Budesonide

What is Budesonide?

• Budesonide oral (Entocort EC) is a corticosteroid used to treat mild to moderate Crohn’s disease.
• Budesonide oral extended-release tablets is used to help get active mild to moderate ulcerative colitis (UC) under control (induce remission).
• Budesonide oral (Tarpeyo) is used to decrease protein in the urine in patients with primary immunoglobulin A nephropathy (kidney disease that occurs in some people when too much immunoglobin A builds up in the kidney, causing inflammation).

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Budesonide

Budesonide

Budesonide ball-and-stick

What are the uses of this medicine?

Budesonide oral (Entocort EC) is a prescription corticosteroid medicine used to treat mild to moderate Crohn’s disease that affects part of the small intestine (ileum) and part of the large intestine (ascending colon):

• in people with active Crohn’s disease
• in adults to help keep symptoms from coming back for up to 3 months

• Budesonide oral extended-release tablets is used to help get active mild to moderate ulcerative colitis (UC) under control (induce remission).

How does this medicine work?

In Crohn’s disease:

• Budesonide is an anti-inflammatory corticosteroid and has a high glucocorticoid effect and a weak mineralocorticoid effect, and the affinity of Budesonide to glucocorticoid receptors, which reflects the intrinsic potency of the drug, is about 200-fold that of cortisol and 15-fold that of prednisolone.

In ulcerative colitis:

• Budesonide has a high topical glucocorticosteroid (GCS) activity and substantial first-pass elimination.
• The formulation contains Budesonide in an extended-release tablet core.
• The tablet core is enteric coated to protect dissolution in gastric juice which delays Budesonide release until exposure to a pH ≥7 in the small intestine.
• Upon disintegration of the coating, the core matrix provides extended release of Budesonide in a time dependent manner.
• Budesonide has a high glucocorticoid effect and a weak mineralocorticoid effect, and the affinity of Budesonide to GCS receptors.
• Treatment with systemically active GCS, including Budesonide extended-release tablets, is associated with a suppression of endogenous cortisol concentrations and an impairment of the hypothalamus-pituitary-adrenal (HPA) axis function.
• Markers, indirect and direct, of this are cortisol levels in plasma or urine and response to ACTH stimulation.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• You are allergic to Budesonide

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, and cyclosporine

• Avoid ingestion of grapefruit juice with Budesonide.

Is this medicine FDA approved?

• Budesonide was initially patented in 1973.
• Initial U.S. Approval: 1997

How should this medicine be used?

Recommended dosage: Mild to moderate active Crohn’s disease:

• Adults: 9 mg once daily for up to 8 weeks; repeat 8 week treatment courses for recurring episodes of active disease.
• Maintenance of clinical remission of mild to moderate Crohn’s disease.

Adults:

• 6 mg once daily for up to 3 months; taper to complete cessation after 3 months. Continued treatment for more than 3 months has not been shown to provide substantial clinical benefit.
• When switching from oral prednisolone, begin tapering prednisolone concomitantly with initiating Budesonide Capsules.

Hepatic Impairment:

• Consider reducing the dosage to 3 mg once daily in adult patients with moderate hepatic impairment.

Mild to moderate ulcerative colitis:

• The recommended dosage for the induction of remission in adult patients with active, mild to moderate ulcerative colitis is one 9 mg tablet to be taken once daily in the morning with or without food for up to 8 weeks.

Administration:

• Budesonide comes as a capsule to take by mouth.
• It is usually taken once a day in the morning.
• Take Budesonide at around the same time every day.
• Swallow the capsules whole; do not split, chew, or crush them.
• If you are unable to swallow the Budesonide (Entocort EC) capsules whole, the capsules may be opened and sprinkled on a tablespoonful of apple sauce, mixed well and swallowed whole with no chewing within 30 minutes of mixing.
• The applesauce mixture should be followed by a full glass of water.
• Take Budesonide extended release tablets 1 time each day in the morning with or without food.
• Take Budesonide extended release tablets whole with water.
• Do not chew, crush, or break Budesonide extended release tablets before swallowing.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Extended-release tablets: 9 mg
• Capsules: 3 mg

This medicine is available in fallowing brand namesː

• Entocort EC

What side effects can this medication cause?

The most common side effects of Budesonide Capsules, include:

• headache
• infection in your air passages (respiratory infection)
• nausea
• back pain
• indigestion
• dizziness
• stomach area (abdominal) pain
• gas
• vomiting
• tiredness
• pain

The most common side effects of Budesonide extended release tablets include:

• headache
• nausea
• decreased blood cortisol levels
• stomach-area pain
• tiredness
• stomach or intestinal gas
• bloating
• acne
• urinary tract infection
• joint pain
• constipation

Budesonide may cause serious side effects, including:

• hypercorticism
• Adrenal suppression
• Worsening of allergies
• Increased risk of infection

What special precautions should I follow?

• Do not drink grapefruit juice during your treatment with Budesonide. Drinking grapefruit juice can increase the level of Budesonide in your blood.
• When corticosteroids are used chronically, systemic effects such as hypercorticism and adrenal axis suppression may occur. Follow a taper schedule, as instructed by their healthcare provider if transferring to Budesonide Capsules from systemic corticosteroids. Advise patients that replacement of systemic corticosteroids with Budesonide Capsules may unmask allergies (e.g., rhinitis and eczema), which were previously controlled by the systemic drug.
• Advise patients to avoid exposure to people with chicken pox or measles and, if exposed, to consult their healthcare provider immediately. Inform patients that they are at increased risk of developing a variety of infections; including worsening of existing tuberculosis, fungal, bacterial, viral or parasitic infections or ocular herpes simplex and to contact their healthcare provider if they develop any symptoms of infection.
• Budesonide has been used orally for several immune mediated gastrointestinal and liver diseases and as nasal spray or by inhalation for allergic rhinitis, asthma and chronic obstructive lung disease. Neither inhalant nor oral Budesonide has been linked to serum enzyme elevations during therapy or to convincing instances of clinically apparent acute liver injury.
• Caution should be taken in patients with hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma or cataracts, or with a family history of diabetes or glaucoma, or with any other condition where glucocorticosteroids may have unwanted effects.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• hypercorticism and adrenal suppression

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Treatment consists of immediate gastric lavage or emesis followed by supportive and symptomatic therapy.
• For chronic overdosage in the face of severe disease requiring continuous steroid therapy, the dosage may be reduced temporarily.

Can this medicine be used in pregnancy?

• Limited published studies report on the use of Budesonide in pregnant women; however, the data are insufficient to inform a drug-associated risk for major birth defects and miscarriage.

Can this medicine be used in children?

• Safety and effectiveness of Budesonide extended-release tablets in pediatric patients have not been established.
• The safety and effectiveness of Budesonide Capsules have not been established in pediatric patients less than 8 years of age.

What are the active and inactive ingredients in this medicine?

Budesonide Capsules:

• Active ingredient: Budesonide
• Inactive ingredients: ethylcellulose, acetyltributyl citrate, lactose monohydrate, methacrylic acid copolymer dispersion, triethyl citrate, sodium hydroxide, talc and sugar spheres.
• The capsule shell contains: gelatin, iron oxide red, iron oxide black, iron oxide yellow and titanium dioxide
• Sugar Spheres contains the following inactive ingredients; Sucrose and corn starch.
• The imprinting ink contains the following nonvolatile components; black iron oxide, potassium hydroxide and shellac.

Budesonide extended release tablets:

• Active Ingredient: Budesonide
• Inactive ingredients: stearic acid, lecithin, microcrystalline cellulose, hydroxypropyl cellulose, lactose, silicon dioxide, magnesium stearate, methacrylic acid copolymer types A and B, talc, triethyl citrate, and titanium dioxide.

Who manufactures and distributes this medicine?

Budesonide Capsules: Manufactured By:

• Appco Pharma LLC
• Piscataway, New Jersey

Distributed By:

• Rising Pharmaceuticals, Inc.
• Saddle Brook, New Jersey

Budesonide extended release tablets: Distributed by:

• Oceanside Pharmaceuticals, a division of
• Bausch Health US, LLC
• Bridgewater, NJ USA

Manufactured by:

• Cosmo S.p.A.
• Milan, Italy

What should I know about storage and disposal of this medication?

• Store Budesonide, at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Budesonide, in a tightly closed container.

• Dailymed label info on Budesonide
• FDA Budesonide

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