Ortikos

Ortikos capsules can be used to treat mild to moderate Crohn's disease in adults and children who are at least 8 years old and weigh 55 pounds (25 kg) or more. These medicines can also be used in adults for up to 3 months to prevent symptoms from coming back.

Ortikos capsules can also help reduce kidney function loss in adults with a kidney disease called primary immunoglobulin A nephropathy, who are at risk of their condition getting worse.

Ortikos oral suspension is used to treat eosinophilic esophagitis in adults and children who are at least 11 years old for up to 12 weeks.

Ortikos extended release tablet is used to treat mild to moderate ulcerative colitis (UC) in adults.

Ortikos may also be used for reasons not listed in this medication guide.

Follow all instructions on your prescription label and read all medication guides or instruction sheets. Your doctor may change your dose from time to time. Use the medicine exactly as directed.

Your dose may change if you switch to a different brand, strength, or form of this medicine. To avoid medication errors, use it exactly as directed on the label or as prescribed by your doctor.

Ortikos oral suspension is taken by mouth twice a day, once in the morning and once in the evening. Do not mix it with liquid or food.

Shake the oral suspension (liquid) for at least 10 seconds before taking it. Wait at least 30 minutes after taking Ortikos oral suspension before you eat or drink.

Ortikos tablet or capsule is usually taken once a day in the morning with a full glass of water.

Certain brand forms of budesonide should be taken at least 1 hour before a meal. Other brands can be taken with or without food. Follow your doctor's dosing instructions very carefully.

Swallow the tablet or capsule whole and do not crush, dissolve, chew, break, or open it.

Do not change your dose or stop using Ortikos suddenly without your doctor's advice. Follow your doctor's instructions about how to taper your dose.

Read and carefully follow the Instructions for Use provided with this medicine on how to prepare, store, throw away, and take if you are unable to swallow Ortikos. Ask your doctor or pharmacist if you do not understand these instructions.

Your dosage needs may change if you have surgery, are ill, or are under stress. Let your doctor know if your medicine seems to stop working.

Call your doctor if your symptoms do not improve or if they worsen.

If you have had hepatitis B, tuberculosis, or any other infection, it may return or get worse. Before you use Ortikos, your doctor may test you for hepatitis B or other infections. You may also need to have frequent medical tests during treatment with this medicine.

Store the medicine tightly closed at room temperature, away from moisture, heat, and light.

You may also store the oral suspension in the refrigerator; do not freeze.

You may be more likely to get infections, including serious or life-threatening ones. Contact your doctor if you have flu symptoms, a cough, night sweats, neck stiffness, diarrhea, confusion, or vision issues.

You should not use Ortikos if you are allergic to it.

Tell your doctor if you have or have ever had:

• tuberculosis;
• herpes infection of the eyes;
• high blood pressure;
• a weak immune system (caused by disease or by using certain medicines);
• osteoporosis or low bone mineral density;
• a stomach ulcer;
• a planned surgery;
• cerebral malaria;
• any allergies;
• diabetes, cataracts, or glaucoma (in you or a family member);
• unexplained diarrhea or if you recently traveled;
• chickenpox or measles (or have been exposed to it); or
• liver disease.

Steroids can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have. Tell your doctor about any recent, active, or chronic illness, especially any type of infection caused by bacteria, virus, fungus, or parasites, including threadworm.

Ortikos may harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using Ortikos.

Get emergency medical help if you have any signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

You may be more likely to get infections, including serious or even fatal ones. Call your doctor right away if you notice signs of infection such as:

• fever, chills, sore throat;
• mouth sores, red or swollen gums;
• pale skin, easy bruising, unusual bleeding; or
• chest discomfort, wheezing, dry cough or hack, diarrhea, or rapid weight loss.

Also contact your doctor immediately if you experience:

• heartburn, chest pain, trouble swallowing, any skin lesion or rash, no matter how mild;
• signs of inflammation in your nose (rhinitis) such as sneezing, stuffy or runny nose;
• increased adrenal gland hormones—hunger, weight gain, swelling, skin discoloration, slow wound healing, sweating, acne, increased body hair, tiredness, mood changes, muscle weakness, missed menstrual periods, sexual changes; or
• signs of thrush (a fungal infection)—sores or white patches in your mouth or throat, trouble swallowing.

High doses or long-term use of budesonide can lead to certain side effects, including symptoms of decreased adrenal gland hormones such as: nausea, vomiting, stomach pain, loss of appetite, feeling tired or light-headed, muscle or joint pain, skin discoloration, and craving salty foods.

Ortikos can impact growth in children. Inform your doctor if your child is not growing at a normal rate while using Ortikos.

Common side effects of Ortikos may include:

• headache, dizziness, high blood pressure, feeling tired;
• upset stomach, nausea, vomiting, diarrhea, stomach pain, bloating, gas, constipation;
• weight gain, back pain, muscle cramps, joint pain;
• thicker or increased hair on your body and face, swelling of the face, lower legs, ankles, and feet;
• pain and burning when you urinate, irritation or inflammation of the skin, acne;
• cold symptoms such as stuffy nose, sneezing, sore throat, increased white blood cell (WBC) counts;
• decreased adrenal gland hormones; or
• fungal infection of the mouth, throat, and esophagus (thrush).

This is not a complete list of side effects, and others may happen. Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Take the medicine as soon as possible, but if it's almost time for your next dose, skip the missed dose. Do not take two doses at once.

If you take Ortikos for primary immunoglobulin A nephropathy, skip the missed dose and take your next dose at the usual time. Do not take two doses at once.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Grapefruit may interact with Ortikos and cause side effects. Do not consume grapefruit products.

Do not receive a "live" vaccine and avoid being near people who are sick or have infections. The vaccine may not work as well while you are using Ortikos. Live vaccines may include measles, mumps, rubella (MMR), varicella (chickenpox), nasal flu vaccine, and others. Also, call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal for people using this medicine.

Sometimes, it is not safe to use certain medicines together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medicines less effective.

Tell your doctor about all your other medicines, especially if you use stomach acid reducers.

This list is not complete. Other drugs may affect Ortikos, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.