Budesonide

BUDESONIDE — budesonide capsule
Rising Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE

1.1 Treatment of Mild to Moderate Active Crohn’s Disease

BUDESONIDE Capsules is indicated for the treatment of mild to moderate active Crohn’s disease involving the ileum and/or the ascending colon.

Pediatric use information is approved for Perrigo Pharma International DAC’s Entocort EC (budesonide) capsules. However, due to Perrigo Pharma International DAC’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

1.2 Maintenance of Clinical Remission of Mild to Moderate Crohn’s Disease

BUDESONIDE Capsules is indicated for the maintenance of clinical remission of mild to moderate Crohn’s disease involving the ileum and/or the ascending colon for up to 3 months in adults.

2 DOSAGE AND ADMINISTRATION

2.1 Administration Instructions

  • Take BUDESONIDE Capsules once daily in the morning.
  • Swallow BUDESONIDE Capsules whole. Do not chew or crush.
  • Avoid consumption of grapefruit juice for the duration of BUDESONIDE Capsules therapy [see Drug Interactions (7.1)].

2.2 Treatment of Mild to Moderate Active Crohn’s Disease

The recommended dosage of BUDESONIDE Capsules is:

Adults: 9 mg orally once daily for up to 8 weeks. Repeated 8 week courses of BUDESONIDE Capsules can be given for recurring episodes of active disease.

Pediatric use information is approved for Perrigo Pharma International DAC’s Entocort EC (budesonide) capsules. However, due to Perrigo Pharma International DAC’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

2.3 Maintenance of Clinical Remission of Mild to Moderate Crohn’s Disease

The recommended dosage in adults, following an 8 week course(s) of treatment for active disease and once the patient’s symptoms are controlled (CDAI less than 150), is BUDESONIDE Capsules 6 mg orally once daily for maintenance of clinical remission up to 3 months. If symptom control is still maintained at 3 months an attempt to taper to complete cessation is recommended. Continued treatment with BUDESONIDE Capsules 6 mg for more than 3 months has not been shown to provide substantial clinical benefit.

Patients with mild to moderate active Crohn’s disease involving the ileum and/or ascending colon have been switched from oral prednisolone to BUDESONIDE Capsules with no reported episodes of adrenal insufficiency. Since prednisolone should not be stopped abruptly, tapering should begin concomitantly with initiating BUDESONIDE Capsules treatment.

2.4 Dosage Adjustment in Adult Patients with Hepatic Impairment

Consider reducing the dosage of BUDESONIDE Capsules to 3 mg once daily for adult patients with moderate hepatic impairment (Child-Pugh Class B). Avoid use in patients with severe hepatic impairment (Child-Pugh Class C) [see Warnings and Precautions (5.1),Use in Specific Populations (8.6)].

3 DOSAGE FORMS AND STRENGTHS

BUDESONIDE Capsules, 3 mg are hard gelatin capsules size “0″ light grey opaque body and pink opaque cap imprinted with Black ink “AC” on cap and “520″ on body filled with white to off white Pellets.

4 CONTRAINDICATIONS

BUDESONIDE Capsules is contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of Budesonide Capsules. Serious hypersensitivity reactions, including anaphylaxis have occurred [see Adverse Reactions (6.2) ].

5 WARNINGS AND PRECAUTIONS

5.1 Hypercorticism and Adrenal Axis Suppression

When corticosteroids are used chronically, systemic effects such as hypercorticism and adrenal axis suppression may occur. Corticosteroids can reduce the response of the hypothalamus-pituitary-adrenal (HPA) axis to stress. In situations where patients are subject to surgery or other stress situations, supplementation with a systemic corticosteroid is recommended. Since BUDESONIDE Capsules contains a corticosteroid, general warnings concerning corticosteroids should be followed [see Warnings and Precautions (5.2),(5.3),(5.4)].

Pediatric patients with Crohn’s disease have a slightly higher systemic exposure of budesonide and increased cortisol suppression than adults with Crohn’s disease [see Use in Specific Populations (8.4), Clinical Pharmacology (12.2)]. Patients with moderate to severe hepatic impairment (Child-Pugh Class B and C respectively) could be at an increased risk of hypercorticism and adrenal axis suppression due to an increased systemic exposure of oral budesonide. Avoid use in patients with severe hepatic impairment (Child-Pugh Class C). Monitor for increased signs and/or symptoms of hypercorticism and consider reducing the dosage in patients with moderate hepatic impairment (Child-Pugh Class B) [see Dosage and Administration (2.4), Use in Specific Populations(8.6), Clinical Pharmacology (12.3)].

5.2 Symptoms of Steroid Withdrawal in Patients Transferred from Other Systemic Corticosteroids

Monitor patients who are transferred from corticosteroid treatment with high systemic effects to corticosteroids with lower systemic availability, such as BUDESONIDE Capsules, since symptoms attributed to withdrawal of steroid therapy, including those of acute adrenal axis suppression or benign intracranial hypertension, may develop. Adrenocortical function monitoring may be required in these patients and the dose of corticosteroid treatment with high systemic effects should be reduced cautiously.

Replacement of systemic corticosteroids with BUDESONIDE Capsules may unmask allergies (e.g., rhinitis and eczema), which were previously controlled by the systemic drug.

5.3 Increased Risk of Infection

Patients who are on drugs that suppress the immune system are more susceptible to infection than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in susceptible patients or patients on immunosuppressant doses of corticosteroids. In patients who have not had these diseases, particular care should be taken to avoid exposure.

How the dose, route and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed, therapy with varicella zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG), as appropriate, may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See prescribing information for VZIG and IG.) If chicken pox develops, treatment with antiviral agents may be considered.

Corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infection, untreated fungal, bacterial, systemic viral or parasitic infections,or ocular herpes simplex.

5.4 Other Corticosteroid Effects

Monitor 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 corticosteroids may have unwanted effects.

6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in labeling:

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