most effective [0.02:<0.04 nmol/L in one infant). The recommended daily dose of UCERIS extended release tablets is higher (9 mg daily) compared with inhaled budesonide (up to 800 mcg daily) given to mothers in the above study. The maximum budesonide plasma concentration following a 9 mg daily dose (in both single- and repeated-dose pharmacokinetic studies) of oral budesonide is approximately 5-10 nmol/L which is up to 10 times higher than the 1-2 nmol/L for a 800 mcg daily dose of inhaled budesonide at steady state in the above inhalation study. Since there are no data from controlled trials on the use of UCERIS by nursing mothers or their infants, and because of the potential for serious adverse reactions in nursing infants from UCERIS, a decision should be made whether to discontinue nursing or to discontinue UCERIS, taking into account the clinical importance of UCERIS to the mother. Budesonide is secreted in human milk. Data from budesonide delivered via dry powder inhaler indicates that the total daily oral dose of budesonide available in breast milk to the infant is approximately 0.3% to 1% of the dose inhaled by the mother. Assuming the coefficient of extrapolation between the inhaled and oral doses is constant across all dose levels, at therapeutic doses of UCERIS, budesonide exposure to the nursing child may be up to 10 times higher than that by budesonide inhalation. Pediatric Use 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. Geriatric Use Clinical studies of UCERIS did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, UCERIS should be used cautiously in elderly patients due to the potential for decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Hepatic Impairment Patients with moderate to severe liver disease should be monitored for increased signs and/or symptoms of hypercorticism. Discontinuing the use of Uceris Tablets should be considered in these patients [see Warnings and Precautions ( 5.4 )]. Overdosage Reports of acute toxicity and/or death following overdosage of glucocorticosteroids are rare. Treatment consists of immediate gastric lavage or emesis followed by supportive and symptomatic therapy. 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. Single oral budesonide doses of 200 and 400 mg/kg were lethal in female and male mice, respectively. The signs of acute toxicity were decreased motor activity, piloerection and generalized edema. Uceris Tablets Description UCERIS (budesonide) extended release tablets, for oral administration, contain budesonide, a synthetic corticosteroid, as the active ingredient. Budesonide is designated chemically as (RS)-11β, 16α, 17,21 tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C 25 H 34 O 6 and its molecular weight is 430.5. Its structural formula is: Budesonide is a white to off-white, tasteless, odorless powder that is practically insoluble in water, sparingly soluble in alcohol, and freely soluble in chloroform. UCERIS, a delayed and extended-release tablet, is coated with a polymer film, which breaks down at or above pH 7.0. The tablet core contains budesonide with polymers that provide for extended release of budesonide. Each tablet contains the following 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. Uceris Tablets - Clinical Pharmacology Mechanism of Action 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. Pharmacodynamics Budesonide has a high glucocorticoid effect and a weak mineralocorticoid effect, and the affinity of budesonide to GCS receptors, which reflects the intrinsic potency of the drug, is about 200-fold that of cortisol and 15-fold that of prednisolone. Treatment with systemically active GCS, including UCERIS, 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. In a study assessing the response to ACTH stimulation test in patients treated with UCERIS 9 mg once daily, the proportion of patients with abnormal response was 47% at 4 weeks and 79% at 8 weeks. Pharmacokinetics Absorption Following single oral administration of UCERIS 9 mg in healthy subjects, peak plasma concentration (C max ) was 1.35 0.96 ng/mL, the time to peak concentration (T max ) on average was 13.3 5.9 hours, although it varied across different individual patients, and the area under the plasma concentration time curve (AUC) was approximately 16.43 10.52 ng hr/mL. The pharmacokinetic parameters of UCERIS 9 mg have a high degree of variability among subjects. There was no accumulation of budesonide with respect to both AUC and C max following 7 days of UCERIS 9 mg once daily dosing. Food Effect A food-effect study involving administration of UCERIS to healthy volunteers under fasting conditions and with a high-fat meal indicated that the C max was decreased by 27% while there was no significant decrease in AUC. Additionally, a mean delay in absorption lag time of 2.4 hours is observed under fed conditions. Distribution The mean volume of distribution (V SS ) of budesonide varies between 2.2 and 3.9 L/kg in healthy subjects and in patients. Plasma protein binding is estimated to be 85 to 90% in the concentration range 1 to 230 nmol/L, independent of gender. The erythrocyte/plasma partition ratio at clinically relevant concentrations is about 0.8. Metabolism Following absorption, budesonide is subject to high first-pass metabolism (80-90%). In vitro experiments in human liver microsomes demonstrate that budesonide is rapidly and extensively biotransformed, mainly by CYP3A4, to its 2 major metabolites, 6β-hydroxy budesonide and 16α-hydroxy prednisolone. The glucocorticoid activity of these metabolites is negligible (> <1/100) in relation to that of the parent compound. In vivo investigations with intravenous doses in healthy subjects are in agreement with the in vitro findings and demonstrate that budesonide has a high plasma clearance, 0.9-1.8 L/min. These high plasma clearance values approach the estimated liver blood flow, and, accordingly, suggest that budesonide is a high hepatic clearance drug. The plasma elimination half-life, t 1/2 , after administration of intravenous doses ranges between 2.0 and 3.6 hours. Excretion Budesonide is excreted in urine and feces in the form of metabolites. After oral as well as intravenous administration of micronized [ 3 H]-budesonide, approximately 60% of the recovered radioactivity is found in urine. The major metabolites, including 6β-hydroxy budesonide and 16α-hydroxy prednisolone, are mainly renally excreted, intact or in conjugated forms. No unchanged budesonide is detected in urine. Special Populations Hepatic Impairment In patients with liver cirrhosis, systemic availability of orally administered budesonide correlates with disease severity and is, on average, 2.5-fold higher compared with healthy controls. Patients with mild liver disease are minimally affected. Patients with severe liver dysfunction were not studied. Absorption parameters are not altered, and for the intravenous dose, no significant differences in CL or VSS are observed. Renal Impairment The pharmacokinetics of budesonide in patients with renal impairment have not been studied. Intact budesonide is not renally excreted, but metabolites are to a large extent, and might therefore reach higher levels in patients with impaired renal function. However, these metabolites have negligible corticosteroid activity as compared with budesonide (> <1/100). Drug-Drug Interactions Budesonide is metabolized via CYP3A4. Potent inhibitors of CYP3A4 can increase the plasma levels of budesonide several-fold. Co-administration of ketoconazole results in an eight-fold increase in AUC of budesonide, compared to budesonide alone. Grapefruit juice, an inhibitor of gut mucosal CYP3A, approximately doubles the systemic exposure of oral budesonide. Conversely, induction of CYP3A4 can result in the lowering of budesonide plasma levels [ see Dosage and Administration ( 2 ) and Drug Interactions ( 7 )] . Oral contraceptives containing ethinyl estradiol, which are also metabolized by CYP3A4, do not affect the pharmacokinetics of budesonide. Budesonide does not affect the plasma levels of oral contraceptives (i.e., ethinyl estradiol). Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity Carcinogenicity studies with budesonide were conducted in rats and mice. In a two-year study in Sprague-Dawley rats, budesonide caused a statistically significant increase in the incidence of gliomas in male rats at an oral dose of 50 mcg/kg (approximately 0.05 times the maximum recommended human dose on a body surface area basis). In addition, there were increased incidences of primary hepatocellular tumors in male rats at 25 mcg/kg (approximately 0.023 times the maximum recommended human dose on a body surface area basis) and above. No tumorigenicity was seen in female rats at oral doses up to 50 mcg/kg (approximately 0.05 times the maximum recommended human dose on a body surface area basis). In an additional two-year study in male Sprague-Dawley rats, budesonide caused no gliomas at an oral dose of 50 mcg/kg (approximately 0.05 times the maximum recommended human dose on a body surface area basis). However, it caused a statistically significant increase in the incidence of hepatocellular tumors at an oral dose of 50 mcg/kg (approximately 0.05 times the maximum recommended human dose on a body surface area basis). The concurrent reference glucocorticosteroids (prednisolone and triamcinolone acetonide) showed similar findings. In a 91-week study in mice, budesonide caused no treatment-related carcinogenicity at oral doses up to 200 mcg/kg (approximately 0.1 times the maximum recommended human dose on a body surface area basis). Mutagenesis Budesonide was not genotoxic in the Ames test, the mouse lymphoma cell forward gene mutation (TK +/- ) test, the human lymphocyte chromosome aberration test, the Drosophila melanogaster sex-linked recessive lethality test, the rat hepatocycte unscheduled DNA synthesis (UDS) test and the mouse micronucleus test. Impairment of Fertility In rats, budesonide had no effect on fertility at subcutaneous doses up to 80 mcg/kg (approximately 0.07 times the maximum recommended human dose on a body surface area basis). However, it caused a decrease in prenatal viability and viability in pups at birth and during lactation, along with a decrease in maternal body-weight gain, at subcutaneous doses of 20 mcg/kg (approximately 0.02 times the maximum recommended human dose on a body surface area basis) and above. No such effects were noted at 5 mcg/kg (approximately 0.005 times the maximum recommended human dose on a body surface area basis). Clinical Studies Induction of Remission in Active, Mild to Moderate Ulcerative Colitis Two similarly-designed, randomized, double-blind, placebo-controlled studies were conducted in a total of 970 adult patients with active, mild to moderate ulcerative colitis (UC) which was defined as an Ulcerative Colitis Disease Activity Index (UCDAI of 4 and 10). Eight hundred ninety-nine of these patients had histology consistent with active UC; this was considered the primary analysis population. UCDAI is a four-component scale (total score of 0 to 12) that encompasses the clinical assessments of stool frequency, rectal bleeding, mucosal appearance and physician s rating of disease activity (score of 0 to 3 for each of the components). The baseline median UCDAI score in both studies was 7. In Study 1, 56% of patients were male, and the median age was 42 years. In Study 2, 57% of patients were male, and the median age was 44 years. In Study 1, 50% of patients were Caucasian, 7% were African American, and 34% were Asian. In Study 2, more than 99% were Caucasian. Both studies compared UCERIS 9 mg and 6 mg with placebo and included an active reference arm (a mesalamine 2.4 g in Study 1 and a budesonide* 9 mg not approved for the treatment of UC in Study 2). The primary endpoint was induction of remission after 8 weeks of treatment. Remission was defined as a UCDAI score of 1, with subscores of 0 for rectal bleeding, stool frequency, and mucosal appearance and with a 1 point reduction in an endoscopy-only score. 2 In both studies, UCERIS 9 mg extended release tablets demonstrated superiority to placebo in inducing remission (Table 4). Table 4. Induction of Remission in Studies 1 and 2 Treatment Group Study 1 n/N (%) Study 2 n/N (%) UCERIS 9 mg 22/123 (17.9) 19/109 (17.4) UCERIS 6 mg 16/121 (13.2) 9/109 (8.3) Reference arm* 15/124 (12.1) 13/103 (12.6) Placebo 9/121 (7.4) 4/89 (4.5) Treatment difference between UCERIS 9 mg and placebo (95% CI) 10.4% (2.2%, 18.7%) 12.9% (4.6%, 21.3%) Remission is defined as a UCDAI score of 1, with subscores of 0 for rectal bleeding, stool frequency, and mucosal appearance and with a 1 point reduction in an endoscopy-only score. 2 The primary analysis population included only patients that had histology consistent with active UC. CI=Confidence Interval *The reference arm in Study 1 is a delayed release mesalamine 2.4 g; the reference arm in Study 2 is a budesonide 9 mg not approved for the treatment of UC. p> <0.025 for UCERIS 9 mg vs. placebo in both Studies 1 and 2 based on the Chi-square test (alpha = 0.025) REFERENCES 1. Falt A, Bengtsson T, Kennedy B, et al. Exposure of infants to budesonide through breast milk of asthmatic mothers. J. Allergy Clin Immunol. 2007;120(4):798-802. 2. Rachmilewitz D. Coated mesalazine (5-aminosalicylic acid) versus sulphasalazine in the treatment of active ulcerative colitis: a randomised trial. BMJ . 1989;298:82-6. How Supplied/Storage and Handling UCERIS (budesonide) extended release tablets 9 mg, are white, round, biconvex tablets and debossed with MX9 . They are supplied as follows: NDC (68012-309-30): Bottles of 30 tablets. Store at 25 C (77 F); excursions permitted to 15 to 30 C (59 to 86 F). [See USP Controlled Room Temperature]. Keep container tightly closed. Protect from light and moisture. Patient Counseling Information Advise the patient to read the FDA-approved patient labeling (Patient Information). Patients being treated with UCERIS extended release tablets should receive the following information and instructions. This information is intended to aid the patient in the safe and effective use of UCERIS. Hypercorticism and Adrenal Suppression Patients should be advised that UCERIS extended release tablets may cause systemic glucocorticosteroid effects of hypercorticism and adrenal suppression. Patients should taper slowly from systemic corticosteroids if transferring to UCERIS extended release tablets [ see Warnings and Precautions ( 5.1 ) and ( 5.2 )]. Immunosuppression Patients who are on immunosuppressant doses of glucocorticosteroids should be warned to avoid exposure to chickenpox or measles and, if exposed, to consult their physician immediately. If exposure to such a person occurs, and the patient has not had chicken pox or been properly vaccinated, a physician should be consulted immediately. Patients should be informed of potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex [see Warnings and Precautions ( 5.3 )]. How to Take UCERIS Extended Release Tablets UCERIS extended release tablets should be swallowed whole with water and NOT CHEWED, CRUSHED, OR BROKEN. Patients should be advised to avoid the consumption of grapefruit juice for the duration of their UCERIS therapy [see Dosage and Administration (2)]. Manufactured for: Salix Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA By: Cosmo SpA Milan, 20020 Italy By license of Cosmo Technologies Ltd., Dublin, Ireland U.S. Patent Nos: 7,410,651; 7,431,943; 8,293,273; 8,784,888; 8,895,064; 9,132,093; 9,192,581; 9,320,716; and RE43799 UCERIS is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates. Valeant Pharmaceuticals North America LLC 9464201 Rev. 11/2016 FDA-approved Patient Labeling UCERIS (u SAIR us) (budesonide) (bew DEH so nide) extended release tablets What are UCERIS extended release tablets? UCERIS is a prescription corticosteroid medicine used to help get mild to moderate ulcerative colitis (UC) under control (induce remission). It is not known if UCERIS is safe and effective in children. Who should not take UCERIS extended release tablets? Do not take UCERIS extended release tablets if: you are allergic to budesonide or any of the ingredients in UCERIS extended release tablets. See the end of this leaflet for a complete list of ingredients in UCERIS extended release tablets. What should I tell my healthcare provider before taking UCERIS extended release tablets? Before you take UCERIS extended release tablets tell your healthcare provider if you: have liver problems are planning to have surgery have chicken pox or measles or have recently been near anyone with chicken pox or measles have an infection have or had a family history of diabetes, cataracts or glaucoma have or had tuberculosis have high blood pressure (hypertension) have decreased bone mineral density (osteoporosis) have stomach ulcers have any other medical condition are pregnant or plan to become pregnant. It is not known if UCERIS extended release tablets will harm your unborn baby. are breastfeeding or plan to breastfeed. UCERIS extended release tablets can pass into your breast milk and may harm your baby. You and your healthcare provider should decide if you will take UCERIS extended release tablets or breastfeed. You should not do both. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter vitamins, and herbal supplements. UCERIS extended release tablets and other medicines may affect each other causing side effects. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How should I take UCERIS extended release tablets? Take UCERIS extended release tablets exactly as your healthcare provider tells you to take them. Your healthcare provider will tell you how many UCERIS extended release tablets to take. Take UCERIS extended release tablets in the morning. 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, call your healthcare provider right away or go to the nearest hospital emergency room. What should I avoid while taking UCERIS extended release tablets? Do not eat grapefruit or drink grapefruit juice while taking UCERIS extended release tablets. Eating grapefruit or drinking grapefruit juice can increase the level of UCERIS extended release tablets in your blood. What are the possible side effects of UCERIS extended release tablets? UCERIS can cause some serious side effects, including: Effects of having too much corticosteroid medicine in your blood (hypercorticism). Long-time use of UCERIS extended release tablets can cause you to have too much glucocorticosteroid medicine in your blood. Tell your healthcare provider if you have any of the following signs and symptoms of hypercorticism: acne bruise easily rounding of your face (moon face) ankle swelling thicker or more hair on your body and face a fatty pad or hump between your shoulders (buffalo hump) pink or purple stretch marks on the skin of your abdomen, thighs, breasts and arms Adrenal suppression. When UCERIS extended release tablets is taken for a long period of time (chronic use), the adrenal glands do not make enough steroid hormones (adrenal suppression). Tell your healthcare provider if you are under stress or have any symptoms of adrenal suppression during treatment with UCERIS extended release tablets including: tiredness weakness nausea vomiting low blood pressure Immune system effects and a higher chance of infections. UCERIS extended release tablets weaken your immune system. Taking medicines that weaken your immune system makes you more likely to get infections. Avoid contact with people who have contagious diseases such as chicken pox or measles, while taking UCERIS extended release tablets. Tell your health care provider about any signs or symptoms of infection during treatment with UCERIS extended release tablets, including: fever pain aches chills feeling tired nausea and vomiting Worsening of allergies. If you take certain other corticosteroid medicines to treat allergies, switching to UCERIS extended release tablets may cause your allergies to come back. These allergies may include eczema (a skin disease) or rhinitis (inflammation inside your nose). Tell your healthcare provider if any of your allergies become worse while taking UCERIS extended release tablets. The most common side effects of UCERIS 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 Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of UCERIS extended release tablets. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store UCERIS extended release tablets? Store UCERIS extended release tablets at room temperature, between 68 F to 77 F (20 C to 25 C) Keep the bottle tightly closed to protect UCERIS from light and moisture. Keep UCERIS extended release tablets and all medicines out of the reach of children. General Information about UCERIS extended release tablets Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use UCERIS for a condition for which it was not prescribed. Do not give UCERIS to other people, even if they have the same symptoms you have. It may harm them. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about UCERIS that is written for health professionals. For more information go to www.UCERIS.com or call (1-800-508-0024). What are the ingredients in UCERIS extended release tablets? Active Ingredients: 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. This Patient Information has been approved by the U.S. Food and Drug Administration. Manufactured for: Salix Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA By: Cosmo SpA Milan, 20020 Italy By license of Cosmo Technologies Ltd., Dublin, Ireland U.S. Patent Nos: 7,410,651; 7,431,943; 8,293,273; 8,784,888; 8,895,064; 9,132,093; 9,192,581; 9,320,716; and RE43799 UCERIS is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates. Valeant Pharmaceuticals North America LLC 9464201 Rev. 11/2016 PRINCIPAL DISPLAY PANEL PACKAGE LABEL PRINCIPAL DISPLAY PANEL 9 mg NDC 68012-309-30 Rx only UCERIS (budesonide) extended release tablets 9 mg Swallow tablet whole, do not chew or break. 30 Tablets Salix PHARMACEUTICALS UCERIS budesonide tablet, extended release Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68012-309 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BUDESONIDE (BUDESONIDE) BUDESONIDE 9 mg Inactive Ingredients Ingredient Name Strength STEARIC ACID LECITHIN, SOYBEAN LACTOSE, UNSPECIFIED FORM SILICON DIOXIDE MAGNESIUM STEARATE METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A TALC TRIETHYL CITRATE TITANIUM DIOXIDE MICROCRYSTALLINE CELLULOSE HYDROXYPROPYL CELLULOSE (80000 MW) Product Characteristics Color WHITE Score no score Shape ROUND Size 10mm Flavor Imprint Code MX9 Contains Packaging # Item Code Package Description 1 NDC:68012-309-02 2 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 2 NDC:68012-309-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE 3 NDC:68012-309-01 2 TABLET, EXTENDED RELEASE in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA203634 01/14/2013 Labeler - Santarus Inc. (104286369) Establishment Name Address ID/FEI Operations Cosmo SpA 630431955 MANUFACTURE(68012-309) Establishment Name Address ID/FEI Operations Carton Service Incorporated 928861723 PACK(68012-309), LABEL(68012-309) Establishment Name Address ID/FEI Operations Patheon Puerto Rico, Inc. 143814544 LABEL(68012-309), PACK(68012-309) Revised: 11/2016 Santarus Inc. Next Interactions Print this page Add to My Med List More about Uceris (budesonide) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Images Drug Interactions Support Group Pricing & Coupons 12 Reviews Add your own review/rating Drug class: glucocorticoids Consumer resources Uceris ... +4 more Professional resources Uceris Foam (FDA) Budesonide (AHFS Monograph) Other brands: Pulmicort Flexhaler , Pulmicort Turbuhaler , Entocort EC Related treatment guides Ulcerative Colitis Ulcerative Colitis, Active> ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturers Salix Pharmaceuticals, Inc. Valeant Pharmaceuticals International, Inc. Drug Class Glucocorticoids Related Drugs glucocorticoids prednisone , triamcinolone , hydrocortisone , budesonide , prednisolone , Medrol Ulcerative Colitis prednisone , Humira , hydrocortisone topical , budesonide , dexamethasone , sulfasalazine , azathioprine , Lialda , cyclosporine , Decadron , Remicade , More... Ulcerative Colitis, Active hydrocortisone topical , budesonide , sulfasalazine , Lialda , mesalamine , Pentasa , Asacol , Proctosol-HC , Proctozone HC , balsalazide , Azulfidine , Canasa , More... Uceris Rating 12 User Reviews 5.9 /10 12 User Reviews 5.9 Rate it! Uceris Images Uceris 9 mg (MX9 ) View larger images} } exercise session
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