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budesonide (rectal)

Pronunciation

Generic Name: budesonide (rectal) (bue DES oh nide)
Brand Name: Uceris

What is budesonide rectal?

Budesonide is a steroid that reduces inflammation in the body.

Budesonide rectal is used to treat ulcerative colitis.

Budesonide rectal may also be used for purposes not listed in this medication guide.

What is the most important information I should know about budesonide rectal?

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.

What should I discuss with my healthcare provider before using budesonide rectal?

You should not use this medicine if you are allergic to budesonide.

To make sure budesonide is safe for you, tell your doctor if you have:

  • tuberculosis (now or in the past);

  • a serious bacterial, viral, or fungal infection;

  • herpes infection of the eyes;

  • cirrhosis or other liver disease;

  • diabetes;

  • high blood pressure;

  • osteoporosis;

  • a stomach ulcer;

  • glaucoma;

  • a weak immune system (caused by disease or by using certain medicines); or

  • if you plan to have surgery.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Budesonide can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Budesonide rectal is not approved for use by anyone younger than 18 years old.

How should I use budesonide rectal?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not take budesonide rectal by mouth. It is for use only in your rectum.

Budesonide rectal is usually given once in the morning and once in the evening for 2 weeks. Then you will use the medicine only once per day (at bedtime) for 4 more weeks. Follow your doctor's dosing instructions very carefully.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Try to empty your bowel and bladder just before using the rectal foam.

Wash your hands before and after using this medicine.

Warm the medicine canister in your hands and shake it for 10 to 15 minutes before each use.

After using budesonide rectal at bedtime, avoid using the bathroom until the next morning.

Budesonide rectal foam is flammable. Do not use near high heat or open flame, or while smoking.

If you plan to have a colonoscopy, tell your doctor ahead of time. You may need to stop using budesonide rectal while you are using laxative medicine to prepare for the colonoscopy. Follow your doctor's instructions about when to start using budesonide rectal foam again.

If you also use another steroid medication, do not stop using it suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor about tapering your steroid dose before stopping completely.

Store at room temperature away from moisture and heat.

Keep the medicine canister away from open flame or high heat, such as in a car on a hot day. The canister may explode if it gets too hot. Do not puncture or burn an empty rectal foam canister.

What happens if I miss a dose?

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

What happens if I overdose?

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

An overdose of budesonide rectal is not expected to produce life threatening symptoms. However, long term use of high steroid doses can lead to symptoms 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.

What should I avoid while using budesonide rectal?

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 steroid medicine.

Grapefruit and grapefruit juice may interact with budesonide and lead to unwanted side effects. Avoid the use of grapefruit products while taking this medicine.

Budesonide rectal side effects

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

Call your doctor at once if you have:

  • signs of infection--fever, chills, body aches, vomiting, flu symptoms; or

  • signs of low adrenal gland hormones--worsening tiredness or muscle weakness, feeling light-headed, nausea, vomiting, loss of appetite, diarrhea, and weight loss.

Common side effects may include:

  • nausea; or

  • low adrenal gland hormones.

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

See also: Side effects (in more detail)

Budesonide dosing information

Usual Adult Dose for Asthma -- Maintenance:

FLEXHALER(R)
Initial dose: 360 mcg via oral inhalation twice a day: in some patients an initial dose of 180 mcg twice a day may be adequate
Maintenance dose: May increase dose in 1 to 2 weeks if response is not adequate; after asthma stability has been achieved, titrate to the lowest effective dose to reduce the possibility of side effects
Maximum dose: 720 mcg twice a day

TURBUHALER(R)
Initial dose: 400 to 2400 mcg via oral inhalation daily in divided doses
Maintenance dose: 200 to 400 mcg via oral inhalation twice a day; higher doses may be necessary for longer or shorter periods of time in some patients; after asthma stability has been achieved, titrate to the lowest effective dose to reduce the possibility of side effects
-Once daily dosing may be considered in patients requiring 400 mcg per day; dose should be given in the evening

Comments:
-Improvement in asthma control can occur as early as 24 hours; maximum benefit is usually achieved within 1 to 2 weeks; individual patients may experience a variable onset and degree of symptom relief.
-If asthma symptoms arise, a fast acting inhaled bronchodilator should be used for immediate relief; this drug should not be used for the relief of acute bronchospasm.

Use: For the maintenance treatment of asthma as prophylactic therapy.

Usual Adult Dose for Crohn's Disease -- Acute:

Enteric coated capsules
Initial dose: 9 mg orally once a day in the morning for up to 8 weeks
-May repeat course for recurring episodes of active disease

Comments:
-Patients with mild to moderate active Crohn's disease involving the ileum and/or ascending colon have been switched from oral prednisolone to this drug with no reported episodes of adrenal insufficiency; prednisolone should be tapered while initiating therapy with this drug.
-Capsules should be swallowed whole; avoid grapefruit juice for the duration of therapy.
-Once patients symptoms are controlled (Crohn's Disease Activity Index [CDAI] less than 150); maintenance dosing should be started.

Use: Treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon.

Usual Adult Dose for Crohn's Disease -- Maintenance:

Enteric coated capsules:
6 mg orally once a day in the morning for up to 3 months
-If symptom control is maintained at 3 months, attempt to taper to complete cessation

Comments:
-Maintenance therapy should be started once symptoms are controlled (Crohn's Disease Activity Index [CDAI] less than 150).
-Swallow capsules whole; avoid grapefruit juice for the duration of therapy.
-Continued maintenance treatment beyond 3 months has not been shown to provide substantial benefit.

Use: Maintenance of clinical remission of mild to moderate Crohn's disease involving the ileum and/or the ascending colon for up to 3 months.

Usual Adult Dose for Ulcerative Colitis:

Extended-release tablets:
Initial dose: 9 mg orally once a day in the morning
Duration of therapy: Up to 8 weeks

Rectal Foam:
For Active Mild to Moderate Distal Ulcerative Colitis Extending up to 40 cm from the Anal Verge:
1 metered dose administered rectally twice a day for 2 weeks, then 1 metered dose administered rectally once a day for 4 weeks

Comments:
-Avoid grapefruit juice for the duration of therapy.

Use: For the induction of remission in patients with active, mild to moderate ulcerative colitis.

Usual Pediatric Dose for Asthma -- Maintenance:

Inhalation Suspension (administer via jet nebulizer):
Age: 1 to 8 years: Initial and maximum dose are based on prior asthma therapy:
-Previously treated with bronchodilators alone: 0.5 mg via oral inhalation once a day or 0.25 mg via oral inhalation twice a day; Maximum daily dose: 0.5 mg
-Previously treated with inhaled corticosteroids: 0.5 mg once a day or 0.25 mg twice a day; may increase up to 0.5 mg twice a day; Maximum daily dose: 1 mg
-Previously treated with oral corticosteroids: 1 mg once a day or 0.5 mg twice a day; Maximum daily dose: 1 mg

Comment: For symptomatic patients who do not respond to non-steroid therapy, an initial inhalation suspension dose of 0.25 mg once a day may be considered.

FLEXHALER(R) Inhalation Powder (oral inhaler):
Age: 6 to 12 years:
-Initial dose: 180 mcg via oral inhalation twice a day; some patients may require an initial dose of 360 mcg twice a day
-Maintenance dose: May increase dose after 1 to 2 weeks if response is not adequate; once asthma stability has been achieved, titrate to the lowest effective dose to reduce the possibility of side effects
-Maximum dose: 360 mcg twice a day

TURBUHALER(R) Inhalation Powder (oral inhaler):
Age 6 to 12 years:
-Initial dose: 100 to 200 mcg via oral inhalation twice a day
Maintenance dose: Lowest dose that keeps patient symptom-free

TURBUHALER(R) Inhalation Powder (oral inhaler):
Age: Over 12 years:
Initial dose: 400 to 2400 mcg via oral inhalation daily in divided doses
Maintenance dose: 200 to 400 mcg via oral inhalation twice a day; higher doses may be necessary for longer or shorter periods of time in some patients; after asthma stability has been achieved, titrate to the lowest effective dose to reduce the possibility of side effects
-Once daily dosing may be considered in patients requiring 400 mcg per day; dose should be given in the evening

Comments:
-Improvement in asthma control can occur as early as 24 hours; maximum benefit is usually achieved within 1 to 2 weeks; individual patients may experience a variable onset and degree of symptom relief.
-If asthma symptoms arise between doses, a fast acting inhaled bronchodilator should be used for immediate relief; this drug should not be used for the relief of acute bronchospasm.
-Once daily dosing may be used unless it does not provide adequate control, then dosing should be administered as a divided dose, adjusting dose as needed.
-Once asthma stability has been achieved, titrate to the lowest effective dose to reduce the possibility of side effects.

Use: For the maintenance treatment of asthma as prophylactic therapy.

Usual Pediatric Dose for Crohn's Disease -- Acute:

Age 8 years or older; weight greater than 25 kg

Enteric coated capsules:
9 mg orally once a day in the morning for up to 8 weeks; then 6 mg orally once a day for 2 weeks

Comments:
-Swallow capsules whole; avoid grapefruit juice for the duration of therapy.

Use: Treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon.

What other drugs will affect budesonide rectal?

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.

Where can I get more information?

  • Your pharmacist can provide more information about budesonide rectal.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.01. Revision Date: 2015-06-26, 9:31:24 AM.

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