypercorticism. Consider dose reduction or discontinuation if hypercorticism occurs.
Severe: Avoid use in patients with severe hepatic impairment (Child-Pugh Class C) due to significantly increased systemic exposure.
Confidence: Medium

Pharmacology

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Mechanism of Action

Budesonide is a glucocorticosteroid that exerts potent anti-inflammatory effects. When administered orally as an extended-release capsule, it targets inflammation locally in the gastrointestinal tract, particularly in the colon. Its high first-pass metabolism limits systemic exposure, thereby reducing systemic corticosteroid side effects. It acts by binding to glucocorticoid receptors, modulating gene expression to inhibit the synthesis of inflammatory mediators (e.g., prostaglandins, leukotrienes, cytokines) and suppress immune cell function.
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Pharmacokinetics

Absorption:

Bioavailability: 10-15% (due to extensive first-pass metabolism)
Tmax: 3-6 hours
FoodEffect: Food does not significantly alter the absorption of budesonide extended-release capsules.

Distribution:

Vd: 2.2-3.9 L/kg
ProteinBinding: 85-90%
CnssPenetration: Limited

Elimination:

HalfLife: 2-3.6 hours
Clearance: Not available (highly variable due to first-pass)
ExcretionRoute: Urine (60%) and feces (40%) as metabolites
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: Not precisely defined for clinical effect; anti-inflammatory effects begin within hours, but clinical remission may take weeks.
PeakEffect: Not precisely defined for clinical effect; peak plasma concentrations reached in 3-6 hours.
DurationOfAction: Approximately 24 hours (consistent with once-daily dosing)
Confidence: Medium

Safety & Warnings

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Side Effects

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 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.
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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.
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Before Using This Medicine

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 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.
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Precautions & Cautions

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 have regular blood tests, and you may need to undergo eye pressure and bone density checks 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 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.
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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

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Contraindicated Interactions

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, nelfinavir, cobicistat, grapefruit juice)
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Major Interactions

  • Moderate CYP3A4 inhibitors (e.g., diltiazem, verapamil, erythromycin, cimetidine)
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Moderate Interactions

  • Oral contraceptives (may increase budesonide exposure)
  • Cholestyramine (may reduce budesonide absorption)
  • Antacids (separate administration by at least 2 hours)
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Adrenal function (e.g., ACTH stimulation test)

Rationale: To assess for pre-existing adrenal suppression, especially if transitioning from systemic corticosteroids.

Timing: Before initiation, if clinically indicated.

Electrolytes (Potassium)

Rationale: Corticosteroids can cause potassium loss.

Timing: Before initiation, if clinically indicated.

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Routine Monitoring

Signs and symptoms of adrenal suppression

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.

Signs and symptoms of infection

Frequency: Routinely

Target: Not applicable

Action Threshold: Promptly evaluate and treat any new infections.

Bone mineral density (BMD)

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.

Ophthalmic examination (for cataracts/glaucoma)

Frequency: Periodically for long-term use (e.g., annually)

Target: Not applicable

Action Threshold: If changes occur, refer to ophthalmologist.

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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

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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:

First Trimester: Potential for increased risk of congenital malformations based on animal data; human data are limited but generally reassuring for low systemic exposure.
Second Trimester: Risk of fetal growth restriction or adrenal suppression, though less likely with low systemic exposure.
Third Trimester: Risk of fetal adrenal suppression, though less likely with low systemic exposure. Monitor neonate for signs of hypoadrenalism.
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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 mother’s clinical need for Ortikos and any potential adverse effects on the breastfed infant.

Infant Risk: Low risk. Monitor breastfed infant for signs of systemic corticosteroid effects (e.g., growth suppression, adrenal suppression).
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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.

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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

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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.
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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)
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Cost & Coverage

Average Cost: $1000 - $2000+ per 30 capsules (6mg)
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (Brand name), Tier 1 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 reach out to your doctor, nurse, pharmacist, or other healthcare provider for guidance. 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 overdose, including the medication taken, the amount, and the time it occurred.