Uceris

Contraindications

Documented hypersensitivity

Cautions

High-fat meal delays absorption

May increase risk of serious or fatal infection in individuals exposed to viral illnesses such as chickenpox or measles

Use with caution in patients with diabetes mellitus, hypertension, hypothyroidism, electrolyte abnormalities, sodium and water retention, infections, immunizations, ocular herpes simplex, myasthenia gravis, peptic ulcer disease, psychosis, or renal insufficiency

Thromboembolic disorders and myopathy may occur

Delayed wound healing is possible

Patients receiving corticosteroids should avoid chickenpox- or measles-infected persons if unvaccinated

Latent tuberculosis may be reactivated (patients with positive tuberculin test should be monitored)

Some suggestion (not fully substantiated) of slightly increased cleft palate risk if corticosteroids are used in pregnancy

Prolonged corticosteroid use may result in elevated intraocular pressure, glaucoma, or cataracts and has been associated with development of Karposi sarcoma

Myopathy has been reported

Secreted in human milk; no data from controlled trials on potential serious adverse reactions in nursing infants; use with caution

When glucocorticosteroids are used chronically, systemic effects such as hypercorticism and adrenal suppression may occur; glucocorticosteroids can reduce response of hypothalamus-pituitary-adrenal (HPA) axis to stress; in situations where patients are subject to surgery or other stress situations, supplementation with systemic glucocorticosteroid recommended

Care needed in transferred from glucocorticosteroid treatment with higher systemic effects to glucocorticosteroids with lower systemic effects; symptoms attributed to withdrawal of steroid therapy, including those of acute adrenal suppression or benign intracranial hypertension, may develop; adrenocortical function monitoring may be required in these patients and dose of glucocorticosteroid treatment with high systemic effects should be reduced cautiously

Glucocorticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infection, untreated fungal, bacterial, systemic viral or parasitic infections

Replacement of systemic glucocorticosteroids with budesonide tablets may unmask allergies (e.g., rhinitis and eczema), which were previously controlled by the systemic drug

Reduced liver function affects elimination of glucocorticosteroids; increased systemic availability of oral budesonide has been demonstrated in patients with liver cirrhosis

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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

Call your doctor at once if you have:

• thinning skin, easy bruising, increased acne or facial hair;

• swelling in your ankles;

• weakness, tiredness, or a light-headed feeling, like you might pass out;

• nausea, vomiting, rectal bleeding;

• pain or burning when you urinate;

• menstrual problems (in women), impotence or loss of interest in sex (in men); or

• stretch marks, changes in the shape or location of body fat (especially in your face, neck, back, and waist).

Common side effects may include:

• headache;

• nausea, stomach pain, gas, bloating, constipation;

• feeling tired;

• joint pain;

• acne; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Many other drugs may interact with budesonide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

This section provides information on the proper use of a number of products that contain budesonide. It may not be specific to Uceris. Please read with care.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking this medicine without first checking with your doctor.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor or pharmacist if you have any questions.

Swallow the capsule and extended-release tablet whole. Do not break, crush, chew, or open it.

Keep using this medicine for the full time of treatment, even if you begin to feel better after a few days. Do not miss any doses.

Grapefruits and grapefruit juice may increase the effects of budesonide by increasing the amount of this medicine in your body. You should not eat grapefruit or drink grapefruit juice while you are taking this medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For mild to moderate Crohn's disease:
    • Adults—9 milligrams (mg) once a day in the morning for up to 8 weeks. Your doctor may adjust your dose as needed.
    • Children 8 to 17 years of age and weighing more than 25 kilograms (kg)—At first, 9 mg once a day in the morning for up to 8 weeks, followed by 6 mg once a day in the morning for 2 weeks.
    • Children 8 to 17 years of age and weighing 25 kg or less—Use and dose must be determined by your doctor.
    • Children younger than 8 years of age—Use and dose must be determined by your doctor.
  • For prevention of symptoms of Crohn's disease from coming back:
    • Adults—6 milligrams (mg) once a day in the morning for up to 3 months. Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.
• For oral dosage form (extended-release tablets):
  • For mild to moderate ulcerative colitis:
    • Adults—9 milligrams (mg) once a day in the morning for up to 8 weeks.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

It is very important that your doctor check your progress at regular visits for any problems or unwanted effects that may be caused by this medicine.

If your condition does not improve or if it become worse, check with your doctor.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, or fainting. Other signs may include changes in color of the skin of the face, very fast but irregular heartbeat or pulse, hive-like swellings on the skin, and puffiness or swellings of the eyelids or around the eyes. If these side effects occur, get emergency help at once.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor if you have more than one of these symptoms while you are using this medicine: darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

If you are taking another steroid medicine and will switch to Uceris™, check first with your doctor. This may increase your chance of having steroid withdrawal side effects, such as headache, loss of appetite, blurred vision, change in the ability to see colors (especially blue or yellow), or vomiting.

You may get infections more easily while using this medicine. Avoid people who are sick or have infections. Tell your doctor right away if you have been exposed to someone with chickenpox or measles.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

When taking Uceris avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using Uceris.

Call your doctor if you have signs of too much corticosteroid in your body, such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Take Uceris exactly as directed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take this medicine in the morning with a full glass of water.

Do not crush, chew, or break an extended release Uceris tablet. Swallow the tablet whole.

Your dosage needs may change if you have surgery, are ill, or are under stress. Do not change your doses or medication schedule without advice from your doctor.

Call your doctor if your symptoms do not improve, or if they get worse while using budesonide.

Uceris can weaken your immune system. Tell your doctor if you have signs of infection such as fever, chills, body aches, vomiting, or feeling tired.

If you use this medicine long-term, you may need frequent medical tests.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

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