Uceris

What is Budesonide tablet, extended release?

• Budesonide tablet, extended release (UCERIS) is a glucocorticosteroid used in patients with active, mild to moderate ulcerative colitis.

What are the uses of this medicine?

• UCERIS extended release tablets are a prescription corticosteroid medicine used to help get active mild to moderate ulcerative colitis (UC) under control (induce remission).

How does this medicine work?

• 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.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• hypersensitivity to budesonide or any of the ingredients of UCERIS.

What drug interactions can this medicine cause?

• Concomitant oral administration of ketoconazole (a known inhibitor of CYP3A4 activity in the liver and in the intestinal mucosa) caused an eight-fold increase of the systemic exposure to oral budesonide.
• Ingestion of grapefruit or grapefruit juice should be avoided in connection with UCERIS administration.
• The release properties and uptake of the compound may be altered when UCERIS is used after treatment with gastric acid reducing agents (e.g., proton pump inhibitors (PPIs), H2 blockers and antacids).

Is this medicine FDA approved?

• Initial U.S. Approval: 1997

How should this medicine be used?

Recommended Dosage:

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

Administration

• Take UCERIS extended release tablets exactly as your healthcare provider tells you to take them.
• Take UCERIS extended release tablets 1 time each day in the morning with or without food.
• Take UCERIS extended release tablets whole with water. Do not chew, crush, or break UCERIS extended release tablets before swallowing.
• If you take too much of UCERIS extended release tablets, call your healthcare provider right away or go to the nearest hospital emergency room.

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

This medicine is available in fallowing doasage form:

• As White, round, biconvex extended-release tablets debossed with “MX9”. Each extended-release tablet contains 9 mg budesonide.

This medicine is available in fallowing brand namesː

• UCERIS

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• nausea
• decreased blood cortisol
• upper abdominal pain
• fatigue
• flatulence
• abdominal distension
• acne[[
• urinary tract infection]]
• arthralgia
• constipation

UCERIS extended release tablets may cause serious side effects, including:

• Effects of having too much corticosteroid medicine in your blood (hypercorticism)
• Adrenal suppression
• Immune system effects and a higher chance of infections
• Worsening of allergies

What special precautions should I follow?

• When glucocorticosteroids are used chronically, systemic effects such as hypercorticism and adrenal suppression may occur. Since UCERIS is a glucocorticosteroid, follow general warnings concerning glucocorticoids.
• Risk of impaired adrenal function when transferring from glucocorticoid treatment with higher systemic effects to glucocorticoid treatment with lower systemic effects, such as UCERIS. Taper patients slowly from systemic corticosteroids if transferring to UCERIS.
• Potential worsening of infections (e.g., existing tuberculosis, fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.
• Reduced liver function affects the elimination of glucocorticosteroids, and increased systemic availability of oral budesonide has been demonstrated in patients with liver cirrhosis.
• 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?

• If glucocorticosteroids are used at excessive doses for prolonged periods, systemic glucocorticosteroid effects, such as hypercorticism and adrenal suppression may occur. For chronic overdosage in the face of severe disease requiring continuous steroid therapy, the dosage may be reduced temporarily.

Management of overdosage:

• Treatment consists of immediate gastric lavage or emesis followed by supportive and symptomatic therapy.

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 UCERIS in pediatric patients have not been established. Glucocorticosteroids, such as UCERIS, may cause a reduction of growth velocity in pediatric patients.

What are the active and inactive ingredients in this medicine?

• 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?

Distributed by: Salix Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA

Manufactured by: Cosmo S.p.A. Milan, 20020 Italy

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

• Store UCERIS extended release tablets at room temperature, between 68° to 77°F (20° to 25°C).
• Keep the bottle tightly closed to protect UCERIS extended release tablets from light and moisture.
• Keep UCERIS extended release tablets and all medicines out of the reach of children.

• Dailymed label info on Uceris
• FDA Uceris

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